Test Code GLYCO 
Methodology Turbidimetric Immunoassay 
Description Useful for monitoring long term blood glucose control in individuals with diabetes mellitus.

1. For diagnostic purposes, % HbA1c values (DCCT/NGSP) should be used in conjunction with information from other diagnostic procedures and clinical evaluations.

2. The test is designed only for accurate and precise measurement of % HbA1c (DCCT/NGSP). The individual results for total Hb and HbA1c concentration should not be reported.

3. The test is not intended for judging day-to-day glucose control and should not be used to replace daily home testing of urine or blood glucose.

4. As a matter of principle, care must be taken when interpreting any HbA1c result from patients with Hb variants. Abnormal hemoglobins might affect the half life of the red cells or the in vivo glycation rates. In these cases even analytically correct results do not reflect the same level of glycemic control that would be expected in patients with normal hemoglobin.

5. Any cause of shortened erythrocyte survival will reduce exposure of erythrocytes to glucose with a consequent decrease in % HbA1c values (DCCT/NGSP), even though the time-averaged blood glucose level may be elevated. Causes of shortened erythrocyte lifetime might be hemolytic anemia or other hemolytic diseases, homozygous sickle cell trait, pregnancy, recent significant or chronic blood loss, etc. Caution should be used when interpreting the HbA1c results from patients with these conditions.

6. Glycated HbF is not detected by the assay as it does not contain the glycated -chain that characterizes HbA1c. However, HbF is measured in the Total Hb assay and as a consequence, specimens containing high amounts of HbF (> 10 %) may result in lower than expected % HbA1c values (DCCT/NGSP).

NOTE: This test, when ordered on Medicare patients, is subject to the National Coverage Determination (NCD) policy "Glycated Hemoglobin / Glycated Protein". Please verify that the diagnosis code (ICD-9) you have chosen demonstrates medical necessity for the test as documented in the physician's patient record. The CMS web site or the NorDx Limited Coverage Documentation Guide are available to assist you with this verification. A properly executed Advance Beneficiary Notice (ABN) must be submitted with the specimen if medical necessity is not demonstrated by the ICD-9 code chosen. 

Specimen Draw blood in a lavender-top (EDTA) tube, and send 3.0 mL (1.5 mL minimum) of EDTA whole blood refrigerated. 
Reference Values 4.5 - 5.7 % 
Analytic Time 1 Day 
Day(s) Test Set Up Monday through Sunday 
CPT Code(s) 83036