WORLD HEALTH ORGANIZATION INTERNATIONAL STANDARD TO HARMONIZE ASSAYS FOR DETECTION OF HEPATITIS E VIRUS RNA

Revista Romana de Boli Infectioase | Volumul XVI, Nr. 3, An 2013

ISSN 1454-3389 | e-ISSN 2069-6051
ISSN-L 1454-3389

Publicarea de articole științifice

Stimați cititori, vă reamintim că autorii primi ai articolelor științifice pot acumula 80 de credite EMC în urma publicării. Dacă un articol are mai mulți autori, cele 80 de credite [...]

PREMIU NAȚIONAL AUTORI

RJID și SNRBI oferă anual Premiul Național pentru Știință și Cercetare - pentru autorii celor mai bune articole științifice publicate [...]

Plagiatul – în actualitate

Tema plagiatului este tot mai mult discutată în ultima vreme. Apariția unor programe performante de căutare și identificare a similitudinilor între texte [...]

Sally A. Baylis, Johannes Blümel, Saeko Mizusaw, Keiji Matsubayashi, Hidekatsu Sakata, Yoshiaki Okada, C. Micha Nübling, Kay-Martin O. Hanschmann and HEV Collaborative Study Group

ABSTRACT

Nucleic acid amplification technique-based assays are a primary method for the detection of acute hepatitis E virus (HEV) infection, but assay sensitivity can vary widely. To improve interlaboratory results for the detection and quantification of HEV RNA, a candidate World Health Organization (WHO) International Standard (IS) strain was evaluated in a collaborative study involving 23 laboratories from 10 countries. The IS, code number 6329/10, was formulated by using a genotype 3a HEV strain from a blood donation, diluted in pooled human plasma and lyophilized. A Japanese national standard, representing a genotype 3b HEV strain, was prepared and evaluated in parallel. The potencies of the standards were determined by qualitative and quantitative assays. Assay variability was substantially reduced when HEV RNA concentrations were expressed relative to the IS. Thus, WHO has established 6329/10 as the IS for HEV RNA, with a unitage of 250,000 International Units per milliliter.

Full text | PDF