Point-of-Care Nucleic Acid Diagnostic for Early Infant Diagnosis of HIV

Diagnostics For All is developing a nucleic acid amplification tests (NAATs) 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 early infant diagnosis (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 antiretroviral therapy (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.