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Background <p>Point-of-care (POC) HbA1c analysis offers an easy and rapid approach of assessing an individual’s glycemic status. However, its accuracy and diagnostic potential remain controversial. Here we compared POC vs. reference laboratory HbA1c testing in selected endocrine patient cohorts at a tertiary, university referral center using the widely established Afinion 2 analyzer.</p> Methods <p>Single-center observational study of consecutive patients referred to the outpatient clinics of the Department of Endocrinology, Diabetes and Metabolism at the University Hospital Essen over 12 weeks. Venous blood samples for POC and laboratory HbA1c (Tosoh) testing were obtained simultaneously. Accuracy and diagnostic capacity of the POC HbA1c testing were evaluated.</p> Results <p>Among 554 patients 47.1% (<i>n</i> = 261) were normoglycemic, 15.9% (<i>n</i> = 88) had prediabetes and 37.0% (<i>n</i> = 205) diabetes. Comparison of POC and laboratory HbA1c testing showed that 87.0% of POC values fell within ± 5.0% of the corresponding reference method values. When applying the German Medical Association guidelines, 58.7% of the POC values fell within ± 3.0% of the corresponding reference method values. ROC-analysis demonstrated an optimal cut-off for diagnosis of prediabetes of 5.65% (38 mmol/mol) and for diabetes of 6.25% (45 mmol/mol). Considering POC HbA1c testing as only tool for treatment decision, a medication error would have occurred in 12/195 patients (6.2%).</p> Conclusion <p>Our study demonstrated, that POC HbA1c testing offers correlation but insufficient analytical agreement and clinically relevant misclassification compared to HPLC reference testing, highlighting that analytical validation in controlled environments does not automatically translate into diagnostic interchangeability in complex tertiary referral cohorts.</p>

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Point-of-care HbA1c testing in a tertiary, university referral center: living up to the potential?

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月2日

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  • Lukas van Baal,
  • Lynn Marlene Srasra,
  • Annie Mathew,
  • Theresia Sarabhai,
  • Janina Kreuz,
  • Roland Assert,
  • Marc Wichert,
  • Dagmar Führer,
  • Denise Zwanziger

摘要

Background

Point-of-care (POC) HbA1c analysis offers an easy and rapid approach of assessing an individual’s glycemic status. However, its accuracy and diagnostic potential remain controversial. Here we compared POC vs. reference laboratory HbA1c testing in selected endocrine patient cohorts at a tertiary, university referral center using the widely established Afinion 2 analyzer.

Methods

Single-center observational study of consecutive patients referred to the outpatient clinics of the Department of Endocrinology, Diabetes and Metabolism at the University Hospital Essen over 12 weeks. Venous blood samples for POC and laboratory HbA1c (Tosoh) testing were obtained simultaneously. Accuracy and diagnostic capacity of the POC HbA1c testing were evaluated.

Results

Among 554 patients 47.1% (n = 261) were normoglycemic, 15.9% (n = 88) had prediabetes and 37.0% (n = 205) diabetes. Comparison of POC and laboratory HbA1c testing showed that 87.0% of POC values fell within ± 5.0% of the corresponding reference method values. When applying the German Medical Association guidelines, 58.7% of the POC values fell within ± 3.0% of the corresponding reference method values. ROC-analysis demonstrated an optimal cut-off for diagnosis of prediabetes of 5.65% (38 mmol/mol) and for diabetes of 6.25% (45 mmol/mol). Considering POC HbA1c testing as only tool for treatment decision, a medication error would have occurred in 12/195 patients (6.2%).

Conclusion

Our study demonstrated, that POC HbA1c testing offers correlation but insufficient analytical agreement and clinically relevant misclassification compared to HPLC reference testing, highlighting that analytical validation in controlled environments does not automatically translate into diagnostic interchangeability in complex tertiary referral cohorts.