Johns Hopkins Diabetes GuideDevices

Point-of-care HbA1c machines

Mark D. Corriere, M.D., Rita Rastogi Kalyani, M.D., M.H.S.
Point-of-care HbA1c machines is a topic covered in the Johns Hopkins Diabetes Guide.

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DESCRIPTION

  • Commercially available laboratory-based hemoglobin A1c testing became available in 1978.
  • Point-of-care (POC) hemoglobin A1c testing became available in the 1990’s and has increased over the last decade.
  • Point-of-care testing allows for testing in the office (or home use) and requires a small amount of blood via a finger prick (similar to a glucometer). Results are generally available within 10 minutes.
  • POC HbA1c testing has waived status from the Clinical Laboratory Improvement Amendments (CLIA) which means the Food and Drug Administration and Center for Disease Control deems the test to be so simple that there is little risk of error. No specific training is needed to operate the machine. Users of the machine are exempt from other CLIA requirements and inspections.
  • A sampling of commonly available machines are listed below.

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Last updated: April 30, 2014