摘要
目的同时用参比试剂和评价试剂检测433例血清样本,探讨评价试剂与参比试剂检测结果的符合率。方法评价试剂采用免疫层析法;参比试剂中的人类免疫缺陷病毒抗体(抗-HIV)、丙型肝炎抗体(抗-HCV)和乙型肝炎病毒表面抗原(HBsAg)检测采用酶联免疫法,梅毒螺旋体抗体(抗-TP)检测采用明胶凝集法,共检测血清标本433例。结果抗-HIV评价试剂与参比试剂的总符合率、阳性符合率和阴性符合率均为100.00%,两种方法比较差异无统计学意义(P>0.05);抗-HCV评价试剂与参比试剂的总符合率、阳性符合率和阴性符合率分别为99.54%、100.00%和99.50%,两种方法比较差异无统计学意义(P>0.05);HBsAg评价试剂与参比试剂的总符合率、阳性符合率和阴性符合率分别为97.92%、96.55%和98.13%,两种方法比较差异无统计学意义(P>0.05)。抗-TP评价试剂与参比试剂的总符合率、阳性符合率和阴性符合率分别为99.31%、96.30%和99.51%,两种方法比较差异无统计学意义(P>0.05)。结论评价试剂与参比试剂的检测结果具有很好的一致性。
Objective To study the coincidence rate of detection results in reference reagent and testing reagent for simultaneously detecting 433 serum samples.Methods There were three different methods used.Control group was tested by tmmunochromatography method,anti-HIV,anti-HCV antibody and HBsAg by enzyme-linked immunosorbent assay and anti-TP antibody by gelatin agglutination method.Totally,433 samples were used.Results The total coincidence rate,positive coincidence rate and negative coincidence rate in the testing reagent and reference reagent of anti-HIV antibody all were 100% without statistical difference between them.The total coincidence rate,positive coincidence rate and negative coincidence rate in the testing reagent and reference reagent of anti-HCV antibody were 99.54%,100.00% and 99.50% respectively.No statistical difference existed between them.The total coincidence rate,positive coincidence rate and negative coincidence rate in the testing reagent and reference reagent of HBsAg were 99.72%,96.55% and 98.13% respectively without statistical difference between them.The total coincidence rate,positive coincidence rate and negative coincidence rate in the testing reagent and reference reagent of anti-TP antibody were 99.13%,96.30% and 99.51%,which showing no statistical difference between them.Conclusion The detection results of reference and testing reagents have better consistency.
出处
《检验医学与临床》
CAS
2011年第3期269-270,273,共3页
Laboratory Medicine and Clinic
关键词
免疫层析法
酶联免疫法
明胶凝集法
tmmunochromatography
enzyme-linked immunosorbent assay
gelatin agglutination
