The emergence of Zika virus (ZIKV) in the Americas has resulted in increased nucleic acid amplification testing (NAT) of clinical samples and blood donations. New molecular diagnostic assays have been developed resulting in a corollary requirement for ZIKV reference material. To address this we have produced and calibrated two African lineage ZIKV reference materials: a highly concentrated secondary standard (NIBSC: 16/110) and a lower concentration external quality control (QC) reagent (NIBSC: 16/124) and compared their performance in three ZIKV NAT assays in relation with the First International Standard (IS) for Zika Virus NAT assays (PEI: 11468/16). In summary the African lineage ZIKV reference materials were detected by all three assays. The ZIKV lineage did not affect the performance of the secondary standard. The external QC reagent (16/124) was detected by all three assays highlighting its suitability for use as a low positive control to monitor assay performance on a regular basis. The relative potency of 16/110 to the IS was 5.49E+06IU/mL (95% CI: 1.46E+06–2.06E+07) and 16/124 to 16/110 was 8.36E+03 (95% CI: 7.83E+03–8.92E+03). The global availability of African lineage ZIKV reference materials will facilitate standardization of ZIKV molecular diagnostic assays between and within laboratories whilst preserving the IS.

美洲寨卡病毒（ZIKV）的出现导致临床样品和献血的核酸扩增测试（NAT）增多。已经开发出新的分子诊断测定法，从而必然需要ZIKV参考材料。为了解决这个问题，我们制作并校准了两种非洲谱系ZIKV参考材料：高浓度二级标准品（NIBSC：16/110）和低浓度外部质量控制（QC）试剂（NIBSC：16/124），并在与Zika病毒NAT分析的第一国际标准（IS）相关的三种ZIKV NAT分析（PEI：11468/16）。总之，通过所有三种测定都检测到非洲谱系ZIKV参考材料。ZIKV谱系不影响二级标准的性能。通过所有三种测定均检测到外部QC试剂（16/124），突显了其适用于作为低阳性对照定期监测测定性能的问题。16/110对IS的相对效价为5.49E + 06IU / mL（95％CI：1.46E + 06–2.06E + 07），而16/124至16/110为8.36E + 03（95％CI： 7.83E + 03–8.92E + 03）。非洲血统ZIKV参考材料的全球可用性将促进实验室之间和实验室内部ZIKV分子诊断测定的标准化，同时保留IS。