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침습성 아스페르길루스증 진단을 위한 Platelia Aspergillus 항원 검사법의 평가

The Evaluation of Clinical Utility of Platelia Aspergillus AntigenImmunoassay for Diagnosis of Invasive Aspergillosis

김미나|정희정|남궁승|성흥섭|표연정
대한임상미생물학회 (Korean Society of Clinical Microbiology)|2005.10|Annals of Clinical Microbiology|제8권 제2호|pp. 113-120

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배경：침습성 아스페르길루스증(invasive aspergillosis, IA)은 치명율이 50%가 넘기 때문에 조기 진단과 적절한 치료가 예후에 결정적인 영향을 준다. 최근 Aspergillus galactomannan 항원(AG) 검사가 IA를 진단하고 모니터링하는 방법으로 인정받고 있어서, IA 진단을 위해 AG 검사를 도입하고 그 유용성을 평가하고자 하였다. 방법：2004년 9월부터 2005년 5월까지 AG 검사를 의뢰한 149명의 175검체를 대상으로 후향적으로평가하였다. IA의 정의는 European Organization for Research and Treatment of Cancer/Mycoses Study Group(EORTC/MSG)의 진단기준을 적용해서 ‘증명된’, ‘거의 확실한’, ‘가능성 있는’IA로 구분하였다. AG는 Platelia Aspergillus (Bio-Rad, Hercules, CA, USA) 항원 면역검사법으로 검사하였으며, 두 개의 cut-off 대조군의 평균으로 나눈 cut-off 비가 1.5 이상은 양성, 1.0-1.5는 불확실로 해석하였다. 검사를 의뢰한 환자들의 항진균제, 항균제 투여력 등의 전산의무기록을 검토하였다. 결과：175검체 중 양성은 19검체 (10.9%), 불확실은 14검체 (8.0%), 음성은 142검체 (81.1%)였다. 환자의 병력을 검토한 결과 ‘증명된’, ‘거의 확실한’, ‘가능성 있는’IA 환자는 각각 2명 (1.3%), 15명 (10.1%), 28명 (18.8%)이었다. 위음성인 5명 중 항원 검사 전에 항진균제 치료를 받은 4명을 제외하면 검사의 예민도, 특이도, 양성예측도 및 음성예측도는 cut-off 비 1.5일 때 각각 76.9%, 94.7%, 58.8% 및 97.7%였다. 결론：Platelia Aspergillus 항원 면역검사법은 IA 진단을 위한 예민도, 특이도 및 음성예측도가 우수하였다. IA 진단을 위해 미생물학적 검사, 임상 평가 등과 함께 혈청 Aspergillus 항원을 측정하면 IA 진단에 유용할 것으로 판단하였다.

Abstract

Background: Because the mortality rate of invasive aspergillosis (IA) is more than 50%, an early diagnosis and appropriate management are important to achieve a favorable outcome. Aspergillus galactomannan (AG) antigen test has recently been introduced for diagnosis and monitoring of IA. This study was to evaluate the clinical utility of AG detection in diagnosis of IA. Methods:One hundred and seventy-five samples from 149 patients were tested for AG during the period from September 2004 to May 2005 and the results were evaluated retrospectively. IA was diagnosed into ‘proven’, ‘probable’and ‘possible’, groups based on patients’clinical laboratory findings as per European Organization for Research and Treatment of Cancer/Mycoses Study Group. AG was tested using a Platelia Aspergillus antigen ELISA (Bio-Rad, Hercules, CA, USA); the optical density (OD) of the test specimen was divided by the mean OD of two cut-off controls. The test was classified as positive when the OD ratio was ≥1.5; ratios 1-1.5 were classified as equivocal. Clinical Information was obtained from the electronic medical records of the patients. Results: Of the 175 samples tested, 19 were positive, 14 equivocal, and 142 negative for AG. A number of the ‘proven’, ‘probable’, and ‘possible’IA patients were 2, 15, and 28, respectively. At the OD ratio of 1.5, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 76.9%, 94.7%, 58.8%, and 97.7%, respectively, when 4 false-negative patients treated with amphotericin B before Aspergillusantigen test were excluded. Conclusion: The Platelia Aspergillus ELISA demonstrated an excellent sensitivity, specificity and NPV for the diagnosis of IA. A combined use of the antigen test with microbiological and clinical evaluation might facilitate the early diagnosis of IA and, consequently, improve its clinical outcome.

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