摘要
目的追踪分析1种严重急性呼吸系统综合征冠状病毒2(severe acute respiratorysyndrome coronavirus 2,SARS-CoV-2)抗体酶联免疫吸附实验(enzyme linked immunosorbent assay,ELISA)试剂盒临床检测结果及诊断效能。方法应用SARS-CoV-2总抗体(TAb)ELISA试剂,筛查献血者血浆,采血1月后追踪TAb阳性献血者。TAb阳性献血者第1次采集标本以及追踪标本补充SARS-CoV-2特异性IgG、IgM及SARS-CoV-2假病毒中和试验(pseudotype lentivirus-based neutralization test,ppNAT)。以ppNAT阳性标本及其追踪标本ppNAT及IgG抗体同时阳性作为抗体确认标准,分析SARS-CoV-2总抗体ELISA试剂灵敏度、特异度、阳性预测值、阴性预测值、正确率和约登指数。结果2020年1月31日~4月28日16016人次献血者血浆标本中,61例SARS-CoV-2总抗体ELISA试剂阳性,6例ppNAT阳性,其中2例ppNAT和IgG抗体同时阳性;追踪检测46例总抗体阳性献血者,4例ppNAT阳性,其中2例IgG抗体同时阳性。SARS-CoV-2总抗体试剂灵敏度100.00%,特异度99.60%,阳性预测值3.28%,阴性预测值100.00%,正确率99.60%,约登指数99.60%,假阳性率0.40%,假阴性率0.00。结论SARS-CoV-2总抗体ELISA试剂具有较高灵敏度,较好的临床诊断效能,但在低危献血人群中假阳性率相对较高,在临床应用时,应综合ppNAT,IgG及追踪检测结果,更准确判断既往感染状况,分析阳性结果。
Objective To track and evaluate the clinical diagnostic efficacy of an enzyme linked immunosorbent assay(ELISA)kit for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).Methods Total antibody(TAb)specific to SARS-CoV-2 in blood donors were determined using ELISA reagent.TAb positive donors were followed up 1 month after blood donation.SARS-CoV-2 specific IgG,IgM and pseudotype lentivirus based neutralization test(ppNAT)were conducted for TAb positive blood donors and follow-up samples.ppNAT and IgG antibodies simultaneously positive in ppNAT positive samples and its follow-up samples was used as the standard for antibodies validation.The sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV),accuracy and Youden index of SARS-CoV-2 TAb ELISA were analyzed.Results Among 16016 blood donors from January 31 to April 28,2020,61 donors were diagnosed as TAb positive,6 cases were positive for ppNAT,in which 2 were positive for both ppNAT and IgG;4 of 46 TAb positive follow-up samples were positive for ppNAT,in which 2 were positive for IgG simultaneously.The sensitivity,specificity,PPV,NPV,accuracy,Youden index,false positive rate and false negative rate of SARS-CoV-2 TAb reagent were 100.00%,99.60%,3.28%,100.00%,99.60%,99.60%,0.40%and 0.00%,respectively.Conclusion SARS-CoV-2 TAb ELISA has high sensitivity and good clinical diagnostic efficacy,but the false positive rate is relatively high in low-risk blood donors.Therefore,ppNAT,IgG and follow-up results should be fully considered in clinical in order to analyze the positive results and determine the infection status more accurately.
作者
张红
邬林枫
刘国都
李彤
刘衡
崔秀娟
杜丹丹
曾劲峰
王立林
ZHANG Hong;WU Linfeng;LIU Guodu;LI Tong;LIU Heng;CUI Xiujuan;DU Dandan;ZENG Jinfeng;WANG Lilin(Shenzhen Blood Center,Shenzhen 518035,China)
出处
《中国输血杂志》
CAS
2021年第10期1082-1086,共5页
Chinese Journal of Blood Transfusion
基金
2020年度广东省医学基金项目(A2020259)
深圳市医学重点学科建设经费(SZXK070)
深圳市医疗卫生三名工程项目(SZSM201811092)。
