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I N T E R N AT I O N A L C ATA L O G U E - D I A G N O S I S

2 0 1 9 - 2 0 2 0
RACHEL THOMANN
Tel.: (+33) 3 88 77 57 23
E-mail: thomann@biosynex.com

SAÏD EL CHIBANI
Tel.: (+33) 3 88 77 57 22
E-mail: elchibani@biosynex.com

PATRICK SENE
Tel.: (+33) 3 88 77 57 28
E-mail: sene@biosynex.com

IHAB KAZMA
Tel.: (+33) 3 88 78 78 87
E-mail: kazma@biosynex.com

CUSTOMER SERVICES INTERNATIONAL


Tel.: +33 (0)3 88 77 57 52
Fax: +33 (0)3 59 81 21 74
E-mail: export@biosynex.com

VISIT OUR WEBSITE


www.biosynex.com/en
BIOSYNEX,
THE FRENCH LEADER IN
RAPID DIAGNOSTIC TESTS
(RDT)

OUR TASKS
To design, develop and offer innovative solutions devoted to health.
To guarantee a favoured commercial relationship for each partner.
To remain attentive to our customers’ needs and market trends.

OUR DNA
A strong entrepreneurial culture, and one of innovation and quality
on which our expertise is based
A committed, trained team of men and women with a mutual objective:
customer satisfaction.
Anticipating tomorrow’s needs is proof of masteret expertise.

OUR IDENTITY
Biosynex is the partner for healthcare specialists:
“For us the performance of our expertise lies in the knowledge and
understanding of our customers!“

QUALITY CERTIFICATION
EN ISO 9001: 2015
EN ISO 13485: 2016
CE CERTIFICATES

BIOSYNEX • 3
Contents
BACTERIOLOGY Trichomonas vaginalis /
Chlamydia trachomatis . . . . . . . . . . . . . . . . . . . . . . 37
RDT - LATERAL FLOW Trichomonas vaginalis /
Chlamydia trachomatis . . . . . . . . . . . . . . . . . . . . . . . . 9 Gardnerella vaginalis . . . . . . . . . . . . . . . . . . . . . . . . . 37
Clostridium difficile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Parvum / Ureaplasma urealyticum. . . . . . . . . . 37
Clostridium tetani. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Helicobacter pylori. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Legionella pneumophila . . . . . . . . . . . . . . . . . . . . . 12
Streptococcus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 MYCOLOGY
Treponema pallidum. . . . . . . . . . . . . . . . . . . . . . . . . . 14 RDT - LATERAL FLOW
MOLECULAR BIOLOGY (PCR) Cryptococcosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Chlamydia trachomatis . . . . . . . . . . . . . . . . . . . . . . . 15 CULTURE MEDIA
Neisseria gonorrhoeae. . . . . . . . . . . . . . . . . . . . . . 15 Candidiasis - Identification. . . . . . . . . . . . . . . . . . . 42
Ureaplasma urealyticum. . . . . . . . . . . . . . . . . . . . . . 15 Mycology - Identification. . . . . . . . . . . . . . . . . . . . . 42
Gardnerella vaginalis . . . . . . . . . . . . . . . . . . . . . . . . . 16
AGGLUTINATION TEST ON SLIDE
Mycoplasma genitalium. . . . . . . . . . . . . . . . . . . . . . 16
Candidiasis - Identification. . . . . . . . . . . . . . . . . . . 43
Mycoplasma hominis. . . . . . . . . . . . . . . . . . . . . . . . . . 16
Treponema pallidum. . . . . . . . . . . . . . . . . . . . . . . . . . 16 AGGLUTATION TEST ON MICROPLATE
Multiplex Sti. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Aspergillosis - Serology . . . . . . . . . . . . . . . . . . . . . . 44
Chlamydia pneumoniae. . . . . . . . . . . . . . . . . . . . . . 19 Candidiasis - Serology. . . . . . . . . . . . . . . . . . . . . . . . 44
Mycobacterium tuberculosis . . . . . . . . . . . . . . . . 20 STAINING REAGENTS
Legionella pneumophila . . . . . . . . . . . . . . . . . . . . . 20 Mycosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Bordetella pertussis parapertussi. . . . . . . . . . . 20 MOLECULAR BIOLOGY (PCR)
Helicobacter pylori . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Candida albicans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Tick Borne Infections. . . . . . . . . . . . . . . . . . . . . . . . . . 21 Candida albicans /
AGGLUTINATION ON SLIDE Gardnerella vaginalis . . . . . . . . . . . . . . . . . . . . . . . . . 46
Treponema pallidum. . . . . . . . . . . . . . . . . . . . . . . . . . 22
Staphylococcus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Streptococcus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
STAINING REAGENTS. . . . . . . . . . . . . . . . . . . . . . 24 VIROLOGY
STRIPS RDT - LATERAL FLOW
Mycoplasma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Epstein-barr Virus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Dengue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Respiratory infections. . . . . . . . . . . . . . . . . . . . . . . . . 53
Gastrointestinal infections . . . . . . . . . . . . . . . . . . . 54
PARASITOLOGY Hepatitis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
RDT - LATERAL FLOW Human immunodeficiency virus (HIV) . . . . . 57
Malaria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 MOLECULAR BIOLOGY (PCR)
Malaria staining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Human immunodeficiency virus (HIV) . . . . . 58
INSTRUMENTS Hepatitis B Virus (HBV). . . . . . . . . . . . . . . . . . . . . . . . 58
Malaria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Hepatitis C Virus (HCV) . . . . . . . . . . . . . . . . . . . . . . . 58
Human immunodeficiency virus /
CONCENTRATION AND STAINING
Hepatitis B Virus / Hepatitis C Virus
Stool concentration and staining . . . . . . . . . . 33
(HBV / HCV / HIV). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
AGGLUTINATION TESTS Herpes simplex virus (HSV1/2). . . . . . . . . . . . . . 60
Amoebiasis - Serology. . . . . . . . . . . . . . . . . . . . . . . . 35 Human papillomavirus. . . . . . . . . . . . . . . . . . . . . . . . 60
Bilharziosis - Serology . . . . . . . . . . . . . . . . . . . . . . . . 35 Cytomegalovirus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Distomatosis - Serology . . . . . . . . . . . . . . . . . . . . . . 35 Epstein-Barr Virus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Toxoplasmosis - Serology. . . . . . . . . . . . . . . . . . . . 36 Human Herpesvirus - 6 (HH6) . . . . . . . . . . . . . . . 61
Hydatidosis - Serology. . . . . . . . . . . . . . . . . . . . . . . . 36 Varicella Zoster Virus (VZV) . . . . . . . . . . . . . . . . . . 61
MOLECULAR BIOLOGY (PCR) Rubella virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Trichomonas vaginalis . . . . . . . . . . . . . . . . . . . . . . . . 37 Tick-borne encephalitis virus (TBEV). . . . . . . 62

4
Zaire Ebola virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

BIOCHEMISTRY
ONCOLOGY
RDT - LATERAL FLOW
Toxicology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Urinary strips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Colorectal cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Bladder tumor antigen . . . . . . . . . . . . . . . . . . . . . . . 72
C reactiv protein CRP . . . . . . . . . . . . . . . . . . . . . . . . . 72
Prostate cancer PSA . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Cardiac makers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Hemostasis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Micro-albumin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

WOMEN’S HEALTH
RDT - LATERAL FLOW
Obstetrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Hormonology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

IMMUNOLOGY
RDT - LATERAL FLOW
Celiac disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Rhumatoid factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
AGGLUTINATION
Rhumatoid factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

INSTRUMENTS
READER
Rapid test Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Strip Reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
MOLECULAR BIOLOGY
Extraction instrument . . . . . . . . . . . . . . . . . . . . . . . . . 94
qPCR instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
STAINER INSTRUMENT. . . . . . . . . . . . . . . . . . . . 96

BIOSYNEX • 5
6
BACTERIOLOGY
B AC T E R I O LO GY
BACTERIOLOGY

Summary
BORDETELLA PERTUSSIS MYCOPLASMA
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 PCR. . . . . . . . . . . . . . . . . . . . . 16, 17, 18, 19
STRIPS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
CHLAMYDIA PNEUMONIAE
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 NEISSERIA GONORRHOEAE
PCR. . . . . . . . . . . . . . . . . . . . . 15, 17, 18, 19
CHLAMYDIA TRACHOMATIS
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 STAPHYLOCOCCUS
PCR. . . . . . . . . . . . . . . . . . . . . 15, 17, 18, 19 Aggluitnation on slide. . . . . . . . . . . . 22

CLOSTRIDIUM DIFFICILE STREPTOCOCUS


RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9,10 RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 13
Agglutination on slide. . . . . . . . . . . . 23
CLOSTRIDIUM TETANI
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 TREPONEMA PALLIDUM
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
HELICOBACTER PYLORI PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Agglutination on slide. . . . . . . . . . . . . 22
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
UREAPLASMA UREALYTICUM
GARDNERELLA VAGINALIS PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . 15, 17, 18
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . 16, 17, 18

LEGIONELLA PNEUMOPHILA
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

LYME (BORRELIA)
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

MYCOBACTERIUM TUBERCULOSIS
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

8
BACTERIOLOGY
RDT - LATERAL FLOW
CHLAMYDIA TRACHOMATIS
REF. 1030003

CHLAMYTOP®
Detection of Chlamydia antigens.
20 tests
Kit content:
• 20 test cassettes
• 1 bottle of solution A
• 1 bottle of solution B
• 20 extraction tubes
• 20 Dacron swabs (CE)
Storage:  12 months at 2-30°C

CLOSTRIDIUM DIFFICILE
REF. 1030009 REF. 6120004

IMMUNOQUICK® Positive and Negative


TOX A & B controls C. difficile
Detection of toxin A & B from C. difficile Tox A & B
bacteria in stool samples. 2 x 0.5 mL
20 tests For 10 positive controls and
10 negative controls with
Kit content:
IMMUNOQUICK® TOX A&B
• 20 test cassettes
(ref. 1030009)
• 20 vials of sample diluent buffer
• Barcode for test batch identification Storage: 12 months at 2-8°C
Storage: 12 months at 2-30°C

Compatible with BIOSYNEX Reader


See page 91

BIOSYNEX • 9
BACTERIOLOGY

RDT - LATERAL FLOW

REF. 1030008 25 tests


IMMUNOQUICK® Kit content:
C.DIFFICILE GDH • 25 test cassettes
• 25 vials of sample dilution buffer
Detection of glutamate dehydrogenase from
• 1 positive control with recombinant
C.difficile in stool samples GDH
• Barcode for test batch identification
Storage: 18 months at 2-30°C

Compatible avec BIOSYNEX Reader


See page 91

CLOSTRIDIUM TETANI
REF. 1030016 REF. 502880

TETANOTOP® Positive control


Detection of tetanus antitoxin antibodies Tetanus
in serum, plasma or whole blood. 1 x 0.5 mL
20 tests For 10 positive controls with
Kit content: TETANOTOP® (ref. 1030016)
• 20 test cassettes and easyTETANOTOP®
• 20 pipettes (ref.502880)
• 1 vial of buffer Storage: 12 months at 2-8°C
• Barcode card for test batch identification
Storage: 18 months at 2-30°C

Compatible with BIOSYNEX Reader


See page 91

REF. 502880

easyTETANOTOP®
Detection of tetanus antitoxin antibodies
in serum, plasma or whole blood.
25 tests individually packed
Kit content:
• 25 pouches containing each:
° 1 test cassette
° 1 pipette
° 1 bottle of buffer
° 1 sterile lancet
• Barcode card for test batch identification
Storage: 18 months at 2-30°C

Compatible with BIOSYNEX Reader


See page 91

10
BACTERIOLOGY
RDT - LATERAL FLOW

HELICOBACTER PYLORI
REF. 1030011 REF. 24727

PYLORITOP® Ag IgG Positive control


Detection of anti-Helicobacter pylori Helicobacter
antibodies in human stool samples. 1 vial of 200 µL
25 tests For 2 controls with
Kit content: PYLORITOP® Ab (ref. 1030010)
• 25 test cassettes Storage: 12 months at 2-8°C
• 25 vials of diluent
Storage: 24 months at 2-30°C
REF. 24729
IgA Positive control
Helicobacter
1 vial of 200 µL
For 2 controls with
PYLORITOP® Ab (ref. 1030010)
Storage: 12 months at 2-8°C
REF. 1030011-I

PYLORITOP® Ag
with accessories REF. 24724

Detection of anti-Helicobacter pylori IgA Negative control


antibodies in human stool samples. Helicobacter
20 tests with stool collection papers 1 vial of 200 µL

Kit content: For 2 controls with


• 20 test cassettes PYLORITOP® Ab (ref. 1030010)
• 20 vials of diluent Storage: 12 months at 2-8°C
• 20 stool collection papers
Storage: 24 months at 2-30°C

REF. 1030010

PYLORITOP® Ab
Detection of anti-Helicobacter pylori
antibodies in whole blood, serum
or plasma.
25 tests
Kit content:
• 25 test cassettes
• 1 vial of diluent
• 25 pipettes
Storage: 24 months at 2-30°C

BIOSYNEX • 11
BACTERIOLOGY

RDT - LATERAL FLOW

LEGIONELLA PNEUMOPHILA

REF. 1030001

BIOSYNEX® Legionella
Detection of Legionella pneumophila
serogroup 1 antigen in the urine.
25 tests with positive control
Kit content:
• 25 test cassettes
• 25 pipettes
• Positive control
Storage: 18 months at 2-30°C

STREPTOCOCCUS
REF. 1030002

BIOSYNEX® S. pneumoniae
Detection of capsule wall polysaccarides
CWPS in the urine or CSF.
20 tests with positive control
Kit content:
• 20 test cassettes
• 20 pipettes
• 1 vial of buffer
• Positive control
• Barcode for test batch identification
Storage: 18 months at 2-30°C

Compatible with BIOSYNEX Reader


See page 91

12
BACTERIOLOGY
RDT - LATERAL FLOW

REF. 10025 25 tests with contols and accessories


STREPTATEST® Kit content:
Detection of Streptococcus group A • 25 strips
antigens in throat swabs. • Extraction solution 1
• Extraction solution 2
• 25 extraction tubes
• 25 sterile swabs (CE 0086)
• 25 tongue depressors
• Rack
• Positive control
• Negative control
Storage: 24 months at 2-30°C

REF. 1030005

BIOSYNEX® Strep A
Detection of Streptococcus group A
antigens in throat swabs.
20 tests with controls
Kit content:
• 20 test cassettes
• Extraction solution 1
• Extraction solution 2
• 20 extraction tubes
• 20 sterile swabs (CE 0086)
• Rack
• Positive control
• Negative control
Storage: 24 months at 2-30°C

REF. 1030018

STREPTOP® A
Detection of Streptococcus group A
antigens in throat swabs.
20 tests with controls
Kit content:
• 20 strips
• Extraction solution 1
• Extraction solution 2
• 20 extraction tubes
• 20 sterile swabs (CE 0086)
• Rack
• Positive control
• Negative control
Storage: 24 months at 2-30°C

