Minimally-instrumented home HIV detection and care linkage system

Project Summary
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 the Center for 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 a detection limit of 10 targets in a sample (e.g., 350
copies/mL when whole blood sample volume is 100L) 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
the 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: 3R33HD101937-05S1
NIH Institute/Center: NIH
Principal Investigator: Haim Bau