PROMPT POINT-OF-CARE HIV VIRAL LOAD MONITORING

Existing HIV viral load testing workflows require centrifugation to separate plasma and lengthy nucleic acidextraction and amplification routines conducted on centralized laboratory equipment. The cost, lengthyturnaround time, and highly trained personnel required for conducting these tests prohibits widespread accessto viral load testing and limits the ability of patients to self-monitor at home. The project proposed herein willaddress the need for a rapid diagnostic for at-home monitoring of HIV viral load using a portable, sample-toanswermagnetofluidic platform. Magnetofluidic cartridges leverage transfer of magnetic particles throughpreloaded reagents to automate and streamline purification of nucleic acids from clinical samples. Samplepreparation is coupled directly with nucleic acid amplification in a thermoplastic body similar in size and costto lateral flow rapid tests. Results are available in less than 30 minutes using a compact, user-friendlyinstrument with integrated assay controls and on-board interpretation and readout of easy-to-understandresults. The work in this Phase I project will (1) develop the assay for full coverage of HIV-1 circulating in theUS, (2) achieve a limit of detection below 500 copies/mL of plasma from fingerstick volumes of blood, and (3)compare the platform’s performance to laboratory standards with clinical samples.