How to Approach Diagnosing the Next Pandemic. A Lesson From COVID-19

How to Approach Diagnosing the Next Pandemic. A Lesson From COVID-19

Abstract
COVID-19 resulted in PCR becoming part of global lexicon and there cannot be many other examples where diagnostic tests have been discussed so extensively in the press on an international scale. Furthermore, it is very difficult to imagine how the world would have responded to COVID-19 without molecular methods like PCR. Yet routes to assess the performance COVID-19 diagnostics varied with nation, which was exacerbated early in the pandemic by the lack of standards. As the pandemic continued, quality control materials and the WHO standard came available to support test performance evaluation. However, despite this, such controls were often not used to support viral RNA quantification when applied to SARS-CoV-2 specimens. Whether to attempt to stratify patients, assess performance targets, select specimens for subsequent sequencing or to compare with other methods, such as lateral flow tests, uncalibrated quantification was commonplace. Viral quantities, and associated dynamics, were also often not considered when discussing test choice and application. This was possibly linked to the fact that COVID-19 diagnostic tests were typically testing for presence or absence, and not the quantity, of SARS-CoV-2. This presentation will discuss these considerations, outline the potential impact had MIQE been more widely applied and explore routes to improve the rapid development and application of PCR based diagnostics in response to future outbreak threats