Test Catalog

Test Id : HBA1C

Hemoglobin A1c, Blood

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating the long-term control of blood glucose concentrations in patients with diabetes

 

Diagnosing diabetes

 

Identifying patients at increased risk for diabetes (prediabetes)

 

This assay is not useful in determining day-to-day glucose control and should not be used to replace daily home testing of blood glucose.

Method Name
A short description of the method used to perform the test

Ion-Exchange High-Performance Liquid Chromatography (HPLC)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Hemoglobin A1c, B

Aliases
Lists additional common names for a test, as an aid in searching

A1a Hemoglobin

A1b Hemoglobin

A1c Hemoglobin

Glycated Hemoglobin

Glyco HGB (Glycosylated Hemoglobin)

Glyco-Hb

HA1C, B

HBA1c, B

Hemoglobin A1(a)

Hemoglobin A1(b)

Hemoglobin A1C, B

HgbA1c

Glycosylated Hemoglobin

Specimen Type
Describes the specimen type validated for testing

Whole Blood EDTA

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: Lavender top (EDTA)

Specimen Volume: 3 mL

Collection Instructions: Send specimen in original tube. Do not aliquot.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

2 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Whole Blood EDTA Refrigerated (preferred) 7 days
Frozen 7 days
Ambient 24 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating the long-term control of blood glucose concentrations in patients with diabetes

 

Diagnosing diabetes

 

Identifying patients at increased risk for diabetes (prediabetes)

 

This assay is not useful in determining day-to-day glucose control and should not be used to replace daily home testing of blood glucose.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Diabetes mellitus is a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism characterized by hyperglycemia. It is one of the most prevalent diseases, affecting approximately 24 million individuals in the United States. Long-term treatment of the disease emphasizes control of blood glucose levels to prevent the acute complications of ketosis and hyperglycemia. In addition, long-term complications such as retinopathy, neuropathy, nephropathy, and cardiovascular disease can be minimized if blood glucose levels are effectively controlled.

 

Hemoglobin A1c (HbA1c) is a result of the nonenzymatic attachment of a hexose molecule to the N-terminal amino acid of the hemoglobin molecule. The attachment of the hexose molecule occurs continually over the entire life span of the erythrocyte and is dependent on blood glucose concentration and the duration of exposure of the erythrocyte to blood glucose. Therefore, the HbA1c level reflects the mean glucose concentration over the previous period (approximately 8-12 weeks, depending on the individual) and provides a much better indication of long-term glycemic control than blood and urinary glucose determinations. Diabetic patients with very high blood concentrations of glucose have from 2 to 3 times more HbA1c than normal individuals.  

 

Diagnosis of diabetes includes 1 of the following:

-Fasting plasma glucose of 126 mg/dL or greater

-Symptoms of hyperglycemia and random plasma glucose of 200 mg/dL or greater

-Two-hour glucose of 200 mg/dL or greater during oral glucose tolerance test unless there is unequivocal hyperglycemia, confirmatory testing should be repeated on a different day

 

The American Diabetes Association (ADA), International Expert Committee (IEC), and the World Health Organization (WHO) recommend the use of HbA1c to diagnose diabetes, using a threshold of 6.5%. The threshold is based upon sensitivity and specificity data from several studies.

 

Advantages to using HbA1c for diagnosis include:

-Provides an assessment of chronic hyperglycemia

-Assay standardization efforts from the National Glycohemoglobin Standardization Program (NGSP) have been largely successful and the accuracy of HbA1c is closely monitored by manufacturers and laboratories

-No fasting is necessary

-Intraindividual variability is very low (<2% variation)

-A single test could be used for both diagnosing and monitoring diabetes

 

When using HbA1c to diagnose diabetes, an elevated HbA1c should be confirmed with a repeat measurement, except in those individuals who are symptomatic with a plasma glucose concentration above 200 mg/dL. Patients who have an HbA1c between 5.7 and 6.4 are considered at increased risk for developing diabetes in the future. (The terms prediabetes, impaired fasting glucose, and impaired glucose tolerance will eventually be phased out by the ADA to eliminate confusion.)

 

The ADA recommends measurement of HbA1c (typically 3-4 times per year for type 1 and poorly controlled type 2 diabetic patients, and 2 times per year for well-controlled type 2 diabetic patients) to determine whether a patient's metabolic control has remained continuously within the target range.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

4.0-5.6%

<18 years: Hemoglobin A1c criteria for diagnosing diabetes have not been established for patients who are <18 years of age.

> or =18 years: Increased risk for diabetes (prediabetes): 5.7-6.4%

Diabetes: > or =6.5%

 

Interpretive information based on Diagnosis and Classification of Diabetes Mellitus, American Diabetes Association.

