Establishing and evaluating proper controls are critical to the success and accuracy of any diagnostic assay. Successful controls increase confidence in a diagnosis by verifying that every step in the diagnostic process is working properly and providing reliable information. The testing volume and supply shortages incurred due to the COVID-19 pandemic have stressed all aspects of respiratory disease diagnosis, heightening the importance of internal and external controls.
Dr. John R. Barnes from the Centers for Disease Control and Prevention will give a presentation focusing on developing and validating internal and external controls for nucleic-acid based tests for infectious respiratory disease, using the new CDC Influenza SARS-CoV2 Multiplex Assay as an example. The possible effects of shortages and processing changes on diagnosis and the importance of evaluating controls during the COVID-19 pandemic are also discussed.
Tony Prestigiacomo, Sr. Director of R&D at Thermo Fisher Scientific, will then talk about the importance of quality control in serological testing for infectious disease.