- Coronavirus testing at home might soon become a reality, as the FDA has established guidelines for COVID-19 tests that can be self-administered.
- The tests should be reliable, affordable, and easy to use. Several companies are working on at-home tests for COVID-19, but it may take a few months until the FDA approves successful candidates.
- At-home coronavirus testing could deliver much faster responses than traditional PCR testing that can experience significant delays. Patients could isolate and seek medical help faster than before.
One of the reasons the novel coronavirus is surging in various US states and other regions of the world is that there isn’t enough testing available. The scarcity of COVID-19 tests in the early months of the pandemic has been largely fixed. However, there’s still not enough testing to properly screen contacts and communities and ensure faster diagnoses. Contrary to what President Trump keeps saying, the increase in testing is not responsible for the rise in cases. Yes, the more you test, the more cases you’ll find, but if there’s no community transmission, the percentage of positives would be lower and lower as you increase testing. That’s yet to happen in the states that are reporting a record number of cases.
The only way to contain the disease, especially if people are increasingly more resistant to face masks and social distancing, is to increase testing and provide quick results. That way, the people who do get infected will be able to isolate sooner and seek treatment faster. Also, rapid testing would prevent asymptomatic carriers from infecting others. The good news is the Food and Drug Administration (FDA) has approved a game-changing testing initiative. The bad news is that it may be months before we see any results.
The FDA confirmed on Wednesday that it wants new COVID-19 tests that are fast, cheap, and can be performed by anyone at home. Companies will have to stick to a set of rules before their tests are approved for wider use, which means there’s no current test that’s available for home diagnosis.
“These types of tests will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening,” FDA Commissioner Dr. Stephen Hahn said in a statement, per USA Today.
Having people test themselves at home every time they suspect contact with a person who may be infected could be incredibly helpful. People could also use these tests before traveling to other parts of the world or the country or before visiting family members that are in the at-risk categories of patients. The tests could be helpful to the elderly and people who suffer from chronic medical conditions.
But companies working on at-home tests will need to ensure these tests provide fast results, are cheap to manufacture, and are easy to use. Also — and it should go without saying — the tests need to be accurate.
The FDA issued a template for how the samples should be collected and analyzed and how the results should be displayed to a user at home. The rules also explain how accurate the tests must be. USA Today explains that the home tests have slightly lower standards than lab tests.
XPRIZE has a competition meant to kickstart the production of affordable, reliable at-home COVID-19 test kits. The nonprofit will split a prize of $5 million among five winners that can provide results in as little as 15 minutes and cost less than $15. A further $50 million will be split for rapid manufacturing. The competition will last through the end of August, and 200 semifinalists will be selected. Of those, 20 finalists will get a chance of winning one of the five spots. The contenders will have to meet the FDA criteria and get expert advice from other companies that manufacture testing devices. The five winners should be ready to scale up manufacturing by late 2020.
Competition or not, others will continue to work on rapid testing kits for COVID-19. One such test may come from Sorrento Therapeutics, which licensed a new technology developed at Columbia University in New York City. Director of the Columbia University Fertility Center Dr. Zev Williams adapted a test used for couples with genetic diseases or that experienced repeated miscarriages for COVID-19. The team devised a test that can identify the genetic signature of the SARS-CoV-2 virus in saliva. The sample is placed in a container that has certain enzymes in a liquid that will turn red for negative results and yellow when the COVID-19 virus is detected. The test only requires heating and would cost $10 if approved.
Having at-home COVID-19 tests approved months from now might not seem like the best idea, but the illness will not go away anytime soon. The virus is here to stay, and the flu season could make the situation more challenging for hospitals. As some regions flatten the curve, others may experience renewed outbreaks.