New
Option for HIV Testing Now Available Assay Can Help
Provide Important Health Information to Patients Raritan,
NJ, May 29, 2008 -- Ortho Clinical Diagnostics announced the availability of a
new diagnostic assay for the detection of antibodies to Human Immunodeficiency
Virus types 1 and/or 2 (anti-HIV-1 and anti-HIV-2). The VITROS Anti-HIV 1+2 assay
recently received U.S. Food and Drug Administration approval and is now being
shipped to clinical laboratories in the U.S., Puerto Rico, and U.S. territories.
The
VITROS Anti-HIV 1+2 assay offers laboratories and physicians a new option for
conducting HIV testing. With results readily available in less than 50 minutes,
it is the first fully automated anti-HIV 1+2 test that can provide immediate results
upon test completion. The anti-HIV 1+2 assay can be run on the VITROS ECi/ECiQ
Immunodiagnostic System at any time, along with other types of tests and in any
order -- features that can increase productivity and efficiency in the laboratory.
The
U.S. Centers for Disease Control and Prevention (CDC) now recommends routine,
voluntary HIV testing in all health care settings, including health clinics and
emergency rooms, for all individuals ages 13 to 64 without written informed consent.
In addition, testing is recommended at least once a year for those at high risk
and during pregnancy to assess the risk of transmission to the newborn.
"The
VITROS Anti-HIV 1+2 assay is a new diagnostic tool that can help health clinics,
emergency rooms and other screening facilities meet the demand of these new CDC
testing recommendations by delivering fast, quality-controlled HIV test results,"
said Michael Waller, MD, vice president of clinical and medical affairs for Ortho
Clinical Diagnostics. Two multicenter research teams supported in part
by the National Institute on Drug Abuse, National Institutes of Health, have independently
determined through the development of computer models that routine screening for
HIV in health care settings is as cost-effective as screening for other conditions
such as breast cancer and high blood pressure, and can provide important health
and survival benefits. The studies also suggest that screening that leads to a
diagnosis of HIV infection may further lower health care costs by preventing high-risk
practices and decreasing virus transmission. The VITROS Anti-HIV 1+2 assay,
along with offerings from its affiliate companies, Tibotec and Virco, helps to
expand the portfolio of diagnostics and therapeutics to address the needs of the
growing HIV epidemic. The VITROS Anti-HIV 1+2 Assay was co-developed with
Chiron, a business of Novartis Vaccines and Diagnostics Inc.
About
the VITROS ECi/ECiQ Immunodiagnostic System
The VITROS ECi/ECiQ
Immunodiagnostic System is a simple to use, flexible and fully automated laboratory
testing system that provides true continuous, STAT, random access capabilities
for routine and specialty immunodiagnostic testing. The system uses proprietary
enhanced chemiluminescence detection technology to provide excellent assay performance
including wide dynamic ranges and exceptional precision and sensitivity. The VITROS
ECi/ECiQ Immunodiagnostic System also uses Intellicheck Technology, a proprietary
technology designed to verify diagnostic checks throughout automated sample and
assay processing.
The expanding VITROS ECi/ECiQ Immunodiagnostic System
test menu now includes more than 45 tests worldwide for the sensitive measurement
of thyroid function, reproductive health and fertility, bone metabolism, anemia,
metabolic, oncology, emergency cardiology, and infectious diseases.
About
Ortho Clinical Diagnostics
Ortho Clinical Diagnostics,
Inc., a Johnson & Johnson company, delivers high quality in vitro diagnostic
products that give health care professionals around the world the knowledge they
need to make better treatment decisions. The company serves the transfusion medicine
community with donor screening and blood typing products to ensure the safety
of the world's blood supply. Ortho Clinical Diagnostics also brings sophisticated
testing technologies, automation and interpretation tools to clinical laboratories
to help them run more efficiently and improve patient care.
For more information,
visit www.orthoclinical.com.
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