6,7 They are manufactured to predefined concentrations and have recovery targets optimized to the claimed reportable range for various instrument vendors (e.g. Calibration Verification and Linearity experiments are standard procedures of practice in order to fulfill CLIA ‘88, CAP, ISO 15189, COLA, JCAHO, and JCI testing requirements and occurs on a frequency of at least once every 6 months and ideally using materials which are commercially available. 3Įstablishing, validating, and verifying the linear reportable range claims of these methods is another critical component to reporting accurate patient results. Table 2-HbA1c Assay Interference with Hb Variants. Tosoh and BioRad systems) is that the variants that can affect results will be detected in the chromatogram analysis and samples can be retested if necessary. 2,3 The American Diabetes Association sets a normal patient at ☗ percent at 6 percent and/or > ☗ percent at 9 percent HbA1c.3 The table shows that HbC and HbD do not interfere with the majority of the methods, with the exception of the Beckman AU and Tosoh G8 and G7. The NGSP, originally called the National Glycohemoglobin Standardization Program, supports the American Diabetes Association’s recommendations that patients who are meeting glycemic goals be tested for HbA1c twice a year, while patients not meeting glycemic goals or patients with changes to therapies be tested every three months. It is typically performed in a laboratory setting and the test indicates the patient’s average levels of blood glucose over the past 8 to 12 weeks. To address these limitations and provide a broader indication of long-term glycemic control, HbA1c testing is used. However, solely measuring and monitoring blood glucose levels has some limitations as the test only measures glucose levels at the time of testing and it relies on the patient to consistently test their levels at home, using a point-of-care device. Mayo Clinic Laboratories emphasizes the value of controlling glucose levels to prevent long-term complications such as retinopathy, neuropathy, and cardiovascular disease. 2 Current patient management includes diet, exercise, medication, daily monitoring of blood glucose, and HbA1c monitoring. The diagnosis of diabetes mellitus uses a combination of measurements: fasting serum glucose levels, presentation of symptoms, two-hour plasma glucose levels during a glucose tolerance test, and hemoglobin A1c (HbA1c) levels. 1 With more than 400 million people living with and managing diabetes worldwide, the ability to accurately diagnose and track patient management is a growing need. The Diabetes Research Institute Foundation has estimated a 50 percent increase in the number of people living with diabetes mellitus in the United States over the past decade.
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