COBAS TaqMan 48機台於肺外檢體的MTB檢測效能評估

The Performance of Roche COBAS MTB TaqMan 48 Platform in Extra-pulmonary Samples

肺結核主要的致病原為Mycobacterium tuberculosis complex，由於生長緩慢，臨床上若以培養作為診斷之依據，可能會導致治療延誤。本實驗室使用CE-IVD認證的COBAS TaqMan MTB檢驗套組進行MTBC檢測，本篇收集自2013/08/26至2014/08/30期間共2431件檢體，其中肺內檢體有1028件，肺外檢體有1403件（57.7%）。將肺外檢體同時檢測PCR與結核菌培養的結果共1153件進行比對，得敏感度及專一性為80.0%與98.0%，相較於肺內檢體為85.1%與98.9%；且各類檢體在此系統的總抑制率為2.9%。研究成果顯示此檢驗套組可應用於肺外檢體之MTBC檢測。

Mycobacterium tuberculosis complex (MTBC) are the main pathogens of tuberculosis. Identification by culture method may delay diagnosis due to slow growth of the bacteria. We have been using CE-IVD certified COBAS TaqMan MTB for rapid diagnosis of MTBC from sputum samples. In this study, we aim to evaluate the efficacy of COBAS TaqMan MTB system in diagnosis of MTBC from extrapulmonary samples. A total of 2431 samples were collected from 2013/08/26 to 2014/08/30, including 1028 pulmonary and 1403 (57.7%) non-pulmonary samples. Results from extrapulmonary samples were compared with those from the culture method. The sensitivity and specificity were 80.0% and 98.0%, and those were 85.1% and 98.9% from pulmonary samples. The total invalid rate was 2.9%. Results indicate COBAS TaqMan MTB can be applied to clinical diagnosis of MTBC from extrapulmonary samples.