title: Expertise of French laboratories in detection, genotyping, and quantification of hepatitis C virus RNA in serum.
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.
authors.affiliation: Centre Hospitalo-Universitaire d'Amiens, France.
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Lefrère
authors.forename: Françoise
authors.initials: F
authors.lastname: Roudot-Thoraval
authors.forename: Françoise
authors.initials: F
authors.lastname: Lunel
authors.forename: Sophie
authors.initials: S
authors.lastname: Alain
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Chaix
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Dussaix
authors.forename: Michèle
authors.initials: M
authors.lastname: Gassin
authors.forename: Jacques
authors.initials: J
authors.lastname: Izopet
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Pawlotsky
authors.forename: Christopher
authors.initials: C
authors.lastname: Payan
authors.forename: Françoise
authors.initials: F
authors.lastname: Stoll-Keller
authors.forename: Vincent
authors.initials: V
authors.lastname: Thibault
authors.forename: Mary-Anne
authors.initials: MA
authors.lastname: Trabaud
authors.forename: Dominique
authors.initials: D
authors.lastname: Bettinger
authors.forename: Marc
authors.initials: M
authors.lastname: Bogard
authors.forename: Michel
authors.initials: M
authors.lastname: Branger
authors.forename: Claudine
authors.initials: C
authors.lastname: Buffet-Janvresse
authors.forename: Anne
authors.initials: A
authors.lastname: Charrois
authors.forename: Christine
authors.initials: C
authors.lastname: Defer
authors.forename: Catherine
authors.initials: C
authors.lastname: Laffont
authors.forename: Joëlle
authors.initials: J
authors.lastname: Lerable
authors.forename: Thierry
authors.initials: T
authors.lastname: Levayer
authors.forename: Michèle
authors.initials: M
authors.lastname: Martinot-Peignoux
authors.forename: Bernard
authors.initials: B
authors.lastname: Mercier
authors.forename: Arielle R
authors.initials: AR
authors.lastname: Rosenberg
mesh_terms: D000704:Analysis of Variance; D005602:France; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics* / Q000302:isolation & purification*; D006526:Hepatitis C / Q000628:therapy / Q000821:virology; D006801:Humans; D007753:Laboratories; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods* / Q000706:statistics & numerical data
chemical_list: D012367:RNA, Viral