Heptatitis C and Rapid Antibody Testing
Roni Bennet, PharmD, CGP
Giant Eagle Specialty Pharmacy
The author report no financial conflicts with any products discussed in this paper.
Testing these days for various diseases and illnesses
is easier than ever. Many at-home testing kits are
available right at your fingertips when visiting your
local pharmacy. Testing for illnesses such as strep
throat, the flu, or even a urinary tract infection
can be done accurately right inside of your local
pharmacy clinic. Examples of some of the tests
that are available over-the-counter include at home
drug-testing kits for suspecting parents, glucose
testing kits for diabetics, and even urinary tract
infection test strips for women. Innovative products
and technology allow for more accurate and
thorough testing, however, it is still important to have
laboratories follow-up on the results to rule out falsepositive and false-negative results.
Testing that used to only be performed by doctors
and conducted in labs are now being presented
to the public. One such test for example, is the
OraQuick HCV rapid antibody test made by OraSure
Technologies, Inc. for the Hepatitis C Virus. This
test is FDA approved for detecting Hepatitis C virus
antibodies in finger stick and venipuncture whole
blood. Healthcare providers are able to deliver an
accurate diagnosis within 20 minutes. The test
is specific for multiple HCV genotypes, is greater
than 98% accurate, and CLIA-waived according to
OraSure Technologies. CLIA-waived (also known
as Clinical Laboratory Improvement Amendments)
means that the manufacturer or producer applies
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for waiver if the test meets the statutory criteria and
the manufacturer provides scientifically valid data
verifying that the waiver criteria have been met and
the test systems are cleared by the FDA for home
use.
Who is the test for?
This test is for anyone who thinks that they may have
been exposed to the hepatitis C virus regardless of
route of transmission.
Where do you get the test?
The Oraquick Rapid HCV test is appropriate for
testing in locations such as:
• Public Health Settings
• Physician Offices
• Community-Health Clinics
• Laboratories
• Emergency Rooms
Is there a specific testing date for
Hepatitis C awareness?
Yes. May 19th has been designated National
Hepatitis Testing Day in the United States. Check
HERE in April for testing day events. You can also
check here for year round events in your city or one
nearby.