EQUI-TB Tuberculosis Rapid Test之臨床應用評估

Clinical Application and Evaluation of EQUI-TB Tuberculosis Rapid Test

莊慧如(Hui-Ju Chuang) ； 賴爭妍(Cheng-Yen Lai) ； 林博彥(Pual Y. Lin) ； 楊宗翰(Tsung-Han Yang)

《Journal of Biomedical & Laboratory Sciences》 24卷1期 (2011/03) Pp. 20-24

https://doi.org/10.30046/JBLS.201103.0009

摘要

結核病（Tuberculosis，TB）的診斷主要是依賴痰塗片抗酸菌染色鏡檢、胸部X光檢查及結核菌培養。然而痰塗片的敏感度偏低，胸部X光檢查診斷缺乏特異性，所以最終仍需仰賴傳統的結核菌培養鑑定作為診斷標準。傳統培養方法需四至八週，因此許多快速鑑別診斷方法陸續被發展出來，但其臨床應用性需進一步評估。本研究目的在評估EQUI-TB Tuberculosis Rapid Test試劑之臨床應用性。實驗採回溯性設計，收集分析經培養陽性病人之血清檢體共42件（TB32件，NTM10件）進行檢測，另外收集培養陰性病人之血清檢體共10件，做為陰性對照。研究方法是收集病患的血清檢體以EQUI-TB Tuberculosis Rapid Test進行檢測，並與抗酸染色鏡檢分別與TB培養結果進行評估比較。結果顯示，32件TB培養陽性中，其血清檢體有16件為EQUI-TB檢測陽性，而20件TB培養陰性之檢體中，EQUI-TB檢測則均為陰性。經計算EQUI-TB快速血清檢測法之敏感度為50 %，特異性為100 %，陽性預測值為100%，陰性預測值為56%；整個方法的評估效率為69％。此外，相較於抗酸染色與TB培養評估結果，其敏感度為44％、特異性為90％、陽性預測值為88％、陰性預測值為50％，方法的評估效率為62％。EQUI-TB Tuberculosis Rapid Test可排除NTM之干擾，操作簡便快速。因此可作為TB臨床診斷的輔助工具。本次實驗因限於檢體數較低，未來可再增加檢體數測試，以獲得更有力的結果。

關鍵字

肺結核菌 ； 分枝桿菌 ； 評估 ； EQUI-TB結核菌快速檢測

並列摘要

The diagnosis of tuberculosis (TB) mainly relies on acid-fast staining of sputum smears, chest X-ray inspection, and mycobacterial culture. However, sputum smear has low sensitivity, while the chest X-ray inspection lacks specificity. Therefore, traditional mycobacterial culture followed by biochemical identification is used as the diagnostic standard. Even so, the traditional culture process takes four to eight weeks. To circumvent this problem, rapid identification and diagnosis methods, such as the EQUI-TB Tuberculosis Rapid Test, were developed. This study aimed to assess the clinical applicability of EQUI-TB Tuberculosis Rapid Test. A total of 42 serum samples collected from 32 patients with Mycobacterium tuberculosis complex (MTBC) infection and another 10 patients with non-tuberculous mycobacteria (NTM) infection were retrospectively collected and analyzed. In addition, 10 serum samples obtained from patients without TB infection. Culture and acid-fast staining results were used for comparison. Among the 32 TB-positive serum samples, 16 were detected as positive via the EQUI-TB. In contrast, serum samples obtained from the 20 TB-negative patients all produced negative results. The EQUI-TB Rapid Serum Test showed a sensitivity of 50%, specificity 100%, positive predictive value 100%, and negative predictive value 56%. The overall assessment effectiveness was 69%. Besides, in comparison with acid-fast staining method, EQUI-TB Rapid Serum Test showed a sensitivity of 44％, specificity 90％, positive predictive value 88％, and negative predictive value 50％, with overall assessment effectiveness of 62％. The EQUI-TB Tuberculosis Rapid Test appears to distinguish NTM from MTBC very efficiently and is easy to operate. Therefore, the method may be used as an auxiliary tool for TB diagnosis in clinical laboratories. In this study due to limited sample size, may be to increase the number of test specimens in future research to obtain more powerful results.

並列關鍵字

Mycobacterium tuberculosis ； Mycobacterium ； Evaluation ； EQUI-TB Tuberculosis Rapid Test