Email this article QUALITY ASSESSMENT OF HCV RNA DETECTION BY PCR METHOD IN FEDERAL SYSTEM OF EXTERNAL QUALITY ASSESSMENT IN 2005 - 2007
- Authors: Tvorogova M.G1,2,3,4,5,6, Chulanov V.P1,2,3,4,5,6, Volkova R.A1,2,3,4,5,6, Sudarikov A.B1,2,3,4,5,6, Mikhaylov M.I1,2,3,4,5,6, Isaeva O.V1,2,3,4,5,6, Malakhov V.N1,2,3,4,5,6
-
Affiliations:
- Center of External Quality Control of Clinical Laboratory Tests
- State Scientific Center of Prophylactic Medicine
- Central Research Institute of Epidemiology
- Tarasevich State Institute for Standardization and Control of Biological Preparations
- State Scientific Center of Hematology
- Chumakov Institute of Poliomyelitis and Viral Encephalites, Moscow, Russia
- Issue: Vol 86, No 1 (2009)
- Pages: 59-62
- Section: Articles
- URL: https://microbiol.crie.ru/jour/article/view/13275
- ID: 13275
Cite item
Full Text
Abstract
Part of the Federal System of External Quality Assessment of Clinical Laboratory Tests named «PCR-identification of hepatitis C virus (HCV)» and aimed at detection of HCV RNA by polymerase chain reaction (PCR) assay is functioning from 2000. Ninety, 98, and 112 laboratories from more than 50 regions of Russian Federation participated in it in 2000, 2006, and 2007 respectively. Analysis of results of control samples tests, which were performed by participated laboratories, showed increasing proportion of method of amplification in the presence of fluorescent-marked probes both in real-time and in end-point regimens. In these circumstances, significant increase of specificity and sensitivity of tests was observed. In 2007, proportion of correct results obtained by the participants for tests with negative control samples was 96 - 97%, whereas during detection of HCV RNA in concentration 10 3 IU/ml the proportion of correct results was 80 - 83%. Significant proportion of laboratories, which did not detect HCV RNA in concentration 10 3IU/ml, points on the necessity to improve sensitivity of this important method of laboratory tests.
Full Text
ОЦЕНКА КАЧЕСТВА ВЫЯВЛЕНИЯ РНК ВИРУСА ГЕПАТИТА С МЕТОДОМ ПЦР В ФЕДЕРАЛЬНОЙ СИСТЕМЕ ВНЕШНЕЙ ОЦЕНКИ КАЧЕСТВА В 2005 - 2007 ГГ×
About the authors
M. G Tvorogova
Center of External Quality Control of Clinical Laboratory Tests; State Scientific Center of Prophylactic Medicine; Central Research Institute of Epidemiology; Tarasevich State Institute for Standardization and Control of Biological Preparations; State Scientific Center of Hematology; Chumakov Institute of Poliomyelitis and Viral Encephalites, Moscow, Russia
V. P Chulanov
Center of External Quality Control of Clinical Laboratory Tests; State Scientific Center of Prophylactic Medicine; Central Research Institute of Epidemiology; Tarasevich State Institute for Standardization and Control of Biological Preparations; State Scientific Center of Hematology; Chumakov Institute of Poliomyelitis and Viral Encephalites, Moscow, Russia
R. A Volkova
Center of External Quality Control of Clinical Laboratory Tests; State Scientific Center of Prophylactic Medicine; Central Research Institute of Epidemiology; Tarasevich State Institute for Standardization and Control of Biological Preparations; State Scientific Center of Hematology; Chumakov Institute of Poliomyelitis and Viral Encephalites, Moscow, Russia
A. B Sudarikov
Center of External Quality Control of Clinical Laboratory Tests; State Scientific Center of Prophylactic Medicine; Central Research Institute of Epidemiology; Tarasevich State Institute for Standardization and Control of Biological Preparations; State Scientific Center of Hematology; Chumakov Institute of Poliomyelitis and Viral Encephalites, Moscow, Russia
M. I Mikhaylov
Center of External Quality Control of Clinical Laboratory Tests; State Scientific Center of Prophylactic Medicine; Central Research Institute of Epidemiology; Tarasevich State Institute for Standardization and Control of Biological Preparations; State Scientific Center of Hematology; Chumakov Institute of Poliomyelitis and Viral Encephalites, Moscow, Russia
O. V Isaeva
Center of External Quality Control of Clinical Laboratory Tests; State Scientific Center of Prophylactic Medicine; Central Research Institute of Epidemiology; Tarasevich State Institute for Standardization and Control of Biological Preparations; State Scientific Center of Hematology; Chumakov Institute of Poliomyelitis and Viral Encephalites, Moscow, Russia
V. N Malakhov
Center of External Quality Control of Clinical Laboratory Tests; State Scientific Center of Prophylactic Medicine; Central Research Institute of Epidemiology; Tarasevich State Institute for Standardization and Control of Biological Preparations; State Scientific Center of Hematology; Chumakov Institute of Poliomyelitis and Viral Encephalites, Moscow, Russia
References
- Михайлов М.И., Хайдукова И.Л., Исаева О.В. и др. ФСВОК-96 - ФСВОК-2005: внешняя оценка качества лабораторных исследований при диагностике вирусных гепатитов. Вестн. ФСВОК. М., 2005, с. 15-20.
- Mihm U., Hofmann W.P., Kronenberger B. et al. Highly sensitive hepatitis C virus RNA detection assays for decision of treatment (dis)continuation in patients with chronic hepatitis C. J. Hepatol. 2005, 42: 605-606.
- Pawlotsky J-M. Therapy of hepatitis C: from empiricism to eradication. Hepatology. 2006, 43 (1): S207-S220.
- Pisani G., Cristiano K., Wirz M et al. Further evidence on the high proficiency of laboratories involved in plasma pool testing for HCV RNA by nucleic acid amplification technology: external quality assessment. VOX Sang. 2002, 82: 210-212.
- Pisani G., Cristiano K., Saldanha J. et al. External quality assesment for the detection of blood-borne viruses in plasma by nucleic acid amplification technology: the first human immunodeficiency virus and hepatitis B virus studies (HIV EQA/1 and HBV EQA/1) and the fifth hepatitis C virus study (HCV EQA/5). Ibid.2004, 87: 91-95.
- Strader D.B., Wright T., Thomas D.L. et al. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004, 39: 1147-1171.
- WHO International Working group on the standardisation of genomic amplification techniques for the virological safety testing of blood and blood products: introduction of gene amplification techniques (gat) for detection of hepatitis C virus in plasma pools. Addendum to notes for guidelines on plasma derived products 1997: CPMP/ BWP/390/97. UK, London 1997.
Supplementary files
