HbA1C w/ eAG
Test Code: 4543CPT: 83036
|Tests Included||Hemoglobin A1c|
|Use||Determination of hemoglobin A1c provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus.
The process of conversion from hemoglobin A to hemoglobin A1c depends on the blood glucose concentration. Since the average life of a red blood cell is 120 days, measurement of hemoglobin A1c can reflect the mean daily blood glucose concentration over the preceding two months and provides a much better indication of glycemic control than blood or urinary glucose determinations.1,2,3,4
|Clinical Utility||Elevated levels of %HbA1c suggest the need for more aggressive treatment of glycemia. The American Diabetes Association recommends that a primary goal of therapy should be a %HbA1c < 7%, and that physicians should re-evaluate the treatment regimen in patients with %HbA1c values consistently > 8%.5|
|Intended Patient Population||18+ and Older Adult Males & Females|
|Volume||4mL Whole Blood|
|Min Sample Volume||5.0 mLs|
|Reference Ranges||M & F ≥ 18 yrs old; 3.9-5.7 %|
|Analytical Measurement Range||N/A|
|Critical Values||> 15%|
|Test Methodology||High Performance Liquid Chromatography|
|Test Turnaround Time||2 Days|
|Limitations||Should not be used for screening cystic fibrosis-related diabetes, gestational diabetes, diabetes in children, and those with chronic kidney or liver disease.|
|Specimen Stability||4 Days RF|
|Reject Criteria||Frozen Specimens|
|Laboratory Developed Test (LDT)||Yes|
|CMS Guidance||NCD 190.21|
|References||1. M. A. Sperling, ed., Physician‘s Guide to Insulin-Dependent (Type 1) Diabetes: Diagnosis and Treatment, (Alexandria, VA: American Diabetes Association, Inc., 1988). (ISBN 0-945448-01-5)
2. E. Heinze, et al., "Hemoglobin A1c (HbA1c) in Children with Long Standing and Newly Diagnosed Diabetes Mellitus," Acta Paediatr Scand., No. 68 (1979): 609-612 .
3. H. B. Mortensen, "Glycated Hemoglobin," Dan Med Bull. Vol. 32, No. 6 (1985): 309-328.
4. Lehmann, P., "Homogenous Immunoturbimetric Assay for Hemoglobin A1c Adaptable for Most Clinical Chemistry Analyzers: A New Concept in the Care of Diabetic Patients", AACC 45th National Meeting (1993).
5. American Diabetes Association, "Standards of Medical Care for Patients with Diabetes Mellitus", (Position statement), Diabetes Care, 21 (Suppl.1): S23 S31 (1998).