Lin Guigao, Zhang Kuo, Zhang Dong, Han Yanxi, Xie Jiehong, Li Jinming
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, China.
Clin Chim Acta. 2017 Mar;466:138-144. doi: 10.1016/j.cca.2017.01.023. Epub 2017 Jan 19.
The emergence of Zika virus demands accurate laboratory diagnostics. Nucleic acid testing is currently the definitive method for diagnosis of Zika infection. In 2016, an external quality assurance (EQA) for assessing the quality of molecular testing of Zika virus was carried out in China.
A single armored RNA encapsulating a 4942-nucleotides (nt) long specific RNA sequence of Zika virus was prepared and used as positive samples. A pre-tested EQA panel, consisting of 4 negative and 6 positive samples with different concentrations of armored RNA, was distributed to 38 laboratories that perform molecular detection of Zika virus.
A total of 39 data sets (1 laboratory used two test kits in parallel), produced by using commercial (n=38) or laboratory developed (n=1) quantitative reverse-transcriptase PCR (qRT-PCR) kits, were received. Of these, 35 (89.7%) had correct results for all 10 samples, and 4 (10.3%) reported at least 1 error (11 in total). The testing errors were all false-negatives, highlighting the need of improvements in detecting sensitivity.
The EQA reveals that the majority of participating laboratories are proficient in molecular testing of Zika virus.
寨卡病毒的出现需要准确的实验室诊断方法。核酸检测是目前诊断寨卡病毒感染的金标准。2016年，中国开展了一项用于评估寨卡病毒分子检测质量的外部质量保证（EQA）活动。
制备了一种包裹有寨卡病毒4942个核苷酸（nt）长特异性RNA序列的单链装甲RNA，并将其用作阳性样本。一个预先测试过的EQA样本板，由4个阴性样本和6个不同浓度装甲RNA的阳性样本组成，分发给了38个进行寨卡病毒分子检测的实验室。
共收到39组数据（1个实验室同时使用了两种检测试剂盒），这些数据由商用（n = 38）或实验室自行开发（n = 1）的定量逆转录聚合酶链反应（qRT-PCR）试剂盒产生。其中，35组（89.7%）对所有10个样本的检测结果正确，4组（10.3%）至少报告了1次错误（共11次）。这些检测错误均为假阴性，凸显了提高检测灵敏度的必要性。
EQA结果表明，大多数参与实验室在寨卡病毒分子检测方面表现熟练。
