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Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
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Long-Term Performance of Point-of-Care Hemoglobin A1c Assays.

Sujaytha Paknikar1, Rohan Sarmah1, Losika Sivaganeshan1

  • 1Creighton Diabetes Center, Omaha, NE, USA.

Journal of Diabetes Science and Technology
|April 27, 2016
PubMed
Summary

Point-of-care (POC) HbA1c testing offers convenience but shows variable accuracy compared to lab methods. Consistent monitoring requires understanding these limitations for effective diabetes management.

Keywords:
HPLCHbA1cpoint of care

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Area of Science:

  • Clinical Chemistry
  • Diabetes Mellitus Diagnostics
  • Point-of-Care Testing

Background:

  • Point-of-care (POC) HbA1c testing is crucial for timely diabetes management.
  • Accuracy and long-term comparability of POC HbA1c assays remain subjects of debate.
  • Reliable HbA1c monitoring is essential for lifelong diabetes treatment adjustments.

Purpose of the Study:

  • To compare the accuracy and long-term performance of two POC HbA1c assays against central laboratory HPLC methods.
  • To assess the external validity of POC techniques using proficiency testing data over three years.

Main Methods:

  • Comparison of Afinion™ (boronate affinity) and DCA Vantage (immunoassay) POC assays with Tosoh G8 and Bio-Rad Variant II HPLC methods.
  • Three-year study duration incorporating College of American Pathologists and American Proficiency testing data.
  • Evaluation of assay comparability and variability over time.

Main Results:

  • Significant and variable differences observed between POC assays and HPLC methods over time.
  • POC techniques consistently yielded lower values than Tosoh HPLC measurements.
  • Both POC and central lab methods showed variable deviations from National Glycohemoglobin Standardization Program values.

Conclusions:

  • POC HbA1c assays and central laboratory methods have inherent limitations affecting accuracy.
  • Understanding assay variability is critical for clinicians and patients relying on POC results.
  • Comprehensive diabetes assessment should integrate HbA1c with plasma and self-monitored glucose values.