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Published on: October 31, 2010
Real-world HIV diagnostic testing patterns in the United States
Chakkarin Burudpakdee, Aimee M Near, Jenny Tse
1Roche Molecular Systems, Inc, 4300 Hacienda Dr, Pleasanton, CA 94588.
Insights
The CDC HIV diagnostic algorithm is complex, leading to suboptimal testing efficiency. Improvements are needed to reduce indeterminate results and repeat testing for better HIV diagnosis.
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.
Objectives:
To understand real-world implementation of the updated CDC HIV diagnostic testing algorithm.
Study Design:
Retrospective database analysis.
Methods:
Using data from Quest Diagnostics, we identified patients with at least 1 HIV-1/HIV-2 antibody differentiation test (BioRad Geenius HIV 1/2 Supplemental Assay [Geenius]) between January 1 and December 31, 2017. Study measures included Health Insurance Portability and Accountability Act-compliant patient demographics, test results, test frequency, and sequence relative to the CDC HIV diagnostic algorithm, including HIV-1 RNA Qualitative Assay (Aptima) or HIV-2 nucleic acid test (NAT).
Results:
A total of 26,319 patients were identified (mean [SD] age, 40.7 [14.3] years; 66.4% male), with 28,954 Geenius tests, 7234 Aptima tests, and 298 HIV-2 NATs. In 26.4% of test sequences, the Geenius results were indeterminate or negative and required subsequent confirmatory NATs. A total of 8.5% of patients had more than 1 Geenius test in 2017, and 11.2% of the time, results of the first and second tests differed. A total of 74.2% of test sequences matched the CDC-recommended algorithm.
Conclusions:
Our study findings suggest that the CDC HIV diagnostic algorithm is complex and may pose suboptimal testing efficiency. Opportunities to improve diagnostic efficiency by reducing indeterminate results and repeat tests are warranted.
