Performance evaluation and accuracy testing of a fully automated biochemical analyzer for AAT and AAG detection
Objective To evaluate the analytical performance of Beckman AU5800 automatic biochemical analyzer in detectingα1-antitrypsin(AAT)and α1-acidic glycoprotein(AAG)reagents of a company in Chongqing,and whether the reagents meet the manufacturer's declaration and clinical requirements.Methods With reference to the national health industry standard for medical testing,"Performance Verification of Precision and Accuracy of Quantitative Measurement Items in Clinical Testing"(WS/T492-2016),"Guidelines for the Verification of Quantitative Testing Procedures in Clinical Chemistry",and the precision performance evaluation of the quantitative measurement method of CLSI EP5A,and with the determination of the level of AAT and AAG as the indexes,the performance of the Beckman AU5800 automatic biochemistry analyzer was analyzed and verified.The performance of Beckman AU5800 Automatic Biochemistry Analyzer was analyzed and verified by using AAT and AAG levels as the indicators,and the performance of the measurement results was verified in terms of correctness,precision,linear range,reportable range,reference interval,etc.,and the results of the verification were compared with the performance of the manufacturer's declaration and the standards of the People's Republic of China's health industry.Results Correctness verification:The bias of 3 samples assigned by AAT and AAG is＜10％.Precision verification:The intra-lot precision of the two AAT levels was 2.59％and 1.72％,and the inter-lot precision of the two AAT levels was 3.03％and 3.14％,respectively.The intra-lot precision of the two AAG levels was 4.82％and 5.78％,and the inter-lot precision of the two AAG levels was 5.24％and 5.37％,respectively,which were both lower than the industry evaluation standard,intra-lot precision of 8.00％and inter-lot precision of 15.00％.Linear range verification:AAT concentration is a linear interval between 20 and 379mg/dl,and AAG concentration is a linear interval between 20 and 240mg/dl.The upper reportable range of AAT was 798.66mg/dl,and the upper reportable range of AAG was 1125.2mg/dl,and the biological reference interval provided by the manufacturer was acceptable.Conclusion The correctness,precision,linear range,reportable range and reference interval of AAT and AAG reagents on Beckman AU5800 automatic biochemistry analyzer meet the requirements,and the main analytical performance meets the performance declared by the manufacturer and the relevant quality requirements,which can meet the clinical needs.
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