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Q: What are the advantages of
the A1cNow test?
A: A1cNow is the world's first single-use,
disposable, self-contained quantitative test for A1C. A1cNow provides comparable results
to laboratory testing for use in the doctor's office or for patient use at home.
Providing real-time results outside of the laboratory, the A1cNow Monitor
enables in-office
monitoring without expensive laboratory instruments or training.
Physicians can perform multiple tests in their offices simultaneously in 8
minutes, versus waiting several days for lab results. As a result,
A1cNow's accessibility and convenience enable efficient, cost-effective
testing and may result in greater patient compliance.
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Q: How does the A1cNow test
work?
A: The single-use test
provides quantitative results from a single drop of blood. Simply prick
the finger, apply pressure to the finger to obtain a large drop of blood,
touch the tip of a capillary pipette to the drop of blood, mix the blood
with the liquid supplied, shake the mixture, add the sample to the A1cNow
Monitor and wait 8 minutes for the result. Results are comparable with
those of laboratory tests.
Q: How can I purchase the
A1cNow?
A: Please contact STAT
or order online.
Q: What is NGSP?
A: The
National Glycohemoglobin Standardization Program (NGSP), located at the
University of Missouri, Columbia, has standardized glycohemoglobin (GHB)
test results so that clinical laboratory results are comparable to those
reported in the Diabetes Control and Complications Trial (DCCT). The NGSP
acts as a reference laboratory for manufacturers of GHB methods to assist
in standardizing methods and provide comparison data for certification of
traceability to the DCCT. A1cNow is calibrated using NGSP certified
methods.
Q: What is CLIA?
A: Clinical
Laboratory Improvements Amendment (CLIA) is an act of Congress through
which the Health Care Financing Administration (HCFA) regulates all
laboratory testing (except research) performed on humans in the United
States.
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Q: What does CLIA waived
mean?
A: A CLIA waived test has been reviewed by the FDA and HCFA
to determine that errors in operation will be minimized and that
inaccurate test results will not endanger the life of the patient. A CLIA
waiver is specific to the manufacturer and the product. Each test method
is individually examined before a CLIA waiver is granted. A1cNow is CLIA
waived and cleared for patient home use.
Depending on the type of
testing that is done in the laboratory, different types of certification
may be required. In most states, if a clinical practice only does CLIA
waived testing, a certificate of waiver is required. If the physician adds
other tests that are not CLIA waived, a different type of certificate may
be required. For information, contact your local State Survey Agency or
the HCFA Regional Office. |
