biostudies-literatureKim SNIBIB NIH HHSNIAID NIH HHSNational Institutes of Health6268-6280https://www.ebi.ac.uk/biostudies/studies/S-EPMC12574115biostudies-literatureUnknown25(23)Effective monitoring of HIV treatment remains constrained by limited access to affordable, sensitive, and user-friendly viral load diagnostics, particularly in resource-limited settings. To address this critical gap, a fully automated, point-of-care device was developed that integrates microfluidic sample processing with ultrasensitive bioluminescence-based viral load detection. Upon simple sample loading, the system automates all steps, capturing multiple HIV subtypes with antibody-coated magnetic beads without fold-change, amplifying bioluminescence <i>via</i> enzyme cascades, and quantifying viral load using a low-cost optical sensor. Analytical validation using 87 HIV-spiked plasma samples confirmed a 95 copies per mL detection limit and reliable quantification of viral loads. ClinicalLab on a chipA luminescence-based point-of-care HIV viral load test for antiretroviral therapy monitoring.PMC12574115UM1 AI106701R61AI140489R01EB033866R01AI138800UM1 AI068634R61 AI140489UM1AI068636UM1 AI068636UM1AI068634R01 AI138800R33AI140489UM1AI106701R01AI138800-05S1R01 EB033866R33 AI140489Hong HROh JMGwak JLee JKim JLi JZChun JHardie JMKuritzkes DRHusain SMKim SKanakasabapathy MKTsibris AMChellappaa AYoo JShafiee HThirumalaraju PSong YfalseA luminescence-based point-of-care HIV viral load test for antiretroviral therapy monitoring.Effective monitoring of HIV treatment remains constrained by limited access to affordable, sensitive, and user-friendly viral load diagnostics, particularly in resource-limited settings. To address this critical gap, a fully automated, point-of-care device was developed that integrates microfluidic sample processing with ultrasensitive bioluminescence-based viral load detection. Upon simple sample loading, the system automates all steps, capturing multiple HIV subtypes with antibody-coated magnetic beads without fold-change, amplifying bioluminescence <i>via</i> enzyme cascades, and quantifying viral load using a low-cost optical sensor. Analytical validation using 87 HIV-spiked plasma samples confirmed a 95 copies per mL detection limit and reliable quantification of viral loads. Clinical2025-01-01T00:00:00Z2025 Nov2026-06-06T15:46:14.983Z2026-06-02T03:09:23.903ZS-EPMC125741154111494810.1039/d5lc00636h