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Fitzgerald Health Education Associates, Inc., January 2015 fhea.com
harm to the fetus and eventually the mother, the
agency states.
Click here for consumer updates.
Rapid Syphilis Screening Test Now Can
Be Used in More Health Care Settings
The FDA granted a waiver to the Syphilis Health
Check, a rapid screening test for syphilis, now al-
lowing its use in a greater variety of health care
settings. The agency's waiver allows the test to be
distributed to a variety of nontraditional laborato-
ry sites, including clinicians' offices, emergency
departments, maternity wards, health department
clinics, outreach sites, community-based organiza-
tions, and other freestanding counseling and test-
ing sites. This should help contribute to a higher
rate of detection of syphilis infection.
The Syphilis Health Check is performed by ob-
taining a sample of whole blood
from a finger stick. Results are
available as quickly as 12 minutes
later, and may be performed in the
patient's presence. All positive tests
should be followed up with further
syphilis serological laboratory test-
ing and clinical evaluation before final diagnosis.
The rapidity of this test's results allows clinicians
to obtain a second blood sample from a patient
whose test was positive the first time in order to
confirm the test results. This will help increase the
probability that patients, who might not return for
a follow-up test, will receive timely treatment.
The Syphilis Health Check test is manufactured
by VEDA Lab of Alencon, France, for Diagnostics
Direct, LLC, based in Cape May Court House, NJ. It
is also distributed by Trinity Biotech USA, Inc, of
Jamestown, NY.
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