›› 2013, Vol. 28 ›› Issue (5): 408-411.DOI: 10.3969/j.issn.1673-8640.2013.05.015

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Evaluation on the bias of two detection systems for serum cystatin C

  

  1. 1.Department of Clinical Laboratory,Shanghai Eighth People′s Hospital,Shanghai 200235,China; 2. Department of Clinical Laboratory,Huashan Hospital,Fudan University,Shanghai 200040,China
  • Received:2012-09-07 Revised:2012-12-06 Online:2013-05-15 Published:2013-05-14

Abstract: Objective To compare methodologically and evaluate the bias of turbidimetric assay and particle-enhanced nephelometric assay for serum cystatin C(Cys C). Methods According to the National Committee for Clinical Laboratory Standards (NCCLS) EP9-A2 document,40 serum samples were determined in duplicate measurement by Roche MODULAR P800 automatic biochemical analyzer and Siemens BN-Ⅱ specific protein analyzer, respectively. The data were used to check outliers,linear regression was analyzed,and the predictive bias and confidence interval(CI) were calculated. Results The linear regression equation was Y=1.216X-0.139,r 2=0.978. When the Cys C concentrations were 0.53 mg/L and 0.95 mg/L,the acceptable biases were in the range of 95%CI of predictive bias. However, when the Cys C concentration  was 7.85 mg/L,the acceptable bias was<the low limit of 95%CIof predictive bias. Conclusions The results of the 2 detection systems have linear correlation. The predictive bias of measured results between the 2 detection systems is acceptable except the high concentration.

Key words: Cystatin C, Turbidimetric assay, Particle-enhanced nephelometric assay, Bias