ATCC, Manassas, VA, announced the introduction of its SARS-CoV-2 External Control Kit for clinical laboratories and test manufacturers. The ready-to-run and workflow-optimized kit, includes complete genome coverage that is compatible with most commercial and laboratory-developed tests, according to a press release from the company.
Federal regulation requires that clinical laboratories assess the performance of their testing applications. This new ATCC kit 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, the company said.
The SARS-CoV-2 External Control Kit is compatible with most molecular diagnostic tests being used today. The kit includes positive and negative controls that can be used to determine the performance quality of the lab’s entire testing workflow, including sample extraction and target amplification, regardless of which molecular diagnostic test is being used.
