結核分枝桿菌特異性分泌蛋白抗原快速檢測方法之評估

Evaluation of the Rapid Test Detecting Specific Secretory Proteins of Mycobacterium Tuberculosis

賴世遠(Shih-Yuan Lai) ； 吳雪霞(Hsueh-Hsia Wu) ； 莊獻章(Sian-Jang Jaung)

《北市醫學雜誌》 19卷1期 (2022/03) Pp. 45-57

https://doi.org/10.6200/TCMJ.202203_19(1).0005

摘要

目的：目前結核病的臨床診斷以痰液塗片抗酸性染色檢查（Acid-Fast stain; AFS）、結核分枝桿菌（Mycobacterium tuberculosis; MTB）培養鑑定為主，病理和胸部X光檢查為輔，但都有其限制。本研究是評估比對偵測結核分枝桿菌特異性分泌蛋白的快速檢測試驗，與AFS及MTB培養鑑定結果之檢驗效能。方法：收集經診視疑似MTB感染，需做AFS及抗酸菌培養患者之痰液檢體，隨機納入篩選，排除無效的唾液檢體、收集痰液量不足一套AFS檢體，共513例痰液分析檢體。執行痰液塗片AFS和MTB培養與鑑定的同時進行MTB特異性分泌蛋白抗原快速檢測，並進行統計分析。結果：結核抗原快速篩檢檢測的敏感性和特異性，分別為50.0%及76.5%，偽陽性為23.5%，偽陰性為50.0%，另陽性預測值（Positive Predictive Value; PPV）為10.9%，陰性預測值（Negative Predictive Value; NPV）為96.4%，整體檢測的準確度為75.0%。結論：結核抗原快速篩檢試驗是一個簡單、快速且有效的診斷工具，可直接從痰液中檢測MTB的感染，降低病患等待治療的時間，可以做為結核病高危險群初診的臨床篩檢試驗，提供醫護人員另一項檢測的參考。

關鍵字

結核分枝桿菌 ； 抗酸性染色 ； 胸部X光檢查

並列摘要

Objective: The current clinical diagnostic methods for tuberculosis are primarily smeared acid-fast stain and Mycobacterium tuberculosis (Mtb) culture and identification. Although pathological and chest X-ray examinations assist the diagnosis, there are limitations. The current study evaluated the effectiveness of a rapid detection test that detects the specific secretory proteins of Mycobacterium tuberculosis by comparing it with the current clinical smear acid-fast stain and Mycobacterium tuberculosis (Mtb) culture and identification. Methods: A total of 513 sputum samples from the patients with suspected MTB infections requiring AFS and MTB culture were collected. Those samples with saliva as well as insufficient sputum were excluded. We performed AFS, MTB culture and identification, MTB-specific secreted protein antigen detection and statistical analysis. Results: The sensitivity and specificity of the rapid screening test for tuberculosis antigen were 50.0% and 76.5%, respectively. The false-positive value was 23.5%, and the false-negative value was 50.0%. The positive predictive value (PPV), negative prediction value (NPV), and overall detection accuracy were 10.9%, 96.4%, and 75.0%. Conclusion: M. tuberculosis Antigen (TB Ag) Rapid Test is a simple, rapid, and effective diagnostic tool that can detect MTB infection directly from sputum, reducing the waiting time for treatment. It can be used as a supplementary screening test in the first clinic visit of the TB high-risk group and provide an additional reference for the medical staff.

並列關鍵字

mycobacterium tuberculosis (MTB) ； acid-fast staining test (AFS) ； chest x-ray examination