Zhou Rui, Gao Zhi-Qi, Tong Qing, Zuo Chang, Song Zhi-Xin, Wang Wei, Wang Qing-Tao
Clinical Laboratory Department, Beijing Chao-Yang Hospital, affiliated to Capital Medical University, Beijing, China.
Beijing Center for Clinical Laboratories, Beijing, China.
Lab Med. 2017 May 1;48(2):148-153. doi: 10.1093/labmed/lmw073.
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.
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.
HbA 1c 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.
Calibration of laboratory devices by specimens with IFCC-assigned values and by external mathematical calibration could improve the accuracy of POCT HbA 1c measurements. Also, standardized training could improve precision in POCT HbA 1c measurements, especially for semiautomated HbA 1c POCT devices.
评估具有国际临床化学联合会（IFCC）赋值的可互换二级参考物质对提高糖化血红蛋白（HbA1c）检测质量的作用。
我们通过3种不同的特定方法的中心实验室分析仪对3种即时检验（POCT）设备进行重新校准和评估，这些分析仪使用具有IFCC赋值的可互换标本进行校准。对进行POCT的工作人员在培训前后也进行了评估。
经过外部数学校准后，POCT设备测得的HbA1c水平偏差显著减小。在NycoCard组对POCT设备操作人员进行培训后，HbA1c测量的实验室间变异系数从12%降至4%。DCA Vantage和Afinion组的变异系数在培训后也有所改善。
使用具有IFCC赋值的标本并通过外部数学校准对实验室设备进行校准，可以提高POCT HbA1c测量的准确性。此外，标准化培训可以提高POCT HbA1c测量的精密度，特别是对于半自动HbA1c POCT设备。
