Poststudy Point-of-Care Oral Fluid Testing in Human Immunodeficiency Virus-1 Vaccinees.

Area of Science:

• Immunology
• Vaccinology
• Clinical Diagnostics

Background:

• Experimental human immunodeficiency virus (HIV)-1 vaccines can induce antibodies that cross-react with HIV diagnostic tests, leading to vaccine-induced seropositivity/seroreactivity (VISP/VISR).
• Understanding the performance of point-of-care HIV tests in individuals vaccinated with experimental HIV vaccines is crucial for accurate diagnosis and public health.

Purpose of the Study:

• To evaluate the reactivity of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test in detecting HIV-1 vaccine-induced antibodies in participants of clinical trials.
• To assess the diagnostic implications of VISP/VISR in the context of HIV vaccine development.

Main Methods:

• Plasma samples from 57 HIV-uninfected participants who received a candidate HIV vaccine were tested in vitro for cross-reactivity using the OraQuick ADVANCE test.
• Saliva samples from 120 HIV-uninfected participants with confirmed VISP/VISR from various HIV vaccine protocols were screened using the OraQuick ADVANCE test.
• OraQuick ADVANCE results were compared with concurrent blood sample results from commercial HIV screening immunoassays.

Main Results:

• Only 1 out of 57 (1.8%) plasma samples showed reactivity with the OraQuick ADVANCE test in vitro.
• None of the 120 participants with VISP/VISR tested positive using the OraQuick ADVANCE test in a clinical setting (0% reactivity).
• The majority of participants (98.3%) exhibited VISP/VISR, with reactive results on conventional HIV diagnostic tests, highlighting the discrepancy with the OraQuick ADVANCE test.

Conclusions:

• The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test demonstrates limited reactivity to HIV-1 antibodies induced by the evaluated candidate HIV vaccines.
• This patient-controlled test may offer a more specific diagnostic option in populations receiving experimental HIV vaccines, reducing the likelihood of false-positive results due to vaccination.