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Journal of Clinical Microbiology, September 2001, p. 3122-3128, Vol. 39, No. 9
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.9.3122-3128.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Seven Human Immunodeficiency Virus (HIV) Antigen-Antibody Combination Assays: Evaluation of HIV Seroconversion Sensitivity and Subtype Detection

Thoai Duong Ly,1 Lynn Martin,2 David Daghfal,2 Arnold Sandridge,2 Daniel West,2 Richard Bristow,3 Laurence Chalouas,1 Xiaoxing Qiu,2 Sheng C. Lou,2 Jeffrey C. Hunt,2 Gerald Schochetman,2 and Sushil G. Devare2,*

Laboratoire Claude Levy, Ivry sur Seine, France1; Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois2; and Murex Biotech Ltd., Dartford, Kent, United Kingdom3

Received 5 February 2001/Returned for modification 13 April 2001/Accepted 18 June 2001

In this study, we evaluated the performance of two prototype human immunodeficiency virus (HIV) antigen-antibody (Ag-Ab) combination assays, one from Abbott Laboratories (AxSYM HIV Ag-Ab) and the other from bioMerieux (VIDAS HIV Duo Ultra), versus five combination assays commercially available in Europe. The assays were Enzygnost HIV Integral, Genscreen Plus HIV Ag-Ab, Murex HIV Ag-Ab Combination, VIDAS HIV Duo, and Vironostika HIV Uniform II Ag-Ab. All assays were evaluated for the ability to detect p24 antigen from HIV-1 groups M and O, antibody-positive plasma samples from HIV-1 groups M and O, HIV-2, and 19 HIV seroconversion panels. Results indicate that although all combination assays can detect antibodies to HIV-1, group M, subtypes A to G, circulating recombinant form (CRF) A/E, and HIV-1 group O, their sensitivity varied considerably when tested using diluted HIV-1 group O and HIV-2 antibody-positive samples. Among combination assays, the AxSYM, Murex, and VIDAS HIV Duo Ultra assays exhibited the best antigen sensitivity (at ~25 pg of HIV Ag/ml) for detection of HIV-1 group M, subtypes A to G and CRF A/E, and HIV-1 group O isolates. However, the VIDAS HIV Duo Ultra assay had a lower sensitivity for HIV-1 group M and subtype C, and was unable to detect subtype C antigen even at 125 pg of HIV Ag/ml. The HIV antigen sensitivity of the VIDAS HIV Duo and Genscreen Plus combination assays was ~125 pg of HIV Ag/ml for detection of all HIV-1 group M isolates except HIV-1 group O while the sensitivity of Vironostika HIV Uniform II Ag-Ab and Enzygnost HIV Integral Ag-Ab assays for all the group M subtypes was >125 pg of HIV Ag/ml. Among the combination assays, the AxSYM assay had the best performance for detection of early seroconversion samples, followed by the Murex and VIDAS HIV Duo Ultra assays.

* Corresponding author. Mailing address: AIDS Research and Retrovirus Discovery, Abbott Laboratories, D-09NG, Bldg. AP 20, 100 Abbott Park Rd., Abbott Park, IL 60064-6015. Phone: (847) 937-0913. Fax: (847) 937-1401. E-mail: Sushil.Devare{at}abbott.com.

Journal of Clinical Microbiology, September 2001, p. 3122-3128, Vol. 39, No. 9
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.9.3122-3128.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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