Validation of a Low-Volume (100 μL) Plasma Protocol for HIV-1 RNA Quantification Using the Hologic Aptima HIV-1 Quant Dx Assay
Year: 2026
Type: article
Abstract: Pediatric HIV-1 viral load monitoring is often limited by the small blood volumes that can be safely obtained from infants and young children. Standard assays typically require 0.5–0.7 mL of plasma, which can pose challenges in these settings. This study evaluated a modified low-volume protocol using 100 μL of plasma, diluted for use with the Hologic Aptima HIV-1 Quant Dx assay, to determine whether performance was equivalent to the standard 700 μL protocol. An analytical validation was conducted using de-identified EDTA plasma samples spanning a wide range of HIV-1 RNA concentrations. Each specimen was tested using both protocols on the Panther system. Agreement between methods was assessed using log 10 differences, correlation analysis, and Bland–Altman analysis, while within-run and between-run precision were evaluated using replicate testing of negative, low-positive, and high-positive samples. The 100 μL protocol demonstrated excellent concordance with the standard method, with a mean log 10 difference of approximately 0.00 and a maximum difference of 0.12 log 10 copies/mL. No false-positive or false-negative results were observed among 30 fully suppressed samples. Precision analyses showed minimal variability, with all results within predefined acceptability criteria. These findings indicate that the low-volume Aptima protocol provides accurate and reliable HIV-1 RNA quantification and can expand access to viral load testing in pediatric patients and other clinical settings where plasma volume is limited.
Source: Journal of Molecular Diagnostics
Language: English
Topic: HIV Research and Treatment
Subfield: Virology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,000
OpenAlex ID: W7148725821