Work

Evaluation of the Alinity m HIV-1 assay for early infant diagnosis using dried blood spots in resource-limited settings

Year: 2026

Type: article

Abstract: A substantial proportion of children living with HIV worldwide continue to lag behind adults in diagnosis, treatment access, and viral suppression, underscoring persistent gaps in pediatric HIV care. Although many pregnant women receive antiretroviral therapy to prevent transmission and a majority of exposed infants are tested early, prompt diagnosis and immediate treatment initiation in infancy are critical, as early therapy significantly reduces mortality. In resource‑limited settings, dried blood spots (DBS) provide a practical solution by simplifying specimen collection, storage, and transport from remote areas to centralized laboratories. In this study, we evaluated the analytical and clinical performance of the Alinity m HIV‑1 assay, a real‑time PCR test that supports DBS for qualitative early infant diagnosis (EID). The assay demonstrated a limit of detection (LOD) of 392.68 copies/mL, reproducibility at 2.60, 3.60, 5.00, and 7.30 Log copies/mL with total standard deviation ≤1.00 cycles, and sample stability with 100% detection after up to 12 weeks of storage from −20 °C to 31 °C with minimal cycle number variation at 3x and 10x LOD. Clinical evaluation of 391 specimens showed 100% agreement with the comparator assay, with cycle number correlation coefficient (r) of 0.905 for cycle numbers ranging from 19.42 to 36.90. Overall, these results demonstrate the utility of the Alinity m DBS EID HIV-1 assay for use in early infant diagnosis of HIV-1.

Source: Journal of Clinical Virology Plus

DOI: 10.1016/j.jcvp.2026.100270