What is the Origin of Orthogonal Assay Strategy?

The term 'orthogonal' is borrowed from mathematics, where it means statistically independent or non-overlapping. Its application in assay development arose from the need for irrefutable confirmation of results in highly regulated fields like drug manufacturing and clinical pathology. This strategy is a best practice mandated by regulatory bodies to mitigate the risk of false positives or negatives.

What is the Mechanism of Orthogonal Assay Strategy?

The strategy involves selecting two or more assays that measure the analyte using distinct properties. For example, quantifying a hormone might involve an immunoassay (based on antibody binding) and a mass spectrometry method (based on molecular weight and charge). If both methods yield a concordant result, the confidence in the reported concentration is significantly higher than if only one method was used. This multi-layered validation ensures precision and reliability in patient diagnostics and therapeutic product quality.

Orthogonal Assay Strategy ∞ Area

Orthogonal Assay Strategy

Meaning

An Orthogonal Assay Strategy is a robust quality control and validation approach in pharmaceutical development and clinical diagnostics where multiple, independent analytical methods are used to confirm the presence, concentration, or activity of a single substance, such as a hormone or peptide. The term ‘orthogonal’ implies that each method relies on a fundamentally different physical or chemical principle, ensuring that any measurement bias or artifact inherent to one technique is unlikely to affect the results of the others. This is paramount for ensuring the accuracy of bio-identical hormone compounding and peptide purity verification. It provides maximum confidence in analytical results.