Lab Med Online.  2014 Jul;4(3):157-163. 10.3343/lmo.2014.4.3.157.

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

Affiliations
  • 1Department of Laboratory Medicine, Korea University College of Medicine, Seoul, Korea. eqcho1ku@korea.ac.kr

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.

Keyword

HIV; Screening; Sensitivity; Specificity
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