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.
ABSTRACT
Objective To compare the performance of HP-083/4 and rational used instrument on detecting six items.Methods The rational instruments were used as contrast instrument,HP-083/4 was the verified instrument.A total of 100 blood specimens and 100 urine specimens were collected,and the levels of antistreptolysin O(ASO),hypersensitive C reactive protein (hsCRP),D-di-mer(D-D),glycosylated hemoglobin(HbA1c),rheumatoid factor(RF)and urine microalbumin(mAlb)were detected.The regression equation and correlation coefficient(r)of the two methods were calculated,and the Kappa values(κ)were analyzed to evaluate the performance of HP-083/4.Results There was a good linear correlation (r >0.950)for the two methods in detecting the serum ASO,hsCRP,D-D,HbA1c,RF and mAlb,r were 0.991,0.995,0.970,0.957,0.980 and 0.967 respectively.Besides,they had good concordance(κ>0.6),theκ values were 0.830,0.957,0.601,0.720,0.920 and 0.694 respectively.Conclusion HP-083/4 is effec-tive in detecting ASO,hsCRP,D-D,HbA1c,RF and mAlb,which should be suitable for clinical application.