Your browser doesn't support javascript.
loading
Performance verification for high performance liquid chromatography detection of glycated hemoglobin / 国际检验医学杂志
International Journal of Laboratory Medicine ; (12): 2341-2343, 2015.
Artículo en Chino | WPRIM | ID: wpr-476294
ABSTRACT
Objective To verify the detection performance of glycated hemoglobin (HbA1c)by using the BIO-RAD D-10 high performance liquid chromatography method,and to evaluate whether the detection performance can satisfy the requirements of the laboratory and clinical diagnosis and treatment.Methods The method of CLSI EP1 5A2 was used to verify the accuracy and preci-sion.The linear correlation and reference range were verified respectively by linear regression analysis and the method of the WS/T 402 2012.Results The calibration value of HbA1c calibrator level 1 was 5.3% and the validation limit of measured results was 1. 63%-8.78%.The calibration value of HbA1c calibrator Level 2 was 10.0%,and the validation limit of measured results was 4.76%-13.64%.Both calibration values were included in the 95% confidence range of measured values,so the accuracy verifica-tion passed.Laboratory variation coefficient (CV)for HbA1c with concentration of 5.24% was 1.01% and for 9.84% was 0. 54%,both less than the precision that the manufacturer declared,so the precision verification passed.The equation of linear regres-sion analysis for HbA1c linearity calibrator measured value and target value wasY =1.008X +0.023,with correlation coefficient in-dex r 2 of 0.999,so the linearity was good.The measured results of 20 healthy adults specimens were in the reference interval(4.1%-6.2%)that the manufacturer provided.Conclusion Accuracy,precision,linear correlation and reference range of HbA1c meas-ured by BIO-RAD D-10 HPLC detection method were verified.It can provide the accurate and credible measurement results for clin-ical diagnosis and treatment,and can be used in the detection of clinical specimens.

Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Tipo de estudio: Estudio diagnóstico Idioma: Chino Revista: International Journal of Laboratory Medicine Año: 2015 Tipo del documento: Artículo

Similares

MEDLINE

...
LILACS

LIS

Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Tipo de estudio: Estudio diagnóstico Idioma: Chino Revista: International Journal of Laboratory Medicine Año: 2015 Tipo del documento: Artículo