국내에서 분리된 인체분리균주를 이용한 MicroScan KSCM 패널의 항균제 감수성 시험 분석능 평가
Performance Evaluation of Newly Developed Korean Antimicrobial Susceptibility Testing Panels for MicroScan System Using Clinical Isolates from Teaching Hospitals in Korea
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MicroScan의 한국형 항생제 감수성 시험 패널인 KSCM 패널에 대한다기관 임상 분리 균주를 이용한 분석능 평가1연세대학교 의과대학 진단검사의학교실 및 세균내성연구소, 2상지대학교 보건과학대학 일반대학원 임상병리학과강다영1,2, 홍준성1, 박별이1,2, 장인호2, 김도균1, 이혁민1, 정석훈1 배경: 항균제 내성은 공중보건에 계속적인 위협이 되고 있다. 임상미생물 검사실에서의 빠른 항생제 감수성 시험을 통한내성의 검출은 감염관리 및 환자 치료에 중요하며, 이를 위한 적절한 자동화 검사 장비 및 항생제 감수성시험 패널은필수적인 요소이다. 본 연구에서 MicroScan 장비(Beckman Coulter, USA)의 새로운 항생제 감수성 시험패널을 디자인하였으며, 그 검사능을 많은 임상분리 균주를 이용하여 평가하였다. 방법: 총 3종류의 항생제 감수성 패널(KSCM-1, KSCM-2, KSCM-3)을 구성하였다. 1,027주의 그람음성 세균(Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Acinetobacter baumannii, Enterobacter spp.)과 298주의 그람양성 세균(Staphylococcus aureus, Enterococcus faecium, Enterococcus faecalis)을 포함한 총 1,325주의 임상분리 균주를 이용하여 새로이 구성된 패널의 검사능을 평가하였다. MicroScan KSCM 패널의 결과는 디스크확산법, Etest, 한천희석법, 미량액체희석법의 결과와 비교하였다. 결과: 그람 양성알균을 대상으로 한 KSCM-1 패널을 구성하였다. KSCM-1 패널의 결과를 표준검사법과 비교하였을 때, S. aureus에서 categorical agreement (CA) 비율이 90% 이상이었고, major error (ME)는 고농도 mupirocin 내성에서의 4건을제외하고는 관찰되지 않았다. Very major error (VME)는 모든 항생제에서 관찰되지 않았다. Enterococci에서도 CA 비율은90% 이상, ME 비율은 3% 미만이었다. VME는 ampicillin, tetracycline과 quinupristin-dalfopristin에서 각각 1건을 확인하였고, 나머지 항생제에서는 관찰되지 않았다. 장내세균속 검사용 패널(KSCM-2)의 검사능 평가에서, 검사한 모든 항생제에대하여 CA 비율은 90% 이상, ME 비율은 3% 미만이었으며 VME의 비율은 1.5% 이하였다. 포도당 비발효 그람음성막대균의 항생제 감수성 시험 패널(KSCM-3)의 검사능 평가에서도, P. aeruginosa는 CA 비율은 90% 이상이었으며, ME는 ceftazidime과ciprofloxacin에서 각각 한건씩 관찰되었으며, 그 이외의 항생제에서는 관찰되지 않았다. VME의 비율은 검사한 모든 항균제에서 1.5% 미만이었다. A. baumannii에서는 CA 비율 90% 이상이었으며, VME는 piperacillin에서 1건이확인되었다. 결론: 새로이 구성한 KSCM 패널의 결과를 표준검사법의 결과와 비교하였을 때, 높은 일치율을 보여주어 임상미생물검사실에 적용 가능할 것으로 생각한다. [Ann Clin Microbiol 2019;22:61-70]
Abstract
Background: Antimicrobial resistant continues to pose a threat to public health. Therefore, rapid and accurate antimicrobial susceptibility testing is very important. The objectives of this study were to evaluate the performance of the MicroScan system (Beckman Coulter, USA) with newly developed Korean Antimicrobial Susceptibility Testing Panels (KSCM panels) for antimicrobial susceptibility testing (AST) against clinical isolates in South Korea. Methods: Three KSCM panels were designed in this study. For the performance evaluation, a total of 1,325 clinical isolates including 1,027 of Gram-negative bacilli and 298 Gram-positive cocci collected from eight general hospitals in South Korea were used. The results by KSCM panels were compared with those by conventional methods. Results: By KSCM-1 panel for Gram-positive cocci, the rates of categorical agreement (CA) were ＞90% in all the antimicrobials tested in this study. The rates of major error (ME) were also ＜3%, and only three very major error (VME) were identified; each of ampicillin, tetracycline, and quinupristin-dalfopristin in enterococcal isolates. By KSCM-2 panel for Enterobacteriaceae, the rates of CA were also above 90%, and those of ME and VME were less than 3% and 1.5%, respectively. KSCM-3 panels for glucose- non-fermenting Gram-negative bacilli, also showed good agreement rates, i.e., CA rates ＞90%, ME rates ＜3%, and VME rates ＜1.5%. Conclusion: The newly developed three KSCM panels for MicroScan system (Beckman Coulter) showed excellent performance in AST against a large number of clinical isolates, and they are applicable to clinical microbiology laboratories. (Ann Clin Microbiol 2019;22:61-70)
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