摘要
目的:基于WS/T408-2012《临床化学设备线性评价指南》、WS/T492-2016《临床检验定量测定项目精密度与正确度性能验证》以及CNAS-GL037《临床化学定量检验程序性能验证指南》等文件评价某国产品牌在西门子全自动生化分析仪检测全程C反应蛋白的性能,为规范性能验证的实施及全程C反应蛋白的临床推广提供参考。方法:依据中国合格评定国家认可委员会以及国家卫生健康委员会临检中心推荐的方法对乳胶免疫比浊法全程C反应蛋白的正确度、精密度、线性区间、可报告范围、参考区间进行验证,试验结果在厂商规定的范围内或是满足本室的执行标准为性能验证通过。结果:通过选取2种浓度厂商提供的标准溯源物质进行偏移评估,检测结果均符合规定,正确度验证通过。同时验证重复性和精密度,2种浓度的批内标准差和实验室内标准差均小于厂商规定的范围,精密度验证通过。多项式回归最优拟合曲线为一阶线性微分方程y=1.088x–2.884,R2=0.9989,线性区间验证通过。临床可报告范围最高稀释倍数为16倍,高限为340mg/L。20名健康个体的检测结果均在厂商制定的参考范围内。结论:该品牌全程C反应蛋白检测试剂与西门子Atellica-CH930全自动生化分析仪联用性能稳定,可用于临床样品的检测。
Objective:Based on WS/T 408-2012“Guidelines for Linear Evaluation of Clinical Chemistry Equipment”,WS/T 492-2016“Performance Verification of Precision and Accuracy of Quantitative Measurement Items in Clinical Inspections”and CNAS-GL037“Guidelines for Performance Verification of Quantitative Inspection Procedures in Clinical Chemistry”and other documents evaluate the performance of a domestic brand in the detection of full-segment C-reactive protein on a Siemens automatic biochemical instrument,providing reference for the implementation of standardized performance verification and the clinical promotion of full-segment C-reactive protein.Methods:The accuracy,precision,linear interval,reportable range,and reference interval of C-reactive protein in the latex immunoturbidimetric method were verified based on the recommendations of the China National Accreditation Service for Conformity Assessment and the National Health Commission Clinical Inspection Center.The experimental results were obtained from the manufacturer Performance verification is passed if it is performed within the specified range or in this room.Results:By selecting two concentrations of traceable substances provided by manufacturers for offset assessment,the test results were all in compliance with the regulations and the accuracy verification was passed.The repeatability and precision were verified at the same time.The intra-batch variation and intra-laboratory variation of the two concentrations were both less than the range specified by the manufacturer,and the precision verification was passed.The optimal fitting curve of polynomial regression is the first-order equation y=1.0078x-2.9258,R2=0.9992,and the linear interval verification is passed.The dilution factor of the clinically reportable range is 16 times,and the upper limit is 5120IU/mL.The test results of 20 healthy individuals were within the reference range established by the manufacturer.Conclusion:This brand of full-section C-reactive protein detection reagent has stable performance when combined with Siemens Atellica-CH930 automatic biochemistry instrument and can be used for the detection of clinical samples.
作者
邰祺雯
李德全
赵艳红
花海珠
TAI Qi-wen;LI De-quan;ZHAO Yan-hong;HUA Hai-zhu(The First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215006;Shenyang Ping'an Haoyi Medical Laboratory Co.,Ltd.,Liaoning Shenyang 110015)
出处
《中国医疗器械信息》
2024年第7期29-32,共4页
China Medical Device Information