BIOSYNEX • 13
BACTERIOLOGY

RDT - LATERAL FLOW

TREPONEMA PALLIDUM
REF. 1030014 REF. 25117

SYPHILITOP® IgG Positive control


Detection of anti-Treponema pallidum Treponema
antibodies (IgG and IgM) in whole blood, 1 vial of 200 µL
plasma or serum.
For 5 controls with
50 tests SYPHILITOP® (ref. 1030014)
Kit content: Storage : 12 months at 2-8°C
• 50 test cassettes
• 50 pipettes
• 1 vial of buffer
Storage: 24 months at 2-30°C
REF. 25118
IgM Positive control
Treponema
1 vial of 200 µL
For 5 controls with
SYPHILITOP® (ref. 1030014)
Storage : 12 months at 2-8°C

REF. 24724
IgG/IgM Negative
control Treponema
1 vial of 200 µL
For 5 controls with
SYPHILITOP® (ref. 1030014)
Storage : 12 months at 2-8°C

14
BACTERIOLOGY
MOLECULAR BIOLOGY (PCR)
CHLAMYDIA TRACHOMATIS
REF. 3030019 REF. 3030003

RealLine C. trachomatis (lyo) Chlamydia trachomatis


Lyophilized kit for the detection of PCR liquid Kit
Chlamydia trachomatis plasmid and Detection of Chlamydia trachomatis by
genomic DNA in clinical samples by real- real-time PCR.
time PCR.
96 tests
96 tests
Kit content:
Kit content: • 4 Master Mix tubes
• 96 Ready Master Mix tubes • 2 tubes of positive control
(12 strips x 8 tubes) • 2 tubes of internal standard
• 1 tube of positive control
Storage: 12 months at -20°C
• 1 internal control
Storage: 12 months at 4-8°C

NEISSERIA GONORRHOEAE
REF. 3030020 REF. 3030004

RealLine N. gonorrhoeae (lyo) Neisseria gonorrhoeae


Lyophilized kit for the detection of PCR liquid Kit
Neisseria gonorrhoeae DNA in clinical samples Detection of Neisseria gonorrhoeae by real-
by real-time PCR. time PCR.
96 tests 96 tests
Kit content: Kit content:
• 96 Ready Master Mix tubes • 4 Master Mix tubes
(12 strips x 8 tubes) • 2 tubes of positive control
• 1 tube of positive control • 2 tubes of internal standard
• 1 internal control
Storage: 12 months at -20°C
Storage: 12 months at 4-8°C

UREAPLASMA UREALYTICUM
REF. 3030006 96 tests
RealLine Ureaplasma Kit content:
urealyticum (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of
• 1 tube of positive control
Ureaplasma urealyticum DNA in clinical • 1 internal control
samples by real-time PCR.
Storage: 12 months at 4-8°C

BIOSYNEX • 15
BACTERIOLOGY

MOLECULAR BIOLOGY (PCR)

GARDNERELLA VAGINALIS
REF. 3030021 96 tests
RealLine Gardnerella Kit content:
vaginalis (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of
• 1 tube of positive control
Gardnerella vaginalis DNA in clinical • 1 internal control
samples by real-time PCR.
Storage: 12 months at 4-8°C

MYCOPLASMA GENITALIUM
REF. 3030005 96 tests
RealLine Mycoplasma Kit content:
genitalium (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of
• 1 tube of positive control
Mycoplasma genitalium DNA in clinical • 1 internal control
samples by real-time PCR.
Storage: 12 months at 4-8°C

MYCOPLASMA HOMINIS
REF. 3030034 96 tests
RealLine Mycoplasma Kit content:
hominis (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of
• 1 tube of positive control
Mycoplasma hominis DNA in clinical • 1 internal control
samples by real-time PCR.
Storage: 12 months at 4-8°C

TREPONEMA PALLIDUM
REF. 3030035 96 tests
RealLine Treponema Kit content:
pallidum (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the analysis of clinical
• 1 tube of positive control
specimen (scrapings of epithelial • 1 internal control
cells and tissue fluid from erosive and
Storage: 12 months at 4-8°C
ulcerative lesions of the skin and mucous
membranes).

16
BACTERIOLOGY
MOLECULAR BIOLOGY (PCR)

MULTIPLEX STI
REF. 3030014 96 tests
RealLine Chlamydia Kit content:
trachomatis / Neisseria • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
gonorrhoeae (lyo) • 1 tube of positive control
Lyophilized kits for sensitive direct • 1 internal control
detection of Chlamydia trachomatis Storage: 12 months at 4-8°C
plasmid and genomic DNA as well as
Neisseria gonorrhoeae DNA in clinical
samples by real-time PCR. The kit is
designed for qualitative diagnosis.

REF. 3030017 96 tests


RealLine Mycoplasma Kit content:
hominis / genitalium (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of
• 1 tube of positive control
Mycoplasma genitalium / hominis DNA in
• 1 internal control
clinical samples by real-time PCR. The kit is
designed for in vitro diagnosis and provides Storage: 12 months at 4-8°C
qualitative detection.

REF. 3030036 96 tests


RealLine Candida albicans / Kit content:
Gardnerella vaginalis (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of Candida
• 1 tube of positive control
albicans and Gardnerella vaginalis DNA in • 1 internal control
clinical samples by real-time PCR. The kit is
Storage: 12 months at 4-8°C
designed for in vitro diagnosis and provides
qualitative detection.

REF. 3030037 96 tests


RealLine Chlamydia Kit content:
trachomatis / Ureaplasma • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
urealyticum (lyo) • 1 tube of positive control
Lyophilized kit for the detection of • 1 internal control
Chlamydia trachomatis and Ureaplasma
Storage: 12 months at 4-8°C
urealyticum DNA in clinical samples by
real-time PCR in different channels. The
kit is designed for in vitro diagnosis and
provides qualitative detection.

BIOSYNEX • 17
BACTERIOLOGY

MOLECULAR BIOLOGY (PCR)

REF. 3030038 96 tests


RealLine Chlamydia Kit content:
trachomatis / Trichomonas • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
vaginalis (lyo) • 1 tube of positive control
Lyophilized kit for the detection of • 1 internal control
Chlamydia trachomatis and Trichomonas Storage: 12 months at 4-8°C
vaginalis DNA in clinical samples by
real-time PCR. The kit is designed for in
vitro diagnosis and provides qualitative
detection.

REF. 3030039 96 tests


RealLine Ureaplasma Kit content:
urealyticum / parvum (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of
• 1 tube of positive control
Ureaplasma urealyticum / parvum DNA
in clinical samples by real-time PCR. The • 1 internal control
kit is designed for in vitro diagnosis and Storage: 12 months at 4-8°C
provides qualitative detection

REF. 3030040 96 tests


RealLine Gardnerella Kit content:
vaginalis / Trichomonas • 96 Ready Master Mix tubes
(12 strips x tubes)
vaginalis (lyo) • 1 tube of positive control
Lyophilized kit for the detection of • 1 internal control
Gardnerella vaginalis and Trichomonas Storage: 12 months at 4-8°C
vaginalis DNA in clinical samples by
real-time PCR. The kit is designed for in
vitro diagnosis and provides qualitative
detection.

REF. 3030046 100 tests


N.gonorrhoeae/С. Kit content:
trachomatis/M.genitalium/T. • PCR-mix-1-FL : 1 tube
• PCR-mix-2-FRT: 1 tube
vaginalis Real-TM • Polymerase (TaqF): 1 tube
Multiplex Real Time PCR test for the • DNA buffer: 1 tube
qualitative detection of Neisseria • Negative control (C-): 1 tube
gonorrhoeae, Chlamydia trachomatis, • Positive control complex (C+): 1 tube
Mycoplasma genitalium and Trichomonas
• Internal control (IC): 1 tube
vaginalis in the urogenital swabs, urine,
prostatic liquid and other biological Storage: 12 months at 2-8°C and -20°C
materials.

18
BACTERIOLOGY
MOLECULAR BIOLOGY (PCR)

REF. 3030047 100 tests


N.gonorrhoeae/С. Kit content:
trachomatis/M.genitalium • PCR-mix-1-FL: 1 tube
• PCR-mix-2-FRT: 2 tubes
Real-TM PCR • Polymerase (TaqF): 2 tubes
In vitro nucleic acid amplification test for • DNA buffer: 1 tube
the multiplex detection of Chlamydia • Negative control (C-): 1 tube
trachomatis, Neisseria gonorrhoeae and • Positive control complex (C+): 1 tube
Mycoplasma genitalium DNA in clinical • Internal control-FL (IC): 1 tube
materials (urogenital, rectal and pharyngeal Storage: 12 months at 2-8°C and -20°C
swabs; conjunctival discharge; prostatwe
gland secretion; and urine samples) by
using real-time hybridization-fluorescence
detection.

REF. 3030049 100 tests


T.vaginalis/N. Kit content:
gonorrhoeae/C.trachomatis • PCR-mix-1-FL: 1.2 mL
• PCR-mix-2: 2 x 0.3 mL
Real-TM • Polymerase (TaqF): 2 x 0.03 mL
In vitro nucleic acid amplification test • DNA buffer: 0.5 mL
for multiplex detection of Chlamydia • Negative control (C-): 1.2 mL
trachomatis, Neisseria gonorrhoeae • Positive control complex (C+): 1.2 mL
and Trichomonas vaginalis DNA in • Internal control (IC): 1.0 mL
clinical materials (urogenital, rectal and Storage: 12 months at 2-8°C and -20°C
pharyngeal swabs; conjunctival discharge;
prostate gland secretion; and urine
samples) by using real-time hybridization-
fluorescence detection.

CHLAMYDIA PNEUMONIAE
REF. 3030008

Chlamydia pneumoniae
PCR liquid Kit
For the detection of Chlamydia
pneumoniae by the real-time PCR.
96 tests
Kit content:
• 4 Master Mix tubes
• 2 tubes of positive control
• 2 tubes of internal standard
Storage: 12 months at -20°C

BIOSYNEX • 19
BACTERIOLOGY

MOLECULAR BIOLOGY (PCR)

MYCOBACTERIUM TUBERCULOSIS
REF. 3030047 50 tests
MTB Real-TM Kit content:
For the real-time qualitative detection of • PCR-mix-1: 2 x 0.28 mL
Mycobacterium tuberculosis complex • PCR buffer Flu: 0.28 mL
(M. tuberculosis, M. africanum, M. bovis, • Polymerase (TaqF): 0.03 mL
• UDG enzyme: 0.03 mL
M. bovis BCG, M. microti) in the sputum,
• Negative control (C-): 1.2 mL
urine, bronchial lavages, tissue and other • Positive control (C+): 0.1 mL
biological materials. • MTB internal control (IC): 1.0 mL
Storage: 12 months at 2-8°C and -20°C

LEGIONELLA PNEUMOPHILA
REF. 3030011 96 tests
Legionella pneumophila PCR Kit content:
liquid Kit • 4 Master Mix tubes
• 2 tubes of positive control
For the detection of Legionella
• 2 tubes of internal standard
pneumophila by real-time PCR.
Storage: 12 months at -20°C

BORDETELLA PERTUSSIS PARAPERTUSSI


REF. 3030013 96 tests
Bordetella pertussis Kit content:
parapertussis PCR liquid Kit • 4 Master Mix tubes
• 2 tubes of positive control
For the detection and differentiation
• 2 tubes of internal standard
of Bordetella pertussis and Bordetella
Storage: 12 months at -20°C
parapertussis by real-time PCR.

HELICOBACTER PYLORI 
REF. 3030042 48 tests
RealLine Helicobacter pylori Kit content:
For the detection of Helicobacter pylori • 48 Ready Master Mix tubes
DNA in clinical samples by real-time PCR. (12 strips x 8 tubes)
The kit is designed for in vitro diagnosis • 1 tube of positive control
and provides qualitative detection. • 1 internal control
Storage: 12 months at 4-8°C

20
BACTERIOLOGY
MOLECULAR BIOLOGY (PCR)

TICK BORNE INFECTIONS


REF. 3030041 48 tests
RealLine Borrelia Kit content:
burgdorferi s.l. (lyo) • 48 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of Borrelia
• 1 tube of positive control
burgdorferi sensu lato group (Borrelia • 1 internal control
afzelii, Borrelia garinii, Borrelia burgdorferi
Storage: 12 months at 4-8°C
sensu stricto) DNA in clinical samples by
real-time PCR. The kit is designed for in
vitro diagnosis and provides qualitative
detection.

REF. 3030041 48 tests


RealLine Anaplasma / Kit content:
Ehrlichia (lyo) • 48 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of Borrelia
• 1 tube of positive control
burgdorferi sensu lato group (Borrelia • 1 internal control
afzelii, Borrelia garinii, Borrelia burgdorferi
Storage: 12 months at 4-8°C
sensu stricto) DNA in clinical samples by
real-time PCR. The kit is designed for in
vitro diagnosis and provides qualitative
detection.

BIOSYNEX • 21
BACTERIOLOGY

AGGLUTINATION ON SLIDE
TREPONEMA PALLIDUM
REF. 500083 100 tests
RPR Card test Kit content:
Qualitative and semi-quantitative non- • RPR carbon antigen
treponemal macroscopic flocculation test • Test cards
• Dispensing bottle
for the detection of reaginic antibodies in • Single-use mixing sticks
serum or plasma. • Needles
• Negative control
• Weak positive control
• Positive control
Storage: 24 months at 2-8°C

REF. 500085 500 tests


RPR Card test Kit content:
Qualitative and semi-quantitative non- • RPR carbon antigen
treponemal macroscopic flocculation test • Test cards
• Dispensing bottle
for the detection of reaginic antibodies in • Single-use mixing sticks
serum or plasma. • Needles
• Negative control
• Weak positive control
• Positive control
Storage: 24 months at 2-8°C

STAPHYLOCOCCUS
REF. 500400 60 tests
Staph aureus Fumouze® Kit content:
Coagglutination slide test for the • Test red blood cells
identification of Staphylococcus aureus • Droppers
from colonies. • Control red blood cells
Storage: 16 months at 2-8°C

REF. 683400 160 tests


Staph aureus Fumouze® Kit content:
Coagglutination slide test for the • Test red blood cells
identification of Staphylococcus aureus • Droppers
from colonies. • Control red blood cells
Storage: 16 months at 2-8°C

REF. 951000 160 tests


Staph aureus Fumouze® Kit content:
accessories • Slides
• Single-use mixing sticks
Accessories for Staph aureus Fumouze.
Storage: 16 months at 2-8°C

22
BACTERIOLOGY
AGGLUTINATION ON SLIDE

STREPTOCOCCUS
REF. 523800 50 tests
Streptozyme Fumouze® Kit content:
Slide haemagglutination test for the rapid • Test blood cells
qualitative or semi-quantitative detection • Dropper
of 5 antistreptococcic antibodies (ASLO, • Glass card
• Single-use mixing sticks
ASD, ASK, ASH, ANAdase) in serum.
• Positive contol
• Negative control
Storage: 18 months at 2-8°C

REF. 500601 100 tests


ASO Latex Kit content:
Slide haemagglutination test for the • Sensitized latex
qualitative or semi-quantitative detection • Cards
of antistreptolysine O antibodies in serum. • Single-use mixing sticks
• Positive contol
• Negative control
Storage: 30 months at 2-8°C

