基于 Cobas c501 的粒子增强比浊免疫法测定尿胱抑素 C
Particle enhanced turbidimetric immunoassay for the determination of urine cystatin C on Cobas c501.
机构信息
Section of Clinical Chemistry, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
出版信息
Clin Biochem. 2012 Mar;45(4-5):339-44. doi: 10.1016/j.clinbiochem.2011.12.027. Epub 2012 Jan 12.
OBJECTIVE
Urinary cystatin C has been reported to be a good marker for tubular damage and acute kidney injury. The aim of this study was to develop a high throughput assay for the quantification of urine cystatin C.
METHODS
Antigen-excess, imprecision, interference, linearity, recovery, sample stability and reference values were evaluated on Cobas c501.
RESULTS
The assay was linear over the dynamic range of the study (R²=0.9994). The total assay imprecision was below 5%. The assay recovery was estimated at 87-100%. No tendency to antigen-excess (up to 35 mg/L), nor interference with haemoglobin (1.25-10 g/L) was observed. Cystatin C was stable for 1 day at ambient temperature (19-23°C) but for 2 days at +4°C. The reference interval for cystatin C in urine was <0.414 mg/L.
CONCLUSIONS
The urinary cystatin C assay verified to be a reliable assay with convenient performance characteristics, enabling routine testing on clinical chemistry platforms.
目的
尿胱抑素 C 已被报道为肾小管损伤和急性肾损伤的良好标志物。本研究旨在开发一种高通量测定尿胱抑素 C 的方法。
方法
在 Cobas c501 上评估抗原过量、不精密度、干扰、线性、回收率、样品稳定性和参考值。
结果
该测定法在研究的动态范围内呈线性（R²=0.9994）。总测定不精密度低于 5%。回收率估计为 87-100%。未观察到抗原过量（高达 35mg/L）或与血红蛋白（1.25-10g/L）的干扰。胱抑素 C 在室温（19-23°C）下稳定 1 天，但在+4°C 下稳定 2 天。尿胱抑素 C 的参考区间<0.414mg/L。
结论
尿胱抑素 C 测定法具有可靠的性能特征，是一种可靠的测定法，可在临床化学平台上进行常规检测。
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