Test Overview
Test Methodology

Afinion HbA1c is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c in human whole blood.

Test Usage

Hemoglobin A1c is proportional to the level of glucose in the blood over 2 to 3 months. Regular measurement of HbA1C can be used in the long-term clinical monitoring of diabetic patients. Improvement of metabolic control is indicated by a lowering of HbA1C values.

Point of Care Hemoglobin A1C testing is available in certain ambulatory health centers and clinics and is performed by authorized operators in those area on the Abbott Afinion 2.

Reference Range *

Reference ranges are available in the Hemoglobin A1C test procedures located on the POC website: https://www.pathology.med.umich.edu/point-of-care

Reference ranges may change over time. Please refer to the original patient report when evaluating results.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

The Afinion 2 will measure values between 4.0%-15%.The Afinion 2 has the following limitations:

1) Any cause of shortened erythrocyte life span will reduce exposure of erythrocytes to glucose, resulting in a decrease in HbA1c values, regardless of the method used. Caution should be used when interpreting the HbA1c results from patients with conditions such as hemolytic anemia or other hemolytic diseases, homozygous sickle cell trait, pregnancy, blood loss, polycythemia, iron deficiency etc.
2) Diluted samples cannot be used with Afinion HbA1c.
3) Coagulated or hemolyzed samples cannot be used with Afinion HbA1c. Samples with >14% (2000 mg/dL) hemolysis may return an information code.
4) If the sample has a hemoglobin value below 6.0 g/dL or above 20.0 g/dL, no test result will be reported, and an information code will be displayed.
5) Specimens with hemoglobin values less than 7 g/dL should be tested with a different method.

For analytical specificity, limitations, and interferences please refer to the test procedure found on the Michigan Medicine POC website: https://www.pathology.med.umich.edu/point-of-care

Test Details
Analytic Time

6 minutes

Soft Order Code
PA1C2
MiChart Code
A1C, Point of Care
Synonyms
    Laboratory
    Point of Care
    Section
    Point of Care
    Specimen Requirements
    Collection Instructions

    Fingerstick.

    Venous: Whole Blood in heparin, EDTA, Citrate.

    Special Handling

    Sample must be tested within 1 minute after collection in Afinion 2 capillary collection container.

    Contraindications
    Very high levels of Hgb F, severe anemia, polycythemia, and certain hemoglobin derivatives at concentrations specified in the IFU can cause HbA1C results to be lower than expected.

    Reject any sample that has remained in the capillary collection device for longer than one minute prior to analysis.

    For analytical specificity, limitations, and interferences please refer to the test procedure found on the Michigan Medicine POC website: https://www.pathology.med.umich.edu/point-of-care
    Normal Volume

    Fingerstick

    Minimum Volume

    1.5 µL Whole Blood

    Additional Information

    For more test specific information, please refer to the test procedure found on the Michigan Medicine POC website: https://www.pathology.med.umich.edu/point-of-care

    Billing
    CPT Code
    83036
    LOINC
    A1C (4548-4)
    NY State Approved
    No