title: Inter-laboratory comparison of HCV-RNA assay results: implications for multi-centre research.
abstract: To investigate whether it is appropriate to assume comparability of hepatitis virus C (HCV)-RNA results across laboratories in multi-centre studies, nine laboratories of the European Paediatric HCV Network participated in an international proficiency study of HCV-RNA assays. A panel of 12 samples of different dilutions and genotypes was sent to each laboratory and tested with qualitative and/or quantitative HCV-RNA assays according to local procedures. Commercial assays were used in seven laboratories and in-house assays in two. All six laboratories in which a commercial qualitative assay was used were proficient, as were four of six runs (in five laboratories) in which a commercial quantitative assay was used. The proficiency of the laboratories where in-house assays were used could not be assessed according to the VQC definition because of differences in the methods used. Overall, there were several false-negative results, but only one false-positive result with a quantitative assay and none with a qualitative assay. The false-negative results may have implications for the diagnosis of infection, and highlight the need for an antibody test to be performed at 18 months to confirm the absence of infection. The results of qualitative assays were generally consistent across laboratories but it was difficult to evaluate and compare the results of quantitative assays. Multivariate analysis of data collected in multi-centre studies should therefore allow for centre and/or assay used.
authors.affiliation: Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health, London, United Kingdom.
authors.forename: Lucy
authors.initials: L
authors.lastname: Pembrey
authors.forename: Marie-Louise
authors.initials: ML
authors.lastname: Newell
authors.forename: Pier-Angelo
authors.initials: PA
authors.lastname: Tovo
authors.forename: Harry
authors.initials: H
authors.lastname: van Drimmelen
authors.forename: Isabella
authors.initials: I
authors.lastname: Quinti
authors.forename: Giuliano
authors.initials: G
authors.lastname: Furlini
authors.forename: Silvia
authors.initials: S
authors.lastname: Galli
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Meliconi
authors.forename: Sheila
authors.initials: S
authors.lastname: Burns
authors.forename: Nick
authors.initials: N
authors.lastname: Hallam
authors.forename: Anders
authors.initials: A
authors.lastname: Sönnerborg
authors.forename: Gustavo
authors.initials: G
authors.lastname: Cilla
authors.forename: Esther
authors.initials: E
authors.lastname: Serrano
authors.forename: Paolo
authors.initials: P
authors.lastname: Laccetti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Portella
authors.forename: Susanne
authors.initials: S
authors.lastname: Polywka
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Icardi
authors.forename: Bianca
authors.initials: B
authors.lastname: Bruzzone
authors.forename: Luciano
authors.initials: L
authors.lastname: Balbo
authors.forename: Alda
authors.initials: A
authors.lastname: Alfarano
mesh_terms: D002675:Child, Preschool; D005060:Europe; D005189:False Positive Reactions; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D007223:Infant; D007753:Laboratories; D015337:Multicenter Studies as Topic / Q000379:methods / Q000592:standards*; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D011786:Quality Control; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic