August 28, 2020 Christopher Holt
Last week’s edition of the Weekly Checkup considered the Food and Drug
Administration’s (FDA) recent emergency authorization for a new, quick,
low-cost COVID-19 test, and the reality that a vaccine by the end of the year
won’t be a panacea that returns everything to “normal” in the blink of an eye.
Effective, widespread testing that allows public health officials, school
administrators, and employers to quickly identify cases of COVID-19 and
act to mitigate spread is critical to any near-term return to normal. This
week, the FDA announced emergency authorization of yet another cheap and
fast-acting COVID-19 test while at the same time the Centers for Disease
Control and Prevention (CDC) confusingly sought to discourage testing of pre-
and asymptomatic individuals. Let’s discuss.
First consider the news
that Abbott Pharmaceuticals will be rolling out its latest rapid test in September at a cost
of only $5 per test. Unlike the test developed by Yale researchers, this
test doesn’t require a lab, and while it’s intended to be administered by a
medical professional, that professional could be a school nurse, or a
pharmacist, or even say a nurse hired by an employer to administer screenings
as part of preventing spread in an office or factory environment. And because
the test doesn’t require a lab, it’s especially quick, with results in 15
minutes. This test is also different from the Abbott rapid test that
has been used by the White House and others, which had a high rate of false
positives. Instead the new BinaxNOW COVID-19 Ag Card test is 97 percent
accurate. Abbott has been working for some time to
expand its manufacturing capacity and is aiming to deliver 50 million
of the new rapid tests per month to the U.S.
market by October, which is staggering considering that to-date, in
total, the U.S. has only conducted 74 million tests. Additionally, the Trump
Administration last night announced an agreement with Abbott, to purchase 150
million of these tests at a cost of $750 million—or exactly $5 a test—for
distribution to high-risk locations such as nursing homes or schools and
universities.
While the administration is, and should be,
touting this development, there was also news this week about changes to CDC’s recommendations on testing.
The agency is now advising against testing people who are not symptomatic of
the virus, even if they’ve experienced exposure. This might have
made sense earlier in the pandemic when testing capacity was particularly
limited, but it is strange when more and more testing options are coming
online. The Trump Administration hasn’t exactly been successful in explaining
the rationale behind the decision, though it should be noted the FDA’s
emergency use authorization for Abbott’s new test only allows for
use on patients who are symptomatic at this time, so some concerns over testing
capacity might remain. At the same time, some are openly wondering if this policy change isn’t in keeping with the
president’s stated desire to see less testing, which he blames for the increase
in reported cases of COVID-19. Whether this is the case or not, failure to
test pre- and asymptomatic individuals will make it harder to stem the pandemic
and return to some semblance of normal life. Symptomatic individuals know
they’re sick, even if they aren’t certain they have coronavirus, so they can
isolate themselves to prevent the risk of spreading it, but transmission is
most problematic in the pre-symptomatic stage. There is also increasing evidence of asymptomatic transmission, though data on
this facet of the pandemic have been mixed.
Until we have a vaccine and/or a highly
effective treatment, widespread and regular testing of non-symptomatic
individuals, particularly those who are known to have had exposure, will be
critical to returning to school and work. Even with a vaccine, a robust testing
regime will be a necessary compliment for at least the first year and possibly
longer. Perhaps the CDC will provide solid justification for the new guidelines,
but discouraging testing, just at the moment we are ramping up testing
capacity, seems counterproductive at best.
No comments:
Post a Comment