TY - JOUR T1 - 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 performance34020 JF - J.Clin.Microbiol. Y1 - 2011 A1 - Baylis,S.A. A1 - Hanschmann,K.M. A1 - Blumel,J. A1 - Nubling,C.M. A1 - HEV Collaborative Study group KW - a KW - acid KW - ALL KW - an KW - article KW - AS KW - blood KW - Blood Donors KW - Clinical Laboratory Techniques KW - conventional KW - Countries KW - data KW - Diagnosis KW - e KW - electronic KW - EVALUATION KW - genetics KW - Genotype KW - Germany KW - Hepatitis KW - Hepatitis E KW - Hepatitis E virus KW - Humans KW - im KW - International Cooperation KW - IS KW - isolation & purification KW - journal KW - Laboratories KW - means KW - methodology KW - need KW - Nucleic Acid Amplification Techniques KW - ON KW - PARTICIPANTS KW - PCR KW - performance KW - plasma KW - RANGE KW - Reproducibility of Results KW - result KW - Rna KW - routine KW - Sample KW - Samples KW - SB - IM KW - Score KW - SENSITIVITY KW - Sensitivity and Specificity KW - STANDARD KW - STANDARDIZATION KW - standards KW - strain KW - study KW - Test KW - VARIABILITY KW - virology KW - VIRUS AB - 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 approximately 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 VL - 49 CP - 4 U1 - 38042 M3 - http://dx.doi.org/10.1128/JCM.02578-10 ER -