The IsoTag™ LV Residual Reagent assay is a two-site immuno-enzymatic assay intended to quantify IsoTag™ LV Residual Reagent. The F1070 kits incorporate a well-qualified sample treatment method to dissociate the IsoTag™ LV Residual Reagent from the LV virus, virus-like particle or other compatible target. Samples potentially containing residual IsoTag™ LV Reagent are mixed with sample denaturing buffer to dissociate the biopolymer from the LV virus. The samples are then reacted simultaneously with a horseradish peroxidase (HRP) enzyme labeled anti-IsoTag™ LV Reagent antibody in microtiter strips coated with an affinity purified capture antibody. After a wash step to remove any unbound reagents, the strips are reacted with TMB substrate and read on a microtiter plate reader to quantify the concentration of IsoTag™ LV Residual Reagent present in the sample. This immunoassay method provides sensitivity to the IsoTag™ LV Residual Reagent to less than 1ng/mL. This kit can be used as a tool to aid in optimal purification process development and in routine quality control of in-process manufacturing as well as final product.
