When using an ELISA kit, you want to ensure that results are specific, accurate, sensitive, and reproducible,
ELISA assay reliability is important and having access to the assay´s validation data before making a purchase decision is an advantage. Not every ELISA kit supplier offers the same level of assay validation.
This is one of the reasons why the ELISA kits on the market vary so much and one should choose them with care.
In a fully validated ELISA, all components are rigorously tested and therefore fit perfectly together. This minimizes the sources of error, increasing specificity, accuracy, and reproducibility.
ELISA Assay Reliability
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. To increase transparency, we publish our validation data on our website. To learn more, check out https://www.bmgrp.com/quality .
Related literature
Practical Guide to Immunoassay Method Validation. Andreasson U, Perret-Liaudet A, van Waalwijk van Doorn LJ, Blennow K, Chiasserini D, Engelborghs S, Fladby T, Genc S, Kruse N, Kuiperij HB, Kulic L, Lewczuk P, Mollenhauer B, Mroczko B, Parnetti L, Vanmechelen E, Verbeek MM, Winblad B, Zetterberg H, Koel-Simmelink M, Teunissen CE. AFront Neurol. 2015 Aug 19;6:179. doi: 10.3389/fneur.2015.00179. PMID: 26347708; PMCID: PMC4541289.
Abstract
Biochemical markers have a central position in the diagnosis and management of patients in clinical medicine, and also in clinical research and drug development, also for brain disorders, such as Alzheimer’s disease. The enzyme-linked immunosorbent assay (ELISA) is frequently used for measurement of low-abundance biomarkers. However, the quality of ELISA methods varies, which may introduce both systematic and random errors. This urges the need for more rigorous control of assay performance, regardless of its use in a research setting, in clinical routine, or drug development. The aim of a method validation is to present objective evidence that a method fulfills the requirements for its intended use. Although much has been published on which parameters to investigate in a method validation, less is available on a detailed level on how to perform the corresponding experiments. To remedy this, standard operating procedures (SOPs) with step-by-step instructions for a number of different validation parameters is included in the present work together with a validation report template, which allow for a well-ordered presentation of the results. Even though the SOPs were developed with the intended use for immunochemical methods and to be used for multicenter evaluations, most of them are generic and can be used for other technologies as well.
The Measurement and Interpretation of Fibroblast Growth Factor 23 (FGF23) Concentrations.