Implementation of an HIV RNA Qualitative PCR Assay in an HIV Diagnostic Algorithm: A Single-Institution Experience

Area of Science:

• Virology
• Clinical Diagnostics
• Public Health

Background:

• Boston Medical Center (BMC), a major academic medical center, serves a diverse patient population.
• The need for accurate and rapid HIV diagnostics is critical for patient care and public health initiatives.

Purpose of the Study:

• To evaluate the implementation and performance of a new HIV-1/HIV-2 Qualitative RNA PCR (HIV RNA QUAL) test.
• To assess the test's utility in replacing traditional antibody discrimination testing and diagnosing acute HIV infection.
• To develop a guideline-compliant algorithm for screening patients on HIV preexposure prophylaxis.

Main Methods:

• A production monitor was used to collect data for the first 3 months postimplementation.
• Key metrics included test utilization, turnaround time, impact on send-out testing, and result discrepancies.
• The study also involved developing a specific screening algorithm for patients on HIV preexposure prophylaxis.

Main Results:

• The HIV RNA QUAL test was implemented to streamline HIV diagnosis, replacing follow-up antibody testing after reactive serology screens.
• The test serves as a standalone diagnostic for suspected seronegative acute HIV infection.
• A novel algorithm was created for screening patients on HIV preexposure prophylaxis, incorporating both 4G screening and HIV RNA QUAL.

Conclusions:

• The new HIV RNA QUAL test and associated algorithm demonstrate potential for improved HIV diagnostics.
• The findings suggest that this approach may be reproducible and beneficial at other healthcare institutions.
• The implementation highlights the evolving landscape of HIV testing and diagnostics.