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, and Syphilis TP 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, and Syphilis 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, or Syphilis 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, and Syphilis TP 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 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. |
