ArticleDiscoveries (Craiova, Romania)
Validation of commercially available ELISAs for the detection of circulating sclerostin in hemodialysis patients.
Article in Discoveries (Craiova, Romania). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The trial behind it
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Who cites it
8 citing papers in PubMed, 15 citations in OpenAlex.
- Predictors of Hungry Bone Syndrome After Parathyroidectomy in Secondary Hyperparathyroidism: A Narrative Review of Bone Turnover Biomarkers and Risk Prediction Tools.Journal of clinical medicine · 2025Review
- The Relationship between Sclerostin and Kidney Transplantation Mineral Bone Disorders: A Molecule of Controversies.Calcified tissue international · 2024Review
- Sclerostin: From Molecule to Clinical Biomarker.International journal of molecular sciences · 2022Review
- Review
- Clinical advantages and disadvantages of anabolic bone therapies targeting the WNT pathway.Nature reviews. Endocrinology · 2018Review
- Biomarkers Predicting Bone Turnover in the Setting of CKD.Current osteoporosis reports · 2017Review
- Novel bone metabolism-associated hormones: the importance of the pre-analytical phase for understanding their physiological roles.Endocrine · 2017Review
- Review
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 3 countries.
Funding
Abstract
backgroundSclerostin is an endocrine regulator in chronic kidney disease - mineral and bone disorder (CKD-MBD). Validation of assay comparability and pre-analytical handling is mandatory for establishment of sclerostin as a biomarker.
methodsBlood samples (serum, EDTA, heparin and citrate plasma) were obtained from 12 hemodialysis (HD) patients after the long dialysis interval. Passing-Bablok regression analysis and Bland-Altman difference plots were used to evaluate the agreement between sclerostin levels measured with two commercially available ELISAs from TECOmedical and Biomedica.
resultsIndependent of the sample type, the agreement of the two assays was poor with a strong proportional but no systematic bias. Compared to the TECOmedical assay, the Biomedica test yielded almost 2-fold higher sclerostin values throughout all sample types. Spike recovery and linear dilution studies revealed a higher accuracy of the TECOmedical assay (97% and 96%) compared to the Biomedica assay (118% and 78%). Sclerostin levels were stable within 4 hours after sample collection, in particular when analyzed in plasma. In contrast to the Biomedica assay, the TECOmedical showed a systematic but no proportional bias between serum and plasma samples with higher values for plasma samples. Among the 3 different plasma samples no systematic error could be documented.
conclusionCareful consideration of the pre-analytical handling and comparative assay validation are necessary to facilitate a more differentiated interpretation of studies reporting circulating sclerostin levels. The presence of a proportional bias demonstrates that in HD patients the two ELISAs for measuring sclerostin should not be used interchangeably. Furthermore, caution is necessary when comparing sclerostin results obtained from different blood sample types.
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Registered trials
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