Analytic Core Lab Rutgers
The Analytic Core Laboratory Rutgers provides 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 Core Lab performs several types of assessments, as described below.
Performance
The Analytic Core Lab confirms key performance specifications of prototype tests as described by the manufacturer. As needed, performance testing includes tests of sensitivity, the limit of detection (LOD), specificity, and ubiquity using the FEND-TB sample collection.
Defects, Design Errors & Procedure Testing
The Analytic Core Lab tests assay procedures and determines whether the workflow is suitable for testing at Clinical Study Site laboratories.
Safety
As needed, the Analytic Core Lab assesses and tests the biosafety of the assay procedures.
Post-Clinical Study Discordant Analysis
The Analytic Core Lab can perform specific testing to help developers find the cause of unexpected discordances or errors identified during the FEND-TB clinical investigation.
Leadership Committee
The FEND-TB Leadership Committee may also choose to use the Analytic Core Laboratory 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 the appropriate FEND-TB Clinical Study Sites. If a “no-go” decision is made, the Analytic Core Laboratory 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.
David Alland
FEND-TB Co-PI
Gayatri Shankar Chilambi
Postdoctoral Fellow