Fact 1: William & Mary students had to be tested for the coronavirus before setting foot on campus for the fall semester.
Fact 2: The COVID-19 test kit, a self-administered throat swab test, was mailed to students, so they could test themselves at-home, send the test samples to a laboratory with the test results available before the semester started.
There’s just one thing: Tests given to the students were labeled “For Research Use Only Not For Use in Diagnostic Procedures.”
Just exactly how many tests with those labels were sent to students remains unclear. A representative from W&M’s provider would only say “the sticker has been on the bulk of the vials used to date.”
According to the W&M Dashboard, 4,599 students have been tested.
William & Mary and VCU Health chose Kallaco, a new logistics and software company, to help provide the COVID-19 tests through the company’s lab partner, Opteo Laboratory, who processed the samples sent by students.
But Opteo Laboratory’s tests sent to students has not received FDA’s emergency use authorization, according to an email from FDA spokesman James McKinney.
It’s unclear whether the test is approved under the Clinical Laboratory Improvement Amendments — or CLIA — guidelines, which regulates diagnostic testing and certifies laboratories before they can test on humans.
W&M’s response
WYDaily asked W&M spokeswoman Suzanne Clavet why the test vials sent to the students were labeled for research use only and to clarify the number of students who tested positive for the virus before coming to campus.
The W&M Return to Campus COVID-19 Testing Results dashboard, which is updated once a week on Mondays, shows 12 students tested positive and the “cumulative” number of students who tested positive was 15.
Clavet referred WYDaily to a statement from Kallaco and an Aug. 26 message from W&M Chief Operating Officer Amy Sebring to the college community in response to questions about the COVID-19 test kits.
Sebring noted Kallaco had “high quality” CLIA certified laboratories, a “volume” of tests available and turnaround times. She added Opteo Laboratory is allowed to create the laboratory developed tests and uses those diagnostics tests for COVID-19 through the FDA’s emergency use authorization.
“Opteo confirms it has conducted validations for their COVID-19 diagnostic tests consistent with CLIA certification,” she added. “More information on the test kit, protocols and reliability may be found at Kallaco’s website.”
According to its Testing Services at William & Mary website, the university had been “assured” Opteo Laboratory was allowed to conduct testing at-home and through a health care provider under the FDA’s emergency use authorization order.
“This is a standard process for many labs across the country as they await formal approval from the FDA,” the website noted.
Kallaco’s response
WYDaily asked Kallaco why the test vials were labeled for research purposes only.
“It is common when you create an LDT that there are going to be components that are used for diagnostic purposes and some that are not,” Amy Cheronis, spokeswoman for Kallaco, wrote in an email. “The vial is not used for diagnostic purposes so it is labeled “for research use only”.
“We are not required to put the label on the vial, but we want to be as transparent as possible with respect to the use of our test kit components,” she added.
When asked if the label was causing confusion, Cheronis noted “not that we have seen.”
She confirmed the test was considered “diagnostic” and San San Ng, chief scientific adviser for Kallaco, was also the co-founder and chief scientific officer of Opteo Laboratory, formerly known as iHealth LLC. Ng is not compensated by the company, she added.
Kallaco also posted an updated statement on the company’s website about the COVID-19 tests as well as the company’s partnership with Opteo Laboratory.
“Kallaco only partners with high-complexity CLIA laboratories,” according to the statement. “High-complexity CLIA laboratories, through the Laboratory Developed Test (LDT) process, do not need FDA approval to administer COVID-19 tests, including self-collection.”
The company addressed other questions and answers in the statement, including Opteo Laboratory use of the ThermoFisher Scientific TaqPath COVID-19 Combo Kit — used to process the students test results.
“Although there have been some reports of false test results due to the processing of samples, Kallaco’s partner laboratories have established procedures that mitigate against processing errors and they do not use the same process or software that has been questioned by the FDA,” the company stated.
FDA’s response
Diagnostic testing helps health care providers screen or monitor diseases like the coronavirus and helps providers make decisions for patient care, according to the FDA’s website.
Laboratories may need to create individual test kit parts such as “probes” or “purchase research use only components from third party manufacturers” to create their tests, according to the FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
But the FDA did not object to them using those tests for the coronavirus when the tests has been validated and sent to the FDA for approval within 15 business days.
“This policy does not apply to home collection of specimens to be sent for testing at a laboratory certified under CLIA for high-complexity testing,” the document noted.
However, the FDA noted in a fact sheet to health care providers about LTDs, a health care provider must administer the tests to the person suspected of having the coronavirus.
If someone tests negative, the person could still have the coronavirus and “should not be used as the sole basis for treatment or patient management decisions,” according to the FDA factsheet.
WYDaily looked up Opteo Laboratory in the CLIA database to see if they had been approved but the system, which was last updated on Aug. 24, could not find the laboratory’s record.
In a FDA PowerPoint, the department showed a few ways the laboratories could get a CLIA waiver for approval categorizing the tests as waived, moderate complexity and high complexity.
Tests that are waived or approved for home or over the counter use are categorized as “waived,” according to the FDA’s website. If not, the tests can be categorized as “moderate” or high complexity.”
Kallacao claimed the FDA announced on Aug. 21 the department does not have authority over LDTs.
The FDA news release from Aug. 21 shows the emergency use authorization given to NovaSterilis Inc. for the Nova2200, a machine used to decontaminate N95 respirators for single use, a letter to health care providers about the risk of passive protective barriers and a testing update.
WYDaily asked McKinney, the FDA spokesman, if Opteo Laboratory’s COVID-19 tests was approved under the CLIA policy for at home collection and if the lab was required to get approval from the FDA for at-home testing.
McKinney referred WYDaily to the U.S. Department of Health and Human Services for further comment.
A representative was not immediately available for comment.
As of Thursday, Virginia has 116,570 cases, 9,391 hospitalization and 2,527 deaths, according to the Virginia Department of Health’s website.
UPDATE (Aug. 28, 2020; 10:30 a.m.): Cheronis sent WYDaily a link to the CLIA certification which shows Opteo Laboratory is registered to perform lab testing in “independent” setting with an expiration date of April 28, 2022. However, the report does not state if the laboratory is certified to have the COVID-19 tests performed at-home or through a health care provider.
YOU MIGHT WANT TO CHECK OUT THESE STORIES:
- FDA: W&M COVID-19 testing provider has no emergency use authorization
- Reopening amid the coronavirus: W&M students start trickling into Williamsburg as other universities deal with COVID outbreaks
- At-home COVID-19 tests: W&M expects students to stick to the ‘honor code’
- Returning William & Mary students encouraged to pack for two, three weeks
- William & Mary’s only virologist has serious concerns about the college’s reopening plans amid the coronavirus
- #MaskUp757: Sentara, Riverside and other hospitals raise awareness after spike in Hampton Roads, Peninsula
