Diagnostic Accuracy of Point-of-Care HIV Viral Load Tests vs Laboratory-Based Assays

Point-of-care (POC) HIV RNA viral load testing was found to accurately diagnose antiretroviral therapy (ART) treatment failure (HIV RNA viral load, ≥1000 copies/mL) in patients with HIV infection, according to findings published in Cochrane Database of Systemic Reviews.

Researchers searched 8 electronic databases through November 2020 for primary studies that compared the diagnostic accuracy of POC tests with central laboratory-based assays to determine HIV RNA viral load counts in patients with HIV infection on ART. A total of 14 studies were included in this review, and diagnostic case-control studies with a healthy control group were excluded.

The 14 studies included in this meta-analysis comprised 20 evaluations with a total of 8659 patients. Of the 20 evaluations, 9 included patients on ART, 11 included patients in whom ART treatment was either partial or unknown, 13 included only adults, and 5 included both adults and children.

Compared with laboratory-based assays, the diagnostic accuracy of POC testing effectively detected ART treatment failure, with a pooled sensitivity and specificity of 96.6% (95% CI, 94.8-97.8) and 95.7% (95% CI, 90.8-98.0), respectively. Of note, there was no statistically significant difference in the sensitivity and specificity of the POC tests vs the laboratory-based assays. After restricting the analysis to only patients who were adherent to ART, the pooled sensitivity of POC testing was similar to the overall analysis (96.5% vs 96.6%) and the pooled specificity was decreased (90.1% vs 95.7%).

This study was limited by the inclusion of patients who were nonadherent to ART, as well as differences in reporting among the included studies.

According to the researchers, “more clinical trials evaluating the effect of these POC tests compared [with] laboratory standard-of-care tests on…outcomes such as time to change in treatment, emotional effects (stigma), [and] morbidity and mortality will be useful in gauging the utility of these tests in different settings.”

Reference

Ochodo EA, Olwanda EE, Deeks JJ, Mallett S. Point-of-care viral load tests to detect high HIV viral load in people living with HIV/AIDS attending health facilities. Cochrane Database Syst Rev. Published online March 10, 2022. doi:10.1002/14651858.CD013208.pub2