評估生物晶片及免疫色層分析法檢測結核菌群

Evaluation of Biochip and ICA for the Detection of Mycobacterium Tuberculosis Complex

結核病是由結核分枝桿菌感染引起的慢性傳染病，本研究利用二種快速鑑定方式來個偵測結核菌群，方法一為免疫色層分析法－－偵測結核菌群中獨有MPB-64抗原，方法二為生物晶片－－偵測結核菌群中獨有的IS6110片段，分別比較方法之敏感度、特異性、偽陰性、偽陽性、陰性預測值、陽性預測值等，結果顯示免疫色層分析法檢測方式在特異性、陽性預測值比生物晶片較佳（98.2%、97.0% vs、92.1%、88.0%），兩者有顯著差異，生物晶片在偽陽性比免疫色層分析法檢測方式高（7.9% vs 1.8%）， 兩者有顯著差異；但敏感度、偽陰性、陰性預測值、準確性，兩者無顯著差異（91.4%, 8.6%, 94.9%, 95.7% v.s. 94.3%, 5.7%, 96.3%, 92.9%）；因此臨床可利用快速鑑定檢測方式來做為加速鑑別結核菌群上之診斷依據。

Mycobacterium tuberculosis ,a member of the Mycobacterium tuberculosis complex (MTBC) of bacteria, causes human and animal tuberculosis. In this study, we use Biochip (PCR) to detect IS6110 of TB and Immuno-chromatography (ICA) assay to detect MPB-64 antigen of TB. The specificity, false positive (FP), positive predictive values (PPV) of Immunochromatography assay and the Biochip (PCR) were 98.2 %, 97.0% vs 92.1%, 88.0% (P<0.05), 1.8% vs 7.9% (P<0.05) and the sensitivity , false negative (FN), negative predictive value (NPV) accuracy of Immuno-chromatography assay and the Biochip (PCR) were 91.4%, 8.6%, 94.9%, 95.7% vs 94.3%, 5.7%, 96.3%, 92.9% (P>0.05), respectively. Based on these finding, the Immuno-chromatography assay- (ICA) would be best tool for MTB identification because it is rapidity and easily used, it is device-free, and can be performed at cost.