PERSONAL GENETICS

CENTRU DE GENETICA MEDICALA

str. Frumoasa Nr. 4, Bucuresti, sector 1, 010987
telefon: 0040 213.110.776; fax: 0040 213.110.793
www.personalgenetics.ro

BULETIN DE ANALIZA NR. 1064479

Medic trimitator Proba Pacient

Tip proba: Tampon nazofaringian Nume: PARASCHIV

Nume: OK Medical Prenume: RADU TUDOR
Data receptie: 19.07.2020
Data nasterii: 18.02.1984
Clinica: OK Medical
Varsta: 36 ani, 5 luni Sex: M
Recoltat la: OK Medical
Adresa: - BUCURESTI SECTORUL 1 CNP: 1840218460045
BUCURESTI Data recoltare: 17.07.2020 BI/CI:
Cod: 49604
Data rezultat: 20.07.2020 Telefon: 0745132565
Adresa: , nr.
Cod proba: 1064479

Virusologie moleculara
Test Rezultat UM Interval de referinta

Detectia genelor E, N, RdRP din structura virusului 2019-nCoV prin metoda qRT-PCR

2019-nCOV Detectat Normal - Nedetectat

Concluzii rezultat Pozitiv Normal - Negativ

Observatii -
Comentarii: Rezultatul reprezinta statusul viral din momentul recoltarii, astfel un rezultat
sau mai multe rezultate nedetectabile nu exclud posibilitatea existentei
infectiei cu Covid–19.
Prezenta genei E sugereaza o infectie respiratorie de tip SARSr-CoV
nespecifica 2019-nCoV, dar specifica tuturor virusurilor respiratorii din Linia B
(subgenul Sarbecovirus) care include tulpinile SARS-CoV, SARS-CoV-2, si Bat
SL-CoV-WIV1
Factori care pot genera rezultate fals negative:
Calitatea slaba a probelor biologice recoltate si transportate necorespunzator
de la pacienti constituie cea mai importantă sursa de eroare în diagnosticul de
laborator al COVID-19. O proba prelevata mai devreme de 5 zile de la infectie
poate da un rezultat fals negativ.
Unul sau mai multe rezultate negative, in special din probe prelevate de la
nivelul tractului superior nu exclud posibilitatea infectiei cu SARS-CoV2.
Un rezultat fals negativ poate fi explicat prin aparitia de mutatii la nivelul
virusului sau a inhibitorilor in reactia PCR. La pacientii cu suspiciune ferma de
infectie cu SARS-CoV-2 se pot preleva si testa probe suplimentare de la nivelul
tractului respirator inferior.
Recomandari:
Pentru orice rezultat discordant se recomanda repetarea recoltarii si retestare
la centrul de referinta national.
Metodologie: Test qRT-PCR prin care pot fi detectate 3 secvente de la nivelul genelor E, N,
RdRP din structura virusului 2019-nCoV.
Gene de referinta: Gena E, Gena N, Gena RdRP
Limita de detectie a metodei (qRT-PCR, AllplexTM 2019-nCoV Assay): 100
copii virale/reactie.
Metoda utilizata detecteaza genele Gena E, Gena N, Gena RdRP.

Se interzice reproducerea buletinului de analize in alte scopuri decat cel pentru care a fost eliberat, sau reproducerea partiala a acestuia fara acordul scris al laboratorului
care a efectuat analiza. Rezultatele buletinului de analize se refera numai la probele supuse analizei.

Personal Genetics SRL este inregistrat in Registrul de evidenta a operatorilor de date personale cu numarul 22583.
Data tiparire: 20.07.2020 10:14:09 Pagina 1 / 2 F-01 PG 20 Ed.4,Rev.0/10.09.2018
Nume pacient: PARASCHIV RADU TUDOR Nr. cerere: 1064479

Virusologie moleculara
Test Rezultat UM Interval de referinta

Detectia genelor E, N, RdRP din structura virusului 2019-nCoV prin metoda qRT-PCR

Bibliografie: 1. Pan Y, Long L, Zhang D, Yan T, Cui S, Yang P, Wang Q, Ren S. Potential
false-negative nucleic acid testing results for Severe Acute Respiratory
Syndrome Coronavirus 2 from thermal inactivation of samples with low viral
loads. Clin Chem. 2020.
2. Allplex_2019_nCoV_performance_data.pdf
3. https://www.nsmedicaldevices.com/news/seegene-novel-coronavirus-assay/
4. O.B.B.C.S.S.R- Ghid practic orientativ pentru testarea de laborator in
COVID-19
5, Stephen A. Lauer, Kyra H. Grantz, Qifang Bi, Forrest K. Jones, Qulu Zheng,
Hannah R. Meredith, Andrew S. Azman, Nicholas G. Reich, Justin Lessler.
The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly
Reported Confirmed Cases: Estimation and Application. Annals of Internal
Medicine, 2020 DOI: 10.7326/M20-0504

Rezultatele vor fi interpretate in context clinic de catre medicul trimitator.

Autorizat:

Se interzice reproducerea buletinului de analize in alte scopuri decat cel pentru care a fost eliberat, sau reproducerea partiala a acestuia fara acordul scris al laboratorului
care a efectuat analiza. Rezultatele buletinului de analize se refera numai la probele supuse analizei.

