The immunoassay has undergone many re-inventions over the last few decades, moving from single to multiple analyte detection with increasing levels of sensitivity and specificity. A key aspect of an assay’s Analytical Validation is the evaluation of lot-to-lot reproducibility, which has often been traced back to the variability within the assay’s components. Creating these reagents and submitting them to the characterization process provided excellent insight into the various batches. From research and development to their utilization in the creation of multiple lots, these pieces of information added value at each stage.
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