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評估免疫色層分析法之結核菌鑑定報告時效性

Timeliness Evaluation of Immuno-chromatography Assay for Diagnosis of Mycobacterium Tuberculosis Complex

摘要


結核病是由結核桿菌感染引起的慢性傳染病,結核病又稱為“癆病”和“白色瘟疫”,是一種古老的傳染病。本研究利用快速鑑定(免疫色層分析法)偵測結核菌群中獨有MPB-64抗原,先利用結核菌液態快速培養基培養陽性後、再進行抗酸菌染片觀察為結核菌索狀形態後,若原始痰檢體之結核菌價數判斷菌落數分別為4+、3+、2+、1+、scanty、陰性,分別平均6.9、9.2、10.6、13.8、11.6、17.1天即可知道鑑定是否為結核桿菌群,而快速鑑定檢測方式(免疫色層分析法)之檢測發現敏感度、特異性、偽陰性、偽陽性、陽性預測值、陰性預測值、準確性分別為91.9%、98.2%、8.1%、1.8%、96.6%、95.7%,96.0%;快速鑑定檢測方式(免疫色層分析法)其檢測方法簡單只需15分鐘,利用結核菌液態快速培養基陽性後、進行染片觀察結核菌索狀、高價數之結核菌在一週左右即可知道鑑定是否為結核桿菌群,操作快速,且不需任何儀器,成本相對較分子生物檢測方式(PCR)低廉,利用ICA檢測方式(免疫色層分析法)為提供臨床鑑定上良好之結核菌鑑定工具,以利臨床報告之參考依據。

並列摘要


Mycobacterium tuberculosis is a member of the Mycobacterium tuberculosis complex (MTBC) of bacteria that cause human and animal tuberculosis. Tuberculosis is an ancient disease called ”phthisis” or ”white plague”. In this study, we use Immuno-chromatography (ICA) assay, which detects MPB-64 antigen of TB. The samples were processed with tuberculisos culture from MGIT, and checking cord formation by Ziehl-Neelsen stain, sequentially. The result shows that the time to identify takes 6.9,9.2,10.6,13.8,11.6,17.1 days while the smear of sputum was 4+, 3+, 2+, 1+, scanty and negative, the sensitivity, specificity, false negatives (FN), false positives (FP), positive predictive value (PPV), negative predictive value (NPV), and accuracy of Immuno-chromatography assay were 91.9%, 98.2%, 8.1%, 1.8%, 96.6%, 95.7%, and 96.0%. Immuno-chromatography assay (ICA) will be an excellent tool for MTB identification because of its rapidity, easiness, device-free, and lower cost. In strong smear-positive case, the identification results will be reported about 1 week by MGIT culture, checking cord formation, and ICA test. In conclusion, ICA could be a good choice to provide Mycobacterium tuberculosis complex of identification.

並列關鍵字

MPB-64 antigen ICA

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