Tuesday, September 27, 2022

Round 2: W&M is retesting students for COVID; provider to use FDA emergency use authorization tests

(WYDaily file/Courtesy of W&M News)
(WYDaily file/Courtesy of W&M News)

The College of William & Mary has decided to retest all of the students on campus for the fall semester.

The university is still using Kallaco, the same logistics and software partner who processed the W&M’s previous test samples using Opteo Laboratory, one of Kallaco’s partner labs.

While the second round of testing won’t be processed through Opteo Laboratory, Kallaco is still providing logistics.

This time, Kallaco is using different laboratory partner to process the test samples: Wisconsin Diagnostic Laboratories, LLC.

The laboratory is “accredited” in the Clinical Laboratory Improvement Amendments database, CLIA, which regulates diagnostic testing and certifies laboratories before they can test on humans.

Under the accreditation, Wisconsin Diagnostics Laboratories can perform waived, moderate or high complexity tests, according to the CLIA database. But just like the previous lab partner Opteo Laboratory, Wisconsin Diagnostic Laboratories did not receive an Emergency Use Authorization from the FDA either.

But it does not need to.

FDA spokesman Jim McKinney on Friday said the FDA emergency use authorization applies to the test itself not the laboratory and if a laboratory wants to use a previous COVID-19 test already approved by the FDA emergency use authorization instead of creating their own test, they would have to follow the “conditions of use.”

For example, Wisconsin Diagnostic Laboratory is using the ThermoFisher Scientific TaqPath and Roche COVID-19 test which are approved by the FDA emergency use authorization in certain setting. But one condition of use the tests are not approved for is home collection such as testing kits.

While the TaqPath COVID-19 Combo Kit is approved under the FDA emergency use authorization, the test has experienced some issues, mainly false positives, according to a letter sent by the FDA to Clinical Laboratory Staff and Health Care Providers.

“Thermo Fisher Scientific’s conclusion from investigations of customer complaints indicate that inadequate vortexing or centrifugation can lead to false positive results,” according to the letter. “The second issue is related to the assay Internal Positive Control (IPC) and requires laboratory staff to upgrade their software to reduce the risk of invalid, potential false negatives, or inconclusive tests and to decrease the potential need to retest.”

McKinney said any laboratory that is CLIA certified can use the FDA emergency use authorization test as long as it uses “the authorized conditions of use.”

WYDaily asked McKinney if William & Mary used “certified clinicians” to test the students on campus using a COVID-19 that has FDA emergency use authorization, like the Roche cobas SARS-CoV-2 and TaqPath COVID-19 Combo Kit, and the university sent the test swabs to Wisconsin Diagnostic Laboratories for processing, would this use be considered an authorized condition of use or would this be considered an at home test?

McKinney could not answer the question, saying he would need time to find out.

What happened

W&M and VCU Health had partnered with Kallaco to provide COVID-19 at home testing kits for students before they arrived on campus for the fall semester, processing the tests through the one of the Kallaco’s lab partners, Opteo Laboratory. Students then sent the samples to that lab.

Opteo Laboratory’s COVID-19 throat swab test was CLIA approved but the test did not receive an Emergency Use Authorization from the FDA.

The vials sent to students was labeled “For Research Use Only Not for Use in Diagnostics Procedures.”

Amy Cheronis, spokeswoman for Kallaco, would only say a “bulk of the vials” sent were labeled that way.

Round 2

So why is W&M testing the students again?

Erin Zagursky, spokeswoman for the university, quoted an email sent by the W&M Testing Coordination Team.

“Because our initial testing round began several weeks ago – and based on patterns we are seeing at other campuses, during the first week after arrival – we have decided to conduct a second required round of testing,” according to Zagursky’s email. “We must remain vigilant so that we can move quickly to identify positive cases and potential exposures.”

Instead of having the students test themselves with throat swabs, the university is going to have the tests on campus, with “certified clinicians” performing COVID-19 PCR nasal swab tests on students, Zagursky said.

The second round of testing applies to all students who fall into the following categories:

  • students living on campus
  • students taking blended courses
  • students taking remote courses and live within 30 miles of campus with limited exceptions for certain graduate students
  • students with a meal plan

“Students who may be coming to the campus, yet aren’t in any of the groups listed above, may choose to opt-in for the testing,” she added.

On Aug. 21, Marjorie Thomas, William & Mary’s dean of students, sent a letter to college community banning gathering of 10 people or more and having joint party patrols with the Williamsburg Police Department to make sure people are wearing masks and social distancing.