Personal Genetics SRL este inregistrat in Registrul de evidenta a operatorilor de date personale cu numarul 22583.
Data tiparire: 20.07.2020 10:14:09 Pagina 2 / 2 F-01 PG 20 Ed.4,Rev.0/10.09.2018
 PERSONAL GENETICS
CENTRU DE GENETICA MEDICALA
str. Frumoasa Nr. 4, Bucuresti, sector 1, 010987
telefon: 0040 213.110.776; fax: 0040 213.110.793
www.personalgenetics.ro

REPORT NO. 1064479

Physician / Ordered by: Sample Patient

Sample type: Nasopharyngeal swab Name: PARASCHIV

Name: OK Medical Surname: RADU TUDOR
Entry date: 19.07.2020
Birth date: 18.02.1984
Organization: OK Medical
Age: 36 years, 5 months Gender: M
Sender unit: OK Medical
Address: - BUCURESTI SECTORUL Personal No.: 1840218460045
1 BUCURESTI Sample collection date: 17.07.2020 Passport No/CI No:
Internal patient code: 49604
Report date: 20.07.2020 Phone no.: 0745132565
Address: , nr.
Sample code: 1064479

Molecular virology
Test Result Measure Unit Reference Range

Detection of E, N, RdRP genes in the structure of the 2019-nCoV virus by the qRT-PCR method

2019-nCOV Detected Normal - Not detected

Result Positive Normal - Negative

Observations -
Comments: The result represents the viral status at the time of sample collection, all
analyzed genes being negative. Negative results do not preclude SARS-CoV-2
infection and should not be used as the sole basis for patient management
decisions. Negative results must be combined with clinical observations,
patient history, and epidemiological information.
The presence of the E gene suggests a respiratory infection of SARS-CoV
type not specific 2019 -nCoV, but specific to all respiratory viruses from line B
(subgenus Sarbecovirus) which includes strains SARS CoV,SARS-CoV-2,and
bat SL-CoV-WIV-1.
Factors that can generate false negative results:
The quality of biological samples collected and transported improperly from
patients is the most important source of error in the laboratory diagnosis of
Covid -19. A sample taken earlier than 5 days after infection can show a false
negative result. One or more negative results, especially from samples taken
from the upper repiratory tract do not exclude the possibility of infection with
SARS-CoV2.
A false negative result can be explained by the appearance of mutations in the
virus or inhibitors in the PCR reaction. In patients with a firm suspicion of
SARS-CoV-2 infection, additional samples may be taken and tested from the
lower respiratory tract.
Recommendations:
For any discordant result it is recommended to repeat the test, and retest at
the national reference center.
Methodology: qRT-PCR test through which 3 sequences from the E, N, RdRP genes from the
structure of the 2019-nCoV virus can be detected.
Reference genes: E gene, N gene, RdRP gene
Method detection limit (qRT-PCR, AllplexTM 2019-nCoV Assay): 100 viral
copies / reaction.
It is forbidden to reproduce the report for purposes Used method
other than the onedetects
for whichthe genes
it was Gena
issued, or itsE,partial
Genareproduction
N, Genawithout
RdRPthe written consent of the laboratory
who performed the analysis. The report results refers only to the samples under analysis.
Personal Genetics SRL is registered in the Register of records of personal data operators with number 22583.

Print date: 20.07.2020 10:14:09 Page 1 / 2 F-01 PG 20 Ed.4,Rev.0/10.09.2018

Patient name: PARASCHIV RADU TUDOR Order no.: 1064479

Molecular virology
Test Result Measure Unit Reference Range

Detection of E, N, RdRP genes in the structure of the 2019-nCoV virus by the qRT-PCR method

Used method detects the genes Gena E, Gena N, Gena RdRP

Bibliography: 1. Pan Y, Long L, Zhang D, Yan T, Cui S, Yang P, Wang Q, Ren S. Potential
false-negative nucleic acid testing results for Severe Acute Respiratory
Syndrome Coronavirus 2 from thermal inactivation of samples with low viral
loads. Clin Chem. 2020.
2. Allplex_2019_nCoV_performance_data.pdf
3. https://www.nsmedicaldevices.com/news/seegene-novel-coronavirus-assay/
4. O.B.B.C.S.S.R- Practical guide for laboratory testing in COVID-19
5, Stephen A. Lauer, Kyra H. Grantz, Qifang Bi, Forrest K. Jones, Qulu Zheng,
Hannah R. Meredith, Andrew S. Azman, Nicholas G. Reich, Justin Lessler.
The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly
Reported Confirmed Cases: Estimation and Application. Annals of Internal
Medicine, 2020 DOI: 10.7326/M20-0504

The results will be interpreted in a clinical context by the referring physician.

Authorized:

It is forbidden to reproduce the report for purposes other than the one for which it was issued, or its partial reproduction without the written consent of the laboratory
who performed the analysis. The report results refers only to the samples under analysis.
Personal Genetics SRL is registered in the Register of records of personal data operators with number 22583.

Print date: 20.07.2020 10:14:09 Page 2 / 2 F-01 PG 20 Ed.4,Rev.0/10.09.2018