結核病到目前為止仍是造成嚴重呼吸道疾病之重大傳染性疾病之一，結核病是由結核分枝桿菌群 (Mycobacterium tuberculosis complex, MTBC) 感染所造成的。臨床常發生 MTBC 與非結核分枝桿菌 (non-tuberculous mycobacteria, NTM) 混合感染，可能會導致 MTBC 的藥物感受性試驗結果誤判，進而影響病患治療，而且 NTM 對大部分抗結核藥物呈抗性，操作藥物感受性試驗意義不大，目前依照美國胸腔協會治療指引投藥，突顯 NTM 型別鑑定之重要性。 本研究目的為利用晶片探針雜合反應，快速鑑定 MTBC 與 NTM 分型並瞭解 MTBC 與 NTM 分佈情形，提供臨床參考之依據。因 NTM 對大部分抗結核藥物呈抗性所以治療上有困難，必須先鑑定出它的型別才能用藥，故 NTM 之鑑定是相當重要的。利用晶片試劑套組、免疫色層分析法與傳統生化鑑定總計進行了 713 株測試菌株，分析晶片雜合反應鑑定 MTBC 之靈敏度 (sensitivity) 、特異性 (specificity) 、陽性預測值 (positive predictive value, PPV) 以及陰性預測值 (negative predictive value, NPV)，分別為 99.6%、100%、100% 以及 99.8% ，鑑定結果 MTBC 與 NTM 分佈比例是 4 : 6 。免疫色層分析法在報告時效、成本與技術層面方面優於晶片試劑套組，晶片試劑套組優勢在於可進行 NTM 分型，以及 MTBC 對 rifampicin 的抗藥性偵測。未來希望可以進一步評估有關於晶片試劑套組檢測 MTBC 對抗結核藥物 rifampicin 的抗藥性表現，以提供快速檢測 MTBC 對 rifampicin 的抗藥性結果。 Tuberculosis (TB) is remained as one of major infectious diseases causing severe respiratory illnesses today. TB is due to infection with Mycobacterium tuberculosis complex (MTBC). The mixed infections with MTBC and non-tuberculous mycobacteria (NTM) are often discovered in clinical samples. They lead to false positive results of drug susceptibility test for MTBC and affect treatment for TB. NTM is resistant to most of anti-TB drugs in clinical medicine. In current treatment, according to American Thoracic Society guidelines for drugs, it is very important to identify types of NTM. The aim of this research was to identify rapidly the type of MTBC and NTM using chip hybridization method in order to understand the distribution of MTBC and NTM in clinical samples. Identification of the specific NTM strain is especially important. Medical treatment is often difficult because NTM is resistant towards most anti-tuberculosis drugs. Thus the types of NTM strains must be identified. In this research, a total of 713 bacteria strains were identified by the biochip, immunochromatography strip and biochemical detection kit. And the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the TB test were also tested, the results were 99.6%, 100%, 100% and 99.8%, respectively. The result of the distribution of MTBC to NTM was 4 : 6 . Immunohromatography strip was better than the chip in the report timeliness, cost and technical aspects. The advantages of the biochip were to identify NTM types and detect the resistance of MTBC towards rifampicin. In future, the study will be made to evaluate the use of chip detection kit and provide a rapid detection for the resistance of MTBC towards rifampicin.
