- 期刊
HIV抗體診斷試劑效能評估調查研究
Post-Market Surveillance for the Performance Evaluation of the Anti-HIV Diagnostic Kits
摘要
HIV抗體診斷試劑是國際用於篩檢血液愛滋病毒的第一線工具，也是目前公認最經濟的愛滋病檢測方法。目前愛滋病檢驗程序中，若血液檢體經初步HIV抗體診斷試劑檢測為陰性則不再繼續追蹤，因此，當HIV抗體診斷試劑品質不良無法正確檢驗出愛滋病陽性血液檢體時，將延誤愛滋病患者的辨認和後續追蹤治療工作，無法有效控制愛滋病之感染擴散。本局於99年度開始調查市售EIA類HIV抗體診斷試劑之效能，由製造商及代理商處購得15種品項共29批次之同類產品，依據各產品使用說明書描述之檢測方法，以愛滋病國際標準血清對照組（WHO HIV，1（上標 st） International Reference Panel，code: 02/210）為標的檢測，結果29件產品均能檢測出HIV抗體。一般而言，所有抽購產品在效能試驗中均能檢測出HIV抗體，尚符合衛生署規範之HIV抗體診斷試劑品質要求。另以含不同HIV-1抗體濃度之BBI陽轉血清組進行靈敏度檢測，發現所有產品均能檢測出陽轉血清組中之強陽性血清，但除其中2種產品能正確檢出最弱陽性血清外，其餘品項對於弱陽性血清則反應不一，無法有效呈現陽性反應。
並列摘要
This study was focused on the performance evaluation of the anti-HIV diagnostic kits on the market in Taiwan. The WHO (World Health Organization) HIV International Reference Panel, (1(superscript st), code: 02/210) and the diagnostic HIV-1 Seroconversion Panel (BBI(superscript ®), Lot: PRB959) were used as the control standards to evaluate the performance of the 15 various commercial anti-HIV diagnostic kits purchased from the production companies. The sensitivity of all kits was also checked by the two-fold serial dilutions of the NIBSC (National Institute for Biological Standard and Control) HIV-1 antibody standard (British Working Standard, code: 99/750). The results indicated that all the kits could identify various subtypes of HIV-1 M group and HIV-2 type, but 9 of the 15 kits could not detect the weak HIV positive serum of the BBI diagnostic HIV-1 seroconversion panel. The sensitivity tests revealed that all the kits could react with the 4 times diluted NIBSC HIV-1 antibody working standard. We also found that some kits did not give good response possibly caused by the interference of diluents, designed epitope or product formulation. Food and Drug Administration of Taiwan will monitor the quality, efficiency and safety of the therapeutic products continuously.
被引用紀錄
延伸閱讀
- 譚俐俐、游雅言（2013）。HIV抗原／抗體複合檢驗結果的解讀。台灣醫檢會報，28(2)，105-106。https://www.airitilibrary.com/Article/Detail?DocID=P20140729002-201306-201411060012-201411060012-105-106
- Hu, L. Y., Lin, C. Y., Wang, Y. Y., & Shih, Y. L. (2020). 從一位HIV患者感染Ciprofloxacin抗藥型B型志賀氏菌之鑑定探討臨床實驗室鑑別志賀氏菌之挑戰. Journal of Biomedical & Laboratory Sciences, 32(2), 93-101. https://www.airitilibrary.com/Article/Detail?DocID=10137653-202006-202006200006-202006200006-93-101
- 張淑媛（2008）。抗愛滋病毒治療藥物抗藥性檢驗的新進展。愛之關懷季刊，(65)，27-34。https://doi.org/10.29826/AJGHJK.200812.0005
- Chi, B. T., Liu, A. C., Huang, Y. F., & Yang, C. H. (2010). The Program for HIV-infected Case Management and Behavior Changes of the Cases. Epidemiology Bulletin, 26(16), 284-290. https://doi.org/10.6525/TEB.201008_26(16).0001
- 蔡春美、吳秀英、林瓊照（2001）。A Pilot Study of HIV/AIDS Related Knowledge among a Website Community。健康促進暨衛生教育雜誌，(21)，71-79。https://www.airitilibrary.com/Article/Detail?DocID=15613852-200112-x-21-71-79-a