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호흡기검체에서 분리된 결핵균을 이용한 AdvanSure MDR-TB GenoBlot Assay 리팜핀 및 이소니아지드 내성 검출능 평가

Evaluation of the AdvanSure MDR-TB GenoBlot Assay for Detection of Rifampin and Isoniazid Resistant Mycobacterium tuberculosis Complex in Respiratory Specimens

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초록

배경: 본 연구에서는 국내에서 개발된 AdvanSure MDR-TB GenoBlot Assay kit (이하 AdvanSure MDR-TB, LG 생명과학,한국)를 이용하여 전국의 호흡기 검체에서 검출된 결핵균에서 리팜핀(rifampin, RFP) 및 이소니아지드(isoniazid, INH) 내성결핵 검출능을 평가하였다. 방법: 2010년 2-7월 동안 전국에 분포한 국내 6개 대학병원의 총 542명 환자의 호흡기 검체에서 분리된 결핵균을 대상으로 하여 AdvanSure MDR-TB 검사를 시행하고 이를 절대농도법 결과와 비교하였다. 결과: 절대농도법과 비교하여 AdvanSure MDR-TB 검사의 검사일치도, 내성 검출의 예민도 및 특이도는 RFP 검사에서는각각 98.2% (532/542), 84.6% (33/39), 및 99.2% (499/503)였으며, INH 검사에서는 각각 96.1% (521/542), 79.7% (59/74),98.7% (462/468)였다. RFP 내성결핵에서 가장 빈도가 높았던 세 가지 변이형은 rpoB S531L 변이(53.8%), rpoB D516V 변이(15.4%), rpoB H526R 변이(7.7%)였다. INH 내성 결핵에서는 katG S315T 변이 빈도가 가장 높았고(58.1%), 다음은inhA C-15T (23.0%), katG S315N (4.1%)순이었다. 결론: AdvanSure MDR-TB는 절대농도법과 비교하여 RFP 및 INH 내성 결핵 검출에 대해 높은 검사일치도를 보여 RFP와INH 내성 결핵의 조기검출에 유용한 검사법이나 민감도의 보완이 필요할 것으로 생각된다.

Abstract

Background: We evaluated the performance of the AdvanSure MDR-TB GenoBlot Assay kit (AdvanSure MDR-TB, LG Life Science, Korea) to detect mutations related to rifampin (RFP)- and isoniazid (INH)-resistant Mycobacterium tuberculosis complex in respiratory specimens. Methods: From February 2010 to June 2010, a total of 542 M. tuberculosis clinical isolates were collected from pulmonary tuberculosis patients in six university hospitals across Korea. We analyzed the conventional drug susceptibility testing (DST) and compared the results with those of the AdvanSure MDR-TB. Results: Compared with the conventional DST, the overall agreement rates, sensitivity, and specificity were 98.2% (532/542), 84.6% (33/39), and 99.2%(499/503), respectively, for RFP resistance and 96.1% (521/542), 79.7% (59/74), 98.7% (462/468), respectively,for INH resistance. The three common rpoB mutations were rpoB S531L (53.8%), rpoB D516V (15.4%) and rpoB H526R (7.7%) in RFP-resistant strains. For INH resistance, the katG S315T mutation (58.1%) was the most common, followed by inhA C-15T (23.0%) and katG S315N (4.1%). Conclusion: The AdvanSure MDR-TB showed high concordance with the conventional DST and would be helpful for early detection of RFP and INH resistance,although it requires improved sensitivity.

참고문헌 (22)

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