Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Evaluation of the Performances of AdvanSure TB/NTM Real Time PCR Kit for Detection of Mycobacteria in Respiratory Specimens

호흡기 검체를 이용한 AdvanSure TB/NTM Real Time PCR Kit의 항산균 진단 능력평가

Kim, Young-Jin;Park, Mi-Young;Kim, Shine-Young;Cho, Son-A;Hwang, Sang-Hyun;Kim, Hyung-Hoi;Lee, Eun-Yup;Jeong, Joseph;Kim, Kyeong-Hee;Chang, Chulhun L.
김영진;박미영;김신영;조선아;황상현;김형회;이은엽;정윤성;김경희;장철훈

  • Published : 2008.02.10
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Abstract

배경 :PCR법은 마이코박테리아 감염증을 신속하고 정확하게진단하기 위해 널리 쓰이는 방법이다. 본 연구에서는 국내에서 개발된 real time PCR 방법을 기반으로 한 결핵균과 비결핵항산균검출 키트의 민감도와 특이도를 평가해 보았다. 방법 :민감도 평가는 결핵균이 배양된 호흡기 검체 129검체(항산균 염색 양성 82검체, 음성 47검체) 및 비결핵 항산균이 배양된 9개의 검체를 대상으로 실시하였다. 특이도 평가는 처음에항산균 감염증을 완전히 배제되지 않았으나, 추후 항산균 염색 및배양 음성이며 항산균 감염증이 배제된 환자의 호흡기 검체 48검체(특이도 1군)와, 처음부터 항산균 감염증을 의심하지 아니하는환자의 호흡기 검체 51검체(특이도 2군)를 대상으로 하였다. 검사는 AdvanSure TB/NTM real time PCR Kit (LG 생명과학,한국)와 SLAN real time PCR detection system (LG 생명과학)으로 실시하였다. 결핵균은 IS6110, 마이코박테리아는 rpoB유전자를 각각 증폭시켜 검출하였다.결과 :결핵균이 배양된 129개검체중염색양성검체82/82(100%), 염색 음성 검체 35/47 (74.5%)로, 총117개가 real timePCR에서 결핵균 양성 결과를 보였다(민감도 90.7%). NTM 배양양성검체9건의 검체 중 5건(55.6%)이real time PCR에서NTM 양성 결과를 보였다. 특이도 1군에서는 48검체 중 47건(97.9%), 특이도 2군에서는 51검체 모두(100%) 결핵 또는 마이코박테리아 PCR 음성이었다.

