The HIV/AIDS epidemic remains a global health challenge. Plasma‐based HIV viral load testing is the gold standard for monitoring antiretroviral therapy and detecting acute HIV infection; however, conventional centrifugation‐based plasma separation methods restrict testing to centralized laboratories. Here, we present the development, optimization, and clinical validation of a disposable, centrifuge‐free plasma separator for HIV viral load testing at the point of care. To enhance the device's plasma extraction efficiency, we optimized the separator design, membrane selection, and cell gravity sedimentation time. The final device yielded 81.23 ± 3.16 μL of plasma from ∼200 μL of whole blood within 10 min, requiring no external power. To minimize plasma loss and viral adsorption, we covered the device surface with a superhydrophobic self‐cleaning coating. With the optimized plasma separator, we tested 42 devices and conducted a clinical feasibility evaluation in Zambia using whole blood samples from HIV‐positive patients. We quantified the HIV viral load with the Hologic Panther System, demonstrating excellent clinical performance compared to centrifugation method with a strong correlation coefficient ( R 2 = 0.955). This low‐cost, power‐free, efficient technology has significant potential to expand plasma‐based diagnostics for point‐of‐care HIV viral load testing and support broader pathogen detection (e.g., HCV) by combining a portable viral load diagnostic platform.
Hou et al. (Sun,) studied this question.