›› 2012, Vol. 27 ›› Issue (11): 900-903.

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Application of CLSI EP12-A2 document in the performance evaluation of qualitative test of HBeAb

  

  1. 1. Department of Clinical Laboratory,Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangdong Guangzhou 510120,China; 2. Department of Clinical Laboratory,Changzhi Medical College,Shanxi Changzhi 046000,China
  • Online:2012-11-30 Published:2012-11-14

Abstract: Objective To evaluate A and B ELISA kits for detecting qualitatively anti-hepatitis B e antigen antibody(HBeAb),and to provide useful reference for choosing suitable HBeAb kits. Methods According to Clinical and Laboratory Standards Institute(CLSI) EP12-A2 document,the bias and imprecision of A and B HBeAb kits were analyzed,and their C50,C5-C95 intervals and imprecision curves were compared.The HBeAb of 910 specimens were simultaneously determined by both A and B kits.The 95% confidence interval(CI)for concordance was calculated.The Kappa value was calculated to evaluate their concordance. Results C50 for A kit was less than that for B kit.C5-C95 interval of A kit was narrower than that of B kit.The imprecision curve of A kit was steeper than that of B kit.The 95%CI for concordance was calculated as 93.2%-96.1%,and the Kappa value was 0.87. Conclusions EP12-A2 is a useful protocol for the evaluation of qualitative test performance.

Key words: Performance evaluation, Qualitative test, EP12-A2, Anti-hepatitis B e antigen antibody