Validation of a Low-Volume (100 μL) Plasma Protocol for HIV-1 RNA Quantification Using the Hologic Aptima HIV-1 Quant Dx Assay

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 in which plasma volume is limited.

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Publication Details

Journal
Journal of Molecular Diagnostics
Published
2026-04-01
DOI
https://doi.org/10.1016/j.jmoldx.2026.03.006
Primary Topic
HIV Research and Treatment
Type
article
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Validation of a Low-Volume (100 μL) Plasma Protocol for HIV-1 RNA Quantification Using the Hologic Aptima HIV-1 Quant Dx Assay

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Validation of a Low-Volume (100 μL) Plasma Protocol for HIV-1 RNA Quantification Using the Hologic Aptima HIV-1 Quant Dx Assay

Lorna Madurai, Kayla Pillay, Bhavani Manivannan, Kiveshan Reddy, Someshni Nair, Sharana Mahomed
article en

Abstract

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 in which plasma volume is limited.

Journal of Molecular Diagnostics
Centre for the AIDS Programme of Research in South Africa (ZA), Universal University (RU), VRR Diagnostic Services (India) (IN)
Good health and well-being
Openalex Percentile: Top 25%
HIV Research and Treatment
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