11 Apr 2021
The Covid-19 outbreak in the White House raises questions about the efficacy of point-of-care testing regimes. Robin Wickham, CEO at Woodley Trial Solutions, looks back and reflects on what we can learn to improve testing for the future.
On the 2nd of October 2020, Donald Trump tweeted: ‘Tonight, @FLOTUS and I tested positive for COVID-19. We will begin our quarantine and recovery process immediately. We will get through this TOGETHER!’ Despite a regular, antigen-testing regime, Donald Trump was but one of many White House staff – at least three dozen according to some reports1– to contract the virus and enter quarantine in the first few weeks of October. So, what, if anything, went wrong? And what does this mean for the future of point-of-care (POC) testing?
It’s clear that that the White House’s testing regime was not sufficient to prevent the virus from spreading to the former president, but there are some indications that the outbreak could have been minimized if not prevented altogether. Choosing the right test and understanding its sensitivity and accuracy is crucial to an effective POC testing regime. The antigen test used by the White House offers results in under 15 minutes, a much shorter timeframe than polymerase chain reaction (PCR) tests, which also require a traditional lab set-up to process the swab. However, it is claimed that the antigen tests can miss up to half of the cases detected by PCR, depending on the patient population,2 and such low sensitivity makes it an unusual choice given the disruptive work and health implications of an outbreak for the White House.
Frequency of testing
The main downfall of point-of-care testing is human error. Even with the most accurate machines and the best quality control (QC) protocol, no automation can get around the pitfalls of human error. While we can only conjecture, the prevalence of the virus at the White House does raise questions as to whether the testing was being completed as regularly as claimed. The reality is that a test indicates someone’s condition at the specific moment when it was administered. By the time the test result comes back negative, it is possible that the individual may have contracted the virus. This demonstrates the complexity inherent in POC testing and why increasing the frequency of testing is vital to getting a handle on the spread of a disease.
Any POC testing regime needs to use the best analyzer for the job, which requires working with an impartial, device-agnostic third party who can offer more objective advice than a manufacturer with an analyzer or test to sell. Designing a robust QC protocol takes into account several factors. Staff administering the tests must be properly trained and authorized, reagent expiration dates need to be closely monitored, and cold-chain solutions must be in place if required. Even with training, it’s likely that staff will need ongoing technical support throughout the testing program, ideally from biomedical experts who are not only familiar with the testing procedure but also the underlying scientific rationale.
The outbreak at the WhiteHouse merely reveals that POC testing is not a fail-safe method for containing an infectious disease without a robust QC protocol. Working with an experienced partner to help you choose the appropriate analyzer, to deliver training and monitor reagents is essential to ensure that POC testing is implemented correctly and safely. At Woodley, we are delighted to work with clients to develop QC protocols that accommodate all the requirements above. Should you need our expert advice or guidance, please don’t hesitate to get in touch.