ELISA Assay Reliability
When using an ELISA assay, it is important to ensure that the results are specific, accurate, sensitive, and reproducible. The ELISA assay reliability varies among kit suppliers, so choosing the “right” ELISA requires careful consideration. Access to the assay´s validation data before making a choice may be helpful.
ELISA Assay Reliability
At BIOMEDICA we take pride in developing and manufacturing our ELISA kits following a stringent manufacturing and quality control process, that enables us to maintain consistent and reproducible outcomes with every lot we produce.
At Biomedica we develop and manufacture our ELISA assays with care
All BIOMEDICA kits are fully validated and come with sample data for healthy human subjects, ready-to-use standards and controls. We supply our kits with color-coded vials, and some of the reagents are “colorful” as well, to make the kits easy to use and to avoid possible pipetting errors, To increase transparency, we publish the validation data of every ELISA assay kit on our website.
BIOMEDICA´s QUALITY GUIDELINES
AT BIOMEDICA, our goal is to supply reliable and well-validated ELISA kits for your research.
Here is how we ensure product excellence:
- Optimization: we diligently optimize all Biomedica assay to guarantee reliability, sensitivity, and precision.
- Validation: our kits undergo an extensive validation process in accordance with international quality guidelines (FDA, EMA, and ICH), ensuring the kits accuracy and efficiency.
- Expert Team: our dedicated team consists of highly qualified scientists, many with doctorate-level education and industry training. Our team has extensive research experience and contributes to the development, production, and customer service aspects of our products.
- Quality Management: Biomedica adheres to the ISO 9001: 2015 certified quality management system in our manufacturing process, ensuring consistent and high-quality products.
With these measures in place, we are committed to deliver ELISA assays that meet the highest standards of performance and reliability.
Learn more: https://www.bmgrp.com/quality
Interference in ELISA. Matson RS. 2023. Methods Mol Biol. 2612:91-99. doi: 10.1007/978-1-0716-2903-1_7. PMID: 36795361.
ELISA is a well-established technique used worldwide to quantify analytes present in a diverse milieu of biological samplings. It is especially important to clinicians who rely on the accuracy and precision of the test to administer patient care. Those results are to be held with great scrutiny since the assay is subject to error caused by interfering substances found in the sample matrix. In this chapter, we examine the nature of such interferences and discuss approaches to identify and offer remedies to remove the interference and validate the assay.
Validation of an enzyme-linked immunosorbent assay (ELISA) for quantification of endostatin levels in mice as a biomarker of developing glomerulonephritis. Wallwitz J, Aigner P, Gadermaier E, Bauer E, Casanova E, Bauer A, Stoiber D. 2019. PLoS One. 14(8):e0220935. doi: 10.1371/journal.pone.0220935. PMID: 31404120; PMCID: PMC6690585.
Endostatin, the C-terminal fragment of type XVIII collagen, was shown to be one of the most potent endothelial cell-specific inhibitors of angiogenesis. As altered circulating endostatin concentration is associated with impaired kidney function, new tools for measuring endostatin in rodents may be helpful to further investigate and understand its role within kidney disease progression. A novel and commercially available ELISA for the quantification of mouse and rat endostatin was developed and validated according to international quality guidelines including the parameters specificity, robustness, accuracy, dilution linearity, precision, limit of detection (LOD) and lower limit of quantification (LLOQ). Endostatin and blood urea nitrogen (BUN) concentration were measured in mice with a glomerulonephritis phenotype. The validation revealed that within the range of 0.5-32 nmol/L the immunoassay is robust and highly specific for the measurement of rodent endostatin with high sensitivity (LOD 0.24 nmol/L, LLOQ 0.5 nmol/L) and good reproducibility (intra- and inter-assay CV <10%). Also accuracy and dilution linearity were within the range of acceptance. BCL2 transgenic and ETV6/RUNX1;BCL2 double transgenic mice develop a glomerulonephritis phenotype over time, which was displayed by staining of kidney sections. Even before full manifestation of disease serum endostatin concentration rises significantly, whereas BUN levels just slightly increase. This newly developed and commercially available ELISA provides a reliable and accurate tool for the quantification of mouse and rat endostatin and may give new perspectives in the investigation of the role of endostatin as an important and early biomarker for reduced kidney function. Measurement of endostatin concentration is recommended to be used as a superior biomarker for chronic kidney disease compared to BUN.
Practical Guide to Immunoassay Method Validation. Andreasson U et al. 2015. Front Neurol. 19;6:179. doi: 10.3389/fneur.2015.00179. PMID: 26347708; PMCID: PMC4541289.