Performance Verification of Analyzing IgG by Immune Nephelometry Assay / 现代检验医学杂志

ABSTRACT

Objective To test and verify the performance of analyzing IgG using nephelometry assay,and discuss reasonable model of performance verification of this system.Methods According to related documents and standards,this study verified the precision,accuracy,assay measurement range(AMR)and reference interval.Results The within-run precision in low level was 2.24%,while it was 2.73% in high level.The overall precision in low level was 2.25%,while it was 2.68%.The relative bias between the results of analyzing the calibrator with a different lot from that used for calibrating and its concen-tration printed was 5.18%.The AMR of the original dilution was 2.44~33.5 g/L.The results of reference interval verifica-tion identified with what the manufactur declares.Conclusion The major performances of analyzing IgG by this system are identifies with the manufactur declares.The reference interval offered by the manufactur is acceptable.The verification and calculation methods are simple and convenient,with strong operability.