호흡기 검체에서 Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila 검출을 위한 EuDxTM-PN MLC Detection 키트의 평가
Evaluation of EuDxTM-PN MLC Detection Kit for Detection of Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Legionella pneumophila in Respiratory Specimens
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배경: 세포 내 세균인 Mycoplasma pneumoniae, Chamydophila pneumoniae, 그리고 Legionella pneumophila는 지역사회획득 폐렴의 흔한 원인균이다. 본 연구는 호흡기 검체에서 M. pneumoniae, C. pneumoniae 그리고 L. pneumophila를 동시에 검출할 수 있는 새로운 다중 실시간 PCR 검사인 EuDxTM-PN MLC Detection Kit (EUDIPIA)를 평가하고자 하였다. 방법: 총 353 검체를 대상으로 다중 PCR (Seeplex PneumoBacter ACE Detection Kit) 검사와 두 종류의 다중 실시간 PCR 검사(EuDxTM-PN MLC Detection Kit와 AnyplexTM II RB5 Detection Kit)로 검사하였다. M. pneumoniae, C. pneumoniae 그리고 L. pneumophila에 대한 검사결과는 3종류의 검사 결과 중 2개 이상 일치한 결과 또는 단일 실시간 PCR을 결과를 기준(Extended standard)으로 분석하였다. 결과: EuDxTM-PN MLC Detection Kit의 민감도와 특이도는 각각 93.3-100%와 100%였다. M. pneumoniae, C. pneumoniae 그리고 L. pneumophila에 대한 EuDxTM-PN MLC Detection Kit와 AnyplexTM II RB5 Detection Kit 간 일치도와 kappa 값은 각각 70.0-100%와 0.82-1였다. 결론: 이러한 결과들은 EuDxTM-PN MLC Detection Kit가 호흡기 검체에서의 비정형 병원균 검출 시 민감하고 특이하여 선별검사로 유용할 것으로 판단되며, 호흡기 감염 환자를 위한 적절한 항균요법의 선택에 도움이 될 것으로 생각된다. [Ann Clin Microbiol 2017;20:97-102]
Abstract
Background: Infection by the intracellular bacteria Mycoplasma pneumoniae, Chamydophila pneumoniae, and Legionella pneumophila are common causes of community-acquired pneumonia (CAP). This study describes the evaluation of a new multiplex real-time PCR test, EuDxTM-PN MLC Detection Kit (EUDIPIA), which allows the simultaneous detection of M. pneumoniae, C. pneumoniae, and L. pneumophila in respiratory samples. Methods: A total of 353 samples were tested using three PCR kits: multiplex PCR (Seeplex PneumoBacter ACE Detection Kit) and two multiplex real-time PCR (EuDxTM-PN MLC Detection Kit and AnyplexTM II RB5 Detection Kit). The results were considered true positives (expanded standard) for M. pneumoniae, C. pneumoniae, and L. pneumophila if they were positive according to any of the three tests. Results: The sensitivity and specificity of EuDxTM-PN MLC Detection Kit were 93.3-100% and 100%, respectively. The agreement rate and Cohen's kappa coefficient (value) between EuDxTM-PN MLC Detection Kit and AnyplexTM II RB5 Detection Kit for M. pneumoniae, C. pneumoniae, and L. pneumophila were 70-100% and 0.82-1, respectively. Conclusion: These results demonstrate that the EuDxTM-PN MLC Detection Kit is a sensitive, specific, and useful screening tool for the detection of atypical pathogens in respiratory samples and can be helpful in selecting appropriate antimicrobial therapy for patients with respiratory infection. (Ann Clin Microbiol 2017;20:-102)
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