臺灣地區市售愛滋病篩檢試劑之評估

EVALUATION OF DIAGNOSTIC KITS FOR DETECTION OF ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS IN TAIWAN AREA

為了暸解臺灣地區市售愛滋病篩檢試劑之品質，自民國79年10月至同年12月向各進口代理商抽購HIV-1抗體篩檢試劑計19批號12種產品，分別依該試劑檢驗方法進行分析檢驗，計有酵素免疫分析法、粒子凝集法、被動血球凝集法及膠乳凝集法等；HIV-1抗體與HIV-2抗體混合型篩檢試劑，計9批號6種產品，其試劑檢驗方法除1種產品為酵素免疫法測試盒外，其餘皆為酵素免疫分析法。依據各篩檢試劑內附之使用說明進行血清組測試及判讀後，結果顯示，HIV-1抗體篩檢試劑中膠乳凝集法有1種產品及酵素免疫分析法1種產品2批號之靈敏度較其他品牌為差；而HIV-1抗體與HIV-2抗體混合型篩檢試劑各產品問之靈敏度大致良好。對於大部份品牌之篩檢試劑測試反應時間約為90~120分鐘。酵素免疫分析法各篩檢試劑之陰性對照血清及陽性對照血清再現性皆甚良好。

In order to understand the quality of diagnostic kits for detection of Anti-HIV in market, 19 lots 12 products of Anti-HIV-1 diagnostic kits and 9 lots 6 products of Anti-HIV-1/ HIV-2 diagnostic kits were purchased from October 1990 to December 1990 in Taiwan area. The result showed that one product of diagnostic kit for latex agglutination assay of detection of Anti-HIV-1 and two lost one product of diagnostic kits for enzyme immunoassay of detetion of Anti-HIV-1 were significantly less sensitive than any other products. Most of diagnostic kits took 90-120 minutes for reaction. The reproductivity of diagnostic kits for enzyme immunassay were satisfied with the specification.