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GAITHERSBURG, Md. -- Tetracore, Inc. announced
today that it has received 510(K) clearance from the Food
and Drug Administration (FDA) for RedLine Alert, an antibody-based test
kit for use as an aid in the clinical laboratory identification of Bacillus
anthracis colonies from culture plates.
B. anthracis is the causative agent
of anthrax. The test is a lateral flow immunoassay containing a monoclonal
antibody which is specific for the presence of a cell surface protein found in
Bacillus anthracis vegetative cells. The test can be used on colonies as
early as 12 hours old. Attended time takes as little as 10 minutes and the
test can be fully completed within 20 minutes. In data submitted to the FDA on
145 Bacillus anthracis isolates, the RedLine Alert percentage correct was 98.6 percent; these isolates originated from 28 countries world-wide. This compared favorably to
another well recognized confirmatory test called gamma phage lysis, which can
require an additional day of culture to perform, whose percentage correct was 97.2 percent.
In addition, the RedLine Alert Test had an accuracy of 100 percent in correctly
differentiating B. anthracis from 49 other non-hemolytic Bacillus.
Dr. Beverly L. Mangold of Tetracore commented, "We are excited to be able to
provide a significant new clinical and public health tool to aid in protecting
against bio-terrorism threats."
Tetracore is a biotechnology R&D and product company whose mission is to
create and develop highly innovative diagnostic reagents and assays for
infectious diseases and bio-terrorism threat agents. Areas of company focus
include clinical, veterinary, and domestic preparedness testing.
Source: Tetracore, Inc.