BIOSYNEX • 23
BACTERIOLOGY

STAINING REAGENTS
REF. 502153 REF. 502123

Fluo RAL kit (Auramine) Gram-Nicolle kit


Slide stainer for hematology Slide stainer for hematology
and bacteriology. and bacteriology.
Full kit Full kit
Kit content: Kit content:
• Fixative Fluo-RAL • Carbolic gentian violet
• Auramine Fluo-RAL • PVP stabilised Lugol’s solution
• Carbolic solution for Auramine Fluo-RAL • Fast differentiator (alcohol/acetone)
• Degommier discoloring Fluo-RAL • Ziehl’s fuchsin
• Thiazin red Fluo-RAL Storage: 24 months at 15-25°C
• Carbolic solution for Thiazin red Fluo-RAL
Storage: 12 months at 15-25°C
Compatible with SMART Color See page 96

Compatible with SMART Color See page 96

REF. 502438 REF. 502125

Fast differentiator Quality distilled water


1 vial 2 vials
Kit content: Kit content:
Vial of 1 mL Vials of 5 mL
Storage: 18 months at 15-25°C Storage: 24 months at 4-25°C

Compatible with SMART Color See page 96 Compatible with SMART Color See page 96

REF. 502890 REF. 502891

Diluted Ziehl’s Fuchsin Undiluted Ziehl’s Fuchsin


1 vial 1 vial
Kit content: Kit content:
Vial of 1 mL Vial of 1 mL
Storage: 24 months at 15-25°C Storage: 24 months at 15-25°C

Compatible with SMART Color See page 96 Compatible with SMART Color See page 96

REF. 502892 REF. 502440

PVP stabilised Lugol’s solution Carbolic gentian violet


1 vial 1 vial
Kit content: Kit content:
Vial of 1 mL Vial of 1 mL
Storage: 24 months at 15-25°C Storage: 36 months at 15-25°C

Compatible with SMART Color See page 96 Compatible with SMART Color See page 96

24
BACTERIOLOGY
STRIPS
MYCOPLASMA
REF. 1030007 20 strips
BIOSYNEX® Mycoplasma Kit content:
Identification, numeration and antibiogram • 20 strips
of Mycoplasma hominis and Ureaplasma • 20 vials of diluent
urealyticum in the human genito-urinary • Liquid paraffin oil
tract. Storage: 18 months at 2-8°C

BIOSYNEX • 25
BIOCHEMISTRY
INSTRUMENTS IMMUNOLOGY WOMEN’S HEALTH VIROLOGY MYCOLOGY PARASITOLOGY BACTERIOLOGY
ONCOLOGY

26
PARASITOLOGY
PA R A S I T O L O G Y
PARASITOLOGY

Summary
MALARIA HYDATIDOSIS
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29, 30 Agglutination on slide. . . . . . . . . . . . 36
Staining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Automation . . . . . . . . . . . . . . . . . . . . . . . . . . 32 TOXOPLASMOSIS
Agglutination on microplate. . . . . 36
STOOL CONCENTRATION
& STAINING TRICHOMONAS VAGINALIS
Concentration & staining . . . . . . . . 33 PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

AMOEBIASIS
Agglutination on microplate. . . . . 35
Agglutination on slide. . . . . . . . . . . . . 35

BILHARZIOIS
Agglutination on microplate. . . . . 35

DISTOMATOSIS
Agglutination on microplate. . . . . 35

28
RDT - LATERAL FLOW
MALARIA

PARASITOLOGY
REF. 5499 REF. 6120001

PALUTOP® +4 OPTIMA Malaria Positive


Detection of 4 Plasmodium species control
antigens: Plasmodium falciparum (Pf), Dried control blood
Plasmodium vivax (Pv), Plasmodium compatible with antigen tests
malariae (Pm), Plasmodium ovale (Po) in (RDT) and gene amplification
whole blood or venous blood. (PCR) diagnosis of malaria
10 cassettes (P.falciparum).

Kit content: 1x 8-well plate


• 10 pouches, each containing: Kit content:
- 1 test cassette, • 1x 8-well plate (50 µL)
- 1 sample dose (5 µL), • 9 stirrers
- 1 desiccant
• 1 bottle of lysis buffer (3 mL) Storage : 24 months at 15-30°C
Storage: 24 months at 2-30°C

REF. 0584_K25

BIOSYNEX® Malaria P.f / Pan


Detection of P. falciparum antigens and of
the pLDH (P. faliciparum, P. vivax, P. ovale,
P. malariae) antigen in whole blood.
25 cassettes
Kit content:
• 25 test cassettes
• 25 inverted cups
• 1 bottle of extraction buffer
• 1 bottle of lysis buffer (3 mL)
Storage: 24 months at 2-30°C

BIOSYNEX • 29
RDT - LATERAL FLOW

REF. 5531 10 cassettes


PARASITOLOGY

PALUTOP® + Pf Kit content:


Detection of Plasmodium falciparum (Pf) • 10 test cassettes
via the detection of HRP-2 specific antigen • 10 sample doses (5 µL)
in whole blood or venous blood sample. • 1 bottle of lysis buffer (3 mL)
Storage: 16 months at 4-30°C

REF. 0581_K25 25 cassettes


BIOSYNEX® Malaria P.f / P.v Kit content:
Detection of Plasmodium falciparum • 25 test cassettes
and Plasmodium vivax antigens in whole • 25 inverted cups
blood. • 2 bottles of extraction buffer
Storage: 24 months at 2-30°C

REF. I13FRC25CE 25 cassettes


First Response® MALARIA Kit content:
Ag. P. falciparum • 25 test cassettes
• 25 sterile lancets
Detection of Plasmodium falciparum (Pf) • 25 alcohol wipes
HRP-2 specific antigen in human whole blood. • 1 bottle of assay buffer
Storage: 24 months at 4-30°C

30
RDT - LATERAL FLOW

MALARIA STAINING REAGENTS

PARASITOLOGY
REF. KDCOLOR10 REF. KDCOLOR100

KD-Color GE 10 KD-Color GE 100


All in one reagent for thick drop coloration All in one reagent for thick drop coloration
with heamoglobin removal. with heamoglobin removal.
10 slides 10 slides
Kit content: Kit content:
• 5 mL vial of KD- Reagent 1 • 50 mL vial of KD- Reagent 1
• 10 mL vial of KD- Giemsa • 100 mL vial of KD- Giemsa
• 10 slides • 100 slides
• 10 stirrers • 100 stirrers
• 3 staining containers • 6 staining containers
• Labels • Labels
Storage: 18 months at 2-8°C Storage: 18 months at 2-8°C

BIOSYNEX • 31
INSTRUMENTS
MALARIA
PARASITOLOGY

REF. 5120001 REF. 5120002

CELLSCHECK® CELLSCHECK TEST®


Image processing device for the Cellscheck kit.
quantitative detection and identification of 100 slides and reagents (for 500 patients)
4 Plasmodium species.
Kit content:
1 unit • 100 slides for 500 patients
Specifications: • 1 bottle of Reagent A
• 30 samples / 45 minutes: • 1 bottle of Reagent B
- only 10 minutes incubation time • Storage: 18 months at 2-8°C
- random sample loading
• Power supply: 110-240 V/AC, 5A
• Dimensions: 400 x 400 x 500 mm
• Weight: 25 kg

32
C ONCENTRATION
AND STAINING
STOOL CONCENTRATION AND STAINING

PARASITOLOGY
REF. 501170

Iodesine-Color Fumouze®
Fixation and staining method for the
identification of protozoan parasites in
stools. Formalin-free.
80 tests
Kit content:
• Dropper bottle of Lugol: 1 x 2.1 mL
• Base for Iodesine: 1 x 250 mL
• Spatulas: 80
Storage: 24 months at 18-25°C

REF. 509200

M.I.F.–Color Fumouze®
Fixation and staining method for the
identification of protozoa in stool.
80 tests
Kit content:
• Dropper bottle of Lugol: 1 x 2.1 mL
• Base for Iodesine: 1 x 250 mL
• Spatulas: 80
Storage: 24 months at 18-25°C

BIOSYNEX • 33
CONCENTRATION AND STAINING

NEW
PARASITOLOGY

Para-Selles® Optima
Para-Selles® Optima comes in a series of three kits (A1, A2 and A3) to be
used on the sampling sites, and a complementary technical Kit B to be used
on your technical platforms.
Complete parasitic coprology can be performed by associating either Kit A1,
A2 or A3 with a technical Kit B.

1. Order your pre-analytical kit


REF. 1120010 REF. 1120011 REF. 1120012

Para-Selles® Optima Para-Selles® Optima Para-Selles® Optima


IODESINE BAILENGER IODESINE/BAILENGER
A1 A2 A3
100 tests 100 tests 100 tests
Kit content: Kit content: Kit content:
• IODESINE base: • BAILENGER buffer: • IODESINE base:
100 pre-filled tubes (20 mL) 100 pre-filled tubes (20 mL) 50 pre-filled tubes (20 mL)
• Sampling spoons: 100 • Sampling spoons: 100 • BAILENGER base:
• Spatulas: 100 • Spatulas: 100 50 pre-filled tubes (20 mL)
• Sampling spoons: 100
• Spatulas: 100

Storage: Storage: Storage:


18 months at 18-25°C 18 months at 18-25°C 18 months at 18-25°C

2. Order your technical kit


REF. 1120013 100 tests
Para-Selles® Optima Kit content:
TECHNIQUE B • KOP-COLOR II: 4.5 mL
• LUGOL: 20 mL
Method for the concentration and • Ethyl acetate: 2 x 250 mL
staining of parasitic elements in stools. • Conical tubes: 100 x 10 mL
Formalin-free. Storage: 18 months at 18-25°C

34
A GGLUTINATION TESTS
AMOEBIASIS – SEROLOGY

PARASITOLOGY
REF. 482200 REF. 534000

I.H.A. Amoebiasis Fumouze® Bichro-Latex Amibe


Indirect haemagglutination test for Fumouze®
amebiasis. Colored latex slide agglutination slide for
120 tests or 20 reactions of 6 dilutions extra-intestinal amoebiasis.
Kit content: 25 tests
• Sensitized red blood cells: 1 x 2.4 mL Kit content:
• Non-sensitized red blood cells: 1 x 1 mL • Sensitized latex: 1 x 0.5 mL
• Buffer solution: 1 x 55 mL • Positive control: 1 x 0.5 mL
• Adsorbent: 1 x 2 mL • Negative control: 1 x 0.5 mLDiluent pH 7.2:
• Positive control (titered): 1 x 0.2 mL 1 x 5 mL
• Negative control: 1 x 0.2 mL • Slide (x 8 tests): 4
• Microplates: 2 • Stirrers: 25
• Droppers: 2 • Dropper: 1
Storage: 24 months at 2-8°C Storage: 15 months at 2-8°C

BILHARZIOSIS – SEROLOGY
REF. 514000

Bilharziosis Fumouze®
Indirect haemagglutination test for bilharziosis.
120 tests or 20 reactions of 6 dilutions
Kit content:
• Sensitized red blood cells: 1 x 2.4 mL • Non-sensitized red blood cells: 1 x 1 mL
• Buffer solution: 1 x 55 mL • Adsorbent: 1 x 2 mL
• Positive control (titered): 1 x 0.2 mL • Negative control: 1 x 0.2 mL
• Microplates: 2 • Droppers: 2
Storage: 24 months at 2-8°C

DISTOMATOSIS – SEROLOGY
REF. 524600

Distomatosis Fumouze®
Serodiagnosis of distomatosis by indirect haemagglutination.
102 tests or 17 reactions of 6 dilutions
Kit content:
• Sensitized red blood cells: 1 x 2.2 mL • Non-sensitized red blood cells: 1 x 1 mL
• Buffer solution: 1 x 55 mL • Adsorbent: 1 x 2 mL
• Positive control (titered): 1 x 0.2 mL • Negative control: 1 x 0.2 mL
• Microplates: 2 • Droppers: 2
Storage: 24 months at 2-8°C

BIOSYNEX • 35
AGGLUTINATION TESTS

TOXOPLASMOSIS - SEROLOGY
PARASITOLOGY

REF. 525000 REF. 522400

Toxo-HAI Fumouze® Toxolatex Fumouze®


Titration of anti-toxoplasma IgG and IgM Latex particle slide agglutination test
antibodies by indirect haemagglutination. for the detection of IgG and IgM anti-
120 tests or 20 reactions of 6 dilutions toxoplasma antibodies.

Kit content: Kit content:


• Sensitized red blood cells: 1 x 2.4 mL • Sensitized latex suspension: 1 x 3 mL
• Non-sensitized red blood cells: 1 x 1 mL •
• Buffer solution: 1 x 55 mL • Positive control: 1 x 0.5 mL
• Adsorbent: 1 x 2 mL • Negative control: 1 x 0.5 mL
• Positive control (titered): 1 x 0.2 mL • Glycocolle buffer: 1 x 60 mL
• Negative control: 1 x 0.2 mL • Slides (x 10 tests): 12
• Microplates: 2 • Stirrers: 120
• Droppers: 2 • Droppers
Storage: 24 months at 2-8°C Storage: 24 months at 2-8°C

HYDATIDOSIS – SEROLOGY
REF. 524800

Hydatidosis Fumouze®
Serodiagnosis of hydatidosis by indirect
haemagglutination.
102 tests or 17 reactions of 6 dilutions
Kit content:
• Sensitized red blood cells: 1 x 2.2 mL
• Non-sensitized red blood cells: 1 x 1 mL
• Buffer solution: 1 x 55 mL
• Adsorbent: 1 x 2 mL
• Positive control (titered): 1 x 0.2 mL
• Negative control: 1 x 0.2 mL
• Panels: 2
• Droppers: 2
Storage: 24 months at 2-8°C

36
MOLECULAR BIOLOGY (PCR)
TRICHOMONAS VAGINALIS

PARASITOLOGY
REF. 3030007 96 tests
RealLine Trichomonas Kit content:
vaginalis (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilized kit for the detection of
• 1 positive control tube
Trichomonas vaginalis genomic DNA in
• 1 internal control
clinical samples by real-time PCR. The
kit is designed for in vitro diagnosis and Storage: 12 months at 4-8°C
provides qualitative detection.

TRICHOMONAS VAGINALIS / CHLAMYDIA TRACHOMATIS


REF. 3030038 96 tests
RealLine Chlamydia Kit content:
trachomatis / Trichomonas • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
vaginalis (lyo) • 1 positive control tube
Lyophilized kit for the detection of • 1 internal control
Trichomonas vaginalis kits detect the Storage: 12 months at 4-8°C
Chlamydia trachomatis and the Trichomonas
vaginalis DNA in clinical samples by real-
time PCR. The kit is designed for in vitro
diagnosis and provide qualitative detection.

TRICHOMONAS VAGINALIS / GARDNERELLA VAGINALIS


REF. 3030040 96 tests
RealLine Trichomonas Kit content:
vaginalis / Gardnerella • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
vaginalis (lyo) • 1 positive control tube
Lyophilized kit for the detection of • 1 internal control
Gardnerella vaginalis and Trichomonas Storage: 12 months at 4-8°C
vaginalis DNA in clinical samples by real-
time PCR. The kit is designed for in vitro
diagnosis and provide qualitative detection.

