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Issue: Vol. 566 No. special (2026): Hệ thống Y tế Hùng Vương
Section: Các bài báo
DOI: 10.51298/vmj.v566ispecial.19016
Date Published: 06/10/2026
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Downloads 31
How to Cite
Nguyễn, T. Đ., Nguyễn, V. T., Lương, T. C., Mai, D. H., Trần, T. L., Lê, T. H., Nguyễn, X. H., Lê, T. N., Nguyễn, T. H., Lê, T. H., & Phạm, T. H. (2026). VALIDATION OF THE PRECISION AND TRUENESS OF QUANTITATIVE HbA1c TESTS USING THE ADAMS HA-8380V DEVICE AT 360 LE HOAN CLINIC. Vietnam Medical Journal, 566(special). https://doi.org/10.51298/vmj.v566ispecial.19016

VALIDATION OF THE PRECISION AND TRUENESS OF QUANTITATIVE HbA1c TESTS USING THE ADAMS HA-8380V DEVICE AT 360 LE HOAN CLINIC

Trọng Đại Nguyễn1, , Việt Tuấn Nguyễn1, Thị Cúc Lương1, Duy Hoan Mai1, Thị Loan Trần1, Thị Hường Lê1, Xuân Hòa Nguyễn1, Trung Nam Lê1, Thị Hoa Nguyễn1, Thị Hạnh Lê1, Thu Hà Phạm2
1 Phòng khám Đa khoa 360 Lê Hoàn
2 Bệnh viện đa khoa Hà Đông

Main Article Content

Abstract

Objective: To verify the precision and trueness of the HbA1c assay performed using the cation-exchange high-performance liquid chromatography (HPLC) method on the ADAMS HA-8380V analyzer at 360 Le Hoan General Clinic.


Materials and Methods: The study utilized control samples at two concentration levels (QC1 and QC2) from Canterbury Scientific (New Zealand). An experimental study design was employed, following the CLSI EP15-A3 guidelines. Results: The within-laboratory coefficients of variation (CVWL) for QC1 and QC2 were 0.87% and 0.40%, respectively; both values ​​were lower than those declared by the manufacturer. The mean values ​​obtained for QC1 and QC2 were 5.532% and 10.796%, respectively, both falling within the validation range. Based on these results, we confirm that the precision and trueness of the HbA1c assay on the ADAMS HA-8380V analyzer are consistent with the manufacturer’s specifications.

Keywords

Method performance validation, precision, trueness, HbA1c, HPLC

Article Details

References

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