| Clinical utility of Amplified Mycobacterium tuberculosis Direct Test in the Diagnosis of Pulmonary Tuberculosis. |
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Sam Seok Park, Kyung Rok Kwak, Ji Yun Hwang, Sang Myeong Yun, Chi Chan Ryue, Chul Hun Chang, Min Gi Lee, Sun Gue Park |
1Department of Internal Medicine, College of Medicine, Pusan National University, Pusan, Korea.
2Department of Clinical Pathology, College of Medicine, Pusan National University, Pusan, Korea. |
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| Abstract |
BACKGROUND
Acid-fast stain and cultures for diagnosis of pulmonary tuberculosis are primary and essential method, but have their limitation:low sensitivity and time consuming. The objective of this s tudy is comparison of amplified Mycobacterium tuberculosis direct test(MTD) by the conventional AFB smears and cultures in the detection of Mycobacterium tuberculosis in respiratory specimens. METHODS: During the period between November, 1997 and May, 1998 a total of 267 respiratory specimens (sputum 173, bronchial washing 94) from 187 patients suspected pulmonary tuberculosis were subjected to AFB smears, cultures and MTD test. MTD is based on nucleic acid amplification. We compared the MTD with 3% Ogawa culture method. In positive AFB smear and negative MTD specimen, positive culture identification between nontuberculous mycobacterium and M.tuberculosis was assesed by using Accuprobe M.tuberculosis complex probe. In negative AFB smear and negative AFB culture, MTD results are assessed by clinical follow-up. RESULTS: 1) Compared with culture in sputum and bronchial fluid specimens, sensitivity and specificity of MTD in positive AFB smear is 79.7% and 20.0%, sensitivity and specificity of MTD in negative AFB smear specimens is 75.0% and 79.7%. 2) Discrepant analysis is assessed by clinical follow-up and other specimen results beyond study. Culture negative but MTD positive specimens were proved to be true positive and gave MTD sensitivity 79.2%, specificity of 84.4%, positive predictive value 80.5% and negative predictive value 83.2%. 3) 14 out of 31 specimens in negative AFB smear, negative AFB culture and positive MTD showed pulmonary tuberculosis diagnosed on clinical follow-up and sensitivity is 45.2%. 4) 2 out of 13 specimens in positive AFB smear, positive AFB culture and negative MTD diagnosed as nontuberculous mycobacterium by Accuprobe culture. CONCLUSION: This study suggested that MTD in respiratory specimens is simple and rapid diagnostic method, but considered adjuvant method rather than replace the conventional AFB smear and culture. |
| Key Words:
Amplified Mycobacterium, pulmonary tuberculosis, rapid diagnosis, nucleic acid amplification |
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