Abstract
Quality Control for Molecular Diagnostics (QCMD), an international provider for External Quality Assessment (EQA) programmes, has introduced a programme for molecular diagnostics of Zika virus (ZIKV) in 2016, which has been continuously offered to interested laboratories since that time. The EQA schemes provided from 2016 to 2018 revealed that 86.7% (92/106), 82.4% (89/108), and 88.2% (90/102) of the participating laboratories reported correct results for all samples, respectively in 2016, 2017, and 2018. The review of results indicated a need for improvement concerning analytical sensitivity and specificity of the test methods. Comparison with the outcomes of other EQA initiatives briefly summarized here show that continuous quality assurance is important to improve laboratory performance and to increase preparedness with reliable diagnostic assays for effective patient management, infection and outbreak control.
Highlights
Zika virus (ZIKV) is a mosquito-borne flavivirus which had been considered to have low pathogenicity, with only very sporadic human cases and outbreaks reported in the past [1]
Review of the three Quality Control for Molecular Diagnostics (QCMD) External Quality Assessment (EQA) schemes performed between 2016 and 2018 demonstrate that the overall qualitative performance of participating laboratories for molecular diagnostics of ZIKV was at an acceptable level
The continued use of the World Health Organization (WHO) international standard (IS) as included in the QCMD EQA programme for molecular diagnostics of ZIKV will help to support assay standardization and to improve quality performance of molecular ZIKV diagnostics
Summary
Zika virus (ZIKV) is a mosquito-borne flavivirus which had been considered to have low pathogenicity, with only very sporadic human cases and outbreaks reported in the past [1]. We review the results of the EQA schemes performed from 2016 to 2018 showing need for improvement concerning analytical sensitivity and specificity of the test methods.
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