37 BIOSYNEX • 37
BIOCHEMISTRY
INSTRUMENTS IMMUNOLOGY WOMEN’S HEALTH VIROLOGY MYCOLOGY PARASITOLOGY BACTERIOLOGY
ONCOLOGY

38
MYCOLOGY
M YC O LO GY
Summary
MYCOLOGY

CRYPTOCOCCOSIS
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

CANDIDIASIS
Agglutination on slide. . . . . . . . . . . . . 43
Agglutination on microplate. . . . . 44
Culture media. . . . . . . . . . . . . . . . . . . . . . . 42
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

ASPERGILLUS
Agglutination on microplate. . . . . 44

MYCOSIS
Culture media. . . . . . . . . . . . . . . . . . . . . . . 42
Staining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

40
RDT - LATERAL FLOW
CRYPTOCOCCOSIS

REF. 1120001

BIOSYNEX® CryptoPS
Semi-quantitative detection of Cryptococcus sp. antigens in serum, plasma, whole
blood, and cerebrospinal fluid.
20 cassettes
Kit content:

MYCOLOGY
• 20 test cassettes
• 20 capillary tubes (20 µL)
• 1 dropper bottle of diluent
• 1 bottle of diluent for the the titration protocol
• 1 bottle of positive control
• Instructions for use
Storage: 18 months at 2-25°C

Compatible with BIOSYNEX Reader


See page 91

BIOSYNEX • 41
CULTURE MEDIA
CANDIDIASIS - IDENTIFICATION

REF. 3140000 40 tests


Glabrata R.T.T. Fumouze® Kit content:
(“Rapid Trehalose Test“) • 10 cards of 12 wells containing dehydrated
media TMB
Identification of Candida glabrata from the
- T well = base reagent and trehalose
most currently used culture media. - M well = base reagent and maltose
- B well = base reagent
MYCOLOGY

• Each card allows 4 identifications


• 3 Revealing agents (dried)
Storage: 12 months at 2-8°C

MYCOLOGY - IDENTIFICATION

NEW

REF. BORELPC18

Borelli pre-poured medium


Petri dish medium for subculture and
identification of dermatophytes.
(sporulation and pigmentation).
18 Petri dishes
Storage : 6 months at 2-8°C

Also available in boxes of 9 Petris dishes


REF. BORELPC9

REF. BORELFL20 18 tubes of 10 mL


Borelli Medium Kit content:
Tubed medium for subculture and • 18 tubes of 10 mL
identification of dermatophytes • Instructions for use
(sporulation and pigmentation). Storage: 12 months at 12-25°C

REF. BORELT19 4 bottles of 50 mL


Borelli Medium Kit content:
Bottled medium for subculture and • 4 bottles of 50 mL
identification of dermatophytes • Instructions for use
(sporulation and pigmentation). Storage: 12 months at 12-25°C

42
A GGLUTINATION TEST
ON SLIDE
CANDIDIASIS - IDENTIFICATION

REF. 524700 60 tests


Bichro-Latex Albicans Kit content:
Fumouze® • 1 mL of latex reagent
• 3 dried dissociating reagents
Immunological identification of Candida
• 8 test cards (8 tests)

MYCOLOGY
albicans / Candida dubliniensis from • 60 stirrers
colonies by agglutination of latex particles • 1 dropper
sensitized with a monoclonal antibody. Storage: 15 months at 2-8°C

REF. 524900 360 tests


Bichro-Latex Albicans Kit content:
Fumouze® • 2 x 3 mL of latex reagent
• 3 dried dissociating reagents
• 50 test cards (8 tests)
• 60 stirrers
• 1 dropper
Storage: 15 months at 2-8°C

REF. 810000 100 tests


Bichro-Dubli Fumouze® Kit content:
Latex agglutination test for the direct • 2 mL of latex reagent
identification of Candida dubliniensis from • 13 disposable cards
colonies. • 100 disposable stirrers
Storage: 18 months at 2-8°C

REF. 509800 30 tests


Krusei-Color Fumouze® Kit content:
Immunological identification of Candida • 1.2 mL of latex reagent
krusei from colonies by agglutination • 4 test cards (x 8 tests)
of latex particles sensitized with a Storage: 12 months at 2-8°C
monoclonal antibody.

BIOSYNEX • 43
A GGLUTINATION TEST
ON MICROPLATE
ASPERGILLOSIS - SEROLOGY
REF. 524400

Aspergillosis Fumouze®
Serodiagnosis of aspergillosis by indirect haemagglutination.
102 tests or 17 reactions of 6 dilutions
Kit content:
MYCOLOGY

• 2.2 mL of sensitized red blood cells


• 1 mL of non-sensitized red blood cells
• 55 mL of buffer solution
• 2 mL of adsorbent
• 0.2 mL positive control (titered)
• 0.2 mL of negative control
• 2 microplates
• 2 droppers
Storage: 18 months at 2-8°C

CANDIDIASIS - SEROLOGY
REF. 513400

Candidiasis Fumouze®
Serodiagnosis of candidiasis by indirect haemagglutination.
120 tests or 20 reactions of 6 dilutions
Kit content:
• 2.4 mL of sensitized red blood cells
• 1 mL of non-sensitized red blood cells
• 55 mL of buffer solution
• 2 mL of adsorbent
• 0.2 mL positive control (titered)
• 0.2 mL of negative control
• 2 microplates
• 2 droppers
Storage: 16 months at 2-8°C

44
STAINING REAGENTS
MYCOSIS

MYCOLOGY
REF. MYCOL60 REF. MYFLU60

MycetColor MycetFluo
Staining of fungal elements for direct Fluorescent staining of fungal elements for
microscopic examination from the samples. direct microscopic examination from the
60 tests samples.

Kit content: 60 tests


• 1 vial of dissociating reagent Kit content:
• 1 vial of staining reagent 1 • 1 vial of dissociating reagent
• 1 vial of staining reagent 2 • 4 vials of staining reagent A
• 4 black cards • 2 vials of diluent B
• 125 single-use sticks • 4 black cards
Storage: 18 months at 12-25°C • 125 single-use sticks
Storage: 18 months at 12-25°C

REF. MYBLU4

MycetBlue
Staining of fungal elements for microscopic
identification after culture.
2 vials of 2 mL
Kit content:
2 vials of staining reagent
Storage: 18 months at 12-25°C

BIOSYNEX • 45
MOLECULAR BIOLOGY (PCR)
CANDIDA ALBICANS
REF. 3120018 96 tests
RealLine Candida Kit content:
albicans (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilised kit for the detection of
• 1 positive control tube
Candida albicans DNA in clinical samples • 1 internal control
by real-time PCR. The kit is designed for
Storage: 12 months at 4-8°C
in vitro diagnosis and provides qualitative
MYCOLOGY

detection.

CANDIDA ALBICANS /
GARDNERELLA VAGINALIS
REF. 3030036 96 tests
RealLine Candida albicans / Kit content:
Gardnerella vaginalis (lyo) • 96 Ready Master Mix tubes
(12 strips x 8 tubes)
Lyophilised kit for the detection of
• 1 positive control tube
Candida albicans and Gardnerella • 1 internal control
vaginalis DNA in clinical samples by
Storage: 12 months at 4-8°C
real-time PCR. The kit is designed for in
vitro diagnosis and provides qualitative
detection.

46
BIOSYNEX
• 47
BIOCHEMISTRY
INSTRUMENTS IMMUNOLOGY WOMEN’S HEALTH VIROLOGY MYCOLOGY PARASITOLOGY BACTERIOLOGY
ONCOLOGY
BIOCHEMISTRY
INSTRUMENTS IMMUNOLOGY WOMEN’S HEALTH VIROLOGY MYCOLOGY PARASITOLOGY BACTERIOLOGY
ONCOLOGY

48
MYCOLOGY
VIROLOGY
V I R O LO GY
Summary
CYTOMEGALOVIRUS HUMAN PAPILLOMAVIRUS
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
VIROLOGY

EPSTIEN-BARR VIRUS RESPIRATORY INFECTIONS


RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
RUBELLA VIRUS
DENGUE PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
TICK-BORNE ENCEPHALITIS
GASTROINTESTINAL INFECTIONS VIRUS (TBEV)
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54, 55 PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

HEPATITIS VARICELLA ZOSTER VIRUS


RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58, 59
ZAIRE EBOLA VIRUS
HERPES SIMPLEX VIRUS PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60, 61

HIV
RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58, 59

50
RDT - LATERAL FLOW
EPSTEIN-BARR VIRUS

REF. 1150014 REF. 1150015

MNITOP® Optima BIOSYNEX® EBV


Detection of infectious IgG
mononucleosis heterophilic Detection of anti-VCA p18 IgG
antibodies in human serum, and anti-EBNA-1 IgG in whole
plasma or whole blood. blood, serum or plasma.
20 tests 25 tests
Kit content: Kit content:
• 20 test cassettes • 25 test cassettes
• 20 droppers • 1 bottle (27 mL) of diluent
• 5 mL of buffer (compatible with BIOSYNEX®
• 1 mL of negative control EBV IgM/Mono Ref. 1150016)
• 1 mL of positive control
Storage: 12 months at 2-30°C
• 1 holder
Storage: 18 months at 2-30°C

VIROLOGY
REF. 1150016

BIOSYNEX® EBV
IgM/Mono
Detection of anti-VCA
p18 IgM and heterophile
antibodies in whole blood,
serum or plasma.
25 tests
Kit content:
• 25 test cassettes
• 1 bottle (27 mL) of diluent
(compatible with BIOSYNEX®
EBV IgG Ref. 1150015)
Storage: 12 months at 2-30°C

BIOSYNEX • 51
RDT - LATERAL FLOW

DENGUE
NEW
REF. 1150019_S REF. SW4002

BIOSYNEX® Dengue NS1 BIOSYNEX®


BSS Dengue Combo BSS
Qualitative detection of NS1 dengue virus Qualitative detection of NS1 antigen
antigen in blood, serum and plasma. and anti Dengue virus IgG/IgM
25 tests antibodies in whole blood, serum or
plasma.
Kit content:
• 25 test cassettes 20 tests
• 25 droppers Kit content:
• 1 vial of buffer • 20 test cassettes
Storage: 24 months at 2-30°C • 1 diluent
• 20 pipettes for NS1
• 20 pipettes for IgG/IgM
Storage: 24 months at 2-30°C
VIROLOGY

REF. 1150018

BIOSYNEX® Dengue
IgG & IgM
Detection of anti Dengue virus IgG and
IgM antibodies in human serum, plasma or
whole blood.
25 tests
Kit content:
• 25 test cassettes
• 25 capillary tubes
• 1 dropper bottle of diluent (3.5 mL)
Storage: 24 months at 2-30°C

52
RDT - LATERAL FLOW

RESPIRATORY INFECTIONS

REF. SW40002

INFLUENZATOP® BSS
Detection of Influenza type A and type B from nasal swabs, throat swabs
or nasal aspirate samples
20 tests
Kit content:
• 20 test cassettes
• 20 sterile swabs (CE 0086)
• 20 extraction tubes
• 20 dropper tips
• 1 vial of extraction buffer
• 1 influenza A sterile positive control (swab)
• 1 influenza B sterile positive control (swab)
• Workstation
Storage: 18 months at 2-30°C

VIROLOGY
REF. 1150006

RSVTOP®
Detection of respiratory syncytial virus antigen common to groups A and B from
nasal swab, throat wash or nasal aspiration samples.
10 tests
Kit content:
• 10 test cassettes
• 10 sterile swabs (CE 0123)
• 10 tubes of diluent (0.5 mL)
• 1 positive control of inactive RSV (swab)
Storage: 12 months at 2-30°C

BIOSYNEX • 53
RDT - LATERAL FLOW

GASTROINTESTINAL INFECTIONS

REF. 1150013

IMMUNOQUICK® NoRotAdeno
Norovirus, Rotavirus and Adenovirus detection in
stool samples.
20 tests
Kit content:
• 20 test cassettes
• 20 swabs
• 2 bottles of extraction buffer (10 mL)
• 20 extraction tubes
• Holder
Storage: 24 months at 2-30°C
VIROLOGY

REF. 1150010 REF. 6150001

IMMUNOQUICK® Positive control


Norovirus gp I
Norovirus
Norovirus detection in stool. 1 swab

10 tests For 1 control with


IMMUNOQUICK® Norovirus (ref.
Kit content: 1150010) or IMMUNOQUICK®
• 10 test cassettes NoRotAdeno (ref.1150013)
• 10 swabs
• 10 tubes Storage: 12 months at 2-30°C
• 1 bottle of diluent (10 mL)
Storage: 12 months at 2-30°C

REF. 6150002
Positive control
Norovirus gp II
1 swab

For 1 control with


IMMUNOQUICK® Norovirus (ref.
1150010) or IMMUNOQUICK®
NoRotAdeno (ref.1150013)
Storage: 12 months at 2-30°C

54
RDT - LATERAL FLOW

GASTROINTESTINAL INFECTIONS
REF. 6150004
REF. SW40001
Positive control
BIOSYNEX® Adenovirus / Rotavirus
Rotavirus BSS 1 swab
Rotavirus and Adenovirus detection in
For 1 control with BIOSYNEX®
stool samples. Adenovirus/Rotavirus BSS (ref.
25 tests SW40001) or IMMUNOQUICK®
NoRotAdeno (ref.1150013)
Kit content:
• 25 test cassettes Storage: 12 months at 2-30°C
• 25 tubes containing the extraction buffer
• 25 dropper pipettes
Storage: 24 months at 2-30°C

REF. 6150003
Positive control
Adenovirus

VIROLOGY
1 swab

For 1 control with Adenotop®


(ref. 1150026) or BIOSYNEX®
Adenovirus/Rotavirus BSS (ref.
SW40001) or IMMUNOQUICK®
REF. 1150026 NoRotAdeno (ref.1150013)
Adenotop® Storage: 12 months at 2-30°C
Detection of adenovirus in stool,
ocular specimens, nasal and
pharyngeal secretions and cell culture
supernatant.
10 tests
Kit content:
• 20 test cassettes
• 20 tubes with filter corks
• 1 vial of extraction buffer (20 mL)
Storage: 24 months at 2-30°C

BIOSYNEX • 55
RDT - LATERAL FLOW

HEPATITIS

REF. I03FRC30CE REF. I10FRC30CE

First Response® First Response®


HCV HBsAg
Detection of anti hepatitis C Detection of hepatitis B surface
(HCV) antibodies in human antigen (HBsAg) in human serum,
serum, plasma and whole plasma and whole blood.
blood. 30 tests
30 tests Kit content:
Kit content: • 30 test cassettes
• 30 test cassettes • 30 sample pipettes
• 30 sample pipettes • 30 sterile lancets
• 30 sterile lancets • 30 alcohol wipes
• 30 alcohol wipes • 1 bottle of assay buffer
• 1 bottle of assay buffer Storage: 24 months at 2-30°C
Storage: 24 months at 2-30°C
VIROLOGY

REF. 1150017 REF. 1150008

HEVTOP® HAVTOP®
Detection of hepatitis E (HEV) Detection of hepatitis A (HAV) IgM antibodies
IgM antibodies in human in human serum, plasma and whole blood.
serum and plasma. 10 tests
10 tests Kit content:
Kit content: • 10 test cassettes
• 10 test cassettes • 10 capillary tubes
• 10 capillary tubes • 1 bottle of diluent (5 mL)
• 1 bottle of diluent (5 mL) Storage: 18 months at 2-30°C
Storage: 18 months at 2-30°C

