EUROLINE Myositis Profile 3 (IgG) EUROIMMUN

Immunoblots

Autoantibody determination:
EUROASSAY:
flexible profiles of up to 7 antigens from:
Control OJ PL-12 SRP PM-Scl75 Ku ENA and related antigens: nRNP/Sm, Sm,
SS-A, Ro-52, SS-B, Scl-70, Jo-1, dsDNA,
histones, nucleosomes, CENP B,
PM-Scl, ribosomal P-proteins, AMA M2
liver antigens: LKM-1, LC-1, SLA/LP,
MYO AMA M2, M4, M9
ANCA antigens: MPO, PR3
thyroid antigens: TG, TPO
EUROLINE:
Ro-52 EJ PL-7 Jo-1 PM-Scl100 Mi-2 ANA Profile 1: nRNP/Sm, Sm, SS-A, Ro-52,
SS-B, Scl-70, Jo-1, CENP B, dsDNA,
nucleosomes, histones, ribosomal P-proteins
ANA Profile 3: nRNP/Sm, Sm, SS-A, Ro-52,
SS-B, Scl-70, PM-Scl, Jo-1, CENP B,
Indication: Test system for the in vitro determination of antibodies against myositis-associated PCNA, dsDNA, nucleosomes, histones,
ribosomal P-proteins, AMA M2
antigens in human serum or plasma for the diagnosis of the following diseases: dermato- and ANA Profile 5: nRNP/Sm, Sm, RNP70, RNPA, RNPC,
polymyositis, idiophatic myositis, anti-synthetase syndrome, overlap syndrome. SS-A, Ro-52, SS-B, Scl-70, PM-Scl, Jo-1, CENP B,
PCNA, dsDNS, nucleosomes, histones, ribosomal
P-proteins, AMA M2
Anti-ENA Profile 1: nRNP/Sm, Sm, SS-A, Ro-52,
Clinical significance: Myositis is an inflammatory disease of the skeletal musculature. My- SS-B, Scl-70, Jo-1
ositides may be hereditary or caused by infections, malfunctions of the immune system or by Systemic Sclerosis Profile: Scl-70, CENP A, CENP B,
RP11, RP155, Fibrillarin, NOR90, Th/To, PM-Scl100,
toxins. PM-Scl75, Ku, PDGFR, Ro-52
Myositis Profile 3: Mi-2, Ku, PM-Scl100, PM-Scl75,
SRP, Jo-1, PL-7, PL-12, OJ, EJ, Ro-52
Polymyositis is a systemic inflammatory disease of the skeletal muscles of unknown aetiology Liver Profiles: AMA M2, 3E (BPO), Sp100, PML,
gp210, LKM-1, LC-1, SLA/LP, Ro-52
with perivascular lymphocytic infiltration. In cases of skin involvement the disease is known as Neuronal Antigens Profile 2: amphiphysin, CV2.1**
dermatomyositis. There are five different forms of polymyositis: a) primary idiopathic polymy- PNMA2 (Ma-2/Ta), Ri, Yo, Hu
Anti-Ganglioside Profile 1: GM1, GD1b, GQ1b
ositis (33% of cases), b) primary idiopathic dermatomyositis (33%), c) paraneoplastic dermato- Anti-Ganglioside Profile 2: GM1, GM2, GM3,
myositis of the lungs, ovaries, mamma, gastrointestinal tract and in myeloproliferative diseases GD1a, GD1b, GT1b, GQ1b
ANCA Profiles: MPO, PR3, GBM
(8%), d) infantile dermatomyositis and accompanying vasculitis (5% to 10%) and e) myositis EUROLINE-WB:
overlap syndrome in collagenoses (20%). Dermato-/polymyositis is often of paraneoplastic ori- neuronal antigens (+ recomb. Hu, Yo, Ri)
HEp-2 cell antigens (+ SS-A and Ro-52, CENP B)
gin, particularly in elderly patients. Dermatomyositis symptoms can occur before the presence
of the tumour is even diagnostically detectable. Infectious serology:
EUROLINE:
Bordetella pertussis (IgA, IgG)
Clinical symptoms of polymyositis are muscle weakness, unspecific signs of inflammation, Borrelia-RN-AT (p18, p19, p20, p21, p58, OspC,
p39, p83, LBb, LBa, VlsE Bg, VlsE Bb, VlsE Ba)
arthralgia, possibly Reynaud’s syndrome, trouble with swallowing and involvement of inner EBV Profile (IgG, IgM, VCA gp125, VCA p19
and EBNA-1, p22, EA-D)
organs. In dermatomyositis skin symptoms appear as purple-coloured exanthema on the eye Hanta virus (IgG, IgM)
TORCH Profile* (T. gond., rubella, CMV, HSV-1, -2)
lids, nose bridge and cheeks, periorbital oedema, local erythema and scaly eczema dermatitis.
Westernblot:
Borrelia burgdorferi (IgG, IgM)
Laboratory results show an increased level of muscle enzymes. The detection of myositis-asso- Borrelia afzelii (IgG, IgM)
Borrelia garinii (IgG, IgM)
ciated autoantibodies with specific tests is essential in the diagnosis of dermato-/polymyositis, Epstein-Barr virus (IgG, IgM)
Rubella virus (IgG)
in controlling the course of the disease and in therapy management. Although the mortality Treponema pallidum (IgG, IgM)
Yersinia enterocol. virulence fact. (IgA, IgG)
rate is increased by a factor of 4 – with heart and lung diseases being the primary cause of EUROLINE-WB:
death – half of patients recover fully, although a slight weakness of the muscles may remain. Anti-Borrelia (B. afzelii + rec. VlsE)
Anti-HSV (HSV-1 + HSV-2 gG2)
In 30% of cases the disease can be stopped. Around 20% of patients experience deterioration Helicobacter pylori (VacA, Cag A; IgA, IgG)
Treponema pallidum + cardiolipin
despite therapeutic measures.
Allergology:
Antibodies against Mi-2 are highly specific for dermatomyositis. They can be found in 15% to EUROASSAY:
Food Profile (IgE)
30% of dermatomyositis patients and in 8% to 12% of idiopathic myositis cases. Antibodies Inhalation Profile (IgE)
Pediatric/Atopy Profile (IgE)
against Ku have a prevalence of up to 10% in systemic lupus erythematosus (SLE). Anti-Ku an- Insect Venom Profile (IgE)
tibodies are also detected in 5% to 25% of cases of polmyositis/scleroderma overlap syndrome. EUROLINE:

