用Architect ci8200 上的颗粒增强散射免疫比浊法测定尿胱抑素 C。
Measurement of urinary cystatin C with a particle-enhanced turbidimetric immunoassay on Architect ci8200.
机构信息
Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden.
出版信息
J Clin Lab Anal. 2012 Sep;26(5):358-64. doi: 10.1002/jcla.21531.
BACKGROUND
Cystatin C is a low-molecular-weight protein that is freely filtered by the glomerulus and catabolized after reabsorption by the proximal tubular cells in healthy subjects. Urinary cystatin C is a potential biomarker for tubular damage including acute kidney injury (AKI) in the acute phase when patients are submitted to the intensive care unit.
METHODS
The aim of this study was to perform a method validation of urinary analysis of cystatin C by particle-enhanced turbidimetric immunoassay (PETIA) on a high-throughput chemical analyzer. Total assay time was 10 min. The antigen excess, linearity, lower limit of quantification (LoQ), recovery, assay precision, stability, and interference caused by hemoglobin were evaluated.
RESULTS
The LoQ was calculated to 0.020 mg/l with a coefficient of variation (CV) ≤ 10%. No hook effect was observed and the assay was linear over the studied interval less than 0.020-0.950 mg/l with a regression of R² = 0.9994. The assay had a recovery between 93-100% and the assay precision had a total CV of less than 3.5%. Cystatin C was stable for 3 days in room temperature and 14 days in +4C. The assay did not show any major interference with hemoglobin at a hemoglobin concentration of 10 g/L. The reference interval for urine cystatin C was less than 0.166 mg/l.
CONCLUSION
The urinary cystatin C PETIA showed good precision and performance characteristics including short test turnaround times that are necessary qualifications for a biomarker at a routine laboratory.
背景
胱抑素 C 是一种低分子量蛋白质，在健康受试者中可自由通过肾小球滤过，在近端肾小管细胞重吸收后被分解代谢。尿胱抑素 C 是一种潜在的生物标志物，可用于检测包括急性肾损伤（AKI）在内的管状损伤，尤其适用于处于重症监护病房的患者。
方法
本研究旨在对高通量化学分析仪上基于颗粒增强散射比浊免疫测定法（PETIA）的尿胱抑素 C 分析进行方法验证。总检测时间为 10 分钟。评估了抗原过剩、线性、定量下限（LoQ）、回收率、检测精密度、稳定性以及血红蛋白引起的干扰。
结果
LoQ 计算为 0.020mg/L，变异系数（CV）≤10%。未观察到钩状效应，检测在研究区间内呈线性，小于 0.020-0.950mg/L，回归 R²=0.9994。回收率在 93-100%之间，检测精密度总 CV 小于 3.5%。胱抑素 C 在室温下稳定 3 天，在+4°C 下稳定 14 天。在血红蛋白浓度为 10g/L 时，该检测不会对血红蛋白产生明显干扰。尿胱抑素 C 的参考区间小于 0.166mg/L。
结论
尿胱抑素 C 的 PETIA 具有良好的精密度和性能特征，包括较短的检测周转时间，这是常规实验室生物标志物的必要条件。
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