Analytical Performance of ELISA Assays in Urine: One More Bottleneck towards Biomarker Validation and Clinical Implementation

PloS One
Despina ChatziharalambousJerome Zoidakis

Abstract

ELISA is the main approach for the sensitive quantification of protein biomarkers in body fluids and is currently employed in clinical laboratories for the measurement of clinical markers. As such, it also constitutes the main methodological approach for biomarker validation and further qualification. For the latter, specific assay performance requirements have to be met, as described in respective guidelines of regulatory agencies. Even though many clinical ELISA assays in serum are regularly used, ELISA clinical applications in urine are significantly less. The scope of our study was to evaluate ELISA assay analytical performance in urine for a series of potential biomarkers for bladder cancer, as a first step towards their large scale clinical validation. Seven biomarkers (Secreted protein acidic and rich in cysteine, Survivin, Slit homolog 2 protein, NRC-Interacting Factor 1, Histone 2B, Proteinase-3 and Profilin-1) previously described in the literature as having differential expression in bladder cancer were included in the study. A total of 11 commercially available ELISA tests for these markers were tested by standard curve analysis, assay reproducibility, linearity and spiking experiments. The results show disappointin...Continue Reading

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Citations

Oct 6, 2017·Proteomics. Clinical Applications·Agnieszka LatosinskaHarald Mischak
Jan 13, 2018·International Journal of Molecular Sciences·Jan GleichenhagenGeorg Johnen
Jul 28, 2018·Carcinogenesis·Alessandra AllioneGiuseppe Matullo
May 28, 2016·Expert Review of Proteomics·Michael HarpoleVirginia Espina

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Methods Mentioned

BETA
enzyme-linked immunosorbent assays
ELISAs
ELISA

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