RAPIDEC CARBA NP 검사의 Carbapenemase 생성 장내세균의 진단 수행능력 평가
Evaluation of Diagnostic Performance of RAPIDEC CARBA NP Test for Carbapenemase-Producing Enterobacteriaceae
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초록
배경: Extended-spectrum β-lactamase (ESBL)를 생성하는 장내세균은 carbapenem에만 감수성이고 나머지 β-lactam 계열 약물에는 대부분 내성이다. 최근에는 carbapenemase를 생성하는 장내세균(carbapenemase-producing Enterobacteriaceae, CPE)이 분리되고 있어 치료 항균제 선택에 심각한 문제가 되고 있다. CPE 균종들의 병원 내 확산을 방지하기 위해서는 CPE 균종의 신속한 검출 방법이 필요하다. 이에 본 연구에서는 RAPIDEC CARBA NP 검사(bioMérieux, France)의 carbapenemase 생성 장내세균의 진단 수행능력을 평가하였다. 방법: 2015년 11월부터 2016년 3월까지 임상 검체에서 분리된 carbapenem 감수성이면서 ESBL을 생성하는 장내세균 100주(Klebsiella pneumoniae 40주, Escherichia coli 40주, 기타 20주)와 다기관 연구로 carbapenemase 생성을 유전자 검사로 확인하여 보관한 장내세균 59주(K. pneumoniae 56주, Enterobacter cloacae 2, E. coli 1; 내성유전형 종류: KPC 36주, GES 12, NDM 6, VIM 2, OXA 2, IMP 1)를 대상으로 RAPIDEC CARBA NP 검사와 modified Hodge test (MHT) 및 carbapenemase inhibition test (CIT)를 이용한 CPE 표현형 검사를 시행하였다. 결과: Carbapenem 감수성이면서 ESBL 생성하는 장내세균 100주는 RAPIDEC CARBA NP 검사와 CPE 표현형 검사에서 모두 음성이었다. 59주의 CPE 균주는 RAPIDEC CARBA NP 검사에서 53균주가 양성이었고, MHT에서는 42균주가 양성이었다. RAPIDEC CARBA NP 검사의 CPE 검출 예민도와 특이도는 89.8%와 100%였다. 결론: RAPIDEC CARBA NP 검사는 방법이 간단하고 판독이 쉬우며, 3시간 내에 결과를 확인할 수 있는 검사로서 CPE 검출 예민도와 특이도가 매우 높기 때문에 임상검사실에서 사용하기에 매우 유용한 검사로 판단되었다.
Abstract
Background: Extended-spectrum β-lactamase (ESBL)- producing Enterobacteriaceae are resistant to most β-lactam antibiotics except carbapenems. In recent years, infrequently isolated Enterobacteriaceae that produce carbapenemase pose a serious threat in the selection of appropriate therapeutic antibiotics. The rapid detection method of carbapenemase-producing Enterobacteriaceae (CPE) is necessary to prevent the spread of CPE into healthcare facilities. Methods: One hundred clinical Enterobacteriaceae isolates (Klebsiella pneumoniae 40, Escherichia coli 40, others 20) showing susceptibility to carbapenems and positivity in the CLSI ESBL phenotypic test from November 2015 to March 2016 and 59 stocked Enterobacteriaceae isolates harboring resistance genes producing carbapenemase (K. pneumoniae 56, Enterobacter cloacae 2, E. coli 1; types of CPE: KPC 36, GES 12, NDM 6, VIM 2, OXA 2, IMP 1) were subjected to the RAPIDEC CARBA NP test (bioMérieux, France) and CPE phenotypic test using the modified Hodge test (MHT) and carbapenemase inhibition test. Results: All of the 100 Enterobacteriaceae isolates with carbapenem susceptibility and ESBL positivity were negative on the RAPIDEC CARBA NP test and CPE phenotypic test. Of 59 stock CPE isolates, 53 and 42 showed positive results to the RAPIDEC CARBA NP test and MHT, respectively. The sensitivity and specificity of the RAPIDEC CARBA NP test for detecting CPE were 89.8% and 100%, respectively. Conclusion: The RAPIDEC CARBA NP test is simple and produces a result within 3 hr. In conclusion, the test is a useful screen for detecting CPE because it shows high sensitivity and specificity for CPE detection.
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