LabDx

LabDx meets new American Diabetes Association HA1c standards

Technical Update

Test Name: Hemoglobin A1c

Order Code: HA1C

CPT Code: 83036

LabDx announces a change in the methodology to measure Glycosylated Hemoglobin, more commonly known as Hemoglobin A1c. Effective February 21st, Hemoglobin A1c will be analyzed using High Performance Liquid Chromatography (HPLC). The HPLC methodology has long been regarded as the
gold-standard for the measurement of this analyte.

In 2010, American Diabetes Association issued revised clinical practice recommendations for diabetes diagnosis and follow up using the hemoglobin A1c assay. Using this assay as the cornerstone for the assessment of diabetes care necessitated the standardization for its measurement. In order to meet future requirements from the medical community, the College of American Pathologists (CAP) established acceptable accuracy and reporting limits for this assay. It is anticipated that the CAP will continue to tighten the acceptable performance criteria limits over the next several years for those performing this assay.

Recognizing the need for a methodology that meets the CAP’s future requirements for accuracy and precision, LabDx selected the HPLC method. Ultimately, the standardization of this assay will allow physicians to maintain diabetic patients under better glycemic control regardless of their seasonal or geographic migration.