Terry H. Schwadron
May 11, 2020
Among the many reports suddenly circulating about vaccines, testing, treatments and hopeful explorations to counter coronavirus were the FDA’s approving nods towards putative home tests that would be easy to apply, and relatively quick to process once it gets to a lab.
There are so many approaches, so many competing ideas to keep evaluating that the search for hope in the river of virus bad news that they all start blurring.
Still, the idea of a quick, affordable test that could be available online or at the corner drug store without prescription sounded like just the kind of thing that may help break the logjam on getting testing moving and give us some sense of confidence about re-opening our cities.
The news this week was that the FDA gave its go-ahead for home testing as an approach, and issued guidelines to allow companies to develop an market kits for mail-in specimens. The agency also approved for sale a saliva-based home test offered by Rutgers University, which says it has 75,000 ready to ship and process. There was also news of a new doctor’s office quick test of antigens that may be about 85% accurate in showing presence of dead infection cells, not a certain result.
Sure, there are a load of confirmation tests and human clinical tests to run, but let’s trust for the moment that the scientists and medical folks are on the right track for turning a clumsy virus testing process requiring multiple steps and protective gear into a pretty simple home test requiring just a nose swab or a saliva test and a stamp.
My question is assuming the test itself works, how facile will we be in using it and what does it do for us either in the United States or across the world? (Just as an aside, it is amusing that our government trust life and death illness tests in the mail, but not ballots.)
The hope, of course, is that we could significantly expand our overall testing capacity, increasing our societal ability to either find illness or give confidence to go back to work.
Does having a home pregnancy test have an effect on pregnancies, preventive measures or just convenience in learning the results — after discounting for false positive or negatives?
How Does This Work?
There is no doubt that having a home test for under $5, a goal that the Bill & Melinda Gates Foundation have set as a goal in giving companies several millions of dollars to invent, will increase overall testing for the virus. Mass production of such tests obviously would allow far more identification without having to go to a doctor to get permission and then to a clinic, hospital or roadside testing site for testing by medical personnel in full protective gear.
In issuing guidelines, the FDA reviewed studies that determined the accuracy of self-collected samples that spent three days in dry plastic tubes, as would happen in the mail to a lab. The idea is that we would administer such a test at the first sign of illness, mail it, and have a result 24 hours after a specimen arrived at a lab.
So this faster method would still take several days to a week start to finish, right?
Clearly, there are practical issues here, otherwise the FDA will have provided a faster way to test, only to slow for processing.
Once again, we’re depending on individuals to know that they are ill, that they have already obtained a test kit, that the kit worked, that they knew where to mail it, that the delivery was prompt — and that the lab could handle the rush. Maybe. Does it work that way with flu shots or home pregnancy tests?
Once we learn that we have coronavirus, of course, that starts the quarantine process, calls to doctors, and worries about whether hospitalization must follow in about 20 percent of cases. With test result in hand, it requires that we act — and that seems its own morass.
As a society, we seem not to want to quarantine, and to delay as the illness either passes or worsens. We don’t want to act; we just want the virus to go away. Just as a case in point, the White House has learned of virus confirmations in their daily circles, but neither Donald Trump nor Mike Pence is quarantining,
Gates seems on the right track here. Inexpensive home tests would expand disease testing, especially those who may have other medical risks or who lack health insurance. The FDA gets a gold star for making this effort a priority, as well as scientists who need confirmation that specimens could survive the wait for postal services or courier companies under variable heat. Until now, those conditions had required a liquid to successfully hold the swab, something that slowed home testing.
Last month, the first home kit approved cost $119 and a prescription, and review by the company’s own lab. Since then, there are a number of efforts, including the saliva-based test and one using a gene technology, and there have been problems with inaccurate results and ever-present fraud, prompting FDA warnings.
Home testing seems the only way to scale this testing need to tens of millions. But the how-to aspects have proved obstacles. The FDA has approved alternative swabs, for example, and simpler probes than the intrusive deep probes hospitals use.
In the end, at best, these tests confirm that sick people have coronavirus, not that they do anything about it. These home tests do not yet provide any sign of immunity, of course, nor for ending uncertainty about how to adjust behaviors in a time of coronavirus.