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Analytical performance evaluation of the GreenCare A1c and Cera-Stat HbA1c point-of-care testing assays
Joon Hee Lee1,2, Sun-Hee Jun2, Jikyo Lee1,3
1Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea.
Insights
Two point-of-care testing (POCT) assays for Hemoglobin A1c (HbA1c) were evaluated. Both GreenCare and Cera-Stat assays demonstrated reliable performance, meeting international standards for diabetes diagnosis.
Area of Science:
- Clinical Chemistry
- Point-of-Care Diagnostics
- Diabetes Management
Background:
- Diabetes prevalence necessitates accurate diagnostic tools for effective management.
- Hemoglobin A1c (HbA1c) is a key biomarker for assessing long-term glycemic control.
- Point-of-care testing (POCT) offers accessible HbA1c measurement, but accuracy concerns exist.
Purpose of the Study:
- To evaluate the analytical performance of two boronate-affinity based HbA1c POCT assays: GreenCare A1c and Cera-Stat HbA1c.
- To assess precision, linearity, comparison, and accuracy against established guidelines and certification criteria.
- To determine the suitability of these POCT assays for clinical use in diabetes diagnosis.
Main Methods:
- Analytical performance evaluated using Clinical and Laboratory Standards Institute (CLSI) guidelines.
- Assays assessed for precision, linearity, and correlation with a Bio-Rad D100 analyzer.
- Accuracy and interference evaluated using frozen EDTA whole blood samples, adhering to NGSP and IFCC criteria.
Main Results:
- Both GreenCare and Cera-Stat assays showed excellent precision (CV% 1.5-2.2) and linearity (R² > 0.999).
- High correlation (r > 0.978) observed when compared to the Bio-Rad D100 analyzer.
- Both assays met NGSP and IFCC certification criteria, classifying them as 'standard' quality.
Conclusions:
- The GreenCare and Cera-Stat POCT assays are reliable for HbA1c measurement.
- These assays can potentially improve the quality of diabetes diagnosis and treatment.
- Reliable POCT may reduce unnecessary referrals and enhance patient care.
Background:
The escalating prevalence of diabetes underscores the need for precise diagnostic tools to facilitate effective management. Hemoglobin A1c (HbA1c) is a crucial biomarker for long-term glycemic control in diabetic patients. Point-of-care testing (POCT) for HbA1c offers rapid, accessible alternatives to conventional laboratory methods, but uncertainties persist regarding the accuracy and reliability of POCT assays.
Methods:
This study evaluates the analytical performance of two boronate-affinity based HbA1c POCT assays, the GreenCare A1c and Cera-Stat HbA1c. Various analytical parameters including precision, linearity, comparison, and accuracy are assessed following guidelines from Clinical and Laboratory Standards Institute (CLSI), with results applied to certification criteria from the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Furthermore, 52 and 13 frozen EDTA whole blood samples were respectively used for additional evaluation of accuracy and interference due to Hb variants for the GreenCare A1c assay.
Results:
Both GreenCare and Cera-Stat demonstrated good precision (repeatability CV% 1.5-1.9 and total imprecision CV% 1.6-2.2), linearity (R2 = 0.9996 & 0.9990), and correlation (r = 0.982 & 0.978) with an established HbA1c analyzer, the Bio-Rad D100. The GreenCare also exhibited good accuracy with frozen EDTA samples with known HbA1c values. Both assays met the certification criteria from NGSP and IFCC, classifying them as "standard" according to IFCC model for quality targets for HbA1c.
Conclusions:
This evaluation affirms the reliability of GreenCare and Cera-Stat POCT assays for HbA1c measurements, which can potentially reduce unnecessary referrals and enhance the overall quality of diabetes diagnosis and treatment.
