Alongside the myriad difficulties involved with developing the right kind of Covid-19 test to use at home, concerns have been raised about the overarching impact of a test once it’s been made.
The FDA has significantly relaxed its regulatory pathways to expedite the production and distribution of Covid-19 tests. State Departments of Health are now able to approve tests without direct engagement from the FDA. Manufacturers are also able to distribute tests across state lines for 15 days between their own validation and the granting of an EUA, and antibody tests are widely permitted.
Steps like these are essential during a global pandemic, but it’s left some consumers concerned about how reliable the tests they can access are. If a home test is deployed at a large scale and its accuracy turns out to be subpar, the consequences could be catastrophic.
The UK government, for example, has now admitted that none of the 17.5 million antibody tests it ordered work well enough to be used.
Even without an NHS option, Warwick Medical School honorary clinical lecturer Dr James Gill cautions UK residents against opting for the private home-use tests hitting the market instead, saying “I’m intrinsically resistant to something that the patient has to pay for when the NHS offers a service. Yes, they may pay for something to get it faster, but if that particular service or brand is not being offered by the NHS why is that?”
An immunity armband?
Much discussion has also surrounded the concept of ‘immunity passports’, some sort of document or badge a recovered Covid-19 patient with a positive antibody test could keep on their person to prove that they’re immune to the disease and safe to be outside.
“If something like that were to be implemented, I would hope it would only be for a short period of time. It’s easy to see how that could be abused,” says Gill. “There are stories of NHS workers being attacked and having their passes stolen so people can get access to things. How would be that any different to an ‘I’m Covid-free’ armband?”
Even once an appropriate Covid-19 home test is developed for mass distribution, establishing confidence in its serviceability and ensuring the consequences of tests results are properly handled will be just as vital. But until a vaccine is developed and the whole world can be immunised against the deadly disease, some form of large-scale testing must be deployed to help countries safely lift the lockdowns which global citizens are set to live under for the best part of 2020.
“Removing the need to go to a testing facility and get a nasopharyngeal swab, that burden on the healthcare system and the risk to the patient and the public, and instead testing by yourself in the privacy of your own home, that’s a game changer,” says OraSure CEO Stephen Tang. “The burden on the individual is the feeling that you’re not in control of your own life. To empower an individual to learn their Covid-19 status, I think that’s a huge breakthrough.”