We have validated our Concentric by Ginkgo next-generation sequencing (NGS) assay both for individual and pooled samples. When analyzing individual samples, we found a 96% percent positive agreement and 100% percent negative agreement with both nasopharyngeal and anterior nasal swab clinical samples run with a high sensitivity RT-qPCR comparator assay. When testing contrived 35-dry swab pooled samples at no virus (0 copies/mL), low viral concentrations (1500 copies/mL) and high viral concentrations (75,000 copies/mL), we found 100% concordance with the expected result.
Our NGS test is a laboratory-developed test (LDT) that has been validated and is conducted in our CLIA-certified lab located in Boston, Massachusetts. LDTs do not require premarket review or authorization by the FDA. A copy of the test validation report is available upon request.