Performance evaluation of the Sysmex Cystatin C assay on Roche Modular P system
Objectives: Cystatin C (CysC) has been proposed as a sensitive marker to estimate the glomerular filtration rate.The aim of this study is to evaluate the analytical performance of the Sysmex CysC assay on the Roche Modular P Chemistry Analyzer (Modular P).Design and Methods: The evaluation of imprecision, linearity, recovery and interference were performed according to the relevant Clinical and Laboratory Standards Institute guidelines protocols, using quality-controls and patient samples.Methods comparison studies were carried out against Siemens and Roche assay.Results: The Within-run coefficient of variation (CV) was 2.81% and 2.04 % at CysC concentrations of 0.45 and 1.80 mg/L, respectively.Between-run CV was 3.14 % and 3.26 % at the same concentrations.The CysC assay was linear from 0.10 to 8.00 mg/L.Good correlations were achieved in the comparisons of the three CysC measurements.The Sysmex assay appeared to report higher results than the Siemens assay.No interference was detected from haemoglobin 5 g/L, bilirubin (free and conjugated type) 200mg/L and chyle 1500 formazin turbidity units.Conculsions: Sysmex CysC assay showed favorable basic performance, including precision, dilution linearity and effects of interfering substances.It is an acceptable assay for the determination of CysC on the Modular P.
Cystatin C glomerular filtration rate performance evaluation
Min He Pei-feng Ke Jian-hua Xu Wei-ye Chen Hai-biao Lin Cheng Zhang Yun-xiu Wang Jun-hua Zhuang Xian-zhang Huang
Department of Clinical Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, P.R.China
国内会议
第九届粤桂琼检验医学学术会议暨海南省医学会检验医学专业委员会2015年学术年会
海南陵水
英文
84-91
2015-10-01（万方平台首次上网日期，不代表论文的发表时间）