BioFire® Meningitis/Encephalitis Panel의 진단적 유용성 평가: 90일 미만 발열 영아에서의 예비 연구
Diagnostic Evaluation of the BioFire® Meningitis/Encephalitis Panel: A Pilot Study Including Febrile Infants Younger than 90 Days
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목적: 중추신경계 감염의 적절한 치료를 위해서 신속한 원인 병원체의 확인이 중요하다. 본 연구는 열이 있는 영아의뇌척수액 검체에서 원인 병원체 검출을 위한 BioFire® Meningitis/Encephalitis (ME) panel 검사 방법의 진단적 가치를평가하고자 수행되었다. 방법: 2016년 1월부터 2019년 7월까지 발열을 주소로 서울대학교 어린이병원에 내원한 90일 미만의 영아로부터 채취한뇌척수액으로 기존검사(세균 배양, Xpert® enterovirus assay, herpes simplex virus-1 and -2 중합효소 연쇄반응 검사)를시행한 후 −70°C 초저온 냉동고에 보관된 검체를 대상으로 BioFire® ME panel 검사를 시행하였다. 결과: 총 72개 검체(원인 병원체가 검출된 24개와 검출되지 않은 48개)가 포함되었다. BioFire® ME panel 검사 결과, 기존검사로 원인 병원체가 검출되지 않은 48개의 검체 중 41개(85.4%)는 음성이었고 원인 병원체가 검출된 24개 검체 중22개(91.7%)가 동일한 결과(enterovirus 19개, Streptococcus agalactiae 2개, Streptococcus pneumoniae 1개)를 보여 전체 일치율은87.5% (63/72)였다. 병원체가 기존검사에서 검출되지 않았으나 BioFire® ME panel에서 검출된 7개의 검체 중 6개에서human parechovirus (HPeV)가 검출되었다. 결론: 열이 있는 90일 미만 영아에서 BioFire® ME panel 검사법은 원인 병원체가 밝혀진 기존검사 결과와는 비교적 높은일치도를 보이며, HPeV를 추가적으로 진단할 수 있었다. 향후, 소아청소년 진료 영역에서 BioFire® ME panel 검사법을적용할 근거를 마련하기 위한 임상적 유용성과 비용 효과에 대한 연구가 필요하다.
Abstract
Purpose: Rapid detection of etiologic organisms is crucial for initiating appropriate therapy in patients with central nervous system (CNS) infection. This study aimed to evaluate the diagnostic value of the BioFire® Meningitis/Encephalitis (ME) panel in detecting etiologic organisms in cerebrospinal fluid (CSF) samples from febrile infants. Methods: CSF samples from infants aged <90 days who were evaluated for fever were collected between January 2016 and July 2019 at the Seoul National University Children's Hospital. We performed BioFire® ME panel testing of CSF samples that had been used for CSF analysis and conventional tests (bacterial culture, Xpert® enterovirus assay, and herpes simplex virus-1 and -2 polymerase chain reaction) and stored at −70°C until further use. Results: In total, 72 (24 pathogen-identified and 48 pathogen-unidentified) CSF samples were included. Using BioFire® ME panel testing, 41 (85.4%) of the 48 pathogen-unidentified CSF samples yielded negative results and 22 (91.7%) of the 24 pathogen-identified CSF samples yielded the same results (enterovirus in 19, Streptococcus agalactiae in 2, and Streptococcus pneumoniae in 1) as those obtained using the conventional tests, thereby resulting in an overall agreement of 87.5% (63/72). Six of the 7 pathogen-unidentified samples were positive for human parechovirus (HPeV) via BioFire® ME panel testing. Conclusions: Compared with the currently available etiologic tests for CNS infection, BioFire® ME panel testing demonstrated a high agreement score for pathogen-identified samples and enabled HPeV detection in young infants. The clinical utility and cost-effectiveness of BioFire® ME panel testing in children must be evaluated for its wider application.
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