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항산균 검출을 위한 세가지 실시간 중합효소연쇄반응 시약의 진단 성능 평가

Evaluation of Diagnostic Performance of Three Real-Time PCR Assays for the Detection of Mycobacteria Species

박영희|김창현|김윤호|고영진|김상욱|임채승
대한임상미생물학회 (Korean Society of Clinical Microbiology)|2020.06|Annals of Clinical Microbiology|제23권 제2호|pp. 1-12|DOI 10.5145/ACM.2020.23.2.6

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Real-time PCRMycobacterium tuberculosisNontuberculous mycobacteria

초록

배경: 대부분의 국가에서 결핵균(MTB)으로 인한 질병 부담은 계속 감소하고 있지만 비결핵항산균(NTM)으로 인한 질병은 공중보건에 문제가 되고 있다. 본 연구는 결핵균과 비결핵항산균을 검출하는데 있어 AdvanSure TB/NTM real-time PCR kit (AdvanSure; LG Chem., Korea), Genedia MTB/ NTM detection kit (Genedia; Green Cross MS, Korea) 및 PowerChek MTB/NTM Real-time PCR kit (PowerChek; Kogenebiotech, Korea) 세가지 실시간 핵산증폭검사 시약의 진단정확도를 비교하고자 하였다. 방법: 고려대학교 구로병원 진단검사의학과에서 2016년 11월부터 2017년10월까지 접수된 102개의 항산균 도말검사 양성검체와 177개의 음성검체를 대상으로 하였고 Genedia Mycobacteria DNA Prep Kit (Green Cross MS, Korea)를 사용하여 핵산을 추출하였다. 통계분석은 MedCalc 18.11.6 (MedCalc Software, Belgium)을 사용하였다. 결과: 총 279개의 검체 가운데 항산균이 64건, 비결핵항산균이 28건이었다. AdvanSure/ Genedia/PowerChek의 결핵균 검출에 대한 민감도, 특이도, 양성예측도, 음성예측도는 각각96.9%/95.3%/96.9%, 98.5%/99.5%/98.5%, 58.9%/80.9%/58.9%, 99.9%/99.9%/99.9%였고, 비결핵항산균에서는 각각 81.5%/44.4%/88.9%, 99.6%/100.0%/98.7%, 57.3%/100.0%/32.8%, 99.9%/99.6%/99.9% 였다. 비결핵항산균 검출에 대한 AdvanSure와 PowerChek의 ROC 곡선 아래의 면적은 Genedia와유의하게 차이가 있었다(P<0.0001). 결론: 세가지 실시간 PCR은 항상균 도말 양성과 음성 검체에서 결핵균을 검출하는데 신뢰할만한결과를 보였다. 비결핵항산균 검출의 진단정확도는 세가지 시약간의 차이가 존재하였다.

Abstract

Background: The disease burden caused by Mycobacterium tuberculosis (MTB) complex continues to decrease in most countries. However, the diseases caused by the nontuberculous mycobacteria (NTM) become a public health problem. This study aimed to compare the diagnostic accuracy of three real-time PCR assays: AdvanSure TB/NTM real-time PCR kit (AdvanSure; LG Chem., Korea), Genedia MTB/NTM detection kit (Genedia; Green Cross MS, Korea), and PowerChek MTB/NTM Real-time PCR kit (PowerChek; Kogenebiotech, Korea) for the detection of MTB complex and NTM. Methods: Total 102 acid-fast bacilli (AFB) smear-positive and 177 smear-negative specimens from Korea University Medical Center, Guro Hospital, were enrolled. The AFB smear-positive and negative specimens were collected from November 2016 to October 2017 and November to December 2018, respectively. DNA extraction was performed using Genedia Mycobacteria DNA prep Kit (Green Cross MS, Korea). The statistical analysis was performed using MedCalc 18.11.6 (MedCalc Software, Belgium). Results: Among 261 specimens, 64 showed MTB complex growth and 28 exhibited NTM growth. The sensitivity, specificity, positive predictive value, and negative predictive value of AdvanSure/Genedia/PowerChek kits for MTB were 96.9%/95.3%/96.9%, 98.5%/99.5%/98.5%, 58.9%/80.9%/58.9%, and 99.9%/99.9%/99.9%. Whereas those for NTM detection were 81.5%/44.4%/88.9%, 99.6%/100.0%/98.7%, 57.3%/100.0%/32.8% and 99.9%/99.6%/99.9%, respectively. The area under the receiver operating characteristic curve of AdvanSure and PowerChek for NTM detection was statistically different from that of Genedia (P<0.0001). Conclusion: Three real-time PCR assays were reliable for MTB complex in AFB-positive and -negative specimens. There was a difference between these three reagents for the accuracy of NTM detection.

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