Standing Our Ground for Your Data Quality - Nasal Secretion ECP Assay Validation with Expanded Laboratory Management Solutions (ELMS)

Eosinophil cationic protein (ECP) is a biomarker sometimes used to assess levels of inflammation or allergic response in various body tissues. It may be used as a screening or effectiveness marker in clinical trials such as those for asthma or other immune-mediated inflammatory diseases. Assays for ECP can be done on a variety of sample types. Since ECP assays are not common enough to be run in-house at Covance Central Laboratory Services (CLS), these assays are sent to an external laboratory. On one occasion, a clinical trial sponsor requested that we use a specific laboratory to perform ECP assays on nasal secretions. The Covance Expanded Laboratory Management Solutions (ELMS) team uncovered problems with the validation and some of the subsequent trial data, and then worked closely with the sponsor and external laboratory to ensure any data reported would be valid and stand up to regulatory scrutiny as part of an FDA submission.

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