Fu Shui, Zhang Liang, Hu Qi-Lei, Li Zuo-Jie
Department of Clinical Laboratory, Linping Campus, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 311000, People's Republic of China.
Quality Management Section, Linping Campus, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 311100, People's Republic of China.
Int J Gen Med. 2022 Mar 22;15:3247-3254. doi: 10.2147/IJGM.S354260. eCollection 2022.
This study establish and evaluate an internal quality control system for erythrocyte sedimentation rate (ESR) by a "relay" mode based on samples from relevant patients.
The method for establishing a new internal quality control system for ESR by a "relay" mode based on patient's samples was executed from February 2021 to July 2021. In this paper, a total of 219 outpatients were recruited for ESR determination, and their blood samples were stored at 4 °C or room temperature for 24 h. Subsequently, the samples were re-measured for ESR, and the re-measured values were compared with the initial values. The patient samples (15±1mm/h and 50±3mm/h) were selected after the TEST1 ESR analyzer was calibrated, and were stored overnight at 4 °C and measured again the following day. The percentage deviation was determined and entered into the quality control management module for internal quality control. Next, we analyzed the median distribution trend of the patients' ESR values measured by our laboratory every day over five months, as well as the external quality assessment (EQA) results for ESR obtained from the National Center for Clinical Laboratories (NCCL).
The ESR of the room temperature samples after 24 h of storage had significantly decreased (P=0.001), while there was no noticeable difference for those stored at 4 °C (P=0.197). Results of the internal quality control in March were satisfactory, and there was no significant deviation in the median ESR relay results within five months. Besides, the EQA results for the ESR data obtained from NCCL were excellent.
As a precise and practical new method, the ESR relay internal quality control method can be used to scientifically determine the stability and accuracy of the TEST1 ESR analyzer.
本研究基于相关患者样本,通过“接力”模式建立并评估红细胞沉降率(ESR)的内部质量控制体系。
2021年2月至2021年7月执行基于患者样本通过“接力”模式建立ESR新内部质量控制体系的方法。本文共招募219名门诊患者进行ESR测定,其血样在4℃或室温下保存24小时。随后,对样本重新测定ESR,并将重新测定值与初始值进行比较。在TEST1 ESR分析仪校准后,选择患者样本(15±1mm/h和50±3mm/h),于4℃过夜保存,次日再次测量。确定偏差百分比并输入质量控制管理模块进行内部质量控制。接下来,我们分析了本实验室五个月来每天测定的患者ESR值的中位数分布趋势,以及从国家临床检验中心(NCCL)获得的ESR外部质量评估(EQA)结果。
室温保存24小时后的样本ESR显著降低(P=0.001),而4℃保存的样本无明显差异(P=0.197)。3月份内部质量控制结果令人满意,五个月内ESR中位数接力结果无明显偏差。此外,从NCCL获得的ESR数据的EQA结果优秀。
作为一种精确实用的新方法,ESR接力内部质量控制方法可用于科学确定TEST1 ESR分析仪的稳定性和准确性。