56
RDT - LATERAL FLOW

HUMAN IMMUNODEFICIENCY VIRUS (HIV)

REF. I03FR5C30CE REF. 1150025

First Response® Triplex HIV, HCV,


HIV 1-2.O HBsAg
Detection of anti HIV-1 Detection of HIV1 and HIV2,
(including group O) and HCV antiobodies, and HBs
HIV-2 antibodies in human antigen in human serum,
serum, plasma and whole plasma and whole blood.
blood. 20 tests
30 tests Kit content:
Kit content: • 20 test cassettes
• 30 test cassettes • 20 pipettes (50µL)
• 30 sample pipettes • 1 bottle of diluent (3 mL)
• 30 sterile lancets Storage: 24 months at 2-30°C
• 30 alcohol wipes
• bottle of assay buffer

VIROLOGY
Storage: 24 months at 2-30°C

REF. 857318 10 tests


EXACTO® PRO HIV Kit content:
Detection of anti HIV-1 and HIV-2 10 individual pouches, each containing:
antibodies in human serum, plasma and • 1 test cassette
whole blood. • 1 sterile lancet
• 1 sample collection pipette
• 1 vial of diluent
• 1 alcohol wipe
• 1 sterilized pad
• 1 plaster
Storage: 24 months at 2-30°C

BIOSYNEX • 57
MOLECULAR BIOLOGY (PCR)
HUMAN IMMUNODEFICIENCY VIRUS (HIV)
REF. 3150023 96 tests
HIV Real-TM Quant (lyo) Kit content:
Lyophilized amplification test for the • 96 ready-to-use, lyophilized Master Mix tubes
• 4 vials with lyophilized reagent HIV-IC-L, 0.2 g
quantitative detection of HIV-1 RNA in • 4 vials with lyophilized reagent HIV-Pos1-L C+
human plasma and the simultaneous High Positive Control, 0.2 g
detection of a HIV specific Internal Control • 4 vials with lyophilized reagent HIV-Pos2-L C+
(IC), by dual color detection. Low Positive Control, 0.2 g
• 4 vials with Negative Control, 4 mL each
• 4 vials with lyophilized reagent HIV Quantitative
Standard 1, 0.2 g
• 4 vials with lyophilized reagent HIV Quantitative
Standard 2, 0.2 g
Storage: 12 months at 2-8°C

HEPATITIS B VIRUS (HBV)


VIROLOGY

REF. 3150025 96 tests


HBV Real-TM Quant (lyo) Kit content:
Lyophilized amplification test for the • 96 ready-to-use, lyophilized Master Mix tubes
• 4 vials with lyophilized reagent HIV-IC-L, 0.2 g
quantitative detection of Hepatitis B Virus • 4 vials with lyophilized reagent HIV-Pos1-L C+
in human plasma and the simultaneous High Positive Control, 0.2 g
detection of a HBV-specific Internal • 4 vials with lyophilized reagent HIV-Pos2-L C+
Control (IC), by dual color detection. Low Positive Control, 0.2 g
• 4 vials with Negative Control, 4 mL each
• 4 vials with lyophilized reagent HIV Quantitative
Standard 1, 0.2 g
• 4 vials with lyophilized reagent HIV Quantitative
Standard 2, 0.2 g
Storage: 12 months at 2-8°C

HEPATITIS C VIRUS (HCV)


REF. 3150024 96 tests
HCV Real-TM Quant (lyo) Kit content:
Lyophilized amplification test for the • 96 ready-to-use, lyophilized Master Mix tubes
• 4 vials with lyophilized reagent HCV-IC-L, 0.2 g
quantitative detection detection of • 4 vials with lyophilized reagent HCV-Pos1-L
Hepatitis C Virus in human plasma and C+ High Positive Control, 0.2 g
the simultaneous detection of a HCV- • 4 vials with lyophilized reagent HCV-Pos2-L C+
specific Internal Control (IC), by dual color Low Positive Control, 0.2 g
detection. • 4 vials with Negative Control, 4 mL each
• 4 vials with lyophilized reagent HCV Quantitative
Standard 1, 0.2 g
• 4 vials with lyophilized reagent HCV Quantitative
Standard 2, 0.2 g
Storage: 12 months at 2-8°C

58
MOLECULAR BIOLOGY (PCR)

HUMAN IMMUNODEFICIENCY VIRUS /


HEPATITIS B VIRUS /
HEPATITIS C VIRUS (HBV / HCV / HIV)

REF. 3150051 100 tests


HCV/HBV/HIV Real-TM Kit content:
Qualitative in vitro test for comprehensive • Internal Control (IC) Rec1, 2 x 0.5 mL
single-assay Real Time detection of • HCV/HBV/HIV Rec Pos C+2, 2 x 0.2 mL
Human HIV RNA, HCV RNA and HBV • NCS (Neg. Control Sample) 2, 2 x 1.2 mL
• RT-PCR-mix-1-TM, 2 x 0.3 mL
DNA in human plasma with simultaneous
• RT-PCR-mix-2-TM, 2 x 0.3 mL
detection of Internal Control (IC). This kit • Hot Start Taq Polymerase, 2 x 0.03 mL
is intended for use as a donor screening • M-MLV Revertase, 2 x 0.015 mL
test to detect HIV RNA, HCV RNA and • RT-G-mix-2, 2 x 0.015 mL
HBV DNA in plasma from individual • TE-buffer, 2 x 1.2 mL
donors which may be screened as • Pos HCV/HBV/HIV C+, 2 x 0.1 mL
individual samples or may be tested in Storage: 12 months at 2-8 and -20°C
pools comprised of equal aliquots. The

VIROLOGY
recommended quantity of the samples
in one pool must be not more than 5-10
(100-200 µL of the plasma for each
sample).

REF. 3150056 100 tests


HCV/HBV/HIV1/HIV2 Real-TM Kit content:
Qualitative in vitro test for comprehensive • Internal Control (IC) Rec1, 2 x 0.5 mL
single-assay Real Time detection of HIV1 • HCV/HBV/HIV Rec Pos C+2, 2 x 0.2 mL
RNA, HIV2 RNA, HCV RNA and HBV DNA • NCS (Neg. Control Sample) 2, 2 x 1.2 mL
• RT-PCR-mix-1-TM, 2 x 0.3 mL
in human plasma with simultaneous
• RT-PCR-mix-2-TM, 2 x 0.3 mL
detection of Internal Control (IC). This kit • Hot Start Taq Polymerase, 2 x 0.03 mL
is intended for use as a donor screening • M-MLV Revertase, 2 x 0.015 mL
test to detect HIV1 RNA, HIV2 RNA, • RT-G-mix-2, 2 x 0.015 mL
HCV RNA and HBV DNA in plasma from • TE-buffer, 2 x 1.2 mL
individual donors which may be screened • Pos HCV/HBV/HIV C+, 2 x 0.1 mL
as individual samples or may be tested in Storage: 12 months at 2-8 and -20°C
pools comprised of equal aliquots. The
recommended quantity of the samples
in one pool must be not more than 5-10
(100-200 µL of the plasma for each
sample).

BIOSYNEX • 59
MOLECULAR BIOLOGY (PCR)

HERPES SIMPLEX VIRUS (HSV1/2)


REF. 3150052 100 tests
HSV I/II Typing Real-TM Kit content:
Kit for the qualitative detection and • PCR-mix-1-FRT, 1.2 mL
differentiation of Herpes Simplex Virus • PCR-mix-2, 2 x 0.3 mL
• TaqF Polymerase, 2 x 0.03 mL
type I and Herpes Simplex Virus type II • Positive Control, 0.2 mL
DNA in the whole blood, plasma, liquor, • Negative Control C-, 1.2 mL
urogenital swabs, urine, prostatic liquid • Internal Control IC, 1.0 mL
and other biological samples. • DNA-buffer, 0.5 mL
Storage: 12 months at -16°C

HUMAN PAPILLOMAVIRUS
VIROLOGY

REF. 3150053 100 tests


HPV 14 Screening & Kit content:
16,18,45 Typing Quant • PCR-mix-1-FRT HPV14, 1 x 1.2 mL
• PCR-mix-2 buffer, 1 x 0.60 mL
For the detection of the most widespread • TaqF DNA Polymerase, 1 x 0.06 mL
and oncogenic 14 genotypes of human • Negative Control, 1.2 mL
papilloma virus with determination of clinical • QS HPV C1, 1 x 0.2 mL
significance. Since the human papilloma (HPV DNA C+ 16, 18, 45 and human DNA)
• QS HPV C2, 1 x 0.2 mL
virus is an intracellular agent, there is need to
(HPV DNA C+ 16, 18, 45 and human DNA)
monitor the presence of cellular material in
Storage: 12 months at -20°C
the sample, in order to avoid false-negative
results. HPV 14 Screening & 16,18,45 Typing
Quant kit contains the internal control
(human beta-globine gene), which allows to
control the presence of cellular material in
the sample.

CYTOMEGALOVIRUS
REF. 3150022 REF. 3150008

RealLine CMV Quantitative (lyo) CMV Quantitative


Lyophilized kit for the sensitive direct PCR Kit liquid
detection of CMV DNA in clinical samples by Kit for the detection of human
real-time PCR. The kit is designed for in vitro Cytomegalovirus by real-time PCR.
Diagnostics and for qualitative detection.
96 tests
96 tests
Kit content:
Kit content: • 4 Master Mix tubes
• Universal positive control sample 1 vial, 1 mL • 4 tubes of calibrator
• Ready Master Mix (RMM) • 2 tubes of internal standard
• Passport with specific amount of controls
Storage: 12 months at -20°C
Storage: 12 months at 4-8°C

60
MOLECULAR BIOLOGY (PCR)

EPSTEIN-BARR VIRUS
REF. 3150026 REF. 3150009

RealLine EBV Quantitative EBV Quantitative


(lyo) PCR Kit liquid
Kit for the sensitive direct detection Kit for the detection of EBV by real-time
of EBV DNA in clinical samples by real- PCR.
time PCR. The kit is designed for in vitro 96 tests
diagnosis and provide qualitative detection.
Kit content:
96 tests • 4 Master Mix tubes
Kit content: • 4 calibrator tubes
• 1 vial of positive control sample (1 mL) • 2 tubes of internal standard
• 96 Ready Master Mix tubes Storage: 12 months at -20°C
(12 strips x 8 tubes)
• Passport with specific amount of controls
Storage: 12 months at 4-8°C

VIROLOGY
HUMAN HERPESVIRUS - 6 (HH6)
REF. 3150044 48 tests
RealLine HHV-6 (lyo) Kit content:
Kit for the sensitive direct detection • 1 vial of positive control sample (1 mL)
of HHV-6 DNA in clinical samples by • 48 Ready Master Mix tubes
real-time PCR. The kit is designed for in (6 strips x 8 tubes)
vitro diagnosis and provides qualitative Storage: 12 months at 4-8°C
detection of HHV-6.

VARICELLA ZOSTER VIRUS (VZV)


REF. 3150045 REF. 3150010

RealLine VZV (lyo) VZV PCR Kit Liquid


Lyophilized kit for the sensitive direct Kit for the detection of VZV by the real-time
detection of VZV in clinical samples by PCR.
real-time PCR. The kit is designed for in vitro 96 tests
HHV and provides qualitative detection.
Kit content:
48 tests • 4 Master Mix tubes
Kit content: • 4 calibrator tubes
• Universal positive control sample 1 vial (1 mL) • 2 tubes of internal standard
• 48 Ready Master Mix tubes Storage: 12 months at -20°C
(6 strips x 8 tubes)
Storage: 12 months at 4-8°C

BIOSYNEX • 61
MOLECULAR BIOLOGY (PCR)

RUBELLA VIRUS

REF. 3150016 48 tests


RealLine Rubella (lyo) Kit content:
Lyophilized kit for the sensitive direct • 1 vial of positive control sample (1 mL)
detection of Rubella RNA in clinical • 48 Ready Master Mix tubes
samples by one-step real-time PCR. The kit (6 strips x 8 tubes)
is designed for qualitative in vitro diagnosis. Storage: 12 months at 4-8°C

TICK-BORNE ENCEPHALITIS VIRUS (TBEV)

REF. 3150046 48 tests


RealLine TBEV (lyo)
VIROLOGY

Kit content:
Lyophilized kit for the sensitive direct • 1 vial of positive control sample (1 mL)
detection of TBEV RNA in clinical samples • 48 Ready Master Mix tubes
by one-step real-time RT-PCR. The kit is (6 strips x 8 tubes)
designed for in vitro diagnosis and provides Storage: 12 months at 4-8°C
qualitative detection.

ZAIRE EBOLA VIRUS

REF. 3150019 55 tests


Ebola PCR Kit (lyo) Kit content:
In vitro nucleic acid amplification test for • 1 PCR-mix-FL EBOV Zaire
the qualitative detection of the Zaire Ebola • PCR-buffer-C
virus (EBOV Zaire) RNA in the biological • Polymerase (TaqF)
• TM-Revertase (MMlv)
material.
• RT-G-mix-2
• Positive control EBOV Zaire / STI
(C+EBOV Zaire / STI)
• TE-buffer
• Negative control (C–)
• Internal control STI-87-rec (IC)**
• Positive control EBOV Zaire
Storage: 12 months at 4-8°C

62
BIOSYNEX
• 63
BIOCHEMISTRY
INSTRUMENTS IMMUNOLOGY WOMEN’S HEALTH VIROLOGY MYCOLOGY PARASITOLOGY BACTERIOLOGY
ONCOLOGY
64
BIOCHEMISTRY
ONCOLOGY
BIOCHEMISTRY
O N C O LO GY

BIOSYNEX • 65
Summary
RDT - LATERAL FLOW
Toxicology. . . . . . . . . . . . . . . . . . . . . . . 67, 68
Urinary strips . . . . . . . . . . . . . . . . . . . 69, 70
Colorectal cancer . . . . . . . . . . . . . . . . . . 71
Bladder tumor antigen . . . . . . . . . . . 72
C reactiv protein CRP. . . . . . . . . . . . . 72
Prostate-specific antigen PSA . . . . 72
Cardiac makers . . . . . . . . . . . . . . . . . . . . . 73
BIOCHEMISTRY

Hemostasis. . . . . . . . . . . . . . . . . . . . . . . . . . . 73
ONCOLOGY

Micro-albumin . . . . . . . . . . . . . . . . . . . . . . 73

66
RDT - LATERAL FLOW
TOXICOLOGY
DRUGCHECK+ product range
Detection of drugs and their metabolites in the urine.
10 tests per kit
Kit content:
Individual pouches containing each 1 test cassette
and 1 sample transfer pipette.
Storage: 18 months at 2-30°C

Ref. Product name Parameter(s) Cut-off (ng/mL)

