What Does FDA Cleared with an EUA COVID-19 Test Really Mean?
The most frequently asked question of them all when we get a call inquiring about the Coronavirus testing
services we offer is, “Is it FDA approved?”
The short answer is, no it’s not FDA approved and neither are any of the tests available anywhere. In fact
there is no such thing as an FDA Approved test yet because FDA approval takes years and requires exhaustive
data aggregation and validation. It’s a process for which we sometimes have not enough time because of a
So what’s the deal with FDA “approved” tests we hear about in ads and in the media?
The FDA has a tool or option for allowing medical treatments, tests and devices to come to market prior to
their being “approved”. It’s called an Emergency Use Authorization (EUA) and it’s what the FDA is granting to
companies meeting a certain low-bar criteria so tests that would take months or years to validate (and many
test that would never achieve validation because they don’t work) are available right now.
The EUA though can be misleading and has caused myriad issues, including allowing thousands of inaccurate
and unreliable tests to flood into the country from China, Korea and Russia.
The time consuming rigors of gaining FDA Approval exists to protect against these same issues. The EUA
therefore goes against the very mandate of the FDA and its processes.
The FDA’ description of their EUA tool is as follows:
“During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow
the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose,
treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are
no adequate, approved, and available alternatives.”
To be granted and EUA requires no real validation and no FDA review of the COVID-19 tests being sold or the
dozens of companies making and or selling the tests. To put it plainly, no one tests the tests independently of
the company that makes them.
A test with an FDA EUA therefore does not have to be proven accurate, reliable or even inspected to ensure
sanitary packaging or that it meets standards for importation.
Think of the EUA like a tin badge given by an Old West Sheriff to members of his quickly formed posse,
chosen only because they have a good horse and a rifle. Having been “deputized” does not indicate quality at
all but an emergency need for something in place of nothing at all.
How then do you choose what test to use and who can you trust?
The best tests – both for active infection (PCR) and past infection (antibodies) are performed by laboratories
because laboratories have been through FDA approval, must meet certain standards, and the analysis s
performed by trained professionals.
The best of the best though are performed in accredited high tech laboratories that conduct testing for
research and also those related to universities. In Southern California this includes Bach Laboratories,
Exceltox, UCSD, UCI, and Healthquest. These labs use the most high tech and accurate equipment such as the
Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer. They use US made tests by companies like Roche
and ThermoFisher that have dozens of FDA Approved assays.