Evaluation of the Alinity m HIV-1 assay for early infant diagnosis using dried blood spots in resource-limited settings
- 1National Health Laboratory and Diagnostic Services/Central Public Health Laboratory (NHLDS/CPHL), Uganda
- 2Molecular Diagnostics at Abbott, Des Plaines, IL, USA; Corresponding author.
- 3Molecular Diagnostics at Abbott, Des Plaines, IL, USA
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.
Related
- Development and quality evaluation of lyophilized plasma external quality assessment samples for coagulation testing in resource-limited settings
- Clinical Diagnosis Versus Plain Radiography for Diabetic Foot Osteomyelitis: A Prospective Study of Diagnostic Agreement in a Resource‐Limited Settings
- Health system readiness for out-of-hospital-cardiac-arrest management in resource limited settings: A mixed-method study from rural and suburban Sindh, Pakistan
- Remote behavioural activation therapy for depressive symptoms among older adults in resource-limited settings: a protocol for a systematic review and meta-analysis
- Delphi consensus guidelines for fungal sepsis in non-neutropenic critically ill patients in resource-limited settings: fungal infection study forum expert recommendations
BibTeX
@article{isaac2026evaluation,
title = {{Evaluation of the Alinity m HIV-1 assay for early infant diagnosis using dried blood spots in resource-limited settings}},
author = {Ssewanyana Isaac and Grace Esther Kushemererwa and Mark M. Sasaki and Colleen Schmidt and Kristine Fricano and Yun-Min Sung and Rupinder Kular and Danijela Lucic and Shihai Huang and Jeffrey Wuitschick},
journal = {Journal of Clinical Virology Plus},
year = {2026},
month = oct,
doi = {10.1016/j.jcvp.2026.100270},
url = {https://doi.org/10.1016/j.jcvp.2026.100270},
note = {CC BY},
}
RIS
TY - JOUR
TI - Evaluation of the Alinity m HIV-1 assay for early infant diagnosis using dried blood spots in resource-limited settings
AU - Ssewanyana Isaac
AU - Grace Esther Kushemererwa
AU - Mark M. Sasaki
AU - Colleen Schmidt
AU - Kristine Fricano
AU - Yun-Min Sung
AU - Rupinder Kular
AU - Danijela Lucic
AU - Shihai Huang
AU - Jeffrey Wuitschick
PY - 2026
DA - 2026/10/30
JO - Journal of Clinical Virology Plus
DO - 10.1016/j.jcvp.2026.100270
UR - https://doi.org/10.1016/j.jcvp.2026.100270
AB - 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.
SN - 2667-0380
ER -