Real-world HIV diagnostic testing patterns in the United States

Area of Science:

• Medical Diagnostics
• Infectious Disease Research
• Public Health

Background:

• The Centers for Disease Control and Prevention (CDC) updated its HIV diagnostic testing algorithm.
• Real-world implementation of this updated algorithm requires evaluation for efficiency and accuracy.

Purpose of the Study:

• To assess the real-world implementation and efficiency of the updated CDC HIV diagnostic testing algorithm.
• To identify areas for improvement in HIV diagnostic workflows.

Main Methods:

• Retrospective analysis of de-identified patient data from Quest Diagnostics (2017).
• Included HIV-1/HIV-2 antibody differentiation tests (BioRad Geenius HIV 1/2 Supplemental Assay) and confirmatory nucleic acid tests (HIV-1 RNA Qualitative Assay [Aptima], HIV-2 NAT).
• Evaluated test sequences, results, frequency, and adherence to the CDC algorithm.

Main Results:

• 26,319 patients and 28,954 Geenius tests were analyzed.
• 26.4% of test sequences had indeterminate/negative Geenius results requiring confirmatory NAT.
• 74.2% of sequences followed the CDC-recommended algorithm, with 8.5% of patients having multiple Geenius tests and 11.2% showing differing results between tests.

Conclusions:

• The current CDC HIV diagnostic algorithm appears complex, potentially leading to suboptimal testing efficiency.
• Opportunities exist to enhance diagnostic efficiency by minimizing indeterminate results and reducing the need for repeat testing.