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PubMed · 42116799

Assay-dependent variability in peptide biomarker quantification: experimental evidence from renalase in chronic kidney disease.

Natalia Serwin·Elżbieta Cecerska-Heryć·Bartłomiej Grygorcewicz·Magda Wiśniewska·Aleksandra Gomółka·Katarzyna Bąk·Aleksandra Cader-Ptak·Bartosz Wojciuk·Marcin Lisak·Martyna Opara-Bajerowicz·Aleksandra Polikowska·Małgorzata Goszka·Karol Serwin·Mariusz Suwała·Katarzyna Fiedorowicz·Kazimierz Ciechanowski·Barbara Dołęgowska
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Abstract

BACKGROUND: Renalase is a promising biomarker for kidney disease, but published levels vary widely between studies. We hypothesised that variability in commercial enzyme-linked immunosorbent assays (ELISAs) kits and matrix effects (serum vs plasma) drive these inconsistencies. METHODS: Paired serum and plasma samples from 56 participants (28 chronic kidney disease (CKD) stages 2-5, 28 healthy controls) were tested using three commercial renalase ELISAs (BTLAB, Cloud-Clone, EIAab). We assessed intra-assay precision, inter-assay agreement (Spearman's rank correlation and Bland-Altman analysis on log10-transformed values), matrix effects, and associations with estimated glomerular filtration rate (eGFR). Diagnostic performance was evaluated by Receiver operating characteristic (ROC) analysis. RESULTS: Inter-assay renalase concentrations differed markedly (up to orders of magnitude), with weak inter-assay correlations (r&#x2009;&#x2264;&#x2009;0.25). Bland-Altman analyses revealed large, systematic biases between kits. Only the BTLAB assay showed consistent serum/plasma agreement, a significant correlation with eGFR (&#x3c1;&#x2009;&#x2248;&#x2009;0.32-0.42, p&#x2009;<&#x2009;0.05), and moderate discriminatory performance for CKD in serum (AUC = 0.70) and plasma (AUC = 0.68). Cloud-Clone and EIAab produced divergent results and strong matrix-dependent biases. CONCLUSIONS: Observed variability among commercial ELISA platforms may compromise comparability between studies. Harmonisation, standardised reference materials, and cross-validation are necessary before renalase assays can be used reliably in clinical practice.

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HumansBiomarkersRenal Insufficiency, ChronicEnzyme-Linked Immunosorbent AssayFemaleGlomerular Filtration RateMaleMonoamine OxidaseMiddle AgedROC CurveAgedReproducibility of ResultsAdultCase-Control StudiesELISA assay variabilityRenalaseassay standardisationbiomarker variabilitychronic kidney diseasematrix effectJournal ArticleResearch Support, Non-U.S. Gov't

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Natalia Serwin, El&#x17c;bieta Cecerska-Hery&#x107;, Bart&#x142;omiej Grygorcewicz, Magda Wi&#x15b;niewska, Aleksandra Gom&#xf3;&#x142;ka, Katarzyna B&#x105;k, Aleksandra Cader-Ptak, Bartosz Wojciuk, Marcin Lisak, Martyna Opara-Bajerowicz, Aleksandra Polikowska, Ma&#x142;gorzata Goszka, Karol Serwin, Mariusz Suwa&#x142;a, Katarzyna Fiedorowicz, Kazimierz Ciechanowski, Barbara Do&#x142;&#x119;gowska. 2026-05-12. Assay-dependent variability in peptide biomarker quantification: experimental evidence from renalase in chronic kidney disease.. https://doi.org/10.1080/07853890.2026.2668217

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Adult subjectAged subjectBiomarkers subjectCase-Control Studies subjectChronic kidney disease subjectFemale subjectGlomerular Filtration Rate subjectHumans subjectJournal Article subjectJournal Article; Research Support, Non-U.S. Gov't resourceMale subjectMiddle Aged subject

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