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Elecsys HIV combi PT 검사와 ARCHITECT HIV Ag/Ab Combo 검사의 성능 비교 평가

Performance of the Elecsys HIV combi PT Assay Compared to the ARCHITECT HIV Ag/Ab Combo Assay

신경희|이창규|조윤정|최지선|김하늬|정보경
대한진단검사의학회 (Korean Society For Laboratory Medicine)|2014.07|Laboratory Medicine Online|제4권 제3호|pp. 157-163

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참고문헌

키워드

HIVScreeningSensitivitySpecificity

초록

배경: 기능이 향상되어 국내에 소개된 새로운 4세대 HIV 스크리닝검사인 Elecsys HIV combi PT 검사(Roche Diagnostics GmbH, Germany)를 ARCHITECT HIV Ag/Ab Combo (Abbott Laboratories, Germany)와 비교하여 민감도와 특이도를 평가하고자 한다. 방법: 총 2,003개의 신선한 무작위 임상검체, 네 종류의 혈청전환 패널, WHO International Standard p24 항원 민감도 패널, HIV-1 아형 A, B, C, CRF 01_AE 및 F 바이러스 용해질 희석액, HIV-1 아형 A, B, C, D, CRF 01_AE 항체 희석액을 대상으로 사용하였다. 시약 사용설명서에 따라 Elecsys HIV combi PT검사와 ARCHITECT HIV Ag/Ab Combo 검사를 당일 시행하였다. MP Diagnostics HIV BLOT 2.2 (MP Biomedicals, USA) 검사, Elecsys HIV p24 Ag 검사 및 확진검사(Roche Diagnostics GmbH, Germany), COBAS AmpliPrep/COBAS TaqMan HIV-1 검사(Roche Molecular Inc., USA)를 추가검사로 사용하였다. 결과: 두 검사 모두 4종의 혈청검사 패널에서 동일한 채혈일에 HIV 감염을 검출하였고 p24 항원의 최저검출한계는 1 IU/mL 이하였다. ARCHITECT HIV Ag/Ab Combo 검사가 바이러스 용해질 희석액을 약간 더 민감하게 검출하였고 Elecsys HIV combi PT 검사는 5종류의 HIV-1 아형 항체를 더 민감하게 검출하였고 두 검사 모두 5예의 HIV 검체를 정확히 검출하였다. Elecsys HIV combi PT검사와 ARCHITECT HIV Ag/Ab Combo 검사의 특이도는 각각 99.90%와 99.80%였다. 결론: Elecsys HIV combi PT 검사는 ARCHITECT HIV Ag/Ab Combo 검사에 견줄만한 민감도와 특이도를 보여주었고 대학병원과 같은 3차 의료기관에서 HIV 스크리닝 검사로 충분히 사용될 수 있을 것으로 판단된다.

Abstract

Background: The aim of this study was to compare the analytical sensitivity and specificity of the recently updated 4th generation Elecsys HIV combi PT assay (Roche Diagnostics GmbH, Germany) to those of the ARCHITECT HIV Ag/Ab Combo assay (Abbott Laboratories, Germany). Methods: A total of 2,003 fresh random clinical samples, 4 HIV seroconversion panels, a WHO International Standard p24 antigen sensitivity panel, 5 HIV-1 subtype viral lysates, and 5 HIV-1 subtype antibodies were tested in comparative studies with the Elecsys HIV combi PT and ARCHITECT HIV Ag/Ab Combo assays. Samples were assayed with both tests on the same day. The MP Diagnostics HIV Western Blot 2.2 Assay, the Elecsys HIV p24 Ag Test and Confirmatory Test, and the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test were performed as supplementary tests. Results: Both the Elecsys and ARCHITECT assays detected viral antigens in all four seroconversion panels on the same bleed days, and had lower limits of detection of <1 IU/mL with the p24 antigen sensitivity panel. The ARCHITECT assay showed slightly higher sensitivity in detecting viral antigens with some HIV-1 subtype viral lysates, while the Elecsys assay was more sensitive in detecting each of the 5 HIV-1 subtype antibodies. Both assays detected 5/5 HIV+ clinical samples correctly. The analytical specificities of the Elecsys and ARCHITECT assays were 99.90% and 99.80%, respectively. Conclusions: The Elecsys HIV combi PT assay performed comparably to the ARCHITECT HIV Ag/Ab Combo assay. Thus, the Elecsys HIV combi PT assay is suitable for diagnostic testing in university hospital settings.

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