乙肝表面抗原胶体金检测试剂卡性能验证研究

Study on the Performance Verification of the Colloidal Gold Kit for HBsAg

目的探讨胶体金免疫层析试验中试剂卡的性能验证方法,并对本实验室在乙肝表面抗原(HBsAg)检测中所使用的胶体金试剂卡进行性能验证,以判断所用试剂卡能否满足实验室检测工作的基本要求。方法使用本实验室采集日常标本进行胶体金免疫层析检测,通过分析所用试剂卡的最低检出限、特异性、交叉反应、准确度、精密度、干扰实验,与试剂卡说明书提供的性能指标进行对比,判断其是否适合实验室常规检测人群,以此验证该试剂卡的性能指标。结果 HBsAg胶体金试剂卡的最低检出限为2.5 IU/ml;特异性为100%;交叉反应方面,该试剂卡对甲肝病毒、丙肝病毒、AIDS、梅毒的阳性标本及含RF的标本和孕妇的标本不敏感;准确度验证方面,胶体金试剂卡的阴阳性符合率都达到100%;精密度验证方面,该试剂卡的重复性良好;干扰实验验证方面,脂血和溶血均不影响该试剂卡的检测和结果判定。结论厦门英科新创科技有限公司生产的HBsAg胶体金快速检测试剂卡特异性高、重复性好、准确度高,能通过性能验证,适合实验室日常检测工作和受检人群并能保证检测质量。

Objective To investigate the performance verification method of the reagent card in the colloidal gold immunochromatographic test and verify the performance of the colloidal reagent used in the detection of hepatitis B surface antigen（ HBsAg） in order to judge whether the reagent card used can meet the laboratory test the basic requirements of the work. Methods The minimum detection limit,specificity,cross reaction,accuracy,precision and interference test were analyzed by assaying routine samples in the laboratory by colloidal gold immunochromatographic examination and compared to the performance indices provided in the reagent card manual to determine whether it is suitable for routine laboratory testing of the crowd,thereby verifying the performance of the reagent card. Results The minimum detection limit of HBsAg colloidal gold reagent card was 2. 5 IU/ml; specificity is 100%; regarding the cross-reaction,the reagent card was not sensitive to the positive samples of hepatitis A virus,hepatitis C virus,AIDS,syphilis,and samples containing RF and the specimens of pregnant women. In accuracy verification,the positive and negative coincidence rates of the colloidal gold reagent card reached 100%. In precision verification, the reagent card showed good reproducibility. The test and results of the reagent card were not affected by the lipid and hemolysis.Conclusion The colloidal gold kit manufactured by In Tec PRODUCTS,INC. has good specificity,repeatability and precision and has passed performance verification. It is suitable for routine laboratory work and can ensure the quality of detection.