Minimally-instrumented home HIV detection and care linkage system

Minimally-instrumented home HIV detection and care linkage system
Project Summary/Abstract:
According to recent estimates, ~37 million adults and 3.4 million children live with HIV. High sensitivity
diagnostic tests for HIV are needed to reduce the spread and burden of the disease and allow detection during
the seroconversion window to enable “test and treat” and modify behavior. There is also a great need for
inexpensive, home / point of care viral load tests for HIV patients undergoing therapy to individualize treatment,
control the emergence and spread of drug-resistant strains of HIV, and monitor adherence. To address these
needs, an interdisciplinary team of scientists from Penn Engineering, Penn Center for Aids Research
(CFAR), and Centers of Disease Control and Prevention (CDC) is proposing a system consisting of an
inexpensive disposable diagnostic cassette and inexpensive reusable processor. Our cassette will carry
out all unit operations from sample introduction, including plasma separation from whole blood, to multi-
plex enzymatic amplification, facilitating co-detection and quantification of HIV-1 clade B, Hepatitis B
(HBV), Hepatitis C (HCV), and beta Globin (positive control) with detection limit of 10 targets in a sample
(e.g., 350 copies/mL when whole blood sample volume is 100µL) and of HIV-1 Group M (subtype-
independent) in under 40 minutes. The cassette stores all reagents refrigeration-free with a shelf-life
exceeding 12 months. Our cassette mates with a simple battery-powered processor that provides
temperature-control, actuation, and an interface for a smartphone. The smartphone instructs the user in
operating the device; controls device operation, monitors and analyzes enzymatic amplification
processes; reports test results to the patient, to the medical team and public health officials (in
compliance with prevailing laws); and provides counseling. Our system carries out all the necessary unit
operations from sample introduction to test results. At the conclusion of this effort, we will have developed
a remarkable system for home/point-of-care molecular detection of HIV-1 and co-infections with minimal
instrumentation. Our system will be able to detect HIV during seroconversion to encourage individuals to
start therapy early and modify transmission behavior; monitor viral rebound to detect development of drug-
resistance and non-adherence, and enable personalized therapy with novel long-acting agents such as broadly
neutralizing antibody infusions likely to emerge over the next decade; and detect infection in infants born to
HIV–infected mothers (particularly in the developing world). As such, this system has the potential to allow
rapid detection of viremia and rapid intervention to prevent HIV transmission to the uninfected and reduce the
complications of HIV in those infected. More broadly, our system will enable individuals to assume
responsibility for their own care.

Grant Number: 5R33HD101937-05
NIH Institute/Center: NIH
Principal Investigator: Haim Bau