Below
is an excerpt from an Abbott press release describing the new test:Abbott
Receives FDA Approval for First Fully
Automated Blood Screening Test for HIV-1/HIV-2
New Test Completes
the Abbott Prism Hepatitis and Retrovirus Panel
Abbott
Park, IL -- September 21, 2009 -- Abbott (NYSE: ABT) announced today it received
approval from the U.S. Food and Drug Administration (FDA) for its Abbott Prism
HIV O Plus test, the first fully automated blood screening test for HIV-1/HIV-2.
This test can be used by laboratory professionals to screen individual donors
of blood and plasma for antibodies to human immunodeficiency virus type 1 Groups
M and O (anti-HIV-1) and type 2 (anti-HIV-2), and as an aid in the diagnosis of
HIV-1/HIV-2 infection.
The
assay, which provides laboratories a fully automated test compared to the current
method, runs on the Abbott Prism system, which can run 160 samples per hour, making
it possible to test more than 1,200 samples in an eight-hour shift. Speed and
efficiency are important to labs given the volume of blood that is screened each
year. According to the American Association of Blood Banks (AABB), eight million
volunteers donate about 15 million units of whole blood each year in the United
States alone. Each donated unit of blood must be tested for infectious diseases
including hepatitis, HIV and other retroviruses. Abbott's hepatitis and retrovirus
tests are used thousands of times every day around the globe for blood screening
and diagnostic testing.
With
this approval, Abbott now has a complete panel of hepatitis and retrovirus tests
on the Abbott Prism system which includes the following assays: a hepatitis B
core test (Abbott Prism HBcore); a hepatitis B surface antigen test (Abbott Prism
HBsAg along with Abbott Prism HBsAg Confirmatory); a hepatitis C test (Abbott
Prism HCV); and a human T- lymphotropic virus test (Abbott Prism HTLV-I/HTLV-II).
Used in more than 30 countries, the Abbott Prism is used to screen the majority
of the blood supply in the United States and around the world.
"Abbott
has a strong heritage in HIV assay development, beginning in 1985 with the first
blood-screening test for HIV approved in the United States," said Mike Warmuth,
senior vice president, diagnostics, Abbott. "The approval of Abbott Prism
HIV O Plus marks an important milestone as we continue our leadership in HIV and
our work to ensure the safety of the world's blood supply."
Important
Product Usage and Safety Information
The
Abbott Prism HIV O Plus test (Human Immunodeficiency Virus Types 1 and 2 (E. coli,
B. megaterium, Recombinant) Antigen and Synthetic Peptide) can be used by laboratory
professionals to screen individual donations of blood for antibodies to HIV-1
(anti-HIV-1) Groups M and O and /or antibodies to HIV-2 (anti-HIV-2). Abbott Prism
HIV O Plus can also be used as an aid in the diagnosis of HIV-1/HIV-2 infection.
This assay has not been validated for use with pooled specimens and is not intended
for use on cord blood specimens. This product contains human sourced and/or potentially
infectious components. Assay specific information is presented in the assay package
insert which can be accessed at www.abbottdiagnostics.com once the product is
available.
About
Abbott's Diagnostics Businesses
Abbott
is a global leader in in vitro diagnostics and offers a broad range of innovative
instrument systems and tests for hospitals, reference labs, molecular labs, blood
banks, physician offices and clinics. With more than 69,000 customers in more
than 100 countries, Abbott's diagnostic products offer customers automation, convenience,
bedside testing, cost effectiveness and flexibility. Abbott has helped transform
the practice of medical diagnosis from an art to a science through the company's
commitment to improving patient care and lowering costs. The history of Abbott
is filled with examples of first-of-a-kind diagnostic products and significant
technological and research advancements.
About
Abbott
Abbott
is a global, broad-based health care company devoted to the discovery, development,
manufacture and marketing of pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs more than 72,000 people and markets
its products in more than 130 countries.
Abbott's
news releases and other information are available on the company's Web site at
www.abbott.com.
9/25/09
Reference
Abbott.
Abbott Receives FDA Approval for First Fully Automated Blood Screening Test for
HIV-1/HIV-2. Press release. September 21, 20009.