两种乙型肝炎病毒表面抗原检测试剂的性能比较

摘要

Objective To discover the performance differences between two colloidal gold test strips for HBsAg and to explore their clinical applicability.Methods The bias and imprecision of A and B HBsAg kits were analyzed,and the C50,C5-C95 intervals and imprecision curves were compared.At the same time,8 423 specimens collected in the Third People's Hospital of Hangzhou from January to December 2017 were determined for HBsAg by these colloidal gold kits and the so-called "gold standard method"-chemiluminescence assay.The performance differences between the two colloidal gold kits were compared and the consistency analysis was carried out.Results The concentrations of C48 for kit A (2.95 IU/mL) was lower than C50 for kit B (7.08 IU/mL),and had better sensitivity.The C0-C100value of kit A was 0.80-8.85 IU/mL,and was narrower than that of kit B (2.01-16.09 IU/mL).The consistency of kit B (Kappa=0.949) was superior to kit A (Kappa=0.834) when compared with chemiluminescence assay,as well as positive predictive values (93.68 ％ vs 74.56 ％).Conclusions The kit A has better sensitivity and detection range,but kit B has more superiorities than kit A in emergency preliminary screening and preoperative detection.%目的 探讨两种HBsAg胶体金试纸条性能上的差异,及其在临床上的适用性.方法 对A、B两种检测试剂做偏倚和不精密度分析,比较两种试剂的C50、C5～C95区间以及不精密度曲线;同时用杭州市第三人民医院2017年1-12月术前急查HBsAg的共8 423份样本,以免疫化学发光法检测的结果为“金标准”,比较两种胶体金试剂之间的性能差异,并进行一致性分析.结果 A试剂的C48浓度为2.95 IU/mL,低于B试剂的C50浓度(7.08 IU/mL),具有较好的灵敏度.A试剂的C0～C100值为0.80～8.85 IU/mL,B试剂为2.01～16.09 IU/mL,A试剂的不精密度比B试剂窄.B试剂与化学发光法的一致性(Kappa=0.949)优于A试剂(Kappa=0.834),同时B试剂的阳性预测值为93.68％,高于A试剂的74.56％.结论 A试剂虽然具有较好的灵敏度和检测范围,但B试剂应用于急诊初步筛查和手术前检测方面比A试剂更具有优势.