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ROCHE DIAGNOSTICS INTRODUCES 18-MINUTE HEPATITIS B SURFACE ANTIGEN
TEST ON ELECSYS® PLATFORM
Indianapolis, Indiana (October 26, 2001) -Today, Roche Diagnostics
announced the availability of the Elecsys Hepatitis B Surface Antigen
(HBsAg) assay, controls and confirmatory test on the Elecsys®
2010 immunoassay analyzer.
For the first time, HBsAg testing can be performed on a fully automated
instrument with an unprecedented 18-minute assay time. This means
laboratories can run HBsAg tests along with other immunoassays,
such as cardiac markers, fertility, anemia, thyroids and tumor markers,
using the same instrumentation and with the same walk-away convenience.
With this faster assay, results are available to physicians sooner
for timely clinical decision making.
The Elecsys HBsAg assay is indicated for use in the diagnosis of
acute or chronic hepatitis B infection and in the screening of pregnant
women to identify neonates who are at high risk for acquiring hepatitis
B during the prenatal period. HBsAg is an indicator of acute and
chronic hepatitis B infection. An estimated 140,000 new cases of
hepatitis B infection are reported each year in the United States
alone.
Excellent clinical sensitivity and specificity of the Elecsys HBsAg
assay, as well as correlation with the reference method, was demonstrated
on a broad range of patient populations in a multicenter prospective
study. Superior analytical sensitivity was demonstrated using reference
standards established by WHO and PEI. The Elecsys HBsAg assay also
offers the advantage of a small sample size-only 50 microliters.
This assay brings the total number of available assays for the
Elecsys 2010 to 37.
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-oriented healthcare groups in the fields of pharmaceuticals,
diagnostics and vitamins. Roche's products and services address
prevention, diagnosis and treatment of diseases, thus enhancing
well-being and quality of life. Roche's Diagnostics Division supplies
a wide array of innovative testing products and services to researchers,
physicians, patients, hospitals and laboratories worldwide. Roche's
website is located at www.roche.com.
ELECSYS is a trademark of a member of the Roche Group.
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