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Utility of Immunochromatographic Assay for Detecting Mycobacterium Tuberculosis from Positive BACTEC MGIT 960 Cultures

免疫層析法檢測BACTEC MGIT 960培養陽性中結核分枝桿菌的效能

摘要


全自動培養偵測系統Becton Dickinson MGIT 960,藉由儀器內建的標準生長檢測軟體來監測培養管中分枝桿菌的生長,可縮短陽性培養時間且已在台灣微生物實驗室廣泛被使用於檢測分枝桿菌感染。然而,非結核性分枝桿菌的高分離率應該被謹慎地評估。本研究的目地即是評估以免疫層析法(MeDiPro M. tuberculosis Antigen Rapid Test)快速鑑定MGIT 960陽性檢體中結核菌的臨床表現。我們分析從2007年7月20日至9月20日這段期間,在台北醫學大學市立萬芳醫院中以免疫層析法(MeDiPro M. tuberculosis Antigen Rapid Test)分別檢測310個MGIT 960陽性檢體第一天及第七天的結果與傳統生化試驗鑑定結果的比較。310個陽性培養中分離出216株結核菌(69.7%)及94株非結核性分枝稈菌(30.3%)。216株結核菌中以免疫層析法(MeDiPro M. tuberculosis Antigen Rapid Test)檢測MGIT 960第一天陽性的檢體,呈現陽性結果的有175株,39株呈現僞陰性,而2株結果無法判定。94株非結核性分枝桿菌的測試結果則呈現3個僞陽性,89個陰性及2株結果無法判定。排除4個無法判定結果的檢體後,我們得到此法的敏感性、特異性、陽性(陰性)預測值分別爲81.8,96.7,98.3及69.5%。隨後檢測MGIT 960陽性培養後第七天檢體,其結果則分別爲95.4,94.5,97.6及89.6%。免疫層析法(MeDiPro M. tuberculosis Antigen Rapid Test)既簡單又省時且不需在實驗室中設置其它儀器。適合應用於臨床上快速鑑定MGIT 960陽性檢體中之結核菌。

並列摘要


Becton Dickinson MGIT 960, an automated cultivation and detection system, can help minimize the time to detect mycobacterium infections. However, the high non-tuberculous mycobacteria (NTM) isolation rate is a concern that should be carefully evaluated. This study was purposed to evaluate the performance of identifying Mycobacterium tuberculosis (M. tuberculosis) from positive MGIT 960 cultures by immunochromatographic assay (ICA) (MeDiPro M. tuberculosis Antigen Rapid Test). We tested 310 positive MGIT 960 cultures on the first and seventh culture-positive day with ICA in Taipei Medical University-Wan Fang Hospital from July 2007 through September 2007. The results of ICA were compared with conventional methods. Among 310 mycobacterial isolates, 216 isolates (69.7%) were M. tuberculosis and 94 isolates (30.3%) were NTM. The sensitivity, specificity, and positive/negative predictive values of ICA for identifying M. tuberculosis were 81.8%, 96.7%, 98.3%, and 69.5%, respectively, on the first culture-positive day; and they were 95.4%, 94.5%, 97.6%, 89.6%, on the seventh culture-positive day. Based on our results, we suggest that this low-tech rapid test could provide an alternative to currently available identification methods.

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