[摘要]详细介绍了10 种(SARSCoV-2)核酸检测试剂盒的特点和相关技术指标，从样本制备、 检测靶点和阈值判断3个方面总结了不同生产厂家的SARS--CoV-2核酸检测试剂盒产品的设计差异和不足。得出了检测限水平差并是此类产品重要的风险评估指标,提出了使用核酸评价物质衡量试剂盒产品检测限的必要性，以期为SARS--CoV-2核酸检测试剂盒产品的评价提供参考。
[关键词] SARS-CoV-2;荧光定量PCR法;核酸检测;检测靶点;产品评价
Analysis andevaluation of SARS-CoV-2 nucleic acid testing reagent kit
LI Da', YANGZhongh2, W ANG Junl-2, WANG Hui-ruL2°
(1. BeijingInstitute of Medical Testing, Beijing 101111, China; 2. Beijing KeyLaboratory of Medical Device Testing andSafelty Evaluation, Beijing 101111,China)Abstract Thecharacteristics and related technical specifications of 10 novelcoronavirus (SARS - CoV -2) nucleic aciddetection kits were introduced in detail, andthe design differences and shortcomings of SARS-CoV-2 nucleic aciddetectionkits from differentmanufacturers are summarized in terms of sample preparation,detection targets and threshold judgment. Itwas concluded that the difference in detectionlimit level was an important risk assessment index of these kits,and thenecessity of usingnucleic acid evaluation substances to measure the detection limitof the kits was proposed as a reference forthe evaluation of SARS- CoV - 2 nucleic acidtest kits.
Key words SARS-CoV-2; fluorescence PCR; nucleic acid detection;detection target; product evaluation
