Clostridium difficile 감염증 진단을 위한 검사법의 비교 평가
Comparison and Evaluation of Diagnostic Assays for Clostridium difficile Infection
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배경: Clostridium difficile은 항생제 사용 후 발생하는 위막성 대장염(pseudomembranous colitis, PMC)의 주요 원인균이다. C. difficile 감염(C. difficile infection, CDI)의 진단을 위해서는 이전 항생제 사용력, 지속적인 설사 등의 병력을 가지는 환자를 대상으로 C. difficile 독소를 검출하는 것이 필수적이다. 본 연구에서는 한 대학병원 임상미생물 검사실로 CDI 진단을 위해 의뢰된 대변 검체 1,363개를 대상으로 시행된 세 가지 방법의 C. difficile 검사 결과를 분석하여 각 검사법들의 성능과 실제 유용성을 확인하고자 하였다. 방법: 각 검체는 면역검사법인 VIDAS C. difficile Toxin A&B (bioMérieux SA, France) 검사와 실시간중합효소연쇄반응을 기반으로 하는 Xpert C. difficile assay (Cepheid, USA) 검사 및 ChromID C. difficile agar (bioMérieux SA, France)를 이용한 배양 검사를 모두 시행하였다. CDI의 진단기준은 Xpert 검사 결과가 양성인 경우와 VIDAS 검사법이나 배양법 두 가지 중 하나 이상이 양성이면서 영상학적 검사 혹은 내시경 검사에서 PMC가 진단된 경우로 정의하였다. 결과: 전체 검체 중 1,027검체(75.3%)는 세 검사 모두 음성이었고, 101검체(7.4%)는 세 검사 모두 양성으로 세 검사의 전체 일치율은 82.7%였다. 또한 최종적으로 CDI로 진단된 경우는 총 291건(21.3%)이였다. 각 검사법의 민감도와 특이도는 VIDAS 검사법의 경우 38.8%, 99.3%였으며, ChromID 배양법은 각각 71.5%, 96.5%였다. VIDAS 검사법과 배양법의 경우 단독으로 사용하기에는 민감도 면에서 부족한 결과를 보였고, Xpert 검사법은 높은 민감도(98.6%, 287/291)를 보였다. 결론: CDI 진단에 있어 초기 검사법으로 Xpert 검사법과 같은 신속분자진단검사법을 시행하는 것이 효율적일 것으로 생각되었다.
Abstract
Background: Clostridium difficile is a leading causative microorganism of pseudomembranous colitis (PMC) and antibiotic-associated diarrhea. In patients who have a history of antibiotic use and diarrhea, the presence of the C. difficile toxin should be confirmed to diagnose C. difficile infection (CDI). In this study, the results of three assays for CDI, which were performed on 1,363 clinical stool samples at a tertiary hospital, were analyzed to evaluate the performance and usefulness of these assays for diagnosis of CDI. Methods: The results of the VIDAS C. difficile Toxin A&B Immunoassay (bioMérieux SA, France), Xpert C. difficile Real-Time PCR Assay (Cepheid, USA), and ChromID C. difficile Agar (bioMérieux SA, France) culture were analyzed retrospectively. Cases were defined as CDI according to the positive Xpert assay or the positive VIDAS assay and/or culture in the presence of PMC findings after radiological imaging or endoscopic procedures. Results: A total of 1,027 samples (75.8%) tested negative in all three assays, 101 samples (7.4%) tested positive in all three assays, and overall agreement among them was 82.7%. In this study, 291 cases (21.3%) were diagnosed as CDI. Sensitivity and specificity of the VIDAS assay were 38.8% and 99.3%, and those of ChromID culture were 71.5% and 96.5%, respectively. The Xpert assay showed good sensitivity (98.6%, 287/291), whereas the VIDAS assay and ChromID culture showed low sensitivities. Conclusions: These results suggest that rapid molecular diagnostic assays, such as the Xpert assay, are promising candidates for an initial diagnostic test for CDI.
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