摘要
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.
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.
作者
杨永刚
滕勇
李新征
汪隆娟
沈琳
朱伊钒
王冬辉
Yang Yonggang;Teng Yong;Li Xinzheng;Wang Longjuan;Shen Lin;Zhu Yifan;Wang Donghui(Department of Clinical Laboratory,the Third People's Hospital of Hangzhou Jiangzhou 310009,China)
出处
《国际流行病学传染病学杂志》
CAS
2019年第2期131-134,共4页
International Journal of Epidemiology and Infectious Disease
关键词
肝炎表面抗原
乙型
胶体金免疫层析法
性能评价
化学发光法
Hepatitis B surface antigens
Colloidal gold method
Efficacy evaluation
Chemiluminescence assay
