SYSTEMS AND METHODS FOR LABORATORY ASSAY VALIDATION OR VERIFICATION

摘要

Systems and methods are used to generate a protocol for an assay. At least one performance characteristic parameter of an assay and at least one standardized protocol for each assay of a plurality of assays and assay types are stored. A performance characteristic parameter selection and an assay selection are received from a client device of a laboratory. One or more performance characteristic parameters and a standardized protocol are retrieved from the database device. The client device is sent the one or more performance characteristic parameters and one or more study variable values. One or more amendments to the one or more performance characteristic parameters and one or more study variable values are received from the client device. A protocol for the assay is generated based on the one or more amendments.