1140001_SW Drugcheck+ COT Cotinine 100

1140002_SW Drugcheck+ AMP Amphetamines 1000

1140003_SW Drugcheck+ BAR Barbiturates 300

1140004_SW Drugcheck+ BUP Buprenorphine 10

1140005_SW Drugcheck+ BZO Benzodiazepines 300

1140006_SW Drugcheck+ COC Cocaine 300

1140007_SW Drugcheck+ MDMA Ecstasy, Methylenedioxyamphetamine 500

BIOCHEMISTRY
ONCOLOGY
1140008_SW Drugcheck+ MET Metamphétamine 1000

1140009_SW Drugcheck+ MOP Morphine 300

1140010_SW Drugcheck+ MTD Methadone 300

1140011_SW Drugcheck+ PCP Phencyclidine 25

1140012_SW Drugcheck+ TCA Tricyclic antidepressants 1000

1140013_SW Drugcheck+ THC Cannabis metabolites 50

1140021_SW Drugcheck+ EDDP 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 100

1140022_SW Drugcheck+ FYL Fentanyl 10

1140023_SW Drugcheck+ OXY Oxycodone 100

1140024_SW Drugcheck+ PPX Propoxyphene 300

1140025_SW Drugcheck+ TML Tramadol 100

1140014_SW Drugcheck+ 5 AMP, COC, MDMA, MOP, THC See above

Drugcheck+ 10 AMP, BAR, BZO, COC, MTD, MET, MDMA, MOP,


1140015_SW See above
THC, TCA

Drugcheck+ 11 AMP, BUP, BAR, BZO, COC, MTD, MET, MDMA,


1140016_SW See above
MOP, THC, TCA

BIOSYNEX • 67
RDT - LATERAL FLOW

REF. 1140018 REF. 702018

Drugcheck® Positive & Negative


controls COTININE
Sure’Cup 10
Detection of 10 parameters in 2 x 5 mL
the urine: Positive COTININE control,
AMP, BAR, BZO, COC, MDMA, 400 ng/mL, for Drugcheck+
MET, MOP, MTD, TCA, THC. and Drugcheck® products.
Negative control for all drugs
1 cup and metabolites.
Kit content: Storage : 12 months at 2-8°C
2 in 1 device: collection cup and test
cassette
Storage: 18 months at 2-30°C

REF. 702014
Positive & Negative
control Drugcheck+
2 x 5 mL
Positive control for
REF. 1140019-5 12 parameters of the
Drugcheck+ products:
Drugcheck® Tube AMP, BAR, BUP, BZO, COC,
Saliva 4 MDMA, MET, MOP, MTD, PCP,
TCA, THC.
Detection of 4 parameters in Negative control for all drugs
saliva : AMP (50 ng/mL), COC and metabolites.
BIOCHEMISTRY

(20 ng/mL), MOP (40 ng/mL), Storage : 12 months at 2-8°C


ONCOLOGY

THC (12 ng/mL).


5 tubes
Kit content:
• 5 tests individually packed
(collection system included)
• 5 safety labels
Storage: 18 months at 2-30°C

68
RDT - LATERAL FLOW

URINARY STRIPS

Detection of 1 to 13 parameters in the urine.


Result in 60 seconds (leucocytes: 90 to 120 seconds)
100 strips
1 bottle of 100 URITOP®+ strips. Color guide printed on the bottle.
Storage: 18 months at 2-30°C

Compatible with
Uritop® 300 reader and Mini Uritop® reader
See page 92

Specific gravity

Ascorbic acid
Urobilinogen

Microalbumin
Leucocytes

Créatinin
Ref. Product name
Bilirubin
Ketones
Proteins
Glucose

Nitrites
Blood
pH

BIOCHEMISTRY
ONCOLOGY
1040005 URITOP®+3 • • •

1040006 URITOP®+4 • • • •

1040007 URITOP®+5 • • • • •

1040008 URITOP®+7 • • • • • • •

1040009 URITOP®+10 • • • • • • • • • •

1040010 URITOP®+11 • • • • • • • • • • •

1040011 URITOP®+13 • • • • • • • • • • • • •

• semi-quantitative
• quantitative

BIOSYNEX • 69
RDT - LATERAL FLOW

REF. 108 REF. 6040001

EXACTO URITOP® 8 Uritop®+ controls


Glucose, proteins, pH, occult blood, Positive and negative
ketones, leucocytes, nitrites and specific controls for the Uritop®+
gravity detection in the urine. and EXACTO Uritop®
100 strips ranges.

Kit content: 2 vials


1 bottle of 100 EXACTO URITOP® strips with a • 1 vial of 12 mL for 20
color guide on the bottle positive controls (level
Storage: 18 months at 2-30°C 2) with the Uritop®+ (ref.
1040005 à 1040011) and
EXACTO Uritop® (ref. 108 &
110) product ranges
Compatible with U120 Ultra reader • 1 vial of 12 mL for 20
Voir page 92
negative controls (level
1) with the Uritop®+ (ref.
1040005 à 1040011) and
EXACTO Uritop® (ref. 108 &
REF. 110 110) product ranges

EXACTO URITOP® 10 Storage: 12 months at 2-8°C


Glucose, proteins, pH, occult blood,
ketones, leucocytes, nitrites, specific
gravity, bilirubin and urobilinogen
detection in the urine.
100 strips
BIOCHEMISTRY

1 bottle of 100 EXACTO URITOP® strips with a


ONCOLOGY

color guide on the bottle


Storage: 18 months at 2-30°C

Compatible with U120 Ultra reader


Voir page 92

70
RDT - LATERAL FLOW

COLORECTAL CANCER
REF. 1110003 REF. 6110001

BIOSYNEX® FOB Expert Positive control


Detection of haemoglobin in stool samples Haemoglobin
(cut-off 6 µg Hb/g stool). 1 swab
25 tests Swab positive control for
Kit content: BIOSYNEX® FOB Expert and
• 25 test cassettes Hemotrust®
• 25 individual patient sets including: Storage: 12 months at 2-30°C
- 1 vial of extraction buffer (2 mL),
- 1 sample collection paper with instructions
Storage: 18 months at 2-30°C

REF. 1110002

Hemotrust®
Detection of hemoglobin in stool samples
(cut-off 6 µg Hb/mL).
25 tests

BIOCHEMISTRY
Kit content:

ONCOLOGY
• 25 test cassettes
• 25 vials of extraction buffer (2 mL)
Storage: 18 months at 2-30°C

REF. 1110002-1

Hemotrust® with accessories


Detection of haemoglobin in stool samples
(cut-off 6 µg Hb/mL).
20 tests
Kit content:
• 25 test cassettes
• 25 individual patient sets including:
- 1 vial of extraction buffer (2 mL),
- 1 sample collection paper with instructions
Storage: 18 months at 2-30°C

BIOSYNEX • 71
RDT - LATERAL FLOW

BLADDER TUMOR ANTIGEN


REF. 1110004 10 tests
BIOSYNEX® Bladder Tumor Kit content:
Antigen • 10 test cassettes
• 10 sample pipettes
Detection of bladder tumor antigen in the
urine. Storage: 12 months at 2-8°C

C REACTIV PROTEIN CRP


BIOCHEMISTRY
ONCOLOGY

REF. 1100001 20 tests


BIOSYNEX® CRP Kit content:
Semi-quantitative determination of elevated • 20 test cassettes
levels of CRP in human serum, plasma or • 20 end-to-end capillaries
whole blood. • 20 dropper bottles of diluent (20 mL)
• 20 lancets (for fingerstick whole blood only)
Storage: 18 months at 2-30°C

PROSTATE-SPECIFIC ANTIGEN PSA


REF. 1110001 25 tests
BIOSYNEX® PSA Kit content:
Detection of prostate-specific antigen (PSA) • 25 test cassettes
in human serum, plasma or whole blood. • 25 pipettes
Cut-off 3 ng/mL. • 1 bottle of diluent (3 mL)
Storage: 12 months at 2-30°C

72
RDT - LATERAL FLOW

CARDIAC MARKERS
REF. 1050001 20 tests
BIOSYNEX® Troponin I Kit content:
Detection of troponin (cTn l) in human • 20 test cassette and pipettes
serum, plasma or whole blood. • 20 lancets
Cut-off 1 ng/mL. • 1 dropper bottle of diluent (4 mL)
Storage: 24 months at 2-30°C

HEMOSTASIS
REF. 1050002 10 tests
BIOSYNEX® D.Dimer Kit content:
Detection of thrombosis (D.Dimer) in human • 10 test cassette and pipettes
plasma and whole blood. • 20 lancets
Cut-off 500 ng/mL FEU. • 1 dropper bottle of diluent (2 mL)
Storage: 24 months at 2-30°C

BIOCHEMISTRY
ONCOLOGY
MICRO-ALBUMIN
REF. 1040001 20 strips
BIOSYNEX® Micro-Albumin Kit content:
Semi-quantitative detection of micro- • 20 strips in individual pouches
albumin in the urine. • Color scale
Storage: 12 months at 2-30°C

BIOSYNEX • 73
74
W O M E N ’ S H E A LT H

WOMEN’S HEALTH
Summary
RDT - LATERAL FLOW
Obstetrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Hormonology. . . . . . . . . . . . . . . . . . . . . . . . 80
WOMEN’S HEALTH

76
RDT - LATERAL FLOW
OBSTETRICS
REF. 6090001
IGFBP-1 Positive
Control
1 x 0.5mL
1 vial of 0.5 L for 10 controls
with du test AMNIOQUICK®
CARD (ref. 1090004) or 10
controls with AMNIOQUICK®
(ref. 1090003).
Storage: 12 months at 2-8°C
REF. 1090003

AMNIOQUICK®
Rapid test for premature rupture of fetal membranes.
Detection of IGFBP-1. Strip format.

10 strips

Kit content:
10 pouches, each containing:
• 1 test strip
• 1 sterile vaginal swabs
• 1 single-dose diluent dropper
• 1 patient sheet
(with simplified instructions and result recording)
Storage: 18 months at 2-30°C

REF. 1090005

AMNIOQUICK® CARD

WOMEN’S HEALTH
Rapid test for premature rupture of fetal membranes.
Detection of IGFBP-1. Cassette format.

10 tests

Kit content:
10 individual pouches, each containing:
• 1 test cassette
• 1 sterile vaginal swabs in nylon CE 0123
• 1 single-dose diluent dropper
• 1 patient sheet
(with simplified instructions and result recording)
Storage: 18 months at 2-30°C

Compatible with Biosynex Reader


See page 92

BIOSYNEX • 77
RDT - LATERAL FLOW

REF. 1090004 REF. 6090002

AMNIOQUICK® DUO + IGFBP-1 & AFP


Rapid test for premature rupture of fetal Positive Control
membranes. 1 x 0.5mL
Detection of IGFBP-1 and AFP.
1 vial of 0.5 mL for 10 controls
10 tests with AMNIOQUICK® DUO+
(ref. 1090004).
Storage: 12 months at 2-8°C

Kit content:
10 individual pouches, each containing:
• 1 test cassette
• 1 sterile vaginal swab (CE 0123)
• 1 single-dose of diluent
• 1 patient sheet
(with simplified instructions and result recording)
Storage: 18 months at 2-30°C

Compatible with Biosynex Reader


See page 92

REF. 1090009

PREMAQUICK®
WOMEN’S HEALTH

Rapid predictive test of imminent


delivery.

10 tests

Kit content:
10 individual pouches, each containing:
• 1 test cassette
• 1 sterile vaginal swab (CE 0123)
• 1 single-dose of diluent
• 1 patient sheet
(with simplified instructions and result recording)
Storage: 18 months at 2-30°C

78
RDT - LATERAL FLOW

pH controls
1 x 2 mL
Vial of 2 mL for 13 controls
with AMNIOTEST (ref. PL901)
REF. 1090006 or 13 controls with
BIOSYNEX® pH (ref. 1090006).
BIOSYNEX® pH Storage: 12 months at 15-30°C
For the determination of vaginal pH in vaginal samples.
20 tests
Kit content:
20 tests in individual pouches with interpretation card.
Storage: 24 months at 2-30°C Ref. Product name

PL.910 pH 5 control

PL.911 pH 5.5 control

PL.912 pH 6 control
REF. PL.901

AMNIOTESTTM PL.913 pH 6.5 control


Determination of vaginal pH in vaginal samples for the
PL.914 pH 7 control
detection of premature fetal membrane rupture in pregrant
women. PL.915 pH 7.5 control
100 swabs
Kit content:
100 swabs in individual pouches.
Storage: 24 months at 2-30°C

WOMEN’S HEALTH

BIOSYNEX • 79
RDT - LATERAL FLOW

HORMONOLOGY

REF. 1090001 REF. 702013

MINITEST® hCG 10 hCG Positive and


Qualitative detection of human chorionic Negative controls
gonadotropin (hCG) in human urine, serum 2 x 5 mL
or plasma.
2 vials of 5 mL for hCG
50 tests positive and negative
controls with MINITEST
Kit content:
hCG 10 (ref. 1090001) and
• 50 test cassettes
BIOSYNEX® hCG 20.
• 50 sample pipettes
Cut-off: 10 mUI/mL Storage : 12 months at 2-8°C
Storage: 18 months at 2-30°C

Compatible with Biosynex Reader


See page 92

REF. 1090002

BIOSYNEX® hCG 20
Qualitative detection of human chorionic
gonadotropin (hCG) in human urine,
serum or plasma.
40 tests
Kit content:
• 40 test cassettes
• 40 sample pipettes
Storage: 18 months at 2-30°C
WOMEN’S HEALTH

REF. 10016L

ExactoPro® Rapid hCG


Qualitative detection of human chorionic
gonadotropin (hCG) in the urine.
25 tests
Kit content:
25 pregnancy tests
Cut-off : 25 mUI/mL.
Storage: 18 months at 2-30°C

80
BIOSYNEX
• 81
BIOCHEMISTRY
INSTRUMENTS IMMUNOLOGY WOMEN’S HEALTH VIROLOGY MYCOLOGY PARASITOLOGY BACTERIOLOGY
ONCOLOGY
82
I M M U N O LO GY
IMMUNOLOGY
Summary
RDT - LATERAL FLOW
Celiac disease. . . . . . . . . . . . . . . . . . . . . . . 85
Rhumatoid factors . . . . . . . . . . . . . . . . . 85

AGGLUTINATION
Rhumatoid factors . . . . . . . . . . . . . . . . . 86
IMMUNOLOGY

84
RDT - LATERAL FLOW
CELIAC DISEASE
REF. 858865

EXACTO® Gluten Test


Self-test for the detection of Celiac disease
in capillary whool blood.
1 self-test
Kit content:
• 1 test cassette
• 1 sterile lancet
• 1 sample pipette
• 1 bottle of diluent
• 1 alcohol wipe
• 1 plaster
• Instructions for use
Storage: 12 months at 2-8°C

RHUMATOID FACTORS
REF. CCPOINT20

CCPOINT®
Detection of cyclic citrullinated peptide
(CCP) in human serum, plasma and whole
blood.
20 tests
Kit content:
• 20 cassettes
• 22 disposable pipettes
• 2 dropper bottles of diluent 3 mL
Storage: 12 months at 2-25°C
IMMUNOLOGY

