“The COVID-19 pandemic has changed the game for global public health. Never before have diagnostics had the attention of the whole world.”
Governments, key organisations like the WHO and FIND healthcare organisations, and diagnostics suppliers are responding with urgency to the immediate need for comprehensive and mass population COVID-19 testing.
The diagnostics test market is literally being flooded with an increasing number of tests for SARS-CoV-2, the most recent count confirmed 250+ and approaching 600 listed according to the FIND organisation in Geneva: https://www.finddx.org/covid-19/pipeline/. “Understanding which of these tests should be used when, where and how is critical and high priority for us. There is a chronic lack of data across the board that is compromising decision making and frankly putting lives at risk.” Dr. Catharina Boehme CEO FIND and member of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD).
Whereas RT PCR testing may support accurate detection of the SARS-COV-2 virus, inadequate swab processes may result in false negatives. The development of serologic assays that accurately assess prior infection and immunity to SARS–CoV-2 will be essential as part of a confirmatory strategy and further in epidemiologic studies, ongoing surveillance, vaccine studies, and potential for risk assessment of health care workers. Immunoassays are already on the market in some countries, but their diagnostic accuracy and optimal use remain undefined1.
The COVID-19 pandemic began only in January 2020, and consequently, there is still an extraordinary amount to learn about the behaviour of the virus and the course of infection and disease. There are a significant number of reports now of large scale false negatives arising from unproven tests (see reference links below).
Never has Clinical Diagnostics been so centre-stage and now called upon to lead through this pandemic. Equally never has Quality Control been more important in allowing laboratories to release patient results with confidence.
"Demand better quality. Demand data on validation studies, sensitivity, specificity. Conduct those studies in your own lab. Share them with your colleagues. You should add third-party controls to your methods as soon as possible" James Westgard on COVID-19 testing
The key serology test players in the platform diagnostics market and the healthcare market have called on Technopath to deliver QC solutions that can be trusted and we are responding. We will begin the launch of our COVID-19 IgG and Neg products to market from May 2020. COVID-19 IgM Quality Control will launch in June 2020.
Cheng MP, Papenburg J, Desjardins M, et al. Diagnostic Testing for Severe Acute Respiratory Syndrome–Related Coronavirus-2: A Narrative Review. Ann Intern Med. 2020; [Epub ahead of print 13 April 2020]. doi: https://doi.org/10.7326/M20-1301