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. “It’s a logical next step for ATCC as it leverages our deep expertise in materials validation and standards. This reliable kit can help clinical laboratories meet their regulatory obligations, and test manufacturers validate their products so that both may continue to play a critical role as part of the global response to this ongoing pandemic.”
The SARS-CoV-2 External Control Kit is compatible with most molecular diagnostic tests being used today. This broad compatibility is critical as surveys from the Association for Molecular Pathology have shown that supply shortages and other factors have led most clinical laboratories to perform COVID-19 diagnostic testing using more than one commercially available and/or laboratory-developed test. 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.
“The positive and negative controls are, as usual, high-quality products from ATCC. These provide reliable and safe process controls for use across the wide range of settings where SARS-CoV-2 molecular testing will be performed,” said Jesse J. Waggoner, M.D., Assistant Professor, Department of Medicine, at Emory University School of Medicine. “In addition, the positive control is provided at a concentration relevant for clinical diagnostic testing: high enough to provide consistent results, but low enough as to require good test performance for detection.”
The ATCC SARS-CoV-2 External Control Kit combines genome coverage of the entire heat-inactivated, native reference strain of the virus at an optimized concentration and a published genomic sequence so that clinical laboratories and test manufacturers can track the mutation rate of the virus over time and adjust as needed.