A Response to the University of Illinois’ Explanation of Its False Saliva-Test Claim
An article I posted on Twitter via Google Docs on 10/13/20
Photo source
Twitter followers know that I’ve long been concerned about the University of Illinois’ SHIELD saliva test. My initial investigation into the school’s claims about having an Emergency Use Authorization resulted in the FDA calling their bluff - and delayed the use of the test in Illinois’ K12 schools.
Fellow parent James Holderman has done yeoman’s work to raise questions about the testing company. Journalist Mark Konkol’s reporting has also been invaluable.
Now, finally, a group of Illinois legislators is pressing U of I President Tim Killeen with critical questions about SHIELD’s research & development process, research ethics, and use of the millions of saliva samples it’s obtained. The letter followed Rep. Deanne Mazzochi’s grilling of Killeen at an early March House committee meeting, when she posed long-overdue questions about SHIELD’s ownership structure and profits.
I’m hopeful this will eventually lead to a full-scale investigation of the “enterprise” - both its for-profit and non-profit arms.
After the “no EUA” story broke in October 2020, I wrote & tweeted a response to U of I’s attempt to defend itself. I’m posting it here mostly for my own reference and desire to document things I’ve researched during the pandemic. I’m also sharing it with the Illinois legislators who have signaled their interest in SHIELD’s actions.
Posted October 13, 2020
The University of Illinois has explained its false claim to an FDA EUA as a legitimate misunderstanding with no bearing on the validity of its saliva test. Their excuse - that they believed the test had earned EUA via a study that compared performance to Yale’s SalivaDirect EUA - crumbles under scrutiny.
U of I began on-campus diagnostic testing with its SARS-CoV-2 saliva test on July 6, after its vet lab was approved to perform C19 testing on human subjects.
Martin Burke, chemistry professor & co-developer of the test, later said in interviews (here and here) that the July pilot program and other studies showed the test was “accurate and effective.”
U of I spokesperson Robin Kaler said the FDA advised the school via an Aug 5th email that they could either pursue an EUA for the saliva test, or satisfy another option - one of which was to complete bridging studies to an FDA-authorized test. That prompted U of I to conduct what their CLIA lab director approved as a bridging study
Kaler cited section 4-A of FDA’s “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency” (May 11) as the document that guided U of I’s bridging study approach. But Section A-4 applies to modifications to an EUA-authorized test, such as switching out components (“e.g., primers, probes, etc.”) from another lab’s test kit that has already received FDA authorization.
U of I said the test they bridged to was Yale’s SalivaDirect, but SalivaDirect is a protocol, not a test kit, and doesn’t specify primers in order to avoid supply chain issues.
So U of I couldn’t “bridge” because their own saliva test was not using “a new component” for an existing, authorized test. If U of I believed they were testing new components, it’s unclear what those were. Since the U of I saliva test is not a modification of Yale’s SalivaDirect or any other protocol, section A-4 of the FDA’s May guidance doesn’t apply.
U of I also would have needed to notify Yale of its intent to bridge and request lab designation from SalivaDirect. In response to questions about whether U of I had done this, a Yale researcher told me via email, “[University of] lllinois did not formally request to be authorized under our EUA, has not bridged on our EUA, or asked for a right of reference to our data - though we'd be happy to do any of these.”
It’s hard to see how U of I could’ve been confused - and how they didn’t purposely lie when they claimed the umbrella EUA. In a statement quoted the Chicago Tribune, the FDA was unequivocal: “The University of Illinois is not authorized under an umbrella emergency use authorization, and they have not had an emergency use authorization.”
The FDA reached out to U of I about the school’s claim in September, prompted by an inquiry from an Illinois taxpayer. The agency asked them to remove “bridging” and “umbrella” from its language about the test. The school made changes to its August 19th press release and some other web-based descriptions, but a web page about the test still alludes to the Yale EUA.
Via email, Ms. Kaler assigned blame for U of I’s confusion to a consultant: “Based on the explicit advice of our regulatory and compliance consultant, we described the study as a ‘successfully completed bridging study’ that placed our test ‘under the umbrella of an approved EUA.” She identified the consultant as John Nadelin of Axion Regulatory & Compliance, LLC, in Indianapolis. It’s unclear when Mr. Nadelin provided the advice, how much he was paid, and whether the school has reached out to him about his alleged error.
