title: Collaborative study for the establishment of the Ph. Eur. Hepatitis E virus RNA for NAT testing biological reference preparation batch 1.
abstract: A new European Pharmacopoeia (Ph. Eur.) biological reference preparation (BRP) had to be established further to the decision to include nucleic acid testing (NAT) for the detection of hepatitis E virus (HEV) RNA in the monograph Human plasma (pooled and treated for virus inactivation) (1646). To this purpose, an international collaborative study was launched in the framework of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Commission of the European Union (EU). The study was run in conjunction with the establishment of the 1stWorld Health Organization (WHO) international reference panel (IRP) for hepatitis E virus RNA genotypes (8578/13). Twenty-three laboratories used in-house developed and commercially available assays to calibrate a lyophilised candidate BRP prepared from a HEV 3f strain positive human plasma against the 1stWHO International Standard (IS) for HEV RNA (6329/10). Results from quantitative and qualitative assays were in good agreement and were combined to calculate an assigned potency. Real-time stability studies indicated that the candidate BRP is very stable at lower temperatures and is thus suitable for long-term use. Based on these results, in February 2016, the Ph. Eur. Commission adopted the candidate material as the hepatitis E virus RNA for NAT testing BRP batch 1, with an assigned unitage of 2.1 × 104IU/vial (4.32 log10IU/vial).
authors.affiliation: Paul-Ehrlich-Institut (PEI), Langen, Germany.
authors.forename: S A
authors.initials: SA
authors.lastname: Baylis
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France, corresponding author's email: eriko.terao@edqm.eu.
authors.forename: E
authors.initials: E
authors.lastname: Terao
authors.affiliation: Paul-Ehrlich-Institut (PEI), Langen, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Blümel
authors.affiliation: Paul-Ehrlich-Institut (PEI), Langen, Germany.
authors.forename: K-M O
authors.initials: KO
authors.lastname: Hanschmann
mesh_terms: D016752:Hepatitis E virus / Q000235:genetics*; D006801:Humans; D007391:International Cooperation; D021141:Nucleic Acid Amplification Techniques / Q000379:methods / Q000592:standards*; D010602:Pharmacopoeias as Topic / Q000592:standards*; D012328:RNA Viruses / Q000235:genetics*; D012015:Reference Standards
keywords: Nucleic Acid Testing; PCR; hepatitis E; plasma pool