Comparison of Methods Study between a Photonic Crystal Biosensor and Certified ELISA to Measure Biomarkers of Iron Deficiency in Chronic Kidney Disease Patients.

Comparison of Methods Study between a Photonic Crystal Biosensor and Certified ELISA to Measure Biomarkers of Iron Deficiency in Chronic Kidney Disease Patients.
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DOI:
10.3390/s17102203
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发表时间:
2017-09-25
期刊:
Sensors (Basel, Switzerland)
影响因子:
--
通讯作者:
Andrade JE
Andrade JE
中科院分区:
其他
文献类型:
--
作者:
Peterson RD;Wilund KR;Cunningham BT;Andrade JE

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根据经过认证的 ELISA,评估了光子晶体 (PC) 生物传感器在测定作为慢性肾病 (CKD) 患者缺铁性贫血生物标志物的铁蛋白和可溶性转铁蛋白受体 (sTfR) 时的总分析误差。使用功能化氧化铁纳米粒子 (fAb-ION) 从 CKD 患者的血清中提取抗原,然后进行磁力分离。通过固定在 PC 生物传感器表面的互补检测抗体来识别免疫复合物,并使用 BIND 仪器跟踪它们的信号。根据实际蛋白质标准进行定量。总计算误差 (TEcalc) 根据系统误差 (SE) 和随机误差 (RE) 进行估计,并与基于既定质量规范的总允许误差 (TEa) 进行比较。两种检测平台均对生物标志物表现出足够的线性、特异性和灵敏度。两个检测平台的生物标志物之间的平均值、SD 和 CV 相似。与 ELISA 相比,PC 生物传感器对于铁蛋白的固有不精确性较高,但对于 sTfR 则不然。当测量任一生物标志物时,PC 生物传感器中的高 SE 或 RE 导致 TEcalc 高于 TEa。这并不影响 PC 生物传感器区分铁储备低的 CKD 患者的诊断能力。 PC 生物传感器的性能与经过认证的 ELISA 类似;然而,需要优化来减少 TEcalc。
The total analytical error of a photonic crystal (PC) biosensor in the determination of ferritin and soluble transferrin receptor (sTfR) as biomarkers of iron deficiency anemia in chronic kidney disease (CKD) patients was evaluated against certified ELISAs. Antigens were extracted from sera of CKD patients using functionalized iron-oxide nanoparticles (fAb-IONs) followed by magnetic separation. Immuno-complexes were recognized by complementary detection Ab affixed to the PC biosensor surface, and their signals were followed using the BIND instrument. Quantification was conducted against actual protein standards. Total calculated error (TEcalc) was estimated based on systematic (SE) and random error (RE) and compared against total allowed error (TEa) based on established quality specifications. Both detection platforms showed adequate linearity, specificity, and sensitivity for biomarkers. Means, SD, and CV were similar between biomarkers for both detection platforms. Compared to ELISA, inherent imprecision was higher on the PC biosensor for ferritin, but not for sTfR. High SE or RE in the PC biosensor when measuring either biomarker resulted in TEcalc higher than the TEa. This did not influence the diagnostic ability of the PC biosensor to discriminate CKD patients with low iron stores. The performance of the PC biosensor is similar to certified ELISAs; however, optimization is required to reduce TEcalc.
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