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Rapid
testing for infectious diseases has advanced to a new
level in the form of Abbott Laboratories' Determine
assays. The Abbott Determine assays for HIV-1/2,
HBsAg, Syphilis TP and Malaria employ state-of-the-art
materials and reagents to deliver performance that matches,
and in some cases even exceeds, that obtainable by more
complex methodologies. This achievement meets a growing
need in remote or less developed areas for rugged, reliable,
and high quality tests for HIV, Hepatitis, Syphilis
and Malaria infections. Now, any field hospital, remote
village medical unit, and areas without electricity
can have the best in infectious disease testing in the
form of simple, self-contained Determine assays
that work with serum, plasma, and even whole blood specimens.
The capability to test for HIV, Hepatitis, Syphilis
or Malaria infections with a simple device delivering
high quality results with finger stick blood samples
places the Determine assays in a new class of
rapid testing, a class that is superior to other rapid
test technologies.
Intended
Use:
The Determine HIV-1/2 assay is an in-vitro, visually
read, qualitative immunoassay specific for both anti-HIV-1
and anti-HIV-2 antibodies in human serum, plasma, and
whole blood. This test is intended as an aid in the
detection of antibodies to HIV-1 or HIV-2 from infected
individuals.
The
Determine HBsAg assay is intended to detect hepatitis
B surface antigen in serum, plasma, and whole blood
from infected individuals. This assay is also an in-vitro,
visually read, qualitative immunoassay.
The
Determine Syphilis TP assay is an in-vitro, visually
read, qualitative immunoassay for the detection of antibodies
to Treponema pallidum, which is the bacteria that causes
syphilis infections. This test is an aid in the detection
of antibodies to Treponema pallidum in serum, plasma,
and whole blood from infected individuals.
The
Abbott Determine tests for HIV-1/2, HBsAg, Syphilis
TP and malaria represent a new class of high quality,
rapid tests for infectious disease testing. Innovative
design, materials, and reagent components give the Abbott
Determine assays capabilities and performance
that exceed those available in other rapid tests. In
a simple, and easy to use format, the Abbott Determine
HIV-1/2, HBsAg, and Syphilis TP and malaria tests bring
the latest in infectious disease testing to any location.
The Determine HIV-1/2 assay has very high specificity
and high anti-HIV-1, anti-HIV-2, and anti-subgroup O
antibody sensitivity. The Determine HBsAg assay
has very high specificity and sensitivity for HBsAg
that exceeds the next best rapid HBsAg test. Likewise,
the Determine Syphilis TP assay has high sensitivity
and specificity that rivals the best tests available.
In addition, the capability to test whole blood samples
obtained from a simple finger stick allows high quality
testing for HIV-1/2, HBsAg, and Syphilis TP in locations
that do not have the equipment necessary for testing
serum or plasma samples.
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