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혈청학적 방법을 이용한 결핵 진단 방법의 효용성

The Usefulness of Serologic Diagnosis for Tuberculosis with Two Rapid Immunochromatographic Assay Devices

결핵및호흡기질환 1999년 47권 5호 p.586 ~ 594
김덕겸, 권성연, 이석영, 박계영, 정경해, 이춘택, 유철규, 김영환, 한성구, 심영수,
소속 상세정보
김덕겸 ( Kim Deog-Kyeom ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
권성연 ( Kwon Sung-Youn ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
이석영 ( Lee Suk-Young ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
박계영 ( Park Gye-Young ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
정경해 ( Jung Kyung-Hae ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
이춘택 ( Lee Choon-Taek ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
유철규 ( Yoo Chul-Gyu ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
김영환 ( Kim Young-Whan ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
한성구 ( Han Sung-Koo ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine
심영수 ( Shim Young-Soo ) - Seoul National University College of Medicine and Lung institute Department of Internal Medicine

Abstract


BACKGROUND: Many diagnostic tests have developed to diagnose tuberculosis and other mycobacterial diseases but the diagnosis of tuberculosis relies largely on radiological findings and acid-fast staining of sputum and/or culture. Recently, new serologic diagnostic methods, which are safe and easy to use have been introduced into Korea. In this study, the usefulness of serologic diagnosis for tuberculosis and the disease pattern induced variation of the test were evaluated. METHODS: Serological assay was performed upon 108 patients with two test kits, the ICT tuberculosis and the BioSign(TM) TB, which are based upon a rapid immunochromatographic assay technique, capable of being interpreted within 15 minutes. The case groups consisted of 61 patients with active pulmonary tuberculosis(36 patients), extrapulmonary tuberculosis(3 patients), or both (22 patients). Control groups consisted of 47 patients with inactive old pulmonary tuberculosis (17 patients), nontuberculous pulmonary disease(16 patients) and nonpulmonary cardiac disease(14 patients). RESULTS: The diagnostic sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the ICT tuberculosis were 64.3%, 91.5%, 90.0% and 68.3% respectively. The diagnostic sensitivity, specificity, PPV and NPV of the BioSign(TM) TB were 76.5%, 95.3%, 94.1% and 78.8% respectively. Differences in sensitivity were not significant between patients with previous history of tuberculosis or patients without prior history of tuberculosis. The ICT tuberculosis test showed higher sensitivity in pulmonary tuberculosis patients (76.5%) than extrapulmonary tuberculosis patients (33.3%). There was no difference in sensitivity between patients with or without cavitary lesion by chest X-ray. CONCLUSION: Considering high specificity and PPV, serologic diagnosis using a rapid immunochromatographic assay device is another helpful diagnostic method in the diagnosis of tuberculosis, when combined with previous diagnostic methods such as chest X-ray, microbiologic study but it has limitation in terms of confirming the diagnosis for tuberculosis as the only diagnostic method because of relatively low sensitivity and NPV.

키워드

Serological diagnosis; BioSignTMTB; ICT tuberculosis; Mycobacterial infection; Tuberculosis; 38kDa antigen;

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