Document Detail


Standardization of hepatitis E virus (HEV) nucleic acid amplification technique-based assays: an initial study to evaluate a panel of HEV strains and investigate laboratory performance.
MedLine Citation:
PMID:  21307208     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The performance of hepatitis E virus (HEV) RNA nucleic acid amplification (NAT)-based assays has been investigated using a panel of HEV-containing plasma samples. The panel comprised 22 HEV-positive plasma samples representing 10-fold serial dilutions of HEV genotypes 3a, 3b, 3f, and 4c obtained from blood donors. Two negative-control plasma samples were included. All samples were blinded. The plasma samples were prepared as liquid/frozen materials and distributed to participants on dry ice. Laboratories were requested to test the panel using their routine HEV assays and to score samples as either positive or negative and could optionally return data in copies/ml for HEV RNA. Twenty laboratories from 10 different countries participated in the study. Data were returned by all participating laboratories; 10 laboratories returned quantitative data. All assays except one were developed in-house using conventional or real-time reverse transcriptase PCR (RT-PCR) methodologies. There was a 100- to 1,000-fold difference in sensitivity between the majority of assays, independent of the virus strain. Although the quantitative data were limited, for the samples in the range of ∼6 to 4 log(10) copies/ml, the standard deviations of the geometric means of the samples ranged between 0.38 and 1.09. Except for one equivocal result, HEV RNA was not detected in the negative samples. The variability of assay sensitivity highlights the need for the standardization of HEV RNA NAT assays.
Authors:
Sally A Baylis; Kay-Martin Hanschmann; Johannes Blümel; C Micha Nübling;
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Multicenter Study     Date:  2011-02-09
Journal Detail:
Title:  Journal of clinical microbiology     Volume:  49     ISSN:  1098-660X     ISO Abbreviation:  J. Clin. Microbiol.     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-04-05     Completed Date:  2011-07-18     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  7505564     Medline TA:  J Clin Microbiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1234-9     Citation Subset:  IM    
Affiliation:
Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, D-63225 Langen, Germany. baysa@pei.de
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MeSH Terms
Descriptor/Qualifier:
Clinical Laboratory Techniques / standards*
Hepatitis E / diagnosis*,  virology
Hepatitis E virus / genetics*,  isolation & purification*
Humans
International Cooperation
Nucleic Acid Amplification Techniques / standards*
Reproducibility of Results
Sensitivity and Specificity
Virology / standards*
Investigator
Investigator/Affiliation:
Martijn Bouwknegt / ; Saskia Rutjes / ; Thomas Gärtner / ; Saleem Kamili / ; Jan Drobeniuc / ; Samreen Ijaz / ; Jacques Izopet / ; Primashish Kar / ; Thomas Laue / ; Keiji Matsubayashi / ; Birgit Meldal / ; Daniel Candotti / ; Xiang-Jin Meng / ; Ulrich Mohn / ; Andreas Nitsche / ; Marco Kaiser / ; Giulio Pisani / ; Francesco Marino / ; James Wai Kuo Shih / ; Ge Shen Xiang / ; Isabelle Thomas / ; Shigeharu Uchida / ; Youchun Wang / ; Yansheng Geng / ; Jürgen Wenzel / ; Wolfgang Jilg / ; Mei-ying Yu / ; Li Ma /
Comments/Corrections

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