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Improvement In The Quality Of Hba(1c) Determination By Using Commutable Specimens With Ifcc-Assigned Values

LABORATORY MEDICINE(2017)

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Abstract
Background: To assess the usefulness of commutable secondary reference materials with International Federation of Clinical Chemistry (IFCC)-assigned values, for improving the quality of hemoglobin A1c (HbA(1c)) determination.Methods: We recalibrated and evaluated 3 point-of-care-test (POCT) devices via 3 different method-specific central laboratory analyzers that were calibrated using commutable specimens with IFCC-assigned values. The staff members who performed POCT were also evaluated before and after training.Results: HbA1c levels measured with POCT devices showed significantly lesser bias after external mathematical calibration. The interlaboratory CVs for HbA(1c) measurements decreased from 12% to 4% after training of POCT-device-operating personnel in the NycoCard group. The CVs in the DCA Vantage and Afinion groups also improved after training.Conclusion: Calibration of laboratory devices by specimens with IFCC-assigned values and by external mathematical calibration could improve the accuracy of POCT HbA1c measurements. Also, standardized training could improve precision in POCT HbA(1c) POCT devices.
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Key words
hemoglobin A(1c),laboratory analyzers,point-of-care testing devices,standardization
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