The FDA-approved OraSure® Oral Specimen Collection Device is a generic device developed for the purpose of collecting, preserving, and transporting oral fluid specimens. It uses a simple, two-minute collection procedure that can be performed by any trained personnel. OraQuick Rapid Antibody Test has been approved for the detection of antibodies to HIV-1 in oral fluid gathered by this device as well as the detection of antibodies to both HIV-1 and HIV-2 in plasma samples. The FDA has required OraSure Technologies to perform certain post marketing studies.

There are an estimated 65 million HIV tests performed in the United States annually. The cost of testing with OraQuick is estimated at somewhere between 8 and 20 dollars per test. Positive tests must be confirmed by follow-up tests as per existing screening tests.

Point of care diagnostic testing for HIV, and the option for the use of oral fluid versus blood as the specimen of choice, make for a potent combination when it comes to the predicted rate of diffusion of OraQuick Rapid Antibody Test. The potential for this test to transform HIV screening in the United States certainly exists. At the present time, Biohorizon has designated OraQuick as a Moderate Impact Technology as it does not significantly increase the cost of treatment/diagnosis per patient, a requirement for the High Impact Technology designation. However, Biohorizon does recommend that clients with significant HIV screening exposure commence assessment activities.

Technology Details
Target Disease / Indication
HIV

Technology Classification
Diagnostic Test

Body System
Multiple Systems

Program Area
Medicine/Infectious Disease

Regulatory Status
Approved

BioHorizon Impact Score
56/100 – Moderate