NEW AIDS SCREENING TEST
DETECTS VIRUS EARLIERNow Available to Blood and Plasma Collection Centers
MIAMI, FL., March 14, 1996 - Coulter Corporation announces that they have received a license from the FDA to manufacture and market their new blood screening product, the COULTER™ HIV-1 p24 Antigen Assay, which is intended to detect the presence of the p24 antigen of the HIV-1 virus which causes AIDS.
The product, developed and produced by Miami-based Coulter Corporation, is intended for use by blood and plasma collection centers nationwide to screen blood samples for the presence of the HIV-1 virus. Ortho Diagnostic Systems Inc., a Johnson & Johnson Company, will market the product to blood and plasma collection centers on an exclusive basis under the name HIV-1 p24 Antigen ELISA Test System. Ortho is the worldwide market leader in blood viral screening tests which utilize the microplate format.
Currently available tests detect the presence of HIV antibodies approximately 22 days after a person becomes infectious for the HIV-1 virus. A published study1 showed that testing for the p24 antigen could allow detection of samples infected with the HIV virus within about 16 days, approximately six days earlier than currently available tests.
Today, blood and blood components are used in a variety of ways to treat and prevent illnesses. Since a single unit of blood can be separated into various components, a single infected unit could feasibly impact multiple recipients. By detecting infected units that otherwise might have gone undetected, the Coulter p24 antigen test marks another significant step towards ensuring the safety of our nation’s blood supply.
In an August 8, 1995 memo, the FDA’s Director of the Center for Biologics Evaluation and Research recommended to all registered blood and plasma establishments that they begin HIV-1 antigen testing of all prospective donor units of blood, as well as all blood in current inventory, within 90 days of product licensure. “Now that a product is available, we expect that blood and plasma centers will begin testing for p24 Antigen as soon as feasible to further protect and improve our nation’s blood supply”, says Jose Campo, Coulter’s Director of Quality Management and Regulatory Affairs.
_____________________________________ 1Busch MP, LLL Lee, GA Satten, et al. Time Course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion: implications for screening of blood and tissues donors. Transfusion 35(2): 91-7, 1995.
© Coulter International Corporation, 1996. All rights reserved. Copyrights and Trademarks
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