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Related Experiment Video

Updated: Mar 22, 2026

Amplifying and Quantifying HIV-1 RNA in HIV Infected Individuals with Viral Loads Below the Limit of Detection by Standard Clinical Assays
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Fourth generation assays for HIV testing.

Luca Vallefuoco1, Claudia Mazzarella1, Giuseppe Portella1

  • 1a Dipartimento di Scienze Mediche Traslazionali , Università di Napoli Federico II , Napoli , Italy.

Expert Review of Molecular Diagnostics
|April 21, 2016
PubMed
Summary
This summary is machine-generated.

Fourth generation assays improve HIV diagnosis by detecting both HIV p24 antigen and antibodies. This advancement reduces the diagnostic window, aiding early identification of individuals for antiretroviral therapy.

Keywords:
HIV-1HIV-2anti-HIV antibodiesantigen p24combination immunoassaysdiagnostic windowinfection diagnosis

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Area of Science:

  • Clinical diagnostics
  • Immunology
  • Virology

Background:

  • Laboratory diagnosis of HIV infection is crucial for prevention and treatment.
  • Immunoassay technology for HIV detection has evolved significantly since initial antibody assays.
  • Early detection of HIV infection allows for timely initiation of highly active antiretroviral therapy.

Purpose of the Study:

  • To review the advancements in HIV diagnostic assays.
  • To highlight the clinical utility of fourth-generation HIV assays.
  • To discuss the role of combination assays in HIV detection.

Main Methods:

  • Review of fourth-generation immunoassay technology.
  • Assessment of assays detecting both HIV p24 antigen and antibodies.
  • Evaluation of combination assays with separate antigen and antibody results.

Main Results:

  • Fourth-generation assays simultaneously detect HIV p24 antigen and antibodies, reducing the diagnostic window.
  • Combination assays offer distinct results for antibodies and p24 antigen.
  • Studies confirm the clinical utility of these advanced diagnostic tools.

Conclusions:

  • Fourth-generation assays represent an effective tool for laboratory diagnosis of HIV infection.
  • The ADVIA Centaur HIV Ag/Ab Combo assay aligns with current fourth-generation assay standards.
  • Clinical utility assessments support the use of advanced HIV diagnostic technologies.