Clinical Usefulness of Real-time PCR and Amplicor MTB PCRAssays for Diagnosis of Tuberculosis
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배경: PCR 검사가 개발되어 전통적인 항산균 도말과 배양 검사보다 신속하고 예민하게 결핵을 진단할 수 있게 되었다. 본 연구에서는 결핵균(Mycobacterium tuberculosis)과 비결핵항산균(nontuberculous mycobacteria, NTM)을 감별할 수 있게 최근 개발된 AdvanSure TB/NTM PCR 키트(LG Life Science Diagnostic Division, Korea)를 이용한 real-time PCR과 Amplicor MTB PCR (Roche Molecular Systems, USA)의 결핵 진단을 위한 임상적 유용성을 비교하였다. 방법 : 총 213예(호흡기 148예, 비호흡기 65예)에서 real-time PCR, Amplicor MTB PCR, 항산균 도말 및 배양 검사를 함께 시행하였다. 임상소견을 검토하여 각 검사법간의 민감도와 특이도를 비교하였다. 결과 : 배양에서 NTM이 자란 6예 중 4예(67%)가 real-time PCR에서 검출되었다. Real-time PCR과 Amplicor MTB PCR의 일치율은 92% (191/207)였다. 전반적인 real-time PCR의 민감도와 특이도는 91%, 87%, Amplicor MTB PCR의 민감도와 특이도는 86%, 93%이었다. 비호흡기 검체에서 real-time PCR과 Amplicor MTB PCR의 민감도는 각각 67%, 60%였고 특이 도는 모두 100%였으며, 항산균 도말 및 배양의 민감도는 각각 13%, 40%였고, 특이도는 모두 100%이었다. 결론 : AdvanSure TB/NTM 키트를 이용한 real-time PCR과 Amplicor MTB PCR은 결핵균에 대한 민감도와 특이도는 비슷 하였으나 AdvanSure TB/NTM 키트는 NTM을 검출할 수 있었다. PCR은 전통적인 항산균 도말과 배양에 비해 결핵균 검출의 민감도가 우수하였다.
Abstract
Background: PCR assay has provided a mean of more rapid and sensitive detection of Mycobacterium tuberculosis (MTB) complex than conventional acidfast bacilli (AFB) smears and MTB cultures. Using the recently developed AdvanSure TB/NTM kit (LG Life Science Diagnostic Division, Korea), which could differentiate nontuberculous mycobacteria (NTM) from MTB, this study compared clinical usefulness of real- time PCR assay and Amplicor MTB PCR assay (Roche Molecular Systems, USA) for diagnosis of tuberculosis. Methods: A total of 213 specimens (148 respiratory and 65 nonrespiratory specimens) were tested by using real-time PCR, Amplicor MTB PCR, AFB smear, and MTB culture. The sensitivity and specificity of four methods were evaluated according to clinical diagnosis. Results: Of six NTM grown in culture, four (67%) were detected by real-time PCR. The overall agreement of real-time and Amplicor MTB PCR was 92% (191/207). The overall sensitivity and specificity were 91% and 87%, respectively, for real-time PCR, and 86% and 93% for Amplicor MTB PCR. In nonrespiratory specimens, the sensitivities of real-time PCR, Amplicor MTB PCR, AFB smear, and MTB culture were 67%, 60%, 13%, and 40%, respectively, and the specificity of the four methods were all 100%. Conclusion: For diagnosis of tuberculosis, the sensitivity and specificity of the real-time PCR assay using AdvanSure TB/NTM kit and Amplicor MTB PCR were similar, and the former could differentiate NTM from MTB. The PCR assay can be considered as a more sensitive technique for the detection of MTB than the conventional AFB smear and culture.
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