The preparation and evaluation of human whole blood control materials for point-of-care glucose testing
10.3760/cma.j.cn114452-20210913-00571
- VernacularTitle:一种用于即时血糖检测的人源全血质控物研制与评价
- Author:
Yan WANG
1
;
Qingtao WANG
;
Shunli ZHANG
;
Hongyi YIN
;
Jun WU
;
Rui ZHOU
Author Information
1. 北京积水潭医院检验科，北京100035
- Keywords:
Blood glucose;
Point-of-care testing;
Quality control;
Matrix effects;
Whole blood
- From:
Chinese Journal of Laboratory Medicine
2022;45(2):180-185
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To prepare the control materials of point-of-care(POC) glucose testing and evaluate their homogeneity, stability and matrix effects.Methods:The high, medium and low concentration control materials were prepared from patient leftover whole blood, which was centrifuged, fixed, washed, filtered, and aliquoted. The homogeneity and stability of the control materials were evaluated according to CNAS (China National Accreditation Service for Conformity Assessment, CNAS) GL29:2010"Reference materials-General and statistical principles for certification". The control materials were used to evaluate the matrix effects in POC glucose detection systems by Deming regression, according to the Clinical and Laboratory Standards Institute (CLSI) EP14-A3. Meanwhile, these control materials were used as the internal quality control, and their coefficients of variation ( CV) were calculated. One-way ANOVA and t-Test were used to analyze the results. Results:The homemade materials at three concentrations showed good homogeneity[ F< F0.05(9, 20)]. When the control materials were stored at 2-8 ℃, the stable phases for the opened and closed bottles were 10 days and 15 days, respectively, and there was no statistically significant difference between the results of the first day( P>0.05). The control materials at three concentrations also showed good applicability and there were no matrix effects in 10 POC glucose systems. When the control materials were detected in the internal quality control, the CVs of the high, medium and low concentrations were 0.63%, 0.66% and 1.65%, respectively, which were all below 7.5%. Conclusions:The homemade human control materials of POC glucose testing showed good homogeneity, stability and applicability. They met the requirements of quality control in hospital settings, which provided a good application prospect of the quality management of POC glucose testing.
