B型肝炎表面抗原與B型肝炎表面抗體檢驗試劑之評估

EVALUATION OF DIAGNOSTIC KITS FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGEN AND KITS FOR THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN

為了瞭解市售B型肝炎表面抗原與B型肝炎表面抗體檢驗試劑之品質，共調查B型肝炎表面抗原檢驗試劑9種品牌11種商品：B型肝炎表面抗體檢驗試劑8種品牌10種商品。結果顯示，對偵測表面抗原之逆向被動血球，凝集法試劑及偵測表面抗體之被動血球集法試劑其靈敏度均較酵素免疫分析法為差。相同檢測方法之檢驗試劑間其特異性無顯著差異。且酵素免疫分析附檢驗試劑之同次精確度亦甚良好。

In order to understand the quality of diagnostic kits for the detection of HBsAg and kits for the detection of antibody to HBsAg in market, we purchased 9 brands of 11 commercl kits for the detection of HBsAg and 8 brands of 10 commercial kits for the detection of antibody to HBsAg. The results showed that RPHA kits for the detection of HBsAg and PHA kits for the detection of anibody to HBsAg were less sensitive than those of the EIA kits. The specificity to assays of the different diagnostic kits described above were found to be nonsignificant difference. The wihtin-run precision of EIA kits were satisfied with the requirements.