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Comparative Study
. 2004 May;42(5):2027-30.
doi: 10.1128/JCM.42.5.2027-2030.2004.

Expertise of French laboratories in detection, genotyping, and quantification of hepatitis C virus RNA in serum

Jean-Jacques Lefrère  1 , Françoise Roudot-Thoraval, Françoise Lunel, Sophie Alain, Marie-Laure Chaix, Elisabeth Dussaix, Michèle Gassin, Jacques Izopet, Jean-Michel Pawlotsky, Christopher Payan, Françoise Stoll-Keller, Vincent Thibault, Mary-Anne Trabaud, Dominique Bettinger, Marc Bogard, Michel Branger, Claudine Buffet-Janvresse, Anne Charrois, Christine Defer, Catherine Laffont, Joëlle Lerable, Thierry Levayer, Michèle Martinot-Peignoux, Bernard Mercier, Arielle R Rosenberg
Affiliations
Comparative Study

Expertise of French laboratories in detection, genotyping, and quantification of hepatitis C virus RNA in serum

Jean-Jacques Lefrère et al. J Clin Microbiol. 2004 May.

Abstract

Before initiating new large-scale therapeutic trials for hepatitis C virus (HCV)-infected patients, the French Health Authorities for HCV research decided to organize an evaluation of the expertise of laboratories that could be engaged to undertake molecular biology assays in such trials; 21 experienced laboratories participated in this national evaluation of laboratory expertise, which was performed in two successive rounds. The first round evaluated the laboratories for their abilities to detect HCV RNA in serum, determine genotypes, and quantify HCV RNA loads. The results observed by qualitative assays for HCV RNA detection were 100% sensitivity and 100% specificity for all laboratories. The genotyping results were 100% concordant for 9 laboratories and greater than 90% for 10 laboratories. By contrast, large coefficients of variation were observed for quantitative determination of HCV RNA loads, leading to a second round with standardized quantitative assays only. The dispersion of the results was larger by the AMPLICOR HCV Monitor assay than by the branched-DNA assay (mean coefficients of variation, 57.4 and 16.9%, respectively). In the majority of cases, discrepancies between the results of the two tests were found for samples with high viral loads. These results indicate the usefulness of validating, by controlling for expertise, both the reliabilities of laboratories involved in multicenter work and the standardized assays chosen for use in the evaluation of the biological impacts of new therapies.

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Figures

FIG. 1.
FIG. 1.
Out-of-range values observed by the AMPLICOR HCV Monitor assay in the second round. The bars represent the differences between each out-of-range measure and the mean value of the corresponding HCV RNA load calculated without it. The letters under the bars correspond to the laboratories where the out-of-range measures were found. The numbers on the abscissa correspond to the numbers of serum samples.
FIG. 2.
FIG. 2.
Ranges of HCV RNA loads measured in the 20 serum samples in the second round by the AMPLICOR HCV Monitor and b-DNA assays.
FIG. 3.
FIG. 3.
Relationship between the mean viral load and the range of values measured by the 21 laboratories by the b-DNA assay (a) and the AMPLICOR HCV Monitor assay (b).
See this image and copyright information in PMC

References

    1. Bogard, M., C. Buffet-Janvresse, J. F. Cantaloube, P. Biagini, G. Duverlie, S. Castelain, J. Izopet, M. Dubois, C. Defer, I. Lepot, J. Coste, P. Marcellin, M. Martinot-Peignoux, P. Halfon, V. Gerolami, L. Frangeul, J. M. Pawlotsky, F. Roudot-Thoraval, E. Dussaix, P. Loiseau, N. Ravera, P. Lewin, J. Lamoril, J. Lerable, P. Lebon, et al. 1997. GEMHEP multicenter quality control of PCR detection of GB virus C/hepatitis G virus RNA in serum. J. Clin. Microbiol. 35:3298-3300. - PMC - PubMed
    1. Chayama, K., F. Suzuki, A. Tsubota, N. Akuta, T. Someya, M. Kobayashi, Y. Arase, S. Saitoh, Y. Suzuki, K. Ikeda, and H. Kumada. 2001. Evaluation of quantitative measurements of hepatitis C virus RNA to predict sustained response to interferon by genotype. J. Virol. Methods 95:33-45. - PubMed
    1. French Study Group for the Standardization of Hepatitis C Virus PCR. 1994. Improvement of hepatitis C virus RNA polymerase chain reaction through a multicentre quality control study. J. Virol. Methods 49:79-88. - PubMed
    1. Gretch, D. R., C. De la Rosa, L. Corey, and R. L. Carithers. 1996. Assessment of hepatitis C viremia using molecular amplification technologies. Viral Hep. Rev. 2:85-96. - PubMed
    1. Irwing, W. L. 2002. The role of the virology laboratory in the management of hepatitis C virus infection. J. Clin. Virol. 25:3-13. - PMC - PubMed

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