BIOSYNEX • 85
AGGLUTINATION
RHUMATOID FACTORS
REF. 523200

Polyartest Fumouze®
Waaler-Rose type immunologic slide test
for the detection of rheumatoid factors.
25 tests
Kit content:
• Revealing reagent, 1.3 mL
• Control reagent, 1.3 mL
• Positive control, 0.5 mL
• Negative control, 0.5 mL
• 9 slides (x 3 tests)
• 50 stirrers
• 4 droppers

REF. 535600

Polyartitre Fumouze®
Waaler-Rose type immunologic test on
a microtitration plate for the quantitative
determination of rheumatoid factors.
220 tests or 20 reactions of 11 dilutions
Kit content:
• Revealing reagent, 4.4 mL
• Control reagent, 1 mL
• Absorbant, 2 mL
• Buffer, 55 mL
• Positive control, 0.5 mL
• Negative control, 0.5 mL
• 3 microplates
• 2 droppers

REF. 556000

Rhumalatex Fumouze®
Latex slide test for qualitative and semi-
quantitative determination of rheumatoid
factors.
60 tests
IMMUNOLOGY

Kit content:
• Sensitized latex, 3 mL
• Positive control, 1 mL
• Negative control, 1 mL
• Buffer, 60 mL
• 10 slides (x 6 tests)
• 60 stirrers
• 1 dropper (50 μL)

86
INSTRUMENTS
INSTRUMENTS
Summary
READERS
Rapid test Reader. . . . . . . . . . . . . . . . . . 91
Strip Reader . . . . . . . . . . . . . . . . . . . . 92, 93

MOLECULAR BIOLOGY
Extraction Instrument. . . . . . . . . . . . . 94
qPCR Instrument . . . . . . . . . . . . . . . . . . . 95

STAINING INSTRUMENT
INSTRUMENTS

88
READERS
RAPID TEST READERS

REF. 5060001

BIOSYNEX® READER
Reader and printer for qualitative and quantitative
assessment.
1 unit
Specifications:
• Compatibility:
° Biosynex® S.pneumoniae
° easyTetanotop® & Tetanotop®
° Immunoquick® C. difficile GDH
° Immunoquick® Tox A&B
° Biosynex® CryptoPS
° Amnioquick® Card
° Amnioquick® Duo+
• Traceability: SD card, printer, barcodes, L.I.S connection
• Calibration
• Autonomy: 8 hours on battery
• Size: 210 x 130 x 70 mm
• Weight: 800 g

REF. 5060002

PAPER ROLLS
10 rolls
INSTRUMENTS

BIOSYNEX • 89
READERS

STRIP READERS

REF. 5040001

URITOP 300® READER


URITOP+ urinary strip reader with waterproof
keyboard.
1 instrument
Specifications:
• Reader for URITOP® +5 (ref. 1040007), +7 (ref. 1040008),
+10 (ref. 1040009), +11 (ref. 1040010), +13 (ref.1040011)
• 300 samples /hour
• Qualitative and quantitative reading
• Waterproof keyboard
• Size: 275 x 250 x 170 mm
• Weight: 1.3 kg

REF. 5040002

Mini URITOP® READER


Portable reader for URITOP+ urinary strips.
1 instrument
Specifications:
• Reader for URITOP +3 (ref.1040005), +4 (ref.1040006),
+5 (ref. 1040007), +7 (ref. 1040008), +10 (ref. 1040009)
• 40 to 50 samples /hour
• Qualitative and quantitative reading
• Size: 188 x 74 x 77 mm
• Weight: 460 g

REF. 5040007

EXACTO URITOP® U120 ULTRA


Reader for EXACTO Pro URITOP® 8
and EXACTO Pro URITOP® 10 urinary strips.
1 instrument
Specifications:
• Reader for EXACTO Pro URITOP® 8 (ref.108) and
EXACTO Pro URITOP® 10 (ref. 110)
• Qualitative and quantitative reading
• Size: 188 x 74 x 77 mm
• Weight: 460 g
INSTRUMENTS

90
READERS

REF. 5040003

URITOP Barcode Reader


Barcode reader for URITOP 300 & URITOP 120 ULTRA.
1 instrument

REF. 5040004

Calibration strips for URITOP 300


1 bottle of 25 calibration strips.
1 bottle

REF. 5040005

PRINTER
External printer for use with Mini URITOP® READER.
1 instrument

REF. 5040006

PRINT PAPER
Print paper for use with URITOP 300 Reader (ref. 5040001) and PRINTER (ref. 5040005).
5 rolls
Specifications:
• Print 200 results with 1 roll
• Roll size: 51 mm x 20.5 mm

INSTRUMENTS

BIOSYNEX • 91
MOLECULAR BIOLOGY
EXTRACTION INSTRUMENT
REF. 5060012

AMPLIX-12
Nucleic acids automated extractor.
1 instrument
Specifications:
• Automatic extraction of 1 to 12 samples
in series or case by case
• UV sterilization
• Barcode reader for extraction protocols
• Power supply: 110-240 V
• Dimensions: 560 x 510 x 580 mm
• Weight: 60 kg

REF. 3030001 REF. 3150001

Bacterial DNA Extraction Kit Viral Nucleic Acid


Bacterial genomic DNA extraction kit. Extraction Kit
48 extractions Viral genomic DNA and RNA extraction kit.
Kit content: 48 extractions
• 48 samples tubes Kit content:
• 48 eluate tubes • 48 samples tubes
• 48 cartridges reagent • 48 eluate tubes
• 48 filter tips • 48 cartridges reagent
• 48 small tips • 48 filter tips
• 48 piercing tips • 48 small tips
• 48 reaction chambers • 48 piercing tips
• 1 bottle of BL2B buffer • 48 reaction chambers
Storage: 12 months at 15-25°C • 1 tube of RNA Carrier
Storage: 12 months at 15-25°C

REF. 3130001

Blood DNA Extraction Kit 200


Human genomic DNA and RNA
extraction kit.
48 extractions
Kit content:
• 48 samples tubes
• 48 eluate tubes
• 48 cartridges reagent
• 48 filter tips
• 48 small tips
• 48 piercing tips
• 48 reaction chambers
Storage: 12 months at 15-25°C
INSTRUMENTS

92
MOLECULAR BIOLOGY

qPCR INSTRUMENT

REF. 5060014 REF. 5060015

AMPLIX-NG48 AMPLIX-NG96
Real-time PCR machine. Real-time PCR machine.
1 instrument 1 instrument
Specifications: Specifications:
• Amplification of 1 to 48 samples • Amplification of 1 to 96 samples
• 4 or 5 detection channels (FAM, HEX, ROX, • 4 or 5 detection channels (FAM, HEX, ROX,
Cy5, Cy5.5), with possible Multiplexing Cy5, Cy5.5), with possible Multiplexing
• Intuitive software with automatic • Intuitive software with automatic
results interpretation results interpretation
• Open system • Open system
• L.I.S. compatible • L.I.S. compatible
• Power supply: 220 V • Power supply: 220 V
• Dimensions: 210 x 480 x 310 mm • Dimensions: 210 x 540 x 540 mm
• Weight: 17 kg • Weight: 17 kg

INSTRUMENTS

BIOSYNEX • 93
STAINING INSTRUMENT

REF. 502121

SMART Color
Slide stainer for haematology and
bacteriology.
1 unit
Specifications:
• Stainer with 5 tanks
• Rack for 24 slides
• Programming card and power cable
INSTRUMENTS

94
BIOSYNEX
• 95
BIOCHEMISTRY
INSTRUMENTS IMMUNOLOGY WOMEN’S HEALTH VIROLOGY MYCOLOGY PARASITOLOGY BACTERIOLOGY
ONCOLOGY
Index
A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Drugcheck+ MDMA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Drugcheck+ MET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
67
67
Drugcheck+ MOP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Adenotop®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Drugcheck+ MTD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
AMNIOQUICK® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Drugcheck+ OXY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
AMNIOQUICK® CARD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Drugcheck+ PCP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
AMNIOQUICK® DUO +. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Drugcheck+ PPX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
AMNIOTESTTM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Drugcheck+ TCA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
AMPLIX-12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Drugcheck+ THC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
AMPLIX-NG48. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Drugcheck+ TML. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
AMPLIX-NG96. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Drugcheck® Sure’Cup 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
ASO Latex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Drugcheck® Tube Saliva 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Aspergillosis Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

B E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

easyTETANOTOP®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Bacterial DNA Extraction Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Ebola PCR Kit (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Bichro-Dubli Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 EBV Quantitative PCR Kit liquid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Bichro-Latex Albicans Fumouze® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 EXACTO Gluten Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Bichro-Latex Amibe Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 EXACTO URITOP® 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Bilharziosis Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 EXACTO URITOP® 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
BIOSYNEX® Adenovirus / Rotavirus BSS. . . . . . . . . . . . . . . . . . . . . . . . . . 63 EXACTO PRO® HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
BIOSYNEX® Bladder Tumor Antigen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 EXACTO PRO® Rapid hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
BIOSYNEX® CRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 EXACTO URITOP® U120 ULTRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
BIOSYNEX® CryptoPS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
BIOSYNEX® D.Dimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
BIOSYNEX® Dengue Combo BSS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BIOSYNEX® Dengue IgG & IgM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Fast differentiator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
BIOSYNEX® Dengue NS1 BSS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 First Response® HBsAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
BIOSYNEX® EBV IgG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 First Response® HCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
BIOSYNEX® EBV IgM/Mono. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 First Response® HIV 1-2.O. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
BIOSYNEX® FOB Expert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 First Response® MALARIA Ag. P. falciparum . . . . . . . . . . . . . . . . . . . . . 30
BIOSYNEX® hCG 20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Fluo RAL kit (Auramine) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
BIOSYNEX® Legionella. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
BIOSYNEX® Malaria P.f / P.v. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
BIOSYNEX® Malaria P.f / Pan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BIOSYNEX® Micro-Albumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Glabrata R.T.T. Fumouze® («Rapid Trehalose Test»). . . . . . . . . . . . . . 42
BIOSYNEX® Mycoplasma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Gram-Nicolle kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
BIOSYNEX® pH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

H
BIOSYNEX® PSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
BIOSYNEX® Reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BIOSYNEX® S. pneumoniae. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Haemoglobin control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
BIOSYNEX® Strep A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
HAVTOP® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
BIOSYNEX® Troponin I. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
hCG Positive and Negative controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Blood DNA Extraction Kit 200. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
HBV Real-TM Quant (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Bordetella pertussis parapertussis PCR liquid Kit . . . . . . . . . . . . . . . 20
HCV Real-TM Quant (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Borelli pre-poured medium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 HCV/HBV/HIV Real-TM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Borelli Medium. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 HCV/HBV/HIV1/HIV2 Real-TM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Hemotrust®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
C
71
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hemotrust® with accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
HEVTOP®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Calibration strips for URITOP 300. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 HIV Real-TM Quant (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Candidiasis Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 HPV 14 Screening & 16, 18, 45 Typing Quant. . . . . . . . . . . . . . . . . . . . 68
Carbolic gentian violet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 HSV I/II Typing Real-TM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
CCPOINT®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Hydatidosis Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
CELLSCHECK. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
CELLSCHECK TEST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Chlamydia pneumoniae PCR liquid Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chlamydia trachomatis PCR liquid Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 I.H.A. Amoebiasis Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
CHLAMYTOP®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 IgA Negative control Helicobacter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
CMV Quantitative PCR Kit liquid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 IgA Positive control Helicobacter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
IgA Positive control Yersinia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IGFBP-1 & AFP Positive Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
IGFBP-1 Positive Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Diluted Ziehl’s Fuchsin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 IgG Positive control Helicobacter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Distomatosis Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 IgG Positive control Treponema. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Drugcheck+ 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IgG Positive control Yersinia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Drugcheck+ 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IgG/IgA Negative control Helicobacter. . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Drugcheck+ 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IgG/IgA Negative control Yersinia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Drugcheck+ AMP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IgG/IgM Negative control Treponema . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Drugcheck+ BAR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IgM Positive control Treponema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Drugcheck+ BUP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IMMUNOQUICK® C.DIFFICILE GDH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Drugcheck+ BZO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IMMUNOQUICK® NoRotAdeno . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Drugcheck+ COC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IMMUNOQUICK® Norovirus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Drugcheck+ COT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IMMUNOQUICK® TOX A & B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Drugcheck+ EDDP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 INFLUENZATOP® BSS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Drugcheck+ FYL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Iodesine-Color Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

96
K
RealLine Chlamydia trachomatis / Ureaplasma urealyticum (lyo).1 7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RealLine CMV Quantitative (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
KD-Color GE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 RealLine EBV Quantitative (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Krusei-Color Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 RealLine Gardnerella vaginalis
/ Trichomonas vaginalis (lyo) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 37
L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RealLine Gardnerella vaginalis (lyo) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Legionella pneumophila PCR liquid Kit . . . . . . . . . . . . . . . . . . . . . . . . . . 20 RealLine Helicobacter pylori. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
RealLine HHV-6 (lyo) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RealLine Mycoplasma genitalium (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
RealLine Mycoplasma hominis / genitalium (lyo). . . . . . . . . . . . . . . . 17
M.I.F. - Color Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Malaria Positive Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RealLine Mycoplasma hominis (lyo) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
38
Mini URITOP® READER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 RealLine N. gonorrhoeae (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
MINITEST® hCG 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 RealLine Rubella (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
MNITOP® Optima. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 RealLine TBEV (lyo) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
MycetBlue. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
MTB Real-TM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 RealLine Treponema pallidum (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
MycetColor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 RealLine Trichomonas vaginalis (lyo) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
MycetFluo. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 RealLine Ureaplasma urealyticum / parvum (lyo). . . . . . . . . . . . . . . . 18

N
RealLine Ureaplasma urealyticum / parvum (lyo). . . . . . . . . . . . . . . . 49
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RealLine Ureaplasma urealyticum (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Neisseria gonorrhoeae PCR liquid Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 RealLine VZV (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
N. gonorrhoeae/ C. trachomatis/ M. genitalium/ T. vaginalis Real-TM. . . 18 recomLine® Yersinia IgA [IgM upon request]. . . . . . . . . . . . . . . . . . . . . 21
N. gonorrhoeae/ C. trachomatis/ M. genitalium/ Real-TM. . . . . . 19 recomLine® Yersinia IgG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

P
Rhumalatex Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RPR Card test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
PALUTOP® + Pf. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 RSVTOP®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
PALUTOP® +4 OPTIMA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
PAPER ROLLS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Para-Selles® Optima IODESINE A1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Para-Selles® Optima BAILENGER A2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Para-Selles® Optima IODESINE/BAILENGER A3. . . . . . . . . . . . . . . . . 34 SMART Color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Para-Selles® Optima TECHNIQUE B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Staph Aureus Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
pH level 5.0 Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Staph Aureus Fumouze® accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
pH level 5.5 Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
STREPTATEST®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
pH level 6.0 Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
pH level 6.5 Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 STREPTOP® A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
pH level 7.0 Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Streptozyme Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
pH level 7.5 Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 SYPHILITOP®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Polyartest Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

T
Polyartitre Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Positive control Adenovirus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Positive control Haemoglobin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Positive control Chlamytop®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 TETANOTOP® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Positive control Norovirus gp I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Toxo-HAI Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Positive control Norovirus gp II. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Toxolatex Fumouze®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Positive control Rotavirus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Positive control Tetanus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Triplex HIV, HCV, HBsAg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Positive and Negative controls C. difficile Tox A & B. . . . . . . . . . . . . . . 9 T. vaginalis/ N. gonorrhoeae/ C. trachomatis Real-TM . . . . . . . . . . 19
Positive and Negative controls Cotinine . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Positive and Negative controls Drugcheck+ and Drugcheck®. 69
PREMAQUICK®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 U . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PRINTER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Undiluted Ziehl’s Fuchsin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
PRINT PAPER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
PVP stabilised Lugol’s solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Uritop®+ controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
PYLORITOP® Ab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 URITOP®+10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
PYLORITOP® Ag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 URITOP®+11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
PYLORITOP® Ag with accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
URITOP®+13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Q . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
URITOP®+3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
URITOP®+4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Quality distilled water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 URITOP®+5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

R
URITOP®+7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . URITOP 300® READER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
RealLine Anaplasma / Ehrlichia (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 URITOP BARCODE READER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
RealLine Borrelia burgdorferi s.l. (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
RealLine C. trachomatis (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
RealLine Candida albicans (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RealLine Candida albicans / Gardnerella vaginalis (lyo). . . 17, 46
Varicella-Zoster Virus (VZV) PCR Kit Liquid. . . . . . . . . . . . . . . . . . . . . . . . 61
RealLine Chlamydia trachomatis / Neisseria gonorrhoeae (lyo) . 17
RealLine Chlamydia trachomatis Viral Nucleic Acid Extraction Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
/ Trichomonas vaginalis (lyo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 37

BIOSYNEX • 97
GENERAL TERMS AND CONDITIONS 2019 • INTERNATIONAL
Pursuant to Article L.441-6 of the Commercial Code, the General Terms and Conditions of Sale of Biosynex S.A form the basis
of sales negotiation between the parties relating to the sale of Biosynex S.A. systems, reagents, and consumables (Products).
They govern all orders placed by the Client and take precedence over all conditions of purchase, unless expressly agreed
in writing by the Biosynex Sales Department. The act of placing an order implies that the Client fully and unreservedly accepts the
Biosynex S.A. General Terms and Conditions of Sale, which are available in full at www.biosynex.com or www. diagdirect.com,
and relinquishes its own Conditions of Purchase, whether shown on their purchase orders, acknowledgements of receipt,
or correspondence.

