Observational studyBMC infectious diseases2026
Variability in HIV viral load quantification in real-world service delivery settings: findings from an observational cohort study in Rwanda.
Observational study in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundWhile developments in HIV viral load (VL) testing technologies have improved detection of low-level viremia, there is substantial variation in the quantitative results of available polymerase chain reaction tests, particularly around assay lower limits of quantification (LLOQ). We aimed to describe testing results for paired specimens from the same participants reported by two laboratories in Rwanda using different assays, characterize discordancy in VL quantification, and identify factors associated with quantifiable VL results at a threshold of 40 copies/mL.
methodsIn an observational cohort study of people living with HIV (PWH), aged ≥ 40 years enrolled in HIV care, we used two laboratories to process paired research specimens. We used Kappa statistics and plots to examine between-lab agreement at the LLOQs for assays used by the two labs (Lab A: 20 copies/mL for COBAS AmpliPrep/Taqman and Abbott Alinity-m HIV1 assays; Lab B: 40 copies/mL for Abbott RealTime assay and at thresholds of 200, 1000 and 2000 copies/mL. We used Poisson regression to examine participant characteristics independently associated with unsuppressed viral loads (≥ 200 copies/mL).
results593 results were reported by both laboratories for 572 unique participants. The mean age of study participants was 54.4 years, and 58% were female. Median time on antiretroviral therapy was 16 years, 93.7% were on dolutegravir-based regimens, and 96.9% had CD4 cell counts of > 200 cells/mm
conclusionsWhile VL quantification differed substantially between assays and laboratories used in a real-world service delivery setting, there was high agreement at cut-offs generally used in clinical decision-making. Our findings support the use of higher viral suppression cut-offs used in UNAIDS' 95-95-95 targets because lower thresholds are vulnerable to misclassification.
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