Anti-Ku-antibody-positive patients have myositis, symptoms of scleroderma or SLE in around Atopy Profile (IgE; also region-specific profiles)
Food Profile (IgE; also region-specific profiles)
40% of cases for each, and frequently also exhibit vascular manifestations. The antigens PM- Inhalation Profile (IgE; also region-specific profiles)
Paediatric Profile (IgE)
Scl100 and PM-Scl75 also enable the identification of overlap syndrome. This disease mani- Pollen–Food Cross Reaction Profile (IgE)
Insect Venom Profile (IgE)
fests itself by a combination of polymyositis, dermatomyositis and systemic sclerosis symp-
toms. PM-Scl75 is the main antigen of the anti-PM-Scl immune response in diffuse systemic Software/Automation:
EUROLineScan
sclerosis, although in overlap syndrome the majority of anti-PM/Scl antibodies are directed camera system EUROBlotCamera
scanner system EUROBlotScanner
against PM-Scl100. Since antibodies against PM-Scl75 and PM-Scl100 occur independently of incubation processor EUROBlotMaster
each other, both antibodies should be determined routinely. In this way maximal sensitivity
is attained: 19.8% for diffuse systemic sclerosis and 23.7% for overlap syndrome. Antibodies EUROIMMUN
Radioimmunoassays
against the signal recognition particle (SRP), which participates in protein biosynthesis, have
Autoantibody determination:
a prevalence of 4% to 5% in myositis patients. Antibodies directed against aminoacyl-tRNA thyroid peroxidase (TPO; IgG)
synthetases occur with differing prevalences (anti-Jo-1: 25% to 55 %, anti-PL-7: 3 % to 6 %, thyroglobulin (TG; IgG)
TSH receptor (IgG)
anti-PL-12: up to 3 %, anti-EJ: 1 % , anti-OJ: 1 %) in myositis patients and are often associated acetylcholine receptor (ACHR; IgG)
glutamic acid decarboxylase (GAD; IgG)
with other, simultaneously occurring autoimmune diseases (e.g. SLE, SSc or interstitial lung insulin (IAA; IgG)
P/Q calcium channel* (VGCC; IgG)
fibrosis). Antibodies against Ro-52 are not associated with a specific disease, but are found in tyrosine phosphatase (IA2; IgG)
dsDNA (IgA/IgG/IgM)
autoimmune and infectious diseases with a prevalence of 5% to 81%.
Antigen determination:
thyroglobulin (TG)
Application of the EUROLINE Myositis Profile 3 (IgG): The isolated presence of autoantibodies Hormone determination:
against individual myositis-specific antigens is characteristic for autoimmune myositides. Com- free triiodothyronine (FT3)
prehensive studies in various centres in Europe have shown that the simultaneous investigation free thyroxine (FT4)
thyrotropin (TSH)
of large profiles of various myositis-specific antibodies increases the serological hit rate to up calcitonin

to 37%. For the first time, the EUROLINE Myositis Profile 3 (IgG) enables automated analysis of * Currently not available as IVD in the EU.
11 different myositis-specific antibodies on one test strip. ** CV2 partial protein, which only contains the
N-terminally localised epitopes of the antigen.
Made in Germany

EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail euroimmun@euroimmun.de
EUROIMMUN
Microplate ELISA Test Characteristics
Autoantibody determination:
AMA M2-3E (IgG)
ANCA Profile (IgG)
ANA Screen (IgG)
EUROLINE Myositis Profile 3 (IgG)
ANA Screen 9 or 11 (IgG)
BP180-NC16A-4X (IgG)
BP230-CF (IgG)
C1q (IgG)
cardiolipin (IgA, IgG, IgM, IgAGM)
Test principle: The EUROLINE is a qualitative in vitro immunoassay, in which membrane strips
circulating immune complexes (CIC)
cyclic citrullinated peptide (CCP; IgG)
printed with lines of purified, biochemically characterised antigens are used as solid phase.
centromere protein B (IgG)
desmoglein 1 (IgG)
Each antigen is coated onto a separate membrane fragment, enabling the production process
desmoglein 3 (IgG)
double-stranded DNA (dsDNA, nDNA; IgG)
and thereby the efficiency of antibody detection to be optimised for each protein. Since anti-
dsDNA-NcX (IgG) gen bands are located at defined positions, results can be evaluated visually without the need
ENA Pool (IgG)
ENA PoolPlus (IgG) for additional equipment. Correct performance of all test steps is confirmed by staining of the
ENA ProfilePlus 1 or 2 (IgG)
ENA SLE Profile 1 or 2 (IgG) control band.
GAD
GAD/IA-2 Pool
glomerular basement membrane (GBM; IgG)
ß2-glycoprotein 1 (IgA, IgG, IgM, IgAGM) Computer-based evaluation: The EUROLine-
histones (IgG)
IA-2 Scan programme from EUROIMMUN provides
intrinsic factor (IgG)
Jo-1 (IgG) automated evaluation of EUROLINE analyses
liver cytosolic antigen type 1 (LC-1; IgG)
liver-kidney microsomes (LKM-1; IgG) and detailed documentation of results. The in-
myeloperoxidase (MPO; IgG)
nRNP/Sm (IgG)
cubated membrane strips are either scanned
nucleosomes (IgG)
ovary (IgAGM, Ig typing)
onto a protocol sheet using a flatbed scanner
parietal cells (PCA; IgG)
PM-Scl (PM-1; IgG)
(EUROBlotScanner) or photographed directly
phosphatidylserine (IgA, IgG, IgM, IgAGM)
PR3 hn-hr (IgG)
in the incubation tray using a camera system
PR3 capture (IgG) (EUROBlotCamera). EUROLineScan recognis-
rheumatoid factor (IgA, IgG, IgM)
ribosomal P-proteins (IgG) es the position of the strips, even if they have
Sa (IgG)
Scl-70 (IgG) been laid inexactly. It then identifies the bands
single-stranded DNA (ssDNA; IgG)
SLA/LP (IgG) and measures their intensity. The EUROLine-
Sm (IgG)
spermatozoa (IgAGM, Ig typing) Scan programme facilitates data management
SS-A (Ro; IgG)
SS-B (La; IgG) and eliminates the need to archive potentially
thyroglobulin (TG; IgG)
thyroid peroxidase (TPO; IgG) infectious material. A separate results sheet can be produced for each patient. Online connec-
tiss. transglutaminase (endomy.; IgA, IgG, IgAG)
TSH receptor (TBII; IgG)
tion to other programmes is possible, e.g. laboratory management systems (LIMS).
TRAk Fast (IgG)
zona pellucida (IgAGM, Ig typing)
Latex agglutination tests:
Prevalence and specificity:
spermatozoa
ovary 194 Sera from SLE patients, 131
zona pellucida sera from sclerodermia patients,
153 Sera from myositis patients, 208 Sera from myositis patients,
179 sera from polymyositis/der-
Further autoimmune diagnostics: 77 control sera 214 control sera
