Diagnostics in the spotlight: Lessons from the COVID-19 pandemic

• In vitro diagnostics play an increasingly important role in healthcare, helping millions of people after diagnosis with many major diseases and conditions
• COVID-19 thrust the importance of high quality diagnostics and testing infrastructure into the spotlight
• The pandemic has made the case for incorporating powerful and robust diagnostic testing capabilities in health systems worldwide

The ongoing COVID-19 pandemic has laid bare many strengths and weaknesses of healthcare systems around the world. Faced with an unforeseen wave of infectious disease, governments and health authorities raced to implement a myriad of solutions on a massive scale, including quarantine facilities, contact tracing, artificial ventilation, vaccines and of course, diagnostic testing. The importance of high diagnostic quality was also highlighted during the pandemic.

For decades, in vitro diagnostics (IVDs) have played an increasingly important role in healthcare, influencing over 66% of clinical decision-making.¹ This has come at a very low cost, considering that IVDs account for only about 2% of total healthcare spending.¹

Thanks to the routine use of diagnostic testing, many people are thriving for years after being diagnosed with heart disease and cancer as well as infectious diseases like human immunodeficiency virus (HIV) and hepatitis. There are over 40,000 different IVD products available that provide information to doctors and patients.¹ Testing is such a fundamental aspect of modern medicine that the World Health Organization (WHO) has designated 122 test categories as essential for “advancing universal health coverage, addressing health emergencies and promoting healthier populations.”²

The importance of accurate and reliable diagnostic testing has been well established. However, with the advent of the COVID-19 crisis, diagnostics were instantly thrust into the spotlight. With very little warning, health authorities needed to rapidly procure, carry out and process millions of diagnostic tests. A previously under-promoted aspect of the healthcare system was suddenly at the center of a storm.

Of major importance was understanding how to practically implement these diagnostics, especially in regard to test quality and testing infrastructure. To that end, the pandemic brought certain weaknesses to the forefront and unfortunately showed that incorporating diagnostics on a global scale was inefficient and inadequate. More specifically, the lack of previous investment and preparation in testing capabilities became clear and obvious as the pandemic grew around the world.

This led to shortages, not only of tests themselves, but of the resources needed to process them. The supply chain of pipettes, swabs and reagents was overwhelmed with the sudden explosion of demand. Beyond a lack of materials and testing capacity, there was also the issue of testing infrastructure, such as which facilities can run the tests and where the results can be evaluated. These issues affected many healthcare systems including those that were seen as high-quality and high-functioning in normal situations.

Testing quality was also under scrutiny throughout the crisis, as diagnostic companies worked within extremely tight timelines to be the first to bring desperately needed tools to market. While millions of test kits were being manufactured and delivered in record time, it was no surprise that some failed to meet the typical quality standards. As countries were working hard to find sufficient tests, the pressure on healthcare systems to rapidly scale up their COVID-19 testing capabilities led to the usage of unreliable diagnostic solutions.^3,4

So what can be done to address the weaknesses and gaps in diagnostics that the COVID-19 pandemic has exposed? It is clear that investment in stable, robust diagnostic capabilities and infrastructure is required. This includes increased investment in point of care testing, creation of a more sustainable testing infrastructure, embracing digital solutions and ramping up real time testing. Together, these will help healthcare systems be better prepared for another pandemic, serving as a valuable tool to help promote health and increase the quality of life for individuals.

Diagnostic providers and the healthcare industry need to take this rare opportunity to work with regulators, health authorities and payers to ensure that reimbursement policies and payment methods are based according to the value diagnostics bring, and not the volume of tests run. This will be beneficial not just for the current crisis, but also long-term for all stakeholders.

How can we take the lessons learned about diagnostics from COVID-19 and apply them to healthcare systems moving forward to ensure we can meet the challenge of the next pandemic or healthcare crisis?

To help answer this, we have put together an ebook entitled “The importance of high quality diagnostics: Lessons from COVID-19.”

With this ebook, we aim to answer several questions in light of the COVID-19 pandemic, including:

• Why are diagnostics important?
• What happens when we don’t invest in diagnostic infrastructure?
• What occurs when diagnostic quality is not met?
• What can we do to prepare for the future?