COVID CHRONICLES 05/13/20
These Antibody Tests Are Garbage
As promised, today I turn back to testing, specifically antibody tests. I first visited the general topic back in late March in COVID CHRONICLES Day 3: Testing and Other Advice and again in COVID CHRONICLES Day 17: New Testing on the Horizon and News from China. In the second I discussed the antibody test developed at Stanford and elsewhere. This seemed at the time a great development.
But, as with everything else with this damn virus, we need to stop for a minute. Let’s go back a week [Note: bold added in all news excerpts]
FDA increases oversight, requirements for COVID-19 antibody tests (FierceBiotech)
After allowing unreviewed antibody tests to pervade the U.S. market for weeks, the FDA is closing its open-door policy for coronavirus blood serology tests — bringing their oversight more in line with the molecular diagnostics used to confirm active cases of COVID-19.Since mid-March, the FDA has let manufacturers distribute unauthorized antibody tests, provided they validate the tests themselves and do not advertise them as a standalone method of diagnosing a patient. Instead, they could be used to track the spread of the virus through the population, by detecting signs of an immune response to a previous infection.
However, both the demand and reliance on these blood tests have grown, as more governments have incorporated widespread serology testing — and the potential of antibodies to bring immunity to the coronavirus — into strategies for removing lockdowns and reopening their economies, by allowing people with some level of protection to return to work.
Which has led to this:
From botox clinics to wellness spas, antibody tests become the rage. Are they the real thing? (LA Times)
The answer to that question? NOT YET.
Why a positive Covid-19 antibody test doesn’t mean much of anything yet (CNN)
There are still too many unknowns, both about the accuracy of the antibody tests that are available and about the nature of the virus itself.“It is clear that we’re still not where we need to be. It’s a brutal truth, but one that needs to be told,” said CNN Chief Medical Correspondent Dr. Sanjay Gupta in the May 5 episode of his podcast, called “Coronavirus: Fact vs. Fiction.”
“And this is exactly why I keep advising people to behave like you have the virus,” Gupta said.
Really. NOT YET.
Where is coronavirus testing headed? Here is what experts say (CNBC)
The tests don’t necessarily tell people whether they are immune to COVID-19 because scientists haven’t confirmed whether the antibodies even prevent re-infection. Most of the more than 200 tests on the market haven’t been cleared by regulators, and many could be faulty or of unknown origin, experts say. Across the U.S., several sites have been shut down for offering dubious antibody tests.
Even at Stanford University — considered a leader in developing an antibody test — the results remain unreliable, to the extent they didn’t recommend one for my father-in-law. Lisa will continue with hers this week. Since they know she had the virus, her results will be used to gauge their test’s reliability. If she comes back negative, it’ll show the test may still need work; a positive result would be a good sign for the Stanford team, though not definitive.
Why not? On top of the efficacy of the tests themselves lies an even bigger question: How do you interpret the results? Because here’s the thing…there is STILL NOT ENOUGH KNOWN about the virus itself. We are operating in a period of real-time research and will be for some time. As the above CNBC article says, this means no one can say for certain that Lisa is protected from either being re-infected or becoming contagious again, and even if she is protected we don’t know how long she’ll remain that way. No one can say for sure Lisa’s symptoms won’t return.
That doesn’t mean there’s no value. Gold-standard tests (once we have them) will aid tremendously in tracking the spread of the virus, a key component to responsible re-opening.
In my personal case, all I’m looking for is some validation that I had the virus to confirm our suspicion, and to be able to turn that info over to the county health department. Will it change anything I do? No.
Oh, Lisa’s work arranged for those in our traveling party to get the antibody test at an independent lab. One person who we know had the virus tested negative, as did I. A waste of a vial of blood…
A multidisciplinary team of researchers and physicians at UCSF, UC Berkeley, Chan Zuckerberg Biohub, and Innovative Genomics Institute recently conducted a head-to-head comparison of commercially available “rapid serology tests.” Their goal is to highlight those with the highest success rate to enable broader testing. Groups like this may be key to providing independent and factual information to guide test development. If only our current federal government favored science-based… anything.