gliadin (GAF-3X; IgA, IgG) matomyositis patients, 50 sera
(University of Uppsala, Sweden) (University of Padua, Italy)
Saccharomyces cerevisiae (IgA, IgG) from patients with rheumatoid
arthritis (EUROIMMUN Luebeck)
Infectious serology:
Adenovirus (IgA, IgG, IgM)
Bordetella pertussis (IgA, IgG, IgM) PM- PM- PL-7 or PM-
Antigen Mi-2 Ku Jo-1 PL-7 PL-12 SRP Mi-2 Ku Jo-1 SRP EJ OJ
Bordetella FHA (IgA, IgG) Scl100 Scl100 PL-12 Scl75
Borrelia (IgG, IgM)
Borrelia VlsE (IgG) Preva-
Brucella abortus (IgA, IgG, IgM) 3% 3% 7% 12 % 3% 0% 5% 4% 5% 4% 21 % 4% 4% 1% 1% 6%
Campylobacter jejuni (IgA, IgG) lence
Chlamydia pneumoniae (IgA, IgG, IgM)
Chlamydia trachomatis (IgA, IgG, IgM) Specifi-
Cytomegalovirus (IgG, IgM) 100 % 97 % 100 % 99 % 100 % 100 % 97 % 98 % 95 % 100 % 100 % 100 % 99 % 100 % 100 % 98 %
Dengue virus (IgG, IgM) city
Diphtheria toxoid (IgG)
Echinococcus granulosus (IgG)
Epstein-Barr virus capsid ag (IgA, IgG, IgM)
Epstein-Barr virus early ag (IgA, IgG, IgM)
Epstein-Barr virus nuclear ag, EBNA-1 (IgG)
Hanta virus "Eurasia" + "America" (IgG, IgM) Technical data:
Helicobacter pylori (IgA, IgG)
Helicobacter pylori CagA (IgA, IgG)
HSV-1 (glycoprotein C1; IgA, IgG, IgM)
HSV-2 (glycoprotein G2; IgA, IgG, IgM) Antigens Recombinant: Mi-2: Mi-2 protein; Ku: Ku protein; PM-Scl100: PM-Scl-
HSV-1/2 Pool (IgA, IgG, IgM)
Influenza virus type A (IgA, IgG, IgM) protein (100 kDa); PM-Scl75: PM-Scl protein (75 kDa); SRP: SRP pro-
Influenza virus type B (IgA, IgG, IgM)
Influenza Pool (IgA, IgG, IgM) tein (54 kDa, signal recognition particle); PL-7: PL-7 protein (threo-
Legionella pneumophila (IgA, IgG, IgM)
Measles virus (IgG, IgM) nyl-tRNA synthetase); PL-12: PL-12 protein (alanyl-tRNA synthetase);
Mumps virus (IgG, IgM)
Mycoplasma pneumoniae (IgA, IgG, IgM)
EJ: EJ protein (glycyl-tRNA synthetase); OJ: OJ protein (isoleucyl-tRNA
Parainfluenza virus Pool (IgA, IgG, IgM)
Parvovirus B19 (IgG, IgM)
synthetase); Ro-52: Ro-52 protein (52 kDa).
RSV (IgA, IgG, IgM)
Rubella virus (IgG, IgM)
SARS-CoV (IgG)
TBE virus (IgG, IgM)
Native: Jo-1: Jo-1 antigen (histidyl-tRNA synthetase) purified using af-
Tetanus toxoid (IgG) finity chromatography.
Toxoplasma gondii (IgG, IgM)
Treponema pallidum (IgG, IgM)
Varicella zoster virus (IgG, IgM)
West Nile virus (IgG, IgM) Sample dilution Serum or plasma; 1:101 in sample buffer.
Yersinia enterocol. virulence fact. (IgA, IgG)
Allergology:
total IgE Test procedure 30 min / 30 min / 10 min. Room temperature.
Allercoat™ 6-ELISA (650 different
allergens and allergen mixtures)
Software EUROIMMUN Allercoat™
Test kit format 16 membrane strips.
Serum proteins and tumour markers:
anti-p53
Saliva diagnostics:
Kit includes all necessary reagents.
alpha-amylase
cortisol
DHEA
sIgA
Automation Compatible with all commercial blot processing systems, e.g. with the
testosterone EUROBlotMaster from EUROIMMUN.
Software/Automation:
EUROLabOffice
EUROIMMUN Analyzer I + I2P Order number DL 1530-1601-3 G
* Currently not available as IVD in the EU.
Made in Germany

Version: 10/10
DL_1530_D_UK_A03

EUROIMMUN AG · 23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 451 58550 · Fax 5855591 · E-mail euroimmun@euroimmun.de