Performance Verification of a Domestic Reagent Brand in the Whole Process of C-Reactive Protein Detection by Siemens Atellica-CH930 Automatic Biochemical Analyzer
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.
full C-reactive proteinCRPCNASSiemens automatic biochemistry instrumentperformance verification
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