Rapid Qualitative In Vitro Test for HIV-1 Evaluated

A rapid, in-vitro, qualitative test detects antibodies to human immunodeficiency virus type 1 (HIV-1) in human whole blood, serum, or plasma. The test is capable of providing results in 60-seconds and is intended for use as a screening assay by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices.

Rapid HIV antibody tests seek to improve access to HIV testing but most must be administered in a clinical setting. Currently available rapid tests also have longer response times that can be a deterrent for many who should be tested. The new test, called INSTI, was developed to make it suitable for use in mobile and in-field scenarios allowing all communities access and social barriers to be removed.

INSTI is approved for HIV type 2 detection in a number of countries, including Europe, and is pending similar approval in Canada. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, physicians' offices, and any other primary care facility as a screening assay capable of providing test results in less than 60 seconds.

Initial patient enrollment in a study for approval by the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) of INSTI, the rapid HIV-1 test for point-of-care (POC) testing began July 31, 2007. As of October 15, 2007, 755 patients were enrolled, representing over 30% of the total enrollment. To date, 11 clinical testing sites are involved in the study and are actively enrolling patients.

"The rapid pace of enrollment clearly reflects strong interest by investigators and patients,” commented Rick Galli, chief technical officer at bioLytical (Richmond, Canada), the company that developed the new test, which is named INSTI. Timely site activation has also accelerated our ability to register new patients. We look forward to completing the study and substantiating for the FDA the safety and efficacy of INSTI.

The U.S. Center for Disease Control and Prevention (CDC; Atlanta, GA, USA) estimates that approximately 40,000 persons in the United States become infected with HIV each year. Of those, 25% are unaware of their infection and could be spreading the disease unknowingly. Each year up to 22 million persons in the United States are tested for HIV. With current revisions to both CDC and World Health Organization (WHO; Geneva, Switzerland) guidelines on HIV testing advocating routine HIV screening as part of regular medical practice, the market for rapid HIV tests in the United States will continue to escalate.


Related Links:
U.S. Food and Drug Administration
biolytical
U.S. Center for Disease Control and Prevention