Expertise of French laboratories in detection, genotyping, and quantification of hepatitis C virus RNA in serum.
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.
Lefrère
Jean-Jacques
JJ
Centre Hospitalo-Universitaire d'Amiens, France.
Roudot-Thoraval
Françoise
F
Lunel
Françoise
F
Alain
Sophie
S
Chaix
Marie-Laure
ML
Dussaix
Elisabeth
E
Gassin
Michèle
M
Izopet
Jacques
J
Pawlotsky
Jean-Michel
JM
Payan
Christopher
C
Stoll-Keller
Françoise
F
Thibault
Vincent
V
Trabaud
Mary-Anne
MA
Bettinger
Dominique
D
Bogard
Marc
M
Branger
Michel
M
Buffet-Janvresse
Claudine
C
Charrois
Anne
A
Defer
Christine
C
Laffont
Catherine
C
Lerable
Joëlle
J
Levayer
Thierry
T
Martinot-Peignoux
Michèle
M
Mercier
Bernard
B
Rosenberg
Arielle R
AR
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
D012367:RNA, Viral