The Analytic Laboratory Core will provide a means for FEND-TB to independently test key assay parameters to ensure that assays are ready for evaluation at FEND-TB Clinical Study Sites. The Analytic Laboratory Core will perform several types of assessments: 1) performance. The Core will confirm key performance specifications of prototype tests as described by the manufacturer. As needed, performance testing will include tests of sensitivity, limit of detection (LOD), specificity, and ubiquity using the FEND-TB sample collection 2) defects, design errors and procedure testing. The Analytic Laboratory Core will test assay procedures and determine whether the workflow is suitable for testing at Clinical Study Site laboratories. 3) safety. As needed, the Core will assess and test the biosafety of the assay procedures. 4) post clinical study discordant analysis. The Core can perform specific testing to help developers find the cause of unexpected discordances or errors identified during FEND-TB clinical investigation.
The FEND-TB Leadership Committee may also choose to use the Analytic Laboratory Core results to determine whether an assay meets minimal requirements and a “go” decision can be made to progress that assay to evaluation under the appropriate FEND-TB study protocol at appropriate FEND-TB Clinical Study Sites. The Core may also assist in creating case report forms and clinical study site testing procedures based on their in house experience with the test. If a “no-go” decision is made, the Analytic Laboratory Core will provide feedback to the developer to help it resolve outstanding performance issues, after which the revised assay could be resubmitted via the FEND-TB website for consideration for re-assessment.