Point-of-care HIV viral load system using RPA and MXR

ABSTRACT HIV AIDS continues to be a major global health problemwith a worldwide estimate by the CDC ofmillion people with HIVHIV viral loadVLtest measures the number of HIVRNA per mL of bloodThe test is a marker of antiretroviral treatmentARTefficacy and adherence to treatmentwhich is critical for disease managementAboutmillion people with HIV are on ARThoweverexisting HIV VL tests are not suitable for use at the point of carePOCin resource limited settingsThese systems are expensiverequire reliable electricityand skilled operator trainingHencethere is an urgent demand for HIV VL testing at POC to decentralize ART monitoringThe goal of this SBIR Phase I project is to demonstrate feasibility of rapid HIVVL quantification from a finger stickusing methods suitable for POCThis project combines Redbud Labsandapos s microfluidic solutions enabling fastersmaller molecular testing with the HIV detection expertise of the Diagnostics Program at PATHSeattleWAPATH has demonstrated a reverse transcriptase Recombinase Polymerase AmplificationRT RPAassay to rapidly amplify HIVRNA and DNAThis assay is dependent on efficient mixing for maximum sensitivity and accuracyWe will combine PATHandapos s work on HIVdetection with our microfluidic mixerMXRand novel blood tool for blood fractionationWe will demonstrate each step of the protocol from sample processingi eblood stabilizationfractionationand nucleic acid extractionto detection on cartridgeThe successful completion of this project will position us to develop a sample to answer system in Phase IIThe public health impact of this work is significant in the effort to meet the UNAIDS goal ofviral suppression byNARRATIVE UNAIDS has recently set a goal to end the AIDS epidemic byand as a resultantiretroviral therapy programs are expected to be scaled upincreasing the demand for viral load tests particularly in resourcelimited settingsOur Phase I work will demonstrate the feasibility of on cartridge end to end sample processing and rapid HIV viral load detection for use at the point of care