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

Zika Virus Collaborative Study Group

Research output: Contribution to journalArticle

Abstract

BACKGROUND: With the ongoing public health emergency due to Zika virus (ZIKV), nucleic acid testing (NAT) is essential for clinical diagnosis and screening of blood donors. However, NAT for ZIKV has not been standardized, and this study was performed to establish a World Health Organization (WHO) International Standard (IS) for ZIKV RNA; WHO ISs have been used to improve detection and quantification of blood-borne viruses.

STUDY DESIGN AND METHODS: The candidate IS (cIS), code number 11468/16, was prepared by heat inactivation and lyophilization of a ZIKV strain isolated from a patient in French Polynesia in 2013. The cIS was evaluated together with other reference materials, including both Asian and African ZIKV lineages as well as a panel of clinical samples and in vitro-transcribed RNAs. The samples for evaluation were distributed to 24 laboratories from 11 countries. The assays used consisted of a mixture of in-house developed and commercial assays (available or in development).

RESULTS: The potencies of the standards were determined by quantitative and qualitative assays. In total, 37 sets of data were analyzed: 19 from quantitative assays and 18 from qualitative assays. Data demonstrated wide variations in reported potencies of the cIS and the other study samples.

CONCLUSIONS: Assay variability was substantially reduced when ZIKV RNA concentrations from the biological reference materials and clinical samples were expressed relative to the cIS. Thus, the WHO has established 11468/16 as the 1stIS for ZIKV RNA, with a unitage of 50,000,000 IU/mL.

Original languageEnglish
Pages (from-to)748-761
Number of pages14
JournalTransfusion
Volume57
Issue number3pt2
DOIs
Publication statusPublished - Mar 2017

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Nucleic Acids
Organizations
Health
RNA
Polynesia
Freeze Drying
Zika Virus
Blood Donors
Emergencies
Public Health
Hot Temperature
Viruses

Keywords

  • Female
  • Humans
  • Male
  • Reference Standards
  • Virus Inactivation
  • World Health Organization
  • Zika Virus
  • Zika Virus Infection

Cite this

Harmonization of nucleic acid testing for Zika virus : development of the 1World Health Organization International Standard. / Zika Virus Collaborative Study Group.

In: Transfusion, Vol. 57, No. 3pt2, 03.2017, p. 748-761.

Research output: Contribution to journalArticle

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N2 - BACKGROUND: With the ongoing public health emergency due to Zika virus (ZIKV), nucleic acid testing (NAT) is essential for clinical diagnosis and screening of blood donors. However, NAT for ZIKV has not been standardized, and this study was performed to establish a World Health Organization (WHO) International Standard (IS) for ZIKV RNA; WHO ISs have been used to improve detection and quantification of blood-borne viruses.STUDY DESIGN AND METHODS: The candidate IS (cIS), code number 11468/16, was prepared by heat inactivation and lyophilization of a ZIKV strain isolated from a patient in French Polynesia in 2013. The cIS was evaluated together with other reference materials, including both Asian and African ZIKV lineages as well as a panel of clinical samples and in vitro-transcribed RNAs. The samples for evaluation were distributed to 24 laboratories from 11 countries. The assays used consisted of a mixture of in-house developed and commercial assays (available or in development).RESULTS: The potencies of the standards were determined by quantitative and qualitative assays. In total, 37 sets of data were analyzed: 19 from quantitative assays and 18 from qualitative assays. Data demonstrated wide variations in reported potencies of the cIS and the other study samples.CONCLUSIONS: Assay variability was substantially reduced when ZIKV RNA concentrations from the biological reference materials and clinical samples were expressed relative to the cIS. Thus, the WHO has established 11468/16 as the 1stIS for ZIKV RNA, with a unitage of 50,000,000 IU/mL.

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