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Volume 19, Number 5—May 2013

Research

World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA

Sally A. BaylisComments to Author , Johannes Blümel, Saeko Mizusawa, Keiji Matsubayashi, Hidekatsu Sakata, Yoshiaki Okada, C. Micha Nübling, Kay-Martin O. Hanschmann, and the HEV Collaborative Study Group
Author affiliations: Paul-Ehrlich-Institut, Langen, Germany (S.A. Baylis, J. Blümel, C.M. Nübling, K.-M.O. Hanschmann); National Institute of Infectious Diseases, Tokyo, Japan (S. Mizusawa, Y. Okada); Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan (K. Matsubayashi, H. Sakata)

Main Article

Table 2

Overall mean estimates from quantitative and qualitative assays of HEV samples in study to establish a WHO International Standard for HEV RNA NAT-based assays*

Assay type and sample No. Mean (95% CI)† SD % CV
Quantitative
1 123 5.58 (5.32–5.85) 0.54 98
2 125 5.60 (5.33–5.87) 0.53 94
1 + 2 248 5.59 (5.33–5.86) 0.55 99
3 124 5.66 (5.40–5.93) 0.45 77
4 125 5.66 (5.40–5.93) 0.44 76
3 + 4
 249
 5.66 (5.40–5.93)
 0.44
 76
Qualitative
1 19 5.25 (5.01–5.50) 0.51 150
2 20 5.26 (4.97–5.56) 0.62 179
1 + 2 39 5.26 (5.08–5.44) 0.56 163
3 20 5.27 (4.90–5.64) 0.79 226
4 20 5.31 (5.02–5.61) 0.64 183
3 + 4 40 5.29 (5.07–5.52) 0.71 202

*Samples 1 and 2, replicate samples of the candidate WHO International Standard; samples 3 and 4, replicate samples of the candidate Japanese national standard. HEV, hepatitis E virus; WHO, World Health Organization; NAT, nucleic acid amplification technique; no., no. dilutions analyzed (in linear range for quantitative assays); % CV, geometric coefficient of variation.
†Values are log10 copies/mL for quantitative and log10 NAT–detectable units/mL for qualitative assays.

Main Article

1Members of the HEV Collaborative Study Group are listed at the end of this article.

2In memory of Thomas Laue.

Page created: April 01, 2013
Page updated: April 01, 2013
Page reviewed: April 01, 2013
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