Research use only (RUO) label indicates in vitro diagnostic (IVD) products that can be used in the laboratory research phase of development. RUO ELISA kits are helpful for early drug discovery or preliminary diagnostic testing analyses but are not yet fully validated for compliance under GLP or clinical regulations. Commercially available RUO kits for ELISA lab protocols are typically qualified to some degree to ensure specificity, accuracy, and precision. Still, we need to fully validate these kits for the stability of test articles and critical reagents, cross-reactivity, or matrix interference. RUO ELISA Quantification procedures can be validated if the need arises, typically for novel biologic therapeutics reaching the preclinical toxicology phase or for novel clinical biomarkers of disease or therapy.