Interpretation
Provides information to assist in interpretation of the test results

Diagnosing diabetes: American Diabetes Association (ADA)

-Hemoglobin A1c (HbA1c): > or =6.5%

 

Therapeutic goals for glycemic control (ADA)

-Adults:

 - Goal of therapy: < 7.0% HbA1c

 - Action suggested: > 8.0% HbA1c

-Pediatric patients:

 - Toddlers and preschoolers: < 8.5% (but >7.5%)

 - School age (6-12 years): < 8%

 - Adolescents and young adults (13-19 years): < 7.5%

 

The ADA recommendations for clinical practice suggest maintaining a HbA1c value closer to normal yields improved microvascular outcomes for diabetics.(1) Target goals of less than 7% may be beneficial in patients such as those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease. However, in patients with significant complications of diabetes, limited life expectancy, or extensive comorbid conditions, targeting a less than 7% goal may not be appropriate.

 

Since the HbA1c assay reflects long-term fluctuations in blood glucose concentration, a patient with diabetes who has come under good control in recent weeks may still have a high concentration of HbA1c. The converse is true for a patient with diabetes previously under good control who is now poorly controlled.

 

HbA1c results less than 4.0% are reported with the comment: "Falsely low HbA1c results may be observed in patients with clinical conditions that shorten erythrocyte life span or decrease mean erythrocyte age. HbA1c may not accurately reflect glycemic control when clinical conditions that affect erythrocyte survival are present. Fructosamine may be used as an alternate measurement of glycemic control."

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The presence of hemoglobin variants can interfere with the measurement of hemoglobin A1c (HbA1c). The advantage of using ion exchange chromatography methods is most variants that would affect HbA1c results can be detected from analysis of the chromatogram so inaccurate results are less likely to be reported.

 

Many common hemoglobin (Hb) variants (HbF <30%, heterozygous HbE, heterozygous HbD, heterozygous HbC, heterozygous HbS) do not interfere with this method. Other Hb variants that do show interference with this method include, but are not limited to Hb Camperdown, Hb Fukuoka, Hb Philadelphia, Hb Wayne, and Hb Raleigh.

 

In patients with rare homozygous and double heterozygous forms of abnormal Hb (eg, CC, SS, EE, SC), there is no HbA present; therefore, no HbA1c value can be determined. If the specimen cannot be analyzed due to a homozygous variant or other interference, measurement of serum fructosamine may be helpful to monitor glycemic control. See FRUCT / Fructosamine, Serum.

 

Some hemoglobinopathies can be associated with reduced red blood cell lifespan and any measured HbA1c concentration would not provide a true measurement of the patient's glycemic control and could lead to misinterpretation. In such situations, fructosamine should be used as an alternate measurement of glycemia and is recommended for monitoring these patients. See FRUCT / Fructosamine, Serum.

 

In cases of hemolytic anemia, the lifetime of erythrocytes is shortened and will result in decreased HBA1c results. This effect will depend upon the severity of the anemia. Specimens from patients with polycythemia or postsplenectomy may exhibit increased HBA1c values due to a somewhat longer lifespan of the erythrocytes. Caution should be exercised when interpreting the HbA1c results from patients with these conditions. 

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Goldstein DE, Little RR, Lorenz RA, et al: Tests of glycemia in diabetes. Diabetes Care. 2003 Jan;26:S106-S108

2. Nathan DM, Kuenen J, Borg R, et al: Translating the A1c assay into estimated average glucose values. Diabetes Care. 2008 Aug;31:1473-1478

3. American Diabetes Association, Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes. Diabetes Care. 2018; Jan;41:S1

4. National Academy of Clinical Biochemistry. Hb A1c. In: Sacks DB, ed. Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus [Online]; 2011; Chap 9

5. Rodriguez-Capote K, Estey MP, Barakauskas VE, et al: Identification of HbWayne and its effects on HbA1c measurement by 5 Methods. Clin Biochem. 2015;48:1144-1150

6. Bry L, Chen PC, Sacks DB: Effects of hemoglobin variants and chemically modified derivatives on assays for glycohemoglobin. Clin Chem. 2001;47(2):153–163

Method Description
Describes how the test is performed and provides a method-specific reference

The D-100 hemoglobin A1c (HbA1c) test utilizes principles of ion-exchange high-performance liquid chromatography. The samples are automatically diluted on the D-100 and injected into the analytical cartridge. The D-100 delivers a programmed buffer gradient of increasing ionic strength to the cartridge, where the hemoglobins are separated based on their ionic interactions with the cartridge material. The separated hemoglobins then pass through the flowcell, where changes in the absorbance at 415 nm are measured. The D-100 software collects raw data from each analysis and calculates HbA1c values based on a bilevel calibration curve. The HbA1c area is calculated using an exponentially modified Gaussian algorithm. A sample report and a chromatogram are generated for each sample.(Instruction manual: Bio-Rad D-100 HbA1c Instructions For Use, LB0002870revA; 2014)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 day

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83036

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HBA1C Hemoglobin A1c, B 4548-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
HBA1C Hemoglobin A1c, B 4548-4

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports