作者: Lucy Pembrey , Marie-Louise Newell , Pier-Angelo Tovo , Harry van Drimmelen , Isabella Quinti
DOI: 10.1002/JMV.10283
关键词: Multicenter study 、 Multi centre 、 Virology 、 Inter-laboratory 、 Medicine 、 Serial dilution 、 Quantitative assay 、 Round robin test
摘要: To investigate whether it is appropriate to assume comparability of hepatitis virus C (HCV)-RNA results across laboratories in multi-centre studies, nine the European Paediatric HCV Network participated an international proficiency study HCV-RNA assays. A panel 12 samples different dilutions and genotypes was sent each laboratory tested with qualitative and/or quantitative assays according local procedures. Commercial were used seven in-house two. All six which a commercial assay proficient, as four runs (in five laboratories) used. The where could not be assessed VQC definition because differences methods Overall, there several false-negative results, but only one false-positive result none assay. may have implications for diagnosis infection, highlight need antibody test performed at 18 months confirm absence infection. generally consistent difficult evaluate compare Multivariate analysis data collected studies should therefore allow centre