Point-Of-Care Nucleic Acid Diagnostic For Early Infant Diagnosis Of HIV
Immediate antiretroviral therapy (ART) for HIV-infected infants has been shown to reduce mortality by 76% and progression to more serious disease by 75%. Accessing this life-saving treatment is contingent upon diagnosis of infection, which can be difficult in low-resource settings. Early infant diagnosis (EID) of HIV requires detection of viral RNA through nucleic acid amplification tests (NAATs), which are limited to well-funded, centralized facilities. As a result, samples must be collected at local clinics and sent to the few regional labs that can perform the test – a system complicated by poor infrastructure, which often delays results for over a month, if they are returned at all. To reduce mortality and morbidity of HIV-positive infants, diagnosis much be rapidly done at distributed health clinics. Diagnostics For All is developing a NAAT platform that can perform sample preparation, amplification, and detection in a disposable, self-contained, cartridge without any additional instrumentation. We propose adapting this platform to deliver a qualitative HIV EID test that can truly be used at the point-of-care, reducing the turnaround time from over a month to under an hour. Since it can be performed before the mother and child leave the clinic, the proposed technology can result in immediate initiation of ART and eliminate loss to follow-up. Through this 2-year seed grant, we will produce a completely equipment-free, fully-integrated device that can receive and process a whole blood sample, perform isothermal amplification, and provide visual result readout with a clinically appropriate sensitivity for HIV EID.