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Published on: March 13, 2015
Preliminary comparative study of HBA1c measurement by IEX-HPLC Bio-Rad in dried blood spot vs. whole venous blood
Khaoula Hadami1, Redouane Mammar Bennai1, Nora Touyar1
1Biolife medical analysis laboratory, Rabat-Salé-Kénitra, Temara, Harhoura, Morocco.
Insights
Dried blood spot (DBS) sampling offers a convenient alternative to traditional venipuncture for Hemoglobin A1c (HbA1c) testing. This method demonstrates excellent agreement and stability, supporting its use in diabetes detection and monitoring.
Area of Science:
- Clinical Chemistry
- Biomedical Diagnostics
- Laboratory Medicine
Background:
- Hemoglobin A1c (HbA1c) testing is crucial for identifying pre-diabetes and managing diabetes.
- Current whole blood (WB) venipuncture methods for HbA1c analysis present challenges in sample collection and transport.
- Dried blood spot (DBS) sampling is a promising alternative requiring further validation.
Purpose of the Study:
- To evaluate the analytical performance, clinical acceptability, and analyte stability of DBS sampling for HbA1c measurement.
- To compare DBS sampling with traditional WB venipuncture methods.
- To assess the feasibility of DBS for routine HbA1c analysis.
Main Methods:
- 40 participants provided both WB samples and capillary blood for DBS collection.
- WB samples were collected in EDTA tubes, and DBS samples were applied to Whatman 903 paper.
- HbA1c levels were measured using the Bio-Rad D-10 IEX-HPLC instrument for both sample types.
- Analyte stability was assessed at different temperatures (20-25°C, +4°C, -20°C).
Main Results:
- Excellent agreement (LCCC = 0.982) and correlation (PCC = 0.990) were observed between DBS and WB results.
- High repeatability (CV = 1.13) and clinical conformity (K = 0.80) were demonstrated for DBS samples.
- DBS samples showed satisfactory analyte stability under tested storage conditions.
Conclusions:
- DBS sampling is a highly accurate and reliable method for HbA1c measurement.
- The DBS method offers a viable and efficient alternative to WB venipuncture, simplifying sample handling.
- DBS sampling facilitates improved accessibility and convenience for HbA1c testing in diabetes care.
Abstract:
HBA1c testing is a health indicator for pre-diabetes identification or diabetes detection and follow-up. Simplifying collection and transport of blood samples for HBA1c measurement remains of great interest. Capillary dried blood spots (DBS) sampling has been proposed as a potential alternative to classical whole blood (WB) venipuncture, however, international analytical and clinical validation of DBS use is necessary before implementation. We aimed in the present study to assess the performance, clinical acceptability and analyte stability (at 20-25°C, +4°C, -20°C) of DBS sampling method compared to WB. The study enrolled 40 participants. Obtained WB were applied to Whatman 903 protein blotting paper. Prepared DBS samples were compared to WB samples kept in EDTA collection tubes using the Bio-Rad D-10 IEX-HPLC instrument. Statistical analysis was carried out using IBM SPSS Statistics 29.0.1.0 and NCSS v23-0-2 software programs. Agreement (LCCC = 0.982; limits of agreement M ± 1.96SD: -0.45; 0.48) and correlation (PCC = 0.990) between DBS and WB results were excellent. Also, repeatability (CV = 1.13) and clinical conformity (K = 0.80) of the values obtained on DBS were found to be highly satisfactory. Our results clearly showed that DBS sampling could be an efficient alternative to WB venipuncture for HBA1c measurement.
