ATCC, the world’s premier biological materials management and standards organization, today announced the introduction of its new SARS-CoV-2 External Control Kit for clinical laboratories and test manufacturers. The ready-to-run kit provides controls in the rapidly changing COVID-19 testing landscape as a workflow-optimized kit with complete genome coverage that’s widely compatible with most commercial and laboratory-developed tests.
Federal regulation requires that clinical laboratories assess the performance of their testing applications. This new ATCC kit is a practical, kitted solution clinical laboratories can use to meet this requirement. Validated, convenient, and ready-to-use, it offers a universal, full-process positive control (a heat-inactivated virus) and negative control (human cell line) that allow clinical laboratories to easily and accurately verify and assess the quality of their molecular diagnostic assays.
“This is the very first diagnostic quality control product that ATCC has brought to market,” said Raymond H. Cypess, DVM, Ph.D., Chairman and CEO of ATCC. ...