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A1CNow+ provides consistent, lab accurate results without the use of expensive capital equipment.
This system is certified and meets all standards required for certification by the National Glycohemoglobin
Standardization Program (NGSP).7 |
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Clinical Accuracy
The A1CNow+ test is annually certified(7) by the National Glycohemoglobin Standardization Program (NGSP) and therefore traceable to the DCCT. Further, each lot is factory calibrated using a set of blood samples that have been quantitated by an NGSP certified laboratory using an NGSP certified method. Since in-field calibration is neither needed nor possible, the user cannot alter the accuracy of the test. Allowing for the normal variation seen with all laboratory methods, a 7 percent A1C using A1CNow+ will thus be, on average, the same as a 7 percent A1C on other instruments that are also calibrated to NGSP standards.
Background
A1C, also known as glycated hemoglobin or glycosylated hemoglobin, indicates a patient's blood sugar control over the last two to three months. A1C is formed when glucose in the blood binds irreversibly to hemoglobin to form a stable glycated hemoglobin complex. Since the normal life span of red blood cells is 90-120 days, the A1C will only be eliminated when the red cells are replaced; A1C values are directly proportional to the concentration of glucose in the blood over the full life span of the red blood cells. A1C values are not subject to the fluctuations that are seen with daily blood glucose monitoring.
The A1C value is an index of mean blood glucose over the past two to three months with the majority of that value weighted in the last thirty days. This bias is due to the body's natural destruction and replacement of red blood cells. Because red cells are constantly being destroyed and replaced, it does not take 120 days to detect a clinically meaningful change in A1C following a significant change in mean blood glucose.(10)
Clinical Utility
The American Diabetes Association (ADA) recommends A1C testing to determine if a patient's blood sugar is under control over time. The test should be performed every three months, during treatment changes, or when blood glucose is elevated. For stable patients on oral agents the recommended frequency is at least twice per year.(3)
The Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) studies showed that the lower the A1C number, the greater the chances to slow or prevent the development of serious eye, kidney and nerve disease. The studies also showed that any improvement in A1C levels can potentially reduce complications.(8,9)
The ADA considers the diabetes to be under control when the A1C result is 7 percent or less. The Links and Resources page of this site contains several resources to assist you in managing your patients.(3)
Relationship of A1C to Average Whole Blood and Plasma Glucose Levels(11)
HbA1c % |
Mean Blood Glucose (mg/dL) |
Average Plasma Glucose (mg/dL) |
Interpretation |
| 4 |
61 |
65 |
Non-Diabetic Range |
| 5 |
92 |
100 |
| 6 |
124 |
135 |
| 7 |
156 |
170 |
Target for Diabetes in Control |
| 8 |
188 |
205 |
Action Suggested according ADA guidelines |
| 9 |
219 |
240 |
| 10 |
251 |
275 |
| 11 |
283 |
310 |
| 12 |
314 |
345 |
If
you would like more information about
using A1CNow+®
in your practice, please
contact us |
PROFESSIONAL-USE
PRODUCT INSERT (pdf)
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