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Accuracy of Three Commercial Home-Use Hemoglobin A1c Tests.
Laura M Jacobsen1, Laura E Bocchino2, John W Lum2
1Division of Pediatric Endocrinology, University of Florida, Gainesville, Florida, USA.
Diabetes Technology & Therapeutics
|June 28, 2022
Summary
Accurate home hemoglobin A1c (HbA1c) testing is crucial for diabetes management, especially with increased telemedicine use. The Home Access test showed better performance than CoreMedica and A1cNow+ in a recent validation study.
Area of Science:
- Clinical Chemistry
- Diabetes Technology
- Point-of-Care Testing
Background:
- The COVID-19 pandemic accelerated telemedicine adoption, increasing demand for remote patient monitoring tools.
- Accurate home-based hemoglobin A1c (HbA1c) testing is essential for effective diabetes self-management and care.
- Validation studies for commercial home-use HbA1c devices are limited.
Purpose of the Study:
- To evaluate the accuracy and reliability of three commercially available home-use capillary blood HbA1c tests.
- To compare the performance of these tests against central laboratory venous HbA1c measurements.
- To assess the suitability of these devices for supporting telemedicine in diabetes care.
Main Methods:
- A validation study involving 219 participants with type 1 or type 2 diabetes across four clinical sites.
- Comparison of HbA1c results from three home-use capillary tests (Home Access, CoreMedica, A1cNow+) with paired venous samples analyzed by two central reference laboratories.
- Primary outcome: percentage of commercial HbA1c values within 5% (relative difference) of reference values.
Main Results:
- The Home Access test achieved 82% of values within 5% of reference values, significantly outperforming CoreMedica (29%) and A1cNow+ (46%).
- Absolute differences showed Home Access with 75% within 0.3% of reference, compared to 28% for CoreMedica and 44% for A1cNow+.
- None of the tested home-use HbA1c devices met the National Glycohemoglobin Standardization Program goal of ≥90% accuracy.
Conclusions:
- The Home Access home-use HbA1c test demonstrated superior performance compared to CoreMedica and A1cNow+ in this validation study.
- Despite Home Access's better results, none of the evaluated devices fully met established accuracy standards for clinical use.
- Accurate and reliable home-based HbA1c testing remains a critical unmet need for the diabetes community, particularly with the continued expansion of telemedicine.
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