This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Copyright Information Books from ASM Press MicrobeWorld Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Lefrère, J.-J. Articles by Rosenberg, A. R. Search for Related Content PubMed PubMed Citation Articles by Lefrère, J.-J. Articles by Rosenberg, A. R.

Expertise of French Laboratories in Detection, Genotyping, and Quantification of Hepatitis C Virus RNA in Serum

Centre Hospitalo-Universitaire d'Amiens,¹ Institut National de la Transfusion Sanguine,² Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire Necker,⁶ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire Pitié-Salpêtrière,¹² Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire de Bichat,¹⁶ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire Saint-Antoine,¹⁸ Laboratoire de Virologie, Groupe Cochin-Saint-Vincent de Paul, Paris,²⁴ Service de Santé Publique,³ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire Henri-Mondor, Créteil,¹⁰ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire, Angers,⁴ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire, Limoges,⁵ Laboratoire de Virologie-Bactériologie, Hôpital Paul-Brousse, Villejuif,⁷ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire, Nantes,⁸ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire, Toulouse,⁹ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire, Strasbourg,¹¹ Laboratoire de Virologie-Bactériologie, Hospices Civils, Lyon,¹³ Laboratoire de Virologie, Centre Hospitalo-Universitaire, Besançon,¹⁴ Laboratoire de Biologie Moléculaire, Centre Hospitalier de Meaux, Meaux,¹⁵ Laboratoire de Virologie-Bactériologie, Centre Hospitalo-Universitaire, Rouen,¹⁷ Etablissement Français du Sang, Nord-de-France,¹⁹ Hôpital Pasteur, Nice,²⁰ Etablissement Français du Sang, Midi-Pyrénées,²¹ Hôpital Beaujon, Clichy,²² Etablissement Français du Sang, Bretagne, France,²³

Received 9 April 2003/ Returned for modification 14 August 2003/ Accepted 10 December 2003

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.

This article has been cited by other articles:

• Laperche, S., Bouchardeau, F., Thibault, V., Pozzetto, B., Vallet, S., Rosenberg, A. R., Roque-Afonso, A.-M., Gassin, M., Stoll-Keller, F., Trimoulet, P., Gault, E., Chanzy, B., Mercier, B., Branger, M., Pawlotsky, J.-M., Henquell, C., Lunel, F., Gaudy-Graffin, C., Alain, S., Chaix, M.-L., Duverlie, G., Izopet, J., Lefrere, J.-J. (2007). Multicenter Trials Need To Use the Same Assay for Hepatitis C Virus Viral Load Determination. J. Clin. Microbiol. 45: 3788-3790 [Abstract] [Full Text]