Comparison of HBsAg detection results between HISCL kits and Roche kits
10.3760/cma.j.issn.1003-9279.2016.04.017
- VernacularTitle:希森美康试剂和罗氏试剂检测乙肝表面抗原的比较
- Author:
Xin LU
1
;
Haishan YANG
;
Yanxiang HUANG
;
Feili WEI
;
Dexi CHEN
Author Information
1. 100080,北京市海淀区妇幼保健院检验科
- Keywords:
Hepatitis B surface antigens;
Correlation;
Coincidence
- From:
Chinese Journal of Experimental and Clinical Virology
2016;30(4):406-410
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the repeatability of HISCL HBsAg kits and the correlation comparing with Roche kits.Methods A total of 580 serum samples were collected,HBsAg levels were detected by HISCL HBsAg kits and Elecsys HBsAg Ⅱ Quant kits,respectively.Data were analyzed,and the specificity,sensitivity and anti-jamming capability of HISCL kits were assessed by comparing with Roche kits.Results The intra-assay coefficients of variation (CV) of HISCL HBsAg kits was ＜ 5.0％,and Interassay CV was ≤5.5％.238 samples were repeated testing with HISCL HBsAg kits and the coincidence was 100％.Within them,the repeating detection results of 174 positive samples by HISCL HBsAg kits had agood correlation (r =0.999,P ＜0.01).122 cases of normal control were detected negative by both kits,and the coincidence was 100％.The correlation of HBsAg results from 287 HBsAg positive samples detected by the two kits was r =0.996,P ＜ 0.01.For the samples containing suspicious interferences,the results of the two kits were similar(pregnant women and infants r =0.992,P =0.000;antiviral drugs r =0.994,P =0.000;various virus or syphilis r =0.995,P =0.000;HBV gene mutation r =0.998,P =0.000;antinuclear antibodies and rheumatoid factor r =0.997,P =0.000).Conclusions HISCL HBsAg kits have a good repeatability and a excellent correlation with Elecsys HBsAg Ⅱ Quant kits.
