핵균 검출과 항결핵제 감수성 검사를 위한 Anyplex Plus MTB/NTM 및 MDR-TB Detection 키트의 성능 평가
Performance Evaluation of Anyplex Plus MTB/NTM and MDR-TB Detection Kit for Detection of Mycobacteria and for Anti-Tuberculosis Drug Susceptibility Test
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
배경: Anyplex plus MTB/NTM 및 MDR-TB Detection (Seegene, Seoul, Korea) 키트는 실시간 중합효소연쇄반응법을 이용하여 다양한 검체로부터 결핵균과 비결핵항산균을 직접 검출하고 rifampin (RIF)과 isoniazid (INH)에 대한 내성을 검사할 수 있다. 본 연구에서는 Anyplex plus MTB/NTM 및 MDR-TB Detection 키트의 진단적 성능을 평가하였다. 방법: Anyplex plus MTB/NTM 키트의 결핵균 및 비결핵항산균 검출능을 평가하기 위해 557개의 임상검체를 검사하였다. Anyplex plus MTB/NTM Detection 키트의 진단적 성능은 배양검사, 핵산증폭검사, 방사선 소견 및 결핵감염의 임상소견을 종합한 결과에 기반하여 평가하였고, 다른 실시간 중합효소연쇄반응 검사키트와 비교했다. 항결핵제 감수성 검사를 위해서, 51개의 결핵 균주를 검사하였다. Anyplex plus MDR-TB Detection의 임상적 성능은 통상적 항결핵제 감수성 검사결과를 기반으로 평가하였고, 다른 분자진단 항결핵제 감수성 검사 키트와 비교하였다. 결과: Anyplex plus MTB/NTM 키트의 결핵균 검출의 민감도와 특이도는 82.9% (63/76) and 99.4% (478/481)였고, 비결핵항산균에 있어서는 각각 76.5% (13/17)와 89.6% (484/540)였다. Anyplex plus MDR-TB Detection 키트의 RIF 내성 검출에 있어서 민감도와 특이도는 100% (3/3)와 97.9% (47/48)였고, INH 내성 검출에 있어서는 각각 83.3% (5/6)와 100% (45/45)였다. 결론: Anyplex plus MTB/NTM Detection 키트는 결핵균 및 비결핵항산균 검출에 있어 우수한 성능을 보여주었다. 특히 결핵균 양성 검체에서, Anyplex plus MDR-TB Detection 키트는 RIF와 INH 내성에 대해 빠르고 신뢰할 만한 결과를 제공하였다. [Ann Clin Microbiol 2014;17:115-122]
Abstract
Background: The Anyplex plus MTB/NTM and MDR-TB Detection kits (Seegene, Korea) a real-time PCR assays for direct detection of Mycobacterium tuberculosis (MTB) and nontuberculous mycobacteria (NTM) and for identification of rifampin (RIF) and isoniazid (INH) resistance of MTB in various specimens. We evaluated the diagnostic performance of the Anyplex plus MTB/NTM and MDR-TB Detection kit. Methods: To determine the ability of the kit to detect MTB and NTM, 557 samples were tested. The diagnostic performance of the Anyplex plus MTB/NTM Detection kit was determined based on the results of culture, nucleic acid amplification tests (NAAT), radiologic analysis, and clinical features suggestive of mycobacterial infection. The performance of the kit was compared with those of other real-time PCR kits. For the drug susceptibility test (DST), 51 MTB isolates were tested. The diagnostic performance of the Anyplex plus MDR-TB Detection kit was determined based on the conventional DST and compared with other molecular DST kits. Results: Sensitivity and specificity for MTB detection of the Anyplex plus MTB/NTM Detection kit were 82.9% (63/76) and 99.4% (478/481), respectively, while those for NTM detection were 76.5% (13/17) and 89.6% (484/540). Sensitivity and specificity for RIF resistance detection of the Anyplex plus MDR-TB Detection kit were 100% (3/3) and 97.9% (47/48), respectively, while those for INH resistance detection were 83.3% (5/6) and 100% (45/45). Conclusion: The Anyplex plus MTB/NTM Detection kit showed good diagnostic performance for detection of MTB and NTM. Especially in MTB-positive cases, the Anyplex plus MDR-TB Detection kit provided rapid and reliable results of drug resistance to RIF and INH. (Ann Clin Microbiol 2014;17:-122)
참고문헌 (18)
- "Manual of Laboratory Tests for Tuberculosis" (2013)[URL]
- "Practical Guidelines for Laboratory Diagnosis of Tuberculosis" (2011)[URL]
- "Diagnostic Standards and Classification of Tuberculosis in Adults and Children", Am J Respir Crit Care Med, 161, pp.1376~1395 (2000)
- Levidiotou S, "Four-year experience of use of the Cobas Amplicor system for rapid detection of Mycobacterium tuberculosis complex in respiratory and nonrespiratory specimens in Greece", Eur J Clin Microbiol Infect Dis, 22, pp.349~356 (2003)
- "Report of an expert consultation on the use of nucleic acid amplification tests for the diagnosis of tuberculosis: Centers for Disease Control and Prevention"[URL]
- 임진숙, "Multicenter Evaluation of Seegene Anyplex TB PCR for the Detection of Mycobacterium tuberculosis in Respiratory Specimens", Journal of Microbiology and Biotechnology, 24(7), pp.1004~1007 (2014), 한국미생물·생명공학회[DOI]
- Steingart KR, "Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review", Lancet Infect Dis, 6, pp.570~581 (2006)
- 황상선, "LG AdvanSure TB", NTM Real-Time PCR Kit의 항산균 진단 수행 능력 평가, 2011, pp.14(2), 55~59[DOI]
- Telenti A, "Detection of rifampicin-resistance mutations in Mycobacterium tuberculosis", Lancet, 341, pp.647~650 (1993)
- Telenti A., "Genetics and pulmonary medicine. 5. Genetics of drug resistant tuberculosis", Thorax, 53, pp.793~797 (1998)
- Heym B, "Missense mutations in the catalase-peroxidase gene, katG, are associated with isoniazid resistance in Mycobacterium tuberculosis", Mol Microbiol, 15, pp.235~245 (1995)
- Zhang Y, "The catalase-peroxidase gene and isoniazid resistance of Mycobacterium tuberculosis Nature", 358, pp.591~593 (1992)
- Banerjee A, "inhA, a gene encoding a target for isoniazid and ethionamide in Mycobacterium tuberculosis", Science, 263, pp.227~230 (1994)
- Rozwarski DA, "Modification of the NADH of the isoniazid target (InhA) from Mycobacterium tuberculosis", Science, 279, pp.98~102 (1998)
- Ma X, "rpoB Gene mutations and molecular characterization of rifampin-resistant Mycobacterium tuberculosis isolates from Shandong Province, China", J Clin Microbiol, 44, pp.3409~3412 (2006)
- Ohno H, "Relationship between rifampin MICs for and rpoB mutations of Mycobacterium tuberculosis strains isolated in Japan", Antimicrob Agents Chemother, 40, pp.1053~1056 (1996)
- Taniguchi H, "Rifampicin resistance and mutation of the rpoB gene in Mycobacterium tuberculosis", FEMS Microbiol Lett, 144, pp.103~108 (1996)
- Yue J, "Mutations in the rpoB gene of multidrug-resistant Mycobacterium tuberculosis isolates from China", J Clin Microbiol, 41, pp.2209~2212 (2003)