抗新型冠状病毒抗体样本盘在其胶体金测试卡质量评价中的应用

目的建立抗新型冠状病毒(SARS-CoV-2)抗体样本盘,并应用于SARS-CoV-2抗体胶体金测试卡的质量评价。方法采用新型冠状病毒肺炎(Corona Virus Disease 2019,COVID-19)康复者恢复期经病毒灭活的血浆样本建立SARS-CoV-2抗体样本盘,并进行优化。收集国内3个厂家(厂家S、厂家L、厂家H)胶体金测试卡,分别检测样本盘,并提出改进意见,厂家优化改进后,对优化后测试卡进行评价和比较。结果厂家S优化前测试卡的准确度为92.54%,灵敏度为90.78%,特异性为100.00%,约登指数为0.908,但阳性检测线颜色浅,不易辨识;优化后测试卡的灵敏度为95.35%,特异性为98.91%,准确度为97.19%,约登指数为0.943,且显色明显,易于判读。厂家L优化前测试卡检测IgM抗体的灵敏度仅为14.28%,漏检率较高,且显色不明显;优化后测试卡检测IgM抗体的的灵敏度达98.63%,显色明显且快速。厂家H测试卡检测IgG抗体的灵敏度为98.08%,特异性为100.00%,准确度为98.90%,约登指数为0.981;检测IgM抗体的灵敏度为84.50%,特异性为86.49%,准确度为85.71%,约登指数为0.710。结论本实验建立的SARS-CoV-2抗体样本盘可用于SARS-CoV-2抗体检测试剂的质量评价。

Application of SARS-CoV-2 antibody sample panel in quality evaluation of test cassettes for colloidal gold lateral flow assay

Objective To establish a SARS-CoV-2 antibody sample panel and apply to the quality evaluation of test cassettes for colloidal gold lateral flow assay.Methods SARS-CoV-2 antibody sample panel was established with the convalescent plasma samples from patients with Corona Virus Disease 2019(COVID-19) and optimized.Suggestions for modification were put forward on the sample panels from three manufacturers(S,L and H),and the test cassettes after modification were analyzed and compared.Results The accuracy,sensitivity,specificity and Youden index of cassette from manufacturer S were 92.54%,90.78%,100% and 0.908 respectively,while the positive test region was light in color and not easy to be recognized.However,after modification,the accuracy,sensitivity,specificity and Youden index were 95.35%,98.91%,97.19% and 0.943 respectively,while the color of positive test region was developed obviously and easy to be recognized.The sensitivity of cassette from manufacturer L was only 14.28% before modification,while the positive test region was unobvious in color,indicating a high missed detection rate.However,after modification,the sensitivity for IgM was 98.63%,while the color of positive test region was developed obviously and rapidly.The sensitivity,specificity,accuracy and Youden index were 98.08%,100.00%,98.90% and 0.981 for IgG,while were84.50%,86.49%,85.71% and 0.710 for IgM,respectively.Conclusion The developed sample panel may be used for the quality evaluation of SARS-CoV-2 antiobdy detection reagents.