Keywords

References

  1. Cheng VC, Yew WW, Yuen KY. Molecular diagnostics in tuberculosis. Eur J Clin Microbiol Infect Dis 2005;24:711-20 https://doi.org/10.1007/s10096-005-0039-1
  2. Soini H and Musser JM. Molecular diagnosis of mycobacteria. Clin Chem 2001;47:809-14
  3. Park SS, Kwak KR, Hwang JY, Yun SM, Ryue CC, Chang CH, et al. Clinical utility of amplified mycobacterium tuberculosis direct test in the diagnosis of pulmonary tuberculosis. Tuberc Respir Dis 1999;47:747-56. (박삼석, 곽경록, 황지윤, 윤상명, 류기찬, 장철훈 등. 폐결핵 진단에서 Amplified Mycobacterium tuberculosis Direct Test의 임상적 유용성. 결핵 및 호흡기질환 1999;47:747-56.) https://doi.org/10.4046/trd.1999.47.6.747
  4. Kim SY, Park YJ, Kang SJ, Kim BK, Kang CS. Comparison of the BDProbeTec ET system with the roche COBAS AMPLICOR System for detection of Mycobacterium tuberculosis complex in the respiratory and pleural fluid specimens. Diagn Microbiol Infect Dis 2004; 49:13-8 https://doi.org/10.1016/j.diagmicrobio.2003.11.008
  5. Lee CK, Kim CH, Ma KR, Kim YK, Lee KN, Cheong HJ, et al. Comparison of in-house polymerase chain reaction and Amplicor MTB for diagnosis of tuberculosis in the respiratory specimens. J Korean Soc Chemother 1998;16:97-103. (이창규, 김창현, 마경란, 김영기, 이갑노, 정회진 등. 호흡기 검체의 결핵 진단에서 in-house polymerase chain reaction과 Amplicor MTB의 비교. 대한화학요법회지 1998;16:97-103.)
  6. Khan K, Wang J, Marras TK. Nontuberculous mycobacterial sensitization in the United States: national trends over three decades. Am J Respir Crit Care Med 2007;176:306-13 https://doi.org/10.1164/rccm.200702-201OC
  7. Primm TP, Lucero CA, Falkinham III JO. Health impacts of environmental mycobacteria. Clin Microbiol Rev 2004;17:98-106 https://doi.org/10.1128/CMR.17.1.98-106.2004
  8. Koh WJ, Kwon OJ, Jeon K, Kim TS, Lee KS, Park YK, et al. Clinical significance of nontuberculous mycobacteria isolated from respiratory specimens in Korea. Chest 2006;129:341-8 https://doi.org/10.1378/chest.129.2.341
  9. Diagnostic Standards and Classification of Tuberculosis in Adults and Children. This official statement of the American Thoracic Society and the Centers for Disease Control and Prevention was adopted by the ATS Board of Directors, July 1999. This statement was endorsed by the Council of the Infectious Disease Society of America, September 1999. Am J Respir Crit Care Med 2000;161:1376-95 https://doi.org/10.1164/ajrccm.161.4.16141
  10. World Health Organization. Laboratory services in tuberculosis control. Part II. Microscopy. Geneva: World Health Organization, WHO/TB/98.258, 1998
  11. Park H, Jang H, Song E, Chang CL, Lee M, Jeong S, et al. Detection and genotyping of Mycobacterium species from clinical isolates and specimens by oligonucleotide array. J Clin Microbiol 2005;43:1782-8 https://doi.org/10.1128/JCM.43.4.1782-1788.2005
  12. Tortoli E, Tronci M, Tosi CP, Galli C, Lavinia F, Natili S, et al. Multicenter evaluation of two commercial amplification kits (Amplicor, Roche and LCx, Abbott) for direct detection of Mycobacterium tuberculosis in pulmonary and extrapulmonary specimens. Diagn Microbiol Infect Dis 1999;33:173-9 https://doi.org/10.1016/S0732-8893(98)00097-2
  13. Huang TS, Liu YC, Lin HH, Huang WK, Cheng DL. Comparison of the Roche AMPLICOR MYCOBACTERIUM assay and Digene SHARP Signal System with in-house PCR and culture for detection of Mycobacterium tuberculosis in respiratory specimens. J Clin Microbiol 1996;34:3092-6
  14. Eing BR, Becker A, Sohns A, Ringelmann R. Comparison of Roche Cobas Amplicor Mycobacterium tuberculosis assay with in-house PCR and culture for detection of M. tuberculosis. J Clin Microbiol 1998;36:2023-9
  15. Goessens WH, de Man P, Koeleman JG, Luijendijk A, te Witt R, Endtz HP, et al. Comparison of the COBAS AMPLICOR MTB and BDProbeTec ET assays for detection of Mycobacterium tuberculosis in respiratory specimens. J Clin Microbiol 2005;43:2563-6 https://doi.org/10.1128/JCM.43.6.2563-2566.2005
  16. Scarparo C, Piccoli P, Rigon A, Ruggiero G, Scagnelli M, Piersimoni C. Comparison of enhanced Mycobacterium tuberculosis amplified direct test with COBAS AMPLICOR Mycobacterium tuberculosis assay for direct detection of Mycobacterium tuberculosis complex in respiratory and extrapulmonary specimens. J Clin Microbiol 2000;38:1559-62