1 • PURCHASE ORDERS 4 • PRICES


Only purchase orders submitted in written form (e-mail, fax, regular Prices quoted excl. VAT are subject to the addition of VAT at the rate
mail) or by EDI addressed to the Sales Administration at Biosynex in force on the day of shipment. The prices of systems, reagents,
S.A. will be accepted. All orders must quote the Client’s account consumables, and accessories are those shown in the price list
number, delivery address and invoicing address, the item reference, in force on the day of shipment. Unless otherwise specified in
its description in full, its price, its quantity, and the desired dispatch the contract of sale.
or delivery date. Biosynex S.A. reserves the right to refuse to accept
or to suspend the purchase order if it considers that the Client’s 5 • TRAINING
position is such as to present a risk that Biosynex S.A. will not be able Depending on the system and any special conditions mentioned
to recover the outstanding receivables, or in the event of the non- in the contract of sale, arrangements may be made for a training
availability of the Product. All purchase orders with a value of less session to be held. The arrangements for this training session,
than €200 excl. VAT will be subject to a flat-rate surcharge of €28 excl. including the date, location, duration, and the number of Client’s
VAT to help cover handling and shipping costs. participants will be mutually agreed between the Parties when
drawing up the purchase order or the contract governed by these
2 • SUBSCRIPTION TERMS AND CONDITIONS General Conditions of Sale..
The term Subscription refers to a purchase order that includes
a delivery schedule. Subscriptions can be arranged for all current 6 • BILLING
and regularly ordered products. Deliveries with a value of less than Reagents, consumables, and accessories are billed at the date
€200 excl. VAT will be subject to a flat-rate surcharge of €28 excl. VAT of their dispatch, as well as any standard equipment that the Client
to help cover handling and shipping costs. Subscription is mandatory is able to set up itself. Systems requiring the intervention of Biosynex
for the following product types: special manufactures, animal bloods S.A personnel and/or of the subcontracting company to render
and red blood cells, products with a short shelf life. Purchase orders them operational, are billed at the date of delivery. Invoices are
on subscription are accepted for a fixed period of not less than 12 sent in hard-copy form or electronically. Unless Biosynex S.A’s Sales
months for delivery at intervals (monthly) on special terms as agreed Administration queries the invoices raised by the Client within 30
between the Client and Biosynex S.A. These terms and conditions days from their date of issue, the amounts of the said invoices may be
may be cancelled at any time with two months’ notice in writing, taken as having been accepted.
as from the 4th month of subscription. Any changes to be made 7 • PAYMENT
during any period must be advised at least 5 working days prior Except when Biosynex S.A insists on payment prior to delivery,
to the delivery date scheduled for the 20th of each month. payment will be made at 30 days from invoice date, either
3 • DELIVERY by direct debit or by bank transfer. Where payment is by direct debit,
Biosynex S.A undertakes to supply the Client with the Products shown the invoice serves as drawdown notice. In case of payment
on the purchase order accepted by Biosynex S.A. The Products will by automatic collection, the invoice is worth of collection notice.
be delivered in accordance with the terms and conditions set out As required by the NRE law of 15 May 2001 amending Articles
in the purchase order accepted by Biosynex S.A, on the understanding L441-3 et following of the French Commercial Code, penalties
that the deadlines given below are given for reference only. for delay will automatically be applied in the event that the payment
period between the parties is exceeded. In cases of late payment,
a) Reagents and consommables late penalties applicable from the day following the settlement date
Reagents available from stock are delivered at the earliest shown on the invoice are payable by the Client to Biosynex S.A,
opportunity; a reagent ordered before 11:30am Monday to Friday and these apply automatically. This late payment interest will be up
can be delivered the following day subject to a flat-rate charge to 2% per month, to which fixed-rate compensation of €40 will be
of €10 excl. VAT to cover handling and administrative charges added to cover recovery costs (Decree No. 2012-1115 of October 2,
for all orders received by e-mail, fax, or regular mail (non-EDI). 2012). Biosynex S.A may exact supplementary compensation for any
In the event of temporary unavailability, information to that effect costs involved in collecting the debt. Notwithstanding the foregoing,
will be sent within 72 working hours. Order balances will be shipped in the event of failure by the Client to pay a single installment,
as soon as available. Non-EDI urgent handling: a reagent ordered non-compliance with the terms of payment, or if Biosynex S.A should
before 2:00pm Monday to Friday can be delivered the following consider the Client’s financial position to be such as to compromise
day subject to a flat-rate charge of €10 excl. VAT to cover handling the collection of its debts, Biosynex S.A reserves the right to:
and administrative charges. – immediately cancel all payment facilities and special commercial
b) Systems terms allowed,
Systems will be delivered within an estimated period of 6 (six) weeks – suspend or cancel all outstanding orders without prior notice
following notification of acceptance of the duly signed purchase or compensation,
order. In the case of financing by a finance company, the date – demand payment on account before every shipment or apply any
used will be the date on which Biosynex S.A receives the financing other means of payment of Biosynex S.A’s choosing before making
agreement from the said company. Assembly and installation will be any further deliveries,
carried out at the Client’s premises. Following installation, the Parties – demand immediate payment of the entirety of the outstanding
will sign the Certificate of Installation for the corresponding system, balance owed.
in formal acknowledgement of receipt of the system by the Client.
As regards the sale of associated computerized equipment, 8 • LEASING
the Client will need to directly approach a computer services In the event that the system is funded by leasing, the funding
company of its choosing to perform the work of connecting up organization will assume the rights and obligations under these
the various pieces of equipment. Biosynex S.A will not accept liability General Conditions of Sale in its capacity as Client and act as
for the delay in the work of connecting the equipment carried out guarantor of compliance with the rights and obligations of the end
by the computer services company. user under this agreement.

BIOSYNEX FUMOUZE • 98
9 • TRANSFER OF RISK AND RETENTION OF TITLE or for a consideration, a gift, or on any other terms, whether within
Every Product sold remains the property of Biosynex S.A until such the country or outside it, Biosynex S.A will be de facto and without any
time as the principal amount and incidentals have been paid in full. further conditions released from its obligation to fund and arrange
Biosynex S.A reserves the right to use every means at its disposal for the disposal of said waste within the meaning of the decree.
to take back the Product or arrange to have it returned in the event Biosynex S.A agrees to pass on all necessary information relating
of non-payment, with defaulting on payment possibly entailing to the equipment concerned. The Client will be solely responsible
action to recover the Product. The part of the price already paid for good documentary, technical, and administrative management.
to Biosynex S.A in return for the use of the Product will be forfeit; The Client will be answerable for this to Biosynex S.A and will
it does not constitute a payment within the meaning of this clause, indemnify Biosynex S.A and hold them harmless from any liability,
with the presentation of a title creating an obligation to pay. Biosynex costs, actions by third parties, including by the authorities concerned,
S.A covers the risks and costs of transporting the Product. The risks in the event of the faulty execution of this obligation.
are transferred to the Client on delivery of the Product, being the date
from which the Client is responsible for all damage occurring to the 14 • RESPONSABILITY
Products or arising from the Products. The latter should therefore take The Client, as a medical biology professional, will take all necessary
steps to ensure that its insurance covers the delivered Product from measures to ensure that the systems, reagents, and software are
that point onward. used in compliance with the applicable legal requirements and
standards, in particular as regards the installation of systems and
10 • TRACEABILITY the performance of determinations and tests. As an expert in the field,
Products sold by Biosynex S.A present certain specific technical the Client will not only use systems strictly in accordance with Biosynex
characteristics that require the rules of traceability to be observed. S.A guidelines but will also be solely responsible for the interpretation
Biosynex S.A consequently reserves the right to sell their products and use of the results obtained. The Client guarantees Biosynex
exclusively to professionals authorized to provide the results S.A against any third-party action relating to the consequences of
of biologic determinations and tests. The Client agrees to observe all the improper use of the Products. Biosynex S.A’s liability for any loss
rules on traceability that apply to products it orders or uses. Under or damage resulting from any and all causes, including negligence,
no circumstances will Biosynex S.A be held liable for non-compliance shall not in any event exceed the sale price of the Products that are
with these rules beyond the delivery point indicated by the Client the subject of the claim; or, at the sole discretion of Biosynex S.A,
when placing the purchase order. the repair or replacement of said Products, plus associated carriage
costs. Biosynex S.A will not be held liable for indirect or consequential
11 • CLAIMS damages, whether the action be in contract, tort, or otherwise.
All logistic claims should be sent to the Sales Administration
Department of Biosynex S.A and all technical claims to the Technical 15 • PERSONAL DATA
Department within 30 days of receipt of the Products. No Product Certain personal information relating to the Client (in particular
returns are admissible without the prior agreement of Biosynex S.A its telephone numbers, address details, etc.) will be subject to data
which may, at its discretion, decide to replace them. processing operations that have been declared to CNIL [French
authority responsible for data protection legislation] by Biosynex
12 • GARANTIES S.A in accordance with its obligations as a body responsible
For the duration of the warranty period, Biosynex S.A undertakes for processing personal data divulged to it by the Client. The Client
to provide maintenance free of charge or to arrange for a specialist agrees to its personal data being used by Biosynex S.A and other
maintenance company to provide this service on its behalf, under organizations belonging to the Biosynex S.A group in accordance
the maintenance terms quoted in the sales agreement. At all events, with the provisions of the French Data Protection Act of January
the Client is expected to observe the conditions of practice that 6, 1978, as amended by the Act concerning the “protection
applicable to it, in particular those relating to medical biology, as set of individuals with regard to the processing of personal data”
out in the Public Health Code. of August 6, 2004. In accordance with said Act, the Client has a right
a) Reagents to apply to have information about it amended or corrected.
Biosynex S.A reagents are intended for use in in vitro diagnostics. Within the framework of warranty operations relating to the systems
Their conformity with the specifications cited in the technical data sold by Biosynex S.A, the Client agrees to Biosynex S.A having
sheets is warranted until their date of expiry. access to the personal particulars of patients for the time necessary
b) Systems to enable the operations concerned to be carried out. In accordance
Systems are warranted under the conditions mentioned above for with the provisions of Article 35 of said Act and on receipt of written
12 months from the signature date of the Certificate of Installation. instructions from the Client, Biosynex S.A agrees that as soon as it
Biosynex S.A’s warranty will not apply to any Product that has been starts to perform the operation concerned it will put in place suitable
handles or used in a manner that does not conform to the instructions safety devices and procedures, such as to strictly ensure the safety,
for use provided by Biosynex S.A. The above warranties and the integrity, and confidentiality of the Client’s data.
warranty in respect of latent defects are the sole warrantied offered The Client and Biosynex S.A agree to fulfill their respective obligations
by Biosynex S.A. and are accepted by the Client to the exclusion in conformity with said Act of January 6, 1978. It is important to note
of all other warranties, whether oral or written, express or implied, that pursuant to Article 34 of the Act of January 6, 1978, the Client
and in particular any warranty relating to products being adapted has responsibility for the processing of personal particulars that
to a particular use. it passes on to Biosynex S.A which, acting on the Client’s instructions,
is considered a processor within the meaning of the French Data
13 • WASTE Protection Act.
Pursuant to Decree No. 2012-617 of May 2, 2012 on the management
of WEEE (waste electrical and electronic equipment), it is agreed that 16 • ASSIGNMENT
Biosynex S.A will remove and process the waste arising from systems The Client agrees not to assign or transfer in any way whatsoever any
identified and marked as being electrical and electronic equipment. or all of its rights and obligations under the terms of the agreement
The obligations of the Client (especially as regards decontamination to a third-party competitor of Biosynex S.A. In the event that the Client
such as to render equipment safe prior to removal, erasing patient should be the subject of a change of control or of a restructuring
data, etc.) to which the Client must strictly adhere, are set out in the operation (unless within the group) such as a merger, the purchase
“Operating Guide” of the system concerned. The terms on which order will not continue to be applicable except with the prior and
systems are made available, together with the tariffs associated express consent of Biosynex S.A. The Client hereby accepts that
with these services, will be provided to the Client at its request. Biosynex S.A may transfer the order or undergo a change of control
It should be noted that the Client, as keeper of the equipment, will be in favour of a third party.
responsible for the integrity of the system and for making it available 17 • APPLICABLE LAW - JURISDICTION
to Biosynex S.A. All expenses incurred or losses sustained due to These General Terms Conditions of Sale are governed as regards
the Client’s negligence or to any breach of its obligations referred their validity, interpretation, and implementation by French law. In the
to above will give rise to compensation in favour of Biosynex S.A. event of a dispute, the courts of Strasbourg have sole jurisdiction,
The Client expressly agrees that in the event of the resale by it even in cases involving multiple defendants or recourse in warranty.
of equipment supplied by Biosynex S.A and/or any transfer of custody
by whatever means, by way of loan or rental, whether free of charge

Biosynex • Société anonyme au capital de 913 544,80 € • Siège social : 22 Boulevard Sébastien Brant, 67400 ILLKIRCH-GRAFFENSTADEN
friendly-agence.com © getty
C ATA LO G U E • U K V 5 • 0 8 / 2 0 1 9

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