RELATED STORY: W&M student association calls dean’s COVID letter ‘disappointing,’ with ‘accusatory and threatening language’

As of Thursday, fewer than 10 students and fewer than 10 employees have tested positive for the virus while 20 students and fewer than 10 employees have tested positive before arriving on campus, according to the W&M COVID-19 dashboard.

The on-campus positives test statistics are defined as “any student or employee having a local address within a 90-mile drive of the campus is considered an on-campus community member.”

“This includes students taking classes remotely, and employees working remotely,” according to the online dashboard.

What’s up with that 90-mile deal?

“That category recognizes students and employees on campus as well as students who may be likely to come to campus for services, including the use of W&M Libraries, even if they are taking all classes remotely,” Zagursky wrote in an email. “Based on data and feedback collected from our first round of pre-arrival and prevalence testing, W&M has changed the geofencing we’re using to determine testing requirements to more accurately capture the population of community members physically engaging with the university.”

She said for round two of testing, the university is using a 30-mile radius with “additional attributes like course delivery modes, subscribed services and data collected from students to determine testing requirements.”

While the university does not have vending machines to dispense free masks, hand sanitizer or other personal protective equipment for students and staff, Zagursky said the college is providing “wellness kits” to students and staff who return to campus. Each kit includes two reusable cloth masks, hand sanitizer and cleaning wipes.

Some students had reported they had tested themselves, mailed the test kits to Kallaco but received an email stating the lab samples were more than 10 days old and the student had to get retested.

Zagursky said the university sent the test to students before the college “adjusted” the return to campus schedule

“As a result, several students finished their test and then had their return to campus date moved to later,” she said. “We asked these students to retest so they would have a result more relevant to their return to campus date.”

“Most were sent retest kits, but we allowed third-party test results for those who couldn’t complete a retest in time to meet their campus arrival date,” she added.

Kallaco

Cheronis confirmed Kallaco was working with the university for the second round of testing under “its current agreement to provide testing services through Kallaco’s laboratory network.”

Kallaco expects the laboratory test results to be available “within 48 hours from the time the laboratory receives the specimen” and the company does not anticipate the testing to be delayed, Cheronis said.

“Our laboratory partners are well aware of the testing volume and cadence at William & Mary and have prepared to meet the TAT, turnaround time, each day specimens arrive,” she wrote in an email.

WYDaily informed Chernois some W&M students who had sent in test samples were told to get retested because the samples were more than 10 days old. So what should they do and is this acceptable?

“Sometimes specimens arrive at the laboratory that are missing information or need additional data in order to properly proceed with testing,” Cheronis wrote. “In these cases, the lab reaches out to the client and/or student to secure this information.“

If the lab cannot receive the “missing information” within 10 days, the quality of the test sample is considered “compromised and must be recollected,” she wrote.

“There were instances where this scenario happened at William & Mary, and the lab followed its compliance protocols to cancel the specimen and inform the user to get retested,” she added.

WYDaily reached out to Wisconsin Diagnostics Laboratories — a representative did not immediately respond for comment.

The lab has not been approved for a FDA EUA as of Thursday, according to the FDA’s website.

As of Thursday, there are 130,525 cases, 10,085 hospitalizations and 2,708 deaths in Virginia, according to the Virginia Department of Health’s website.

In the Historic Triangle:

The latest coronavirus cases, hospitalizations and deaths in the Historic Triangle from the Virginia Department of Health. (WYDaily/ Julia Marsigliano)
The latest coronavirus cases, hospitalizations and deaths in the Historic Triangle from the Virginia Department of Health. (WYDaily/ Julia Marsigliano)

EDITOR’S NOTE: This story has been updated Friday, Sept. 11, 2020; 7:03 p.m. to reflect this clarification. The headline was also updated: Cheronis told WYDaily Wisconsin Diagnostic Laboratories LLC was using COVID-19 tests that received FDA EUA. WYDaily reached out to FDA spokesman Jim McKinney, who confirmed the FDA EUA does not apply to laboratories only to the tests.

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Julia Marsiglianohttp://wydaily.com
Julia Marsigliano is a multimedia reporter for WYDaily. She covers everything on the Peninsula from local government and law enforcement agencies to family-run businesses and weather updates. Before WYDaily, she covered Hampton and Newport News for WYDaily’s sister publication, HNNDaily before both publications merged in December 2018. Julia was born in Tokyo, Japan and moved to Long Island, New York in 2001. A true New Yorker, she loves pizza, bagels and good Chinese food. Send comments, tips and other tidbits to julia@localvoicemedia.com. You can follow her on Twitter at @jmarsigliano

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