医院内部POCT血糖仪实验室间质量评价方案探索

Exploration of interlaboratory quality assessment scheme for POCT blood glucose meter in hospital

目的:探索医院内部即时检验(point-of-care testing,POCT)血糖仪实验室间质量评价和质量保证的方法。方法:通过每台血糖仪连续20 d室内质控数据计算变异系数(coefficient of variation,CV),评价血糖仪精密度。选取5个水平肝素抗凝混合静脉血,同时在82台血糖仪(A品牌34台、B品牌48台,每个品牌各有1台参加外部室间质评合格的目标仪器)和日立7600-210全自动生化分析仪上检测血糖。以目标血糖仪检测结果为靶值,同品牌血糖仪与其比较,评价每台血糖仪正确度;通过多台同品牌血糖仪对同一样本的测定评价该品牌血糖仪检测结果的复现性;以日立7600-210全自动生化分析仪检测结果为靶值,所有血糖仪均与其进行比较,评价每台血糖仪与日立7600-210全自动生化分析仪检测结果的一致性。结果:82台血糖仪精密度均符合行业要求;82台血糖仪检测结果正确度合格率为96.34%,A品牌合格率为100%,B品牌合格率为93.75%;A品牌血糖仪复现性明显优于B品牌;82台血糖仪与日立7600-210全自动生化分析仪检测结果一致性合格率为84.15%,A品牌合格率为82.35%,B品牌合格率为85.42%。结论:采用该方式对医院内部不同实验室间的POCT血糖仪进行质量评价是可行的,其一致性评价方案亟待完善。

Objective To explore the method of quality assessment and quality assurance for inter-laboratory POCT blood glucose meter.Methods The accuracy of blood glucose meter was evaluated by CV,which was calculated by 20 days'internal quality control data of each blood glucose meter.Five levels of heparin anticoagulant vein were selected and blood glucose was tested on 82 glucose meters and Hitachi 7600-210 auto biochemical analyzer.With the target blood glucose meter as the target value,the blood glucose meter of the same group was compared with each other to evaluate the accuracy of each blood glucose meter.Some brand of glucose meter had its reproducibility evaluated by measuring the same sample with multi meters of the brand.The results of biochemical analyzer were used as target values.All blood glucose meters were compared with each other,and the consistency of each blood glucose meter and biochemical analyzer was evaluated.Results The precision of the 82 glycemic instruments all met the requirements of the industry.The correct rate of the 82 blood glucose meters was 96.34%,of which A brand was 100%and B brand was 93.75%.The conformance rate of 82 blood glucose meters and biochemical instruments was 84.15%,of which A brand was 82.35%,and B brand was 85.42%.Conclusion It is feasible to evaluate the quality of POCT blood glucose meter in different laboratories within the hospital by using the method of laboratory quality evaluation,and its consistency evaluation scheme needs to be improved.