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

Bo Kyeung Jung; Ha-Nui Kim; Ji Seon Choi; Kyunghee Shin; Chang Kyu Lee; Yunjung Cho

doi:10.3343/lmo.2014.4.3.157

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Jung, Kim, Choi, Shin, Lee, and Cho: Performance of the Elecsys HIV combi PT Assay Compared to the ARCHITECT HIV Ag/Ab Combo Assay

Original Article

Diagnostic Immunology

Laboratory Medicine Online 2014; 4(3): 157-163.

Published online: 1 July 2014

DOI: https://doi.org/10.3343/lmo.2014.4.3.157

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

Bo Kyeung Jung, M.D., Ha-Nui Kim, M.D., Ji Seon Choi, M.D., Kyunghee Shin, M.T., Chang Kyu Lee, M.D., Yunjung Cho, M.D.

Department of Laboratory Medicine, Korea University College of Medicine, Seoul, Korea.

Corresponding author: Yunjung Cho. Department of Laboratory Medicine, Korea University Hospital, 73 Inchon-ro, Sungbuk-gu, Seoul 136-705, Korea. Tel: +82-2-920-5612, Fax: +82-2-920-5538, eqcho1ku@korea.ac.kr

Received 13 October 2013 Revised 17 October 2013 Accepted 17 October 2013

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: HIV, Screening, Sensitivity, Specificity

Figures and Tables

Table 1

Characteristics of clinical samples and analytical sensitivity-evaluation samples

Abbreviations: dil, dilutions; DM, diabetes mellitus.

Table 2

Method summary of the Elecsys HIV Combi PT and ARCHITECT HIV Ag/Ab Combo assays

Abbreviations: Ag, antigen; Ab, antibody; Rx, reaction; MAb, monoclonal antibody.

Table 3

Sensitivities of the Elecsys HIV Combi PT and ARCHITECT HIV Ag/Ab Combo assays

^*The analytical sensitivity of either assay for p24 antigen detection (IU/mL) was determined using GraphPad Prism 5.0. Maximum dilution of HIV-1 antigen or antibody detected; ^†WHO International Standard NIBSC Code: 90/636.

Abbreviation: d, days.

Table 4

Performance of the Elecsys HIV Combi PT and ARCHITECT HIV Ag/Ab Combo assays

^*Two samples (one false positive by Elecsys HIV Combi PT assay and one false positive by ARCHITECT HIV Ag/Ab Combo assay) without confirmatory test results were not included in the specificity analysis.

Table 5

Summary of HIV testing results and clinical findings for eight discrepant cases between the Elecsys and ARCHITECT assays

Abbreviations: s/co, signal-to-cutoff ratio; WB, Western blot; N/A, not applicable; TND, target not detected; ND, not done; CKD, chronic kidney disease.

Notes

This article is available from http://www.labmedonline.org

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