FAQ: About Bayer A1CNow+
What are the advantages of Bayers A1CNow+ test?
How does the A1CNow+ test work?
How can I purchase the A1CNow+?
Q: What are the advantages of Bayers A1CNow+ test?
A: A1CNow+ is the world's first multi-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 five 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.
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 five minutes for the result. Results are comparable with those of laboratory tests.
Q: How can I purchase the A1CNow+?
A: Please contact 1-800-248-2637 for product availability and pricing.
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.
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.(7)
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.