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Comparison of Two Enzyme-Linked Immunosorbent Assays forDetecting Parasitic Diseases

이미경|홍성태|채종일|김혜련
대한임상미생물학회 (Korean Society of Clinical Microbiology)|2008.04|Annals of Clinical Microbiology|제11권 제1호|pp. 56-62

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참고문헌

키워드

Clonorchis sinensisEnzyme-Linked Immunosorbent Assay (ELISA)CysticercusParagonimus westermaniSparganum

초록

배경: 오늘날 기생충 질환을 구별하는데 특이항체를 이용한 혈청학적 검사가 많이 쓰이고 있으며, 최근 효소면역법을 이용한 진단용 키트의 사용이 증가되고 있다. 이에 본 연구에서는 기생충증 진단을 위한 두 가지의 효소면역법을 평가해 보고자 한다. 방법: 553개 혈청과 156개 뇌척수액 검체를 마이크로플레이트 자가 제조 효소면역법과 제네디아 항체 엘리자(녹십자, 한국)로 폐흡충, 유구낭미충, 스파르가눔, 간흡충에 대한 검사를 시행하였고 두 검사 사이에 불일치를 보이는 경우는 의무기록을 검토하였다. 제네디아 항체 엘리자의 결과를 자가 제조 효소면역법와 비교하였다. 결과: 자가제조 효소면역법과 제네디아 항체 엘리자를 동시에 시행한 검사에서 일치율은 95.5%이었다. 임상소견을 기준으로 결과를 판정하였을 때 자가제조 효소면역법은 100%의 예민도, 99.0∼99.6%의 특이도, 82.4∼96.4%의 양성 예측도, 100%의 음성 예측도를 보였으며 제네디아 항체 엘리자는 민감도 92.9∼100%, 특이도 88.0∼97.3%, 양성 예측도 41.7∼ 50%, 음성 예측도 99.9∼100%를 보였고 두 검사의 카파 일치율 0.53∼0.63이었다. 4가지 기생충 모두에서 두 효소면역법간의 유의한 차이가 있었다(P＜0.05). 85검체로 시행한 재검에서 자가 제조 효소면역법은 97.7%의 결과의 일치율을, 제네디아 항체 엘리자는 28.2%의 일치율을 보여주었다. 결론: 본 연구 결과 두 방법간의 일치율은 95.5%이었고 제네디아 항체 엘리자가 자가 제조 효소면역법보다 편리하고 빠르긴하지만 중등도의 카파 일치율만을 보이고 있다. 따라서 앞으로 기생충증이 증명된 검체로 두 검사방법간의 일치율을 높이고 임상 증상을 고려한 주의 깊은 판독이 필수적이라 하겠다.

Abstract

Background: Serologic tests for specific antibody nowadays are widely employed for the diagnosis of parasitic diseases. Recently, an increasing numbers of kits have adopted enzyme-linked immunosorbent assay (ELISA) for the detection of parasitic antibodies. In this study, we evaluated two ELISA reagents for the diagnosis of parasitic diseases. Methods: A total of 553 serum and 156 CSF samples were assayed using an in-house micro-ELISA and GenediaⓇ Ab ELISA (Green cross PBM, Korea) for Cysticercus, Paragonimus westermani, Clonorchis sinensis, and Sparganum. We reviewed the medical records of all patients. The results from GenediaⓇ Ab ELISA kit were compared with those from the inhouse micro-ELISA method. Results: The overall concordance rate between the two ELISA tests was 95.5%. When compared with the clinical information, the sensitivity, specificity, positive predictive value, and negative predictive value of the in-house micro-ELISA were 100%, 99.0∼99.6%, 82.4∼96.4%, and 100%, and the respective figures for GenediaⓇ Ab ELISA kit were 92.9~100%, 88.0∼ 97.3%, 41.7∼50%, and 99.9~100% with kappa agreement of 0.53-0.63. Comparison of two ELISA methods showed a significant difference (P＜0.05). Retesting of 85 discordant samples showed that the concordance rate of the in-house ELISA was 97.7% and that of GenediaⓇ Ab ELISA was 28.2%. Conclusion: GenediaⓇ Ab ELISA kit showed an intermediate level of kappa agreement compared with the in-house ELISA. Further studies are necessary to improve the concordance rate of the two methods, and a careful interpretation of these results is required for a precise diagnosis.

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