In every newspaper this morning there is a picture of individuals lined up waiting for COVID-19 tests. The articles talk about testing centers being “overwhelmed.” At this point in the pandemic, almost nine months in, the question should be why aren’t rapid COVID-19 diagnostic tests available for people to use at home?
I’m sure some public health mavens and regulators would argue that these tests might not be sensitive enough to detect all cases of COVID-19. However, removing even 80% of COVID positive individuals from social interactions would be a remarkable achievement. Also, false positive results would not be an issue since people could confirm by repeating the test daily. It is better for a person without COVID-19 to isolate at home for a few days than for an infected person to be out in the world.
People would be much more likely to be tested if they could do it in their own home without having to go to a center or wait for hours in a line. While “gold standard” tests may detect an extra 5% or even 10% of infected individuals a day or two later at a testing facility, a rapid test would give a person an answer in a few minutes so they wouldn’t have to wait. They could make decisions about isolating themselves and do personal contact alerts in a timely manner. People could also test immediately after they are notified of a potential contact and continue to test for a few days to make sure they are clear. This would improve sensitivity.
The technology for rapid home antigen tests is readily available. We allow large commercial labs to do expensive “send in” molecular tests on saliva and anterior nasal swabs, but testing these types of samples now appears to be less sensitive than the “gold standard” nasal pharyngeal (swab) PCR. Certainly, any home test would need to be validated by the FDA, but the rules and criteria for that are already in place. If people can determine if they are pregnant, have HIV infection, or any number of other important issues using home testing, why in the world don’t we have COVID-19 home tests?
Maybe it’s because the government has sunk billions of dollars into Abbott testing machines? Maybe the financial structure of COVID-19 testing just benefits laboratories? Maybe we have been too focused on a few perfect tests rather than many useful ones? Regardless, it’s time for the FDA to encourage home test makers to submit and market rapid COVID-19 home tests