Comparison of the AMPLICOR MYCOBACTERIUM Test with Microscopy and Culture for Diagnosis of Pulmonary Tuberculosis

以AMPLICOR MYCOBACTERIUM Test、鏡檢和培養來診斷肺結核的比較

黃俊凱(Chun-Kai Huang) ； 黃采菽(Tsi-Shu Huang) ； 林錫勳(Hsi-Hsun Lin) ； 李欣蓉(Susan Shin-Jung Lee) ； 劉永慶(Yung-Ching Liu)

《內科學誌》 21卷2期 (2010/04) Pp. 117-124

https://doi.org/10.6314/JIMT.2010.21(2).04

摘要

結核是台灣主要的公衛問題之一，要有效地控制結核仰賴著迅速而正確的診斷和適當的治療。這個研究的目的是比較AMPLICOR MYCOBACTERIUM (AMPLICOR MTB) test、鏡檢和培養用以診斷肺結核的成效。這個研究包括由90個疑似肺結核病人所採集的123套檢體，所有檢體經過處理、染色、培養和使用AMPLICOR MTB test分析以鑑定結核分枝桿菌。所有病人並追蹤一年以確定或排除肺結核的診斷。總共有29套檢體分離出結核分枝桿菌，而根據臨床最後診斷爲肺結核者共50個病人。與培養結果比較，AMPLICOR MTB test的敏感性、特異性、陽性預測率、和陰性預測率分別爲75.9，84，59.5，和91.9%。與最終臨床診斷比較，其敏感性、特異性、陽性預測率、和陰性預測率分別爲72，98.6，97.3，和83.7%。針對抹片陽性檢體，其敏感性爲 84.9%，而針對抹片陰性檢體，其敏感性爲47.1%。我們的研究顯示 AMPLICOR MTB test用於快速診斷肺結核具有高度敏感性與特異性，而針對抹片陰性檢體是否符合成本效益其仍有待進一步研究。

並列摘要

Tuberculosis (TB) is one of the major public health problems in Taiwan. Effective control of TB depends on rapid and correct diagnosis and appropriate treatment. The aim of this study was to evaluate the performance of the Roche AMPLICOR MYCOBACTERIUM (AMPLICOR MTB) test compared with microscopy and culture for diagnosis of pulmonary TB. A total of 123 specimens obtained from 90 suspected pulmonary TB patients were included in this study. All specimens were processed, stained, cultured and assayed using the AMPLICOR MTB test for identification of M. tuberculosis. All patients were followed up for 1 year to confirm or exclude the diagnosis of pulmonary TB. M. tuberculosis was isolated from 29 of these specimens, and final diagnosis of pulmonary TB was identified in 50 patients according to clinical discrepancies. On initial testing, the sensitivity, specificity, positive and negative predictive values of the AMPLICOR MTB test, compared with cultures, were 75.9, 84, 59.5, and 91.9%, respectively. After resolution of discrepancies by the final clinical diagnosis, the sensitivity, specificity, positive and negative predictive values were 72, 98.6, 97.3, and 83.7%, respectively. For smear-positive specimens, the sensitivity was 84.9%, for smear-negative specimens, the sensitivity was 47.1%. Our study demonstrated that the use of the AMPLICOR MTB test was highly sensitive and specific for rapid diagnosis of pulmonary TB. Further studies are needed to determine the cost-effective use of this test with smear-negative specimens.

並列關鍵字

AMPLICOR MTB test ； Polymerase chain reaction ； Mycobacterium tuberculosis