Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies

Valentin, Marie‐Anne; Ma, Shuiqing; Zhao, An; Legay, François; Avraméas, Alexandre

doi:10.1016/j.jpba.2011.03.033

Cited by 134 publications

(133 citation statements)

References 22 publications

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“…This includes preanalytic effects associated with the collection and handling (including storage) of samples and analytical variability arising from the methodology, instrumentation, and also technical skills 18, 21, 22. This aspect becomes especially important for the clinician when utilizing patient‐side (ie, in‐house) diagnostic tests 23.…”

Section: Biomarker Characteristicsmentioning

confidence: 99%

“…This aspect becomes especially important for the clinician when utilizing patient‐side (ie, in‐house) diagnostic tests 23. Important variables that are determined for the preanalytical validation of a biomarker assay include the lower detection limit of the assay, assay sensitivity, dilutional parallelism and linearity, assay accuracy, precision, and reproducibility 14, 21. In addition, quality assurance of a biomarker test requires that a quality control program be in place 22, 23…”

Section: Biomarker Characteristicsmentioning

confidence: 99%

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Clinical utility of currently available biomarkers in inflammatory enteropathies of dogs

Heilmann

Steiner

2018

Veterinary Internal Medicne

108

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Chronic inflammatory enteropathies (CIE) in dogs are a group of disorders that are characterized by chronic persistent or recurrent signs of gastrointestinal disease and histologic evidence of mucosal inflammation. These CIEs are classified as either food‐responsive, antibiotic‐responsive, or immunosuppressant‐responsive enteropathy. Patients not clinically responding to immunomodulatory treatment are grouped as nonresponsive enteropathy and dogs with intestinal protein loss as protein‐losing enteropathy. Disease‐independent clinical scoring systems were established in dogs for assessment of clinical disease severity and patient monitoring during treatment. Histopathologic and routine clinicopathologic findings are usually not able to distinguish the subgroups of CIE. Treatment trials are often lengthy and further diagnostic tests are usually at least minimally invasive. Biomarkers that can aid in defining the presence of disease, site of origin, severity of the disease process, response to treatment, or a combination of these would be clinically useful in dogs with CIE. This article summarizes the following biomarkers that have been evaluated in dogs with CIE during the last decade, and critically evaluates their potential clinical utility in dogs with CIE: functional biomarkers (cobalamin, methylmalonic acid, folate, α1‐proteinase inhibitor, immunoglobulin A), biochemical biomarkers (C‐reactive protein, perinuclear anti‐neutrophilic cytoplasmic antibodies, 3‐bromotyrosine, N‐methylhistamine, calprotectin, S100A12, soluble receptor of advanced glycation end products, cytokines and chemokines, alkaline phosphatase), microbiomic biomarkers (microbiome changes, dysbiosis index), metabolomic biomarkers (serum metabolome), genetic biomarkers (genomic markers, gene expression changes), and cellular biomarkers (regulatory T cells). In addition, important performance criteria of diagnostic tests are briefly reviewed.

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Section: Biomarker Characteristicsmentioning

confidence: 99%

Section: Biomarker Characteristicsmentioning

confidence: 99%

Clinical utility of currently available biomarkers in inflammatory enteropathies of dogs

Heilmann

Steiner

2018

Veterinary Internal Medicne

108

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“…All were within a generally acceptable range (<10% for the intra-assay CV and <15% for the inter-assay CV) [25,26]. We therefore concluded that the PS K196E ELISA system can discriminate KE samples from KK samples.…”

Section: Resultsmentioning

confidence: 84%

ELISA-based detection system for Protein S K196E mutation, a genetic risk factor for venous thromboembolism

慶子¹

2016

Nihon Kessen Shiketsu Gakkaishi

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Protein S (PS) acts as a cofactor for activated protein C in the plasma anticoagulant system. PS Lys196-to-Glu (K196E) mutation is a genetic risk factor for venous thromboembolism in Japanese individuals. Because of the substantial overlap in PS anticoagulant activity between KK (wild-type) and KE (heterozygous) genotypes, it is difficult to identify PS K196E carriers by measuring PS activity. Here, we generated monoclonal antibodies specific to the PS K196E mutant and developed a simple and reliable method for the identification of PS K196E carriers. We immunized mice with a keyhole limpet hemocyanin-conjugated synthetic peptide with Glu196. The hybridoma cells were screened for the binding ability of the produced antibodies to recombinant mutant EGF-like domains of PS (Ile117-Glu283). We obtained three hybridoma cell lines producing PS K196E mutation-specific antibodies. We established a sandwich enzyme-linked immunosorbent assay (ELISA) system in which the PS K196E mutation-specific monoclonal antibody was used as a detection antibody. We measured human plasma samples by using this system and successfully discriminated 11 individuals with the KE genotype from 122 individuals with the KK genotype. The ELISA system using the PS K196E mutation-specific antibody is a useful tool for the rapid identification of PS K196E carriers, who are at a higher risk for venous thromboembolism.

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“…The validation experiments were performed according to ISO/IEC 17025, ISO 5725-2, ISO 5725-4 criteria and the validation protocol was devised with reference to several supporting guidance publications [28][29][30][31][32][33][34][35] . Six laboratories located in Sweden, Denmark, Germany, Norway, Finland and Ireland took part in the study.…”

Section: Methodsmentioning

confidence: 99%

“…Linearity of dilution It is important to be able to demonstrate that if the concentration of a protein of interest is above the ULOQ of an assay that it can be diluted, without affecting accuracy of measurement, to a concentration within the working range of the assay 34 . Linearity of dilution was suboptimal in these experiments as 30% of dilutions were outside the pre-defined acceptance range.…”

Section: Recovery (Selectivity)mentioning

confidence: 99%

Multicenter Immunoassay Validation of Cerebrospinal Fluid Neurofilament Light: A Biomarker for Neurodegeneration

et al. 2016

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Aim: Neurofilament light (NfL) chain, a putative cerebrospinal fluid biomarker, can support neurodegenerative disease diagnosis and indicate disease severity and prognosis. Universal validation protocols when used to measure biomarkers can reduce pre and analytical laboratory variation, thus increasing end-user confidence in the consistency of validation data across sites. Methodology: Here, a commercially available NfL ELISA (UmanDiagnostics, Umeå, Sweden) was validated in a multicentered setting using comprehensive newly developed standard operating procedures. Results: The data showed good assay sensitivity and intra and interassay precision. Interlaboratory precision was, however, suboptimal. Conclusion: The UmanDiagnostics assay is suitable for the quantification of NfL in human cerebrospinal fluid. However, sources of interlaboratory variation in the data require further investigation.

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Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies

Cited by 134 publications

References 22 publications

Clinical utility of currently available biomarkers in inflammatory enteropathies of dogs

Clinical utility of currently available biomarkers in inflammatory enteropathies of dogs

ELISA-based detection system for Protein S K196E mutation, a genetic risk factor for venous thromboembolism

Multicenter Immunoassay Validation of Cerebrospinal Fluid Neurofilament Light: A Biomarker for Neurodegeneration

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