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Validation of suPAR turbidimetric assay on Cobas® (c502 and c702) and comparison to suPAR ELISA.
Scandinavian Journal of Clinical and Laboratory Investigation ( IF 1.3 ) Pub Date : 2020-03-18 , DOI: 10.1080/00365513.2020.1741674
Thor A Skovsted 1 , Eva Rabing Brix Petersen 1 , Maj-Britt Fruekilde 1 , Andreas Kristian Pedersen 2 , Tomasz Pielak 3, 4 , Jesper Eugen-Olsen 3, 5
Affiliation  

suPAR is a plasma marker of chronic inflammation, and an elevated suPAR is consistently associated with worse outcome in a variety of clinical conditions. Quantification of suPAR is useful for determining patient risk in triage, but there is no fast automatized method for quick determination of suPAR. We developed and validated a rapid latex particle-enhanced turbidimetric immunoassay for quantification of plasma suPAR on the c502 and the c702 Roche Cobas® 8000 measurment systems. The turbidimetric assay was validated against the suPARnostic® ELISA (ViroGates, Denmark). This validation demonstrates suPAR can be analysed by turbidimetry giving very similar results (<15% difference) compared to the ELISA method and the observed correlations (n = 103) were strong, r > 0.95. Roche Cobas® 8000 instruments demonstrated repeatability and repoducibility, CV % at 3.4–4.1 and 5.7–11.4, respectively. The estimated limit of detection was 1.30 µg/L and 1.31 µg/L for the Cobas® c502 and c702, respectively. Dilution tests showed linearity of suPAR from 1.8 to 26.5 μg/L. The acceptable concentrations of Bilirubin, Intralipid and Hemoglobin, were 350 µmol/L, 3.3 g/L and 1.4 g/L, respectively. suPAR can be quantified reproducibly within 10 min using a turbidimetry assay. This assay is faster than ELISA with similar results, making it suitable for clinical routine analysis.



中文翻译:

在Cobas®(c502和c702)上验证suPAR浊度分析,并与suPAR ELISA进行比较。

suPAR是慢性炎症的血浆标志物,在各种临床情况下,suPAR升高与预后差有关。suPAR的定量可用于确定分流中的患者风险,但尚无快速自动化的方法可快速确定suPAR。我们开发并验证了快速乳胶颗粒增强的浊度免疫测定法,用于定量在c502和c702罗氏Cobas®8000测量系统上的血浆suPAR。浊度测定法已通过ELISA(丹麦ViroGates)进行了验证。该验证表明,与ELISA方法相比,可以通过比浊法对suPAR进行分析,得出非常相似的结果(差异<15%),并且观察到的相关性(n  = 103)很强,r > 0.95。RocheCobas®8000仪器显示出可重复性和可重复性,CV%分别为3.4-4.1和5.7-11.4。Cobas®c502和c702的估计检出限分别为1.30 µg / L和1.31 µg / L。稀释测试显示suPAR的线性范围为1.8至26.5μg/ L。胆红素,内脂和血红蛋白的可接受浓度分别为350 µmol / L,3.3 g / L和1.4 g / L。suPAR可以使用比浊法在10分钟内重现。该测定比ELISA更快,结果相似,适合用于临床常规分析。

更新日期:2020-03-18
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