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  • Title: [Quality evaluation of locally-prepared kits for HIV antibody detection in clinical applications].
    Author: Li J, Bao Z, Lu F.
    Journal: Zhonghua Liu Xing Bing Xue Za Zhi; 1999 Aug; 20(4):230-3. PubMed ID: 10682503.
    Abstract:
    OBJECTIVE: To evaluate the quality of eight kinds of locally prepared enzyme-linked immunosorbent assay (ELISA) kits for HIV antibody (anti-HIV) detection and study their current status in clinical applications. METHODS: Two hundred serum specimens were tested with eight kinds of locally prepared ELISA kits for anti-HIV screening, with an imported kit as reference, including 100 specimens with confirmed positive, negative or undetermined anti-HIV and 100 specimens collected from the drug abusers in Xinjiang Region. RESULTS: Anti-HIV could be detected in all the 74 confirmed positive specimens with the imported reference kit, with sensitivity of 100%. But, six to eighteen specimens were false negative detected with local prepared kits, with sensitivities of 81.1%-91.9%, mainly in those collected from the drug abusers with weak positive for anti-HIV. Two of the 107 confirmed negative specimens were false positive by the imported reference kit, with a specificity of 98.2%, and 0-8 specimens were false positive by locally prepared kits, with specificities of 92.5%-100%. CONCLUSION: The sensitivity of locally prepared ELISA kits for anti-HIV screening should be improved further to ensure the safety of blood transfusion and the control of AIDS/HIV.
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