Printer Friendly
The Free Library
19,573,952 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

CDC Reports That OraQuick Test Produces Fewer False Positive HIV-1 Results Than Other Available Tests.


Business Editors/Health/Medical Writers

BETHLEHEM, Pa.--(BUSINESS WIRE)--March 4, 2004

OraSure Technologies, Inc. (Nasdaq NM:OSUR OSUR Ohio State University Reactor (Columbus, OH) ), the market leader in oral fluid diagnostics, announced today that its OraQuick(R) Rapid HIV-1 Antibody Test was reported to produce substantially fewer false-positive results than traditional lab-based HIV tests or other U.S. Food and Drug Administration ("FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
") approved rapid HIV tests when used in a laboratory setting. This information is based on the results from clinical trials submitted to the FDA and published by the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  ("CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
") in its Rapid HIV-1 Antibody Testing during Labor and Delivery for Women of Unknown HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  Status: A Practical Guide and Model Protocol, released on January 30, 2004.

The protocol was developed in order to offer guidance to clinics, laboratories, hospital administrators, and policymakers who are planning and implementing a rapid HIV testing program during labor and delivery for women of unknown HIV status. The document can be viewed on the CDC web site (http://www.cdc.gov/hiv/rapid_testing/rt-labor&delivery.htm). The CDC recommends that rapid HIV testing be routinely offered to women whose HIV status is unknown during labor and delivery to provide the opportunity to reduce mother-to-child transmission mother-to-child transmission Vertical transmission, see there  of the virus even among women who do not seek care until labor begins.

"The data highlighted in the protocol indicate that the use of the OraQuick(R) device during labor and delivery will provide rapid and accurate HIV results while minimizing the number of false-positive results compared to other available rapid HIV tests," said Mike Gausling, President and Chief Executive Officer of OraSure Technologies. "We are extremely pleased with our role in the CDC HIV testing labor and delivery protocol, and we look forward to working in conjunction with government partners to make rapid HIV testing available to all who need it."

OraQuick(R) is the first rapid, point-of-care test approved by the FDA to detect antibodies to HIV-1 in fingerstick and venipuncture venipuncture /veni·punc·ture/ (ven?i-pungk´chur) surgical puncture of a vein.

ve·ni·punc·ture or ve·ne·punc·ture
n.
 whole blood specimens in approximately 20 minutes. OraSure received FDA approval of the OraQuick(R) test for fingerstick whole blood on November 7, 2002, and for venipuncture whole blood on September 5, 2003. On January 31, 2003, OraSure received a CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a  (Clinical Laboratory Improvements Amendments of 1988) waiver for the test, permitting its use by more than 180,000 sites in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , including outreach clinics, community-based organizations and physicians' offices.

About OraSure Technologies

OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.

OraSure Technologies is the leading supplier of oral-fluid collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV-1. In addition, the Company supplies oral-fluid testing solutions for drugs of abuse testing. For more information on the Company, please go to www.orasure.com.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Mar 4, 2004
Words:521
Previous Article:Cubic Wins Contract to Help Launch New Fleet Anti-Submarine Warfare Command.
Next Article:Endurance Shareholders Price Secondary Offering Of Ordinary Shares.
Topics:



Related Articles
Mail-order AIDS tests: FDA confronts the implications.
HIV testing 101 (Part 1 of 2).
HIV Testing 101 (Part 2 of 2).
Testing times: the importance of identifying HIV infections before it's too late.
False home testing.
Over-the-counter HIV test has drawbacks.
Quick result, but often false.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles