COVID-19抗体检测试剂盒的制备与应用

Preparation and Application of COVID-19 Antibody Detection Kit

将重组表达的新冠N和S蛋白通过化学反应,偶联到聚苯乙烯微球上,并置换到合适的保存液中,制备出新冠检测试剂2(R_(2))。结合抗原抗体反应特性及降低血清中非特异性吸附,制备出新冠检测试剂1(R_(1))。R_(1)与R_(2)搭配使用构成了定量检测人血清中新冠抗体检测胶乳试剂盒。通过条件可知:制备20 mL胶乳R_(2),包被新冠病毒N蛋白与S蛋白各2.5 mg,同时聚苯乙烯微球粒径为130 nm时,试剂效果最好。该试剂盒通过对1000例常州本地正常临床样本、3例武汉阳性样本与5例上海临床检验中心室间质评样本的评测,结果显示正常样本均表现阴性,阳性样本均检测为阳性,与事实相符,试剂盒性能较好。

The COVID-19 detection reagent 2(R_(2))was prepared by coupling the recombinant expressed COVID-19 N and S proteins to polystyrene microspheres through chemical reaction and replacing them into suitable preservation solution.Combined with the reaction characteristics of antigen and antibody and reducing the non-specific adsorption in serum,the COVID-19 detection reagent 1(R_(1))was prepared and the combination of R_(1)and R_(2)constituted the latex kit for quantitative detection of COVID-19 antibody detection in human serum.The results showed that the best reagent was prepared when 20 mL latex R_(2)was prpared and coated with 2.5 mg N protein of COVID-19 and 2.5 mg S protein respectively,and the particle size of polystyrene microspheres was 130 nm,the kit performance was the best.The kit was evaluated in 1000 normal clinical samples from Changzhou,3 positive samples from Wuhan and 5 samples from Shanghai clinical laboratory center.The results showed that all the normal samples were negative,and all the positive samples were positive,which was consistent with the fact.Therefore,the performance of the kit was good.