LG AdvanSure TB/NTM Real-Time PCR Kit의 항산균 진단 수행 능력 평가
Evaluation of the Diagnostic Performance of the AdvanSure TB/NTM Real-Time PCR Kit for Detection of Mycobacteria
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초록
배경: AdvanSure TB/NTM real-time PCR kit (AdvanSure)는 결핵균과 비결핵 미코박테리아(nontuberculous mycobacteria, NTM)를 검출하기 위해 결핵균과 NTM에 특이적인 IS6110과 rpoB 유전자를 표적으로 하는 primer와 TaqMan probe를 사용하여 국내에서 새로 개발된 검출 키트이다. 본 연구에서는 항산균 도말 염색과 배양법, COBAS Amplicor MTB PCR(Amplicor), AdvanSure의 결과를 비교하여 AdvanSure의 임상적 유용성을 평가하고자 하였다. 방법: 항산균 도말 염색과 배양법, Amplicor가 의뢰된 총 165명의 환자들에서 채취한 182개의 검체(호흡기 105개, 비호흡기 77개)를 대상으로 SLAN real-time PCR detection system으로 AdvanSure 검사를 하였다. AdvanSure의 예민도와 특이도를 AFB 염색과 배양을 기준으로 분석하였다. 결과: 총 182개의 검체 중 AdvanSure와 항산균 배양에 의해 43개의 검체에서 결핵균을 검출하였고, NTM은 12개의 검체에서 검출하였다. 항상균 배양 결과를 기준으로 했을 때 AdvanSure의 결핵균 검출 예민도와 특이도는 97.3% (36/37)와 95.5% (127/133)였고, NTM의 검출 예민도와 특이도는 75.0% (9/12)와 100% (0/133)였다. 결론: AdvanSure는 우수한 예민도와 특이도로 임상검사실에서 결핵균과 NTM을 검출하는 데 유용하게 사용될 수 있을 것으로 판단된다.
Abstract
Background: The AdvanSure TB/NTM real-time PCR kit (AdvanSure) was newly developed in Korea to detect Mycobacterium tuberculosis and nontuberculous mycobacteria (NTM) utilizing a specific primer and TaqMan probe targeting the IS6110 and rpoB genes which are unique to these species. The purpose of the present study was to evaluate the clinical utility of AdvanSure by comparing the results of acid-fast staining, mycobacteria culture, COBAS Amplicor MTB PCR (Amplicor), and AdvanSure. Methods: A total of 182 specimens (105 respiratory and 77 nonrespiratory specimens) were obtained from 165 patients, and acid fast bacilli (AFB) staining, mycobacteria culture, and Amplicor were performed on all specimens. AdvanSure was also performed on the above specimens using the SLAN real-time PCR detection system. The sensitivity and specificity of AdvanSure were analyzed using AFB staining and culture. Results: Of the 182 specimens, M. tuberculosis was detected in 43 specimens and NTM was detected in 12 specimens according to PCR and/or culture. The sensitivity and specificity of the AdvanSure based on AFB culture were 97.3% (36/37) and 95.5% (127/133) in M. tuberculosis and 75.0% (9/12) and 100% (0/133) in NTM, respectively. Conclusion: AdvanSure could be useful for detecting M. tuberculosis and NTM in the clinical laboratory with high sensitivity and specificity.
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