With almost 40 million people currently infected with the Human Immunodeficiency Virus (HIV) and over 40 million who have succumbed to infection, the HIV pandemic is far from over.¹ Early testing is key for preventing transmission and slowing disease progression as infected individuals are more likely to be highly infectious during acute disease.² High sensitivity HIV assays combine testing for anti-HIV antibodies and for the presence of the HIV p24 antigen in the sample. The Beckman Coulter Access HIV Ag/Ab combo assay, part of the infectious disease portfolio available for use on the DxI 9000 Immunoassay Analyzer* is a paramagnetic particle chemiluminescent ELISA^† immunoassay dedicated to the simultaneous qualitative in vitro detection and differentiation of HIV-1 p24 antigen (HIV-Ag) and HIV-1/2 antibody (HIV-Ab) to aid in earlier identification of infection.

Clinical evaluation of the Access HIV Ag/Ab combo assay as compared with competitor assays found:

• The average number of days between positive detection of a bleed previously identified Nucleic Acid Test (NAT) positive compared with competitor assays was reduced by 1.2 to 1.6 days
• The Access HIV Ag/Ab combo assay detected a higher number of bleeds (n=90) than the Elecsys (n = 80) and Architect (n = 77) assays due to earlier Ag detection, indicating earlier detection of virions
• The Access HIV blood test showed a higher sensitivity for HIV-1 p24 antigen compared with the ARCHITECT assay, and the Access HIV assay was able to detect HIV-1 strains that the ARCHITECT assay did not

With its excellent analytical performance—particularly its high HIV-1 p24 Ag sensitivity—the Access HIV Ag/Ab combo assay may help reduce the diagnostic window and thus prevent any delay of treatment for HIV-infected patients.

At Beckman Coulter, we are committed to revolutionizing the next generation in immunoassay testing with precision and sensitivity to drive innovations, advance medical insights, and enhance diagnostic availability.

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*Full name DxI 9000 Access Immunoassay Analyzer

†ELISA = Enzyme-linked Immunosorbent Assay

References:

1. World Health Organization. HIV and AIDS. July 13, 2023. Accessed June 4, 2024. https://www.who.int/news-room/fact-sheets/detail/hiv-aids

2. Masciotra S, McDougal JS, Feldman J, Sprinkle P, Wesolowski L, Owen SM. Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and persons with established HIV infections. J Clin Virol. 2011;52 Suppl 1:S17-22. doi:10.1016/j.jcv.2011.09.011