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Quansys 多重免疫分析法用于检测血清铁蛋白、C 反应蛋白和α-1-酸性糖蛋白,与参考方法相比具有良好的可比性,但与可溶性转铁蛋白受体和视黄醇结合蛋白的检测结果不可比。

The Quansys multiplex immunoassay for serum ferritin, C-reactive protein, and α-1-acid glycoprotein showed good comparability with reference-type assays but not for soluble transferrin receptor and retinol-binding protein.

机构信息

Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.

出版信息

PLoS One. 2019 Apr 29;14(4):e0215782. doi: 10.1371/journal.pone.0215782. eCollection 2019.

Abstract

The Quansys multiplex (Q-Plex) measures ferritin (Fer), soluble transferrin receptor (sTfR), C-reactive protein (CRP), α-1-acid glycoprotein (AGP), and retinol-binding protein (RBP). We compared Q-Plex results with reference-type assays and evaluated Q-Plex performance. Pearson correlation and Lin's concordance coefficients between the Q-Plex and reference assay were: Fer 0.98 and 0.91, sTfR 0.88 and 0.35, CRP 0.98 and 0.98, AGP 0.82 and 0.81, and RBP 0.68 and 0.31, respectively. The median relative difference between the Q-Plex and reference assay were: Fer -2.4%, sTfR 107%, CRP 0.03%, AGP -1.3%, and RBP 51%. The Q-Plex intra-assay CVs were <5%; the inter-assay CVs were higher: Fer 11%, sTfR 14%, CRP 9.3%, AGP 7.5%, and RBP 19%. EDTA plasma produced 74% higher Q-Plex sTfR concentrations compared to serum. Analyte stability was good for ≤5 freeze-thaw cycles. After adjusting Q-Plex data to the reference assays, sensitivity and specificity were >85% for Fer and CRP; specificity was >85% for sTfR, AGP, and RBP. Using performance criteria derived from biologic variation, Fer, CRP, and AGP met the minimum allowable imprecision (<10.7%, <31.7%, and <8.5%, respectively) and difference from the reference assay (<±7.7%, <±32.7%, and <±10.3%, respectively), while sTfR and RBP exceeded these thresholds (<8.5% and <7.8% for imprecision and <±7.7% and <±12% for difference, respectively). The Q-Plex measures multiple biomarkers simultaneously, is easy to perform, and uses small sample volumes. With some improvements in accuracy and precision (i.e., sTfR and RBP), this assay could be a useful tool for low-resource laboratories conducting micronutrient surveys for epidemiologic screening applications. These findings need to be verified using other populations, particularly those with inadequate micronutrient status.

摘要

Quansys 多重检测(Q-Plex)可测量铁蛋白(Fer)、可溶性转铁蛋白受体(sTfR)、C 反应蛋白(CRP)、α-1 酸性糖蛋白(AGP)和视黄醇结合蛋白(RBP)。我们将 Q-Plex 结果与参考类型的检测方法进行了比较,并评估了 Q-Plex 的性能。Q-Plex 与参考检测方法的 Pearson 相关系数和 Lin 的一致性系数分别为:Fer 为 0.98 和 0.91,sTfR 为 0.88 和 0.35,CRP 为 0.98 和 0.98,AGP 为 0.82 和 0.81,RBP 为 0.68 和 0.31。Q-Plex 与参考检测方法的中位数相对差异分别为:Fer 为-2.4%,sTfR 为 107%,CRP 为 0.03%,AGP 为-1.3%,RBP 为 51%。Q-Plex 的批内 CV <5%;批间 CV 更高:Fer 为 11%,sTfR 为 14%,CRP 为 9.3%,AGP 为 7.5%,RBP 为 19%。与血清相比,EDTA 血浆中的 Q-Plex sTfR 浓度高 74%。分析物稳定性在≤5 次冻融循环内良好。调整 Q-Plex 数据至参考检测方法后,Fer 和 CRP 的灵敏度和特异性均>85%;sTfR、AGP 和 RBP 的特异性>85%。使用源自生物学变异的性能标准,Fer、CRP 和 AGP 符合最低允许不精密度(<10.7%、<31.7%和<8.5%)和与参考检测方法的差异(<±7.7%、<±32.7%和<±10.3%),而 sTfR 和 RBP 则超过了这些阈值(<8.5%和<7.8%的不精密度和<±7.7%和<±12%的差异)。Q-Plex 可同时测量多种生物标志物,操作简单,样本量小。如果能在准确性和精密度方面(即 sTfR 和 RBP)有所改进,该检测方法可能成为用于进行流行病学筛查的微量营养素调查的资源有限的实验室的有用工具。这些发现需要使用其他人群进行验证,特别是那些微量营养素状况不足的人群。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bef3/6488062/0b01469b502b/pone.0215782.g001.jpg

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