According to the American Diabetes Association, the total annual economic cost of diabetes in 2002 was estimated to be $132 billion, or one out of every 10 health care dollars spent in the United States. A chronic disease with no cure, diabetes is a group of diseases (including Type 1, Type 2, and gestational) marked by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. Nearly 20 million Americans have diabetes and nearly one-third of them don't even know it.
To combat this problem, the U.S. Department of Health and Human Services launched the Diabetes Detection Initiative to find this undiagnosed population through increased testing. Early diagnosis means that early steps can be taken to manage the disease and to prevent or delay complications.
The American Diabetes Association (ADA) recommends the hemoglobin A1C test, or HbA1c, as the best way to determine a patient's blood glucose control over the past 2-3 months. Specifically, the test measures the concentration of glycosylated hemoglobin. A1C levels are measured upon diagnosis, and, depending on a patient's type of diabetes, how well it is controlled, and his or her health-care provider, levels may be measured two to four times per year. Determining blood glucose control through this laboratory testing gives health-care providers the data they need to monitor the disease and to recommend appropriate treatment. Results from a major diabetes study, the Diabetes Control and Complications Trial (DCCT), confirm this test's importance. The study showed that lowering the HbA1c number can potentially reduce the development of complications and that lowering HbA1c levels by any amount improves a person's chances of staying healthy.
All HbA1c tests are not the same, but there is an ongoing international effort to standardize them by organizations like the National Glycoh emoglobin Standardization Program (NGSP) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). In fact, nearly all laboratories in the United States use NGSP-certified methods. This helps to ensure that a test performed by a laboratory professional in Texas would show the same result as one performed in Pennsylvania. Other recent developments include using the name "A1C" as the test's official name and adopting a reference method suggested by IFCC as the international standard. Such a method requires additional education for both health-care providers and patients because the numbers reported as test results will differ from those currently in use. Eventually, standardization will improve the testing's consistency, but, for now, current methods and result reporting will still be used.
The HbA1c test is usually done in a health-care provider's office, where a small blood sample is drawn. A laboratory tests the sample and then gives the results to the patient's health-care provider. A study published in Diabetes Care (Cagliero E, Levina EV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care 1999; 22:1785-1789) tried to determine if accurate and reliable HbA1c results could be obtained at the time of an office visit by using bench top analyzers. The authors tested the hypothesis that immediately available results could improve glycemic control by changing either physician or patient behavior or both. They concluded that immediate feedback based on HbA1c results at the time of patient encounters resulted in a significant improvement of glycemic control at the 6-month follow-up and persisted for the 12-month study.
Bio-Rad Laboratories, Hercules, CA, has expanded the testing capacity of its D-10 Hemoglobin Testing System with the addition of the D-10 Rack Loader. The Rack Loader increases the system's capacity from 10 to 50 whole blood samples, allowing users to load more samples at one time (and continuously) during a run. The fully automated system combines diabetes monitoring and -thalassemia testing on one platform, offering 3-minute HbA1c program or 6.5-minute HbA2/F/A1c dual program options.
The G7 manufactured by Tosoh Bioscience, Inc., San Francisco, CA, is a fully automated glycohemoglobin analyzer that also offers HbA1c and -thalassemia testing in one platform. Stable HbA1c results are available in 2.2 minutes and -thalassemia results in less than 8 minutes, with quantification of HbF and HbA2. Both systems offer additional features like touch-screen operation and a compact size to conserve counter space.
The circulation of autoantibodies against antigens like insulin provides early markers of autoimmune disease activity. Measurement of these markers has been shown to be valuable in helping health-care providers diagnose and manage their diabetes patients. KRONUS, Inc., Boise, ID, offers a variety of ELISA and RIA kits for the quantitative determination of autoantibodies in serum, like the recently FDA-approved glutamic acid decarboxylase (GAD) Autoantibody RIA Test Kit. Antibodies to GAD have been shown to be the most sensitive single marker for identifying people at risk of developing diabetes.
Available HbA1c analyzers that produce results within minutes are important tools in the detection and management of diabetes. When results are reported during the patient's visit, health-care providers can offer instant feedback and make necessary treatment adjustments. Immediate results mean immediate intervention, resulting in greater diabetes control for both health-care providers and patients.
Beth Wegerbauer is a medical writer and editor with 12 years of experience covering the clinical laboratory field.
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