Analytical performance verification of BECKMAN DxI 800 automated chemiluminescence analyzer in de- tecting thyroid
Chen Fangfan
Abstract
Chen Fangfan
Abstract
Objective To detect the thyroid( TT3,TT4,FT3,FT4,TSH) analytical performance verification by BECKMAN DxI 800 automated chemiluminescence analyzer. Methods According to the American Society for Clinical Laboratory Standards( CLSI) documents,the precision,linearity and biological reference interval of the BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting TT3,TT4,FT3,FT4,TSH were detected. Results The CV values of intra-and inter-precision were less than manufacturer's declaration,and within the allowable range; the validation results of linear range showed that,the value of a test items were( 1 ± 0. 05) within the range,the value of the correlation coefficient r≥ 0. 975,are within the requirements of the instrument, and has good linearity. Biological reference intervals are consisted with Vendor performance metrics. Conclusion The BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting five thyroid hormone in precision,linear range and biological reference intervals three performance indicators,are within the requirements of the instrument,to meet the laboratory requirements,can be used in clinical testing.
A significance statement is not available in the OpenAlex record.
A contribution statement is not available in the OpenAlex record.
Method details are not available in the OpenAlex metadata.
Findings are not separately available in the OpenAlex metadata.
Limitations are not available in the OpenAlex metadata.
Application details are not available in the OpenAlex metadata.
Objective To detect the thyroid( TT3,TT4,FT3,FT4,TSH) analytical performance verification by BECKMAN DxI 800 automated chemiluminescence analyzer. Methods According to the American Society for Clinical Laboratory Standards( CLSI) documents,the precision,linearity and biological reference interval of the BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting TT3,TT4,FT3,FT4,TSH were detected. Results The CV values of intra-and inter-precision were less than manufacturer's declaration,and within the allowable range; the validation results of linear range showed that,the value of a test items were( 1 ± 0. 05) within the range,the value of the correlation coefficient r≥ 0. 975,are within the requirements of the instrument, and has good linearity. Biological reference intervals are consisted with Vendor performance metrics. Conclusion The BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting five thyroid hormone in precision,linear range and biological reference intervals three performance indicators,are within the requirements of the instrument,to meet the laboratory requirements,can be used in clinical testing.
Key concepts: Spectrum analyzer, Chemiluminescence, Linearity, Medicine, Coefficient of variation, Computer science, Chromatography, Statistics