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.

译文

背景:胱抑素C是一种低分子量蛋白质,在健康受试者中被肾小球自由过滤并在近端肾小管细胞重吸收后分解代谢。当患者被送往重症监护病房时,尿半胱氨酸蛋白酶抑制剂C是潜在的肾小管损伤的生物标志物,包括急性期的急性肾损伤(AKI)。
方法:本研究的目的是通过在高通量化学分析仪上进行的颗粒增强浊度免疫测定法(PETIA)对尿液中的胱抑素C进行尿分析进行方法验证。总测定时间为10分钟。评估了抗原过量,线性,定量下限(LoQ),回收率,测定精度,稳定性和血红蛋白引起的干扰。
结果:计算出的最低定量为0.020 mg / l,变异系数(CV)≤10%。没有观察到钩效应,并且在小于0.020-0.950mg / l的研究间隔内该测定是线性的,回归值R 2 = 0.9994。该测定的回收率在93-100%之间,测定精度的总CV小于3.5%。胱抑素C在室温下稳定3天,在4C下稳定14天。该测定在血红蛋白浓度为10 g / L时未显示出对血红蛋白的任何主要干扰。尿胱抑素C的参考间隔小于0.166 mg / l。
结论:尿半胱氨酸蛋白酶抑制剂PETIA显示出良好的精度和性能特征,包括较短的测试周转时间,这是常规实验室中生物标志物的必要资格。

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