scholarly journals Harmonization of nucleic acid testing for Zika virus: development of the 1st World Health Organization International Standard

Transfusion ◽  
2017 ◽  
Vol 57 (3pt2) ◽  
pp. 748-761 ◽  
Author(s):  
Sally A. Baylis ◽  
Kay-Martin O. Hanschmann ◽  
Barbara S. Schnierle ◽  
Jan-Hendrik Trösemeier ◽  
Johannes Blümel ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
World Health Organization ◽  
Zika Virus ◽  
World Health ◽  
Nucleic Acid Testing ◽  
International Standard ◽  
Health Organization

scholarly journals Genome Sequence of a Candidate World Health Organization Reference Strain of Zika Virus for Nucleic Acid Testing

2016 ◽  
Vol 4 (5) ◽  
Author(s):  
Jan-Hendrik Trösemeier ◽  
Didier Musso ◽  
Johannes Blümel ◽  
Julien Thézé ◽  
Oliver G. Pybus ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
World Health Organization ◽  
Zika Virus ◽  
Reference Strain ◽  
Nucleic Acid Amplification ◽  
World Health ◽  
Nucleic Acid Testing ◽  
The World ◽  
Health Organization ◽  
Detection And Quantification

We report here the sequence of a candidate reference strain of Zika virus (ZIKV) developed on behalf of the World Health Organization (WHO). The ZIKV reference strain is intended for use in nucleic acid amplification (NAT)-based assays for the detection and quantification of ZIKV RNA.

scholarly journals World Health Organization International Standard To Harmonize Assays for Detection of Mycoplasma DNA

2015 ◽  
Vol 81 (17) ◽  
pp. 5694-5702 ◽  
Author(s):  
C. Micha Nübling ◽  
Sally A. Baylis ◽  
Kay-Martin Hanschmann ◽  
Thomas Montag-Lessing ◽  
Michael Chudy ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
World Health Organization ◽  
Nucleic Acid Amplification ◽  
World Health ◽  
Expert Committee ◽  
Content Type ◽  
International Standard ◽  
Amplification Technique ◽  
Health Organization ◽  
Nucleic Acid Amplification Technique

ABSTRACTNucleic acid amplification technique (NAT)-based assays (referred to here as NAT assays) are increasingly used as an alternative to culture-based approaches for the detection of mycoplasma contamination of cell cultures. Assay features, like the limit of detection or quantification, vary widely between different mycoplasma NAT assays. Biological reference materials may be useful for harmonization of mycoplasma NAT assays. An international feasibility study included lyophilized preparations of four distantly related mycoplasma species (Acholeplasma laidlawii,Mycoplasma fermentans,M. orale,M. pneumoniae) at different concentrations which were analyzed by 21 laboratories using 26 NAT assays with a qualitative, semiquantitative, or quantitative design. AnM. fermentanspreparation was shown to decrease the interassay variation when used as a common reference material. The preparation was remanufactured and characterized in a comparability study, and its potency (in NAT-detectable units) across different NATs was determined. The World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) established this preparation to be the “1st World Health Organization international standard for mycoplasma DNA for nucleic acid amplification technique-based assays designed for generic mycoplasma detection” (WHO Tech Rep Ser 987:42, 2014) with a potency of 200,000 IU/ml. This WHO international standard is now available as a reference preparation for characterization of NAT assays, e.g., for determination of analytic sensitivity, for calibration of quantitative assays in a common unitage, and for defining regulatory requirements in the field of mycoplasma testing.

scholarly journals A World Health Organization Human Hepatitis E Virus Reference Strain Related to Similar Strains Isolated from Rabbits

2018 ◽  
Vol 6 (16) ◽  
pp. e00292-18 ◽  
Author(s):  
Marco Kaiser ◽  
Déborah Delaune ◽  
Olivier Chazouillères ◽  
Johannes Blümel ◽  
Anne-Marie Roque-Afonso ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Sequence Analysis ◽  
World Health Organization ◽  
Hepatitis E Virus ◽  
Reference Strain ◽  
Hepatitis E ◽  
World Health ◽  
Nucleic Acid Testing ◽  
Full Length Sequence ◽  
Health Organization

ABSTRACT We report here the genome sequence of a hepatitis E virus (HEV) strain from a chronically infected immunodeficient patient. Full-length sequence analysis revealed a distinct HEV strain, of a tentative new subgenotype, clustering with viruses from rabbits. It is a World Health Organization reference strain for validation of nucleic acid testing.

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