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Xpert MTB/RIF을 이용한 결핵균 및 리팜핀 내성 검사의 유효성에 대한 체계적 문헌고찰

A Systematic Review on the Effectiveness of Detection of M. tuberculosis and Rifampin Resistance Using Xpert MTB/RIF

이선희|장선영|정지영
대한임상미생물학회 (Korean Society of Clinical Microbiology)|2014.06|Annals of Clinical Microbiology|제17권 제2호|pp. 42-49

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Meta-analysisMultidrug-resistantRifampinPolymer- ase chain reactionTubercu- losis

초록

배경: Xpert MTB/RIF (Cepheid, USA)는 실시간 이 합효소연쇄반응을 이용하여 결핵균 감염 여부 리팜핀 내성 여부를 동시에 확인하는 검사로 검사정확성을 통해 이에 한 유효성을 평가하고자 한다. 방법: 결핵균 감염 리팜핀 내성 여부의 확인이 필요한 환자를 상으로 Xpert MTB/RIF가 시행된 문헌을 선택하여, 표검사 비 검사정확성을 통해 임상 유효성을 평가하다. 문헌검색은 2011년 8월 16일 1차 검색 시행 후 10월 1일 최종검색 되었다. 국내문헌은 KoreaMed를 심으로 8개 데이터베이스, 국외문헌은 Ovid-MEDLINE, Ovid-EMBASE Cochrane Library 등을 검색하다. 국내 문헌은 130편, 국외 문헌은 1255편으로 총 1385편이 검색되었다. 복된 문헌 580편을 제외한 805편을 토로 선택 배제기을 용하여 국외문헌 20편을 평가에 포함하다. 문헌 검색부터 선택 기 용 자료추출까지 각 단계는 모두 문가들로 구성된 자문원들과 더불어 2명의 평가자가 각 과정을 독립 으로 수행하다. 문헌의 질 평가는 SIGN (Scottish Intercollegiate Guidelines Network)의 도구를 이용하으며, 이에 따라 근거의 수과 권고의 등을 선정하여 평가결과를 기술하다. 결과: 첫째, 결핵균 검출에 한 검사정확성은 결핵균 배양 검사를 참조기으로 하여 총 20편으로 평가하다. 항산균 도말 검사 결과 검체의 종류를 고려하지 않은 체 검체의 경우 민감도 0.69-1.00, 특이도 0.72-1.00, 검사정확도 0.75-1.00이었다. 둘째, 리팜핀 내성에 한 검사정확성은 총 17편을 근거로 하여 평가하다. 항결핵제 감수성 검사를 참조기으로 할 경우 Xpert MTB/RIF의 민감도, 특이도, 검사정확도는 각각 0.75-1.00, 0.96-1.00, 0.95-1.00이었다. 결론: Xpert MTB/RIF는 표검사와 비교시 진단정확성이 뛰어나 결핵균 검출 리팜핀 내성의 진단에 있어 안하고 유효한 검사로 판단된다. [Ann Clin Microbiol 2014;17:42-49]

Abstract

Background: The purpose of this study was to eval- uate the effectiveness of Xpert MTB/RIF (Cepheid, USA) in the detection of Mycobacterium tuberculosis and to determine rifampin resistance. Methods: The literature review covered the period from 16 August 2011 to 1 October 2011, and eight domestic databases and foreign databases including Ovid-Medline, Embase, and Cochrane Library were used. Key words, such as ‘Rifampin, Polymerase Chain Reaction,’ ‘GeneXpert’ and ‘Xpert MTB-RIF’ were used to search a total of 1,385 documents. The SIGN (Scottish Intercollegiate Guidelines Network) tool was used to evaluate the quality of the 20 se- lected studies. Results: Test accuracy for the detection of M. tuber- culosis was assessed on the basis of 20 studies us- ing the M. tuberculosis culture test as the referencestandard. The acid-fast bacteria smearing test had a sensitivity in the range of 0.69-1.00, specificity in the range of 0.72-1.00 and test accuracy in the range of 0.75-1.00. Test accuracy regarding rifampin resist- ance was assessed on the basis of 17 studies. Using an anti-tuberculosis agent sensitivity test as the reference standard, the sensitivity, specificity and test accuracy of real-time, nested PCR were in the ranges of 0.75-1.00, 0.96-1.00 and 0.95-1.00, respe- ctively. Conclusion: Xpert MTB/RIF is a useful test for pa- tients suspected of having rifampin-resistant tuber- culosis. (Ann Clin Microbiol 2014;17:42-49)

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