In an uncanny coincidence, on August 19th (the same day as U of I’s false claims), the U.S. Department of Health and Human Services controversially removed FDA emergency use authorization for tests like U of I’s, if the lab is appropriately federally regulated.
This change allowed U of I to use its saliva test on campus without first obtaining FDA EUA, but only at their own lab. U of I’s lab was still required to validate the test before using it. An FAQ document about the change states clearly that labs must produce records demonstrating validation if asked or challenged.
Although U of I can use the test on campus, nothing about the HHS rescission allowed them to claim they had FDA EUA. The rescission also didn’t remove the EUA requirement if the test is used outside of the campus lab, either in other parts of the state, or in commercial use outside the state.
In August, the University created a LLC, Shield T3, to expand use of the saliva test beyond campus. At least two other Illinois universities have announced plans to use the Shield T3 saliva test for their own student bodies (Northern Illinois University and Southern Illinois University), which suggests Shield T3, LLC has entered commercial contracts without an EUA.
Under the May 11th FDA guidance U of I says it was following, labs were to validate any new test they develop, notify FDA their test has been validated, and submit their validation data informally via email to FDA for review (including “bridged validation data”) within 15 business days
U of I’s Veterinary Diagnostic Lab apparently began the process outlined by the FDA, as it is listed in the database of labs that notified the FDA of having validated a COVID19 diagnostic test. However, the lab’s status is “not FDA authorized,” which indicates U of I didn’t provide validation data.
In a description that was revised after the FDA contacted U of I in September, the school says its saliva test has been approved only by its CLIA-certified lab director.
The page links to a June pre-print which describes the test’s initial performance analysis on 100 specimens collected at the Carle Foundation Hospital Drive-thru COVID-19 testing center in Champaign County.
The vice president of research for Carle Health told a Champaign newspaper last month that the effort enlisted 500 patients during the month of May, collecting over 400 saliva samples in four days.
Yet the June pre-print makes no mention of a larger sample from which the 100 samples were chosen, let alone why only 100 were selected for analysis. Whether all 500+ specimens were given to the U of I researchers is also unclear.
If the data in this June pre-print supported the saliva test’s validity, it raises the question of why U of I didn’t use the data to apply for its own EUA, rather than claim authorization under Yale’s test.
U of I’s website also indicates more than one validity study has taken place: “Our studies to date are consistent with this new saliva test not being less accurate than the nasal test,” it reads. “Our studies to date show that to date our saliva test does not make this less accurate than other saliva-based tests.” No other study or data besides the June publication is linked.
So who is the CLIA-certified director that approved the validation data? U of I hasn’t said. The Illinois Department of Public Health told me they aren't permitted to disclose the name of the director. The current director of U of I's Veterinary Diagnostic Laboratory didn't respond to an email inquiry.
Here are some bottom lines about this ethically-problematic developing story:
First, U of I’s excuses for its false EUA claim are weak, at best. Stakeholders or reporters (preferably both) need to confront the school about its faulty explanation.
Second, the methods of the so-called “validity study” should be challenged, and the name of the CLIA Director disclosed.
Third, U of I must be transparent about the validity data that supports the saliva test. The school has administered over 500,000 saliva tests in a few months - the results of which it has used to imprison tuition-paying students and severely mitigate campus life. The school must be transparent about the validity data that supports the test. Transparency should also include 1) cycle threshold values for positive saliva tests, reported both to individuals and in aggregate as a table or pie chart, 2) the nature of the relationship between the university, Shield T3 LLC, Carle Health, and the Champaign County Department of Public Health.
Finally, Governor Pritizker’s role in the development and promotion of U of I’s saliva test needs to be probed. The Governor has yet to rescind or correct the false claims to FDA authorization that he repeated.
More importantly, the billionaire Governor is on U of I’s board of trustees -- and has been afforded unprecedented executive power over the state government’s COVID19 pandemic response. At an August 19th press conference, it was Pritzker who referred to U of I’s test as being “on the market” and said publicly to U of I President Tim Killeen, “The state of Illinois looks forward to being your biggest customer.”
Illinois residents deserve answers to questions about the validity and purposes of U of I’s saliva test, and the Governor’s relationship to it.
Read more about how the FDA found out about U of I’s false claim to EUA here:
