Safeguard Saliva Testing Program Certified After State Scrutiny

CHICAGO — The company behind the saliva-based coronavirus testing programs at more than a dozen north and west suburban school districts sought and last month received certification to conduct "screening" testing, instead of just "surveillance" testing, public health officials said.

Safeguard Surveillance's certification followed the filing of a complaint containing concerns that the Brookfield-based company had been providing COVID-19 test results to schools in violation of federal certification standards, according to a spokesperson for the Illinois Department of Public Health.

The company's founder and local school officials both say the program has followed evolving guidelines from public health officials all along, as it has processed hundreds of thousands of saliva samples from suburban students. They disputed a recent newspaper report that suggested Safeguard "ran afoul of regulators" and received "warnings" about the program.

Only labs certified under the Clinical Laboratory Improvement Amendments, or CLIA, can provide diagnostic or screening testing for COVID-19. Surveillance testing does not require federal CLIA-certification, but cannot be used to for any individual decision-making, according to a recent update to the IDPH website. It said state public health officials do not recommend the use of surveillance testing in schools.

Safeguard was founded last year by Ed Campbell, a professor at Loyola University Chicago's department of microbiology and immunology — who also serves as a school board member in LaGrange School District 102. Campbell, a virologist who has studied HIV for the past two decades, said he has continually followed guidance from regulators by using surveillance testing to refer people to diagnostic testing.

Campbell developed Safeguard's saliva-based test building on research from the University of Wisconsin–Madison and the University of Colorado Boulder. Instead of using polymerase chain reaction, or PCR, technology, the testing uses loop-mediated isothermal amplification, or RT-LAMP, which makes it faster, cheaper and more accessible, according to researchers.

Plus, collecting saliva samples is considered significantly less invasive than nasal swabs, especially for weekly or biweekly testing.

Before launching the company last fall, Campbell first set up a lab in the La Grange area that provided testing to Districts 102, 105 and 95. The lab serving the community he represents on the board is not operated by Safeguard, and Campbell has received no compensation from the district, Patch reported in January.

Since the business was established in September, Safeguard has expanded to include Glenbrook, New Trier, Stevenson high schools on the North Shore and Oak Park, Elmhurst, Naperville and Downers Grove school districts in the west suburbs. In November 2020, it changed the name of its LLC from Safeguard Screening to Safeguard Surveillance.

At the time New Trier launched its "COVID-19 screening program" last fall, administrators said there was high demand from other school districts for Safeguard's saliva testing. The board approved a contract of up to $1.3 million for the tests and later made submitting saliva samples mandatory for students.

The per-test cost runs about $11, compared to at least $20 for the other saliva-based testing program in use at suburban school districts — the University of Illinois' Shield program, which does not require follow-up testing. In some towns, like Bannockburn and Highland Park, elementary school districts have opted for the Safeguard program, while the high schools have gone with Shield.

Another difference besides cost: non-diagnostic drool can be dropped off, while the CLIA-certified testing requires a witness to the spitting.

As of last Saturday, Safeguard had processed about 345,000 tests from schools, referring 437 of them to diagnostic labs for further testing.

Those references are not reported to IDPH as confirmed cases of COVID-19, although nearly all of them are later confirmed by diagnostic testing at certified labs, which are then included in the state totals.

About 120 of people Safeguard has referred to diagnostic labs for more testing have come from New Trier High School, according to a statement from district officials. It defended New Trier's testing program in response to the publication this week of a newspaper report that described its relationship with Safeguard as a "cautionary tale."

New Trier district officials said the report contained inaccuracies and omissions. According to their statement, the program was authorized by the federal Department of Health and Human Services and endorsed by members of the scientific community.

"New Trier has also met with local and state health authorities to review our use of the program and they have not directed us to change our use of it," it said. "From the time the program began, New Trier has been clear that the saliva program is non-diagnostic and must be confirmed by a lab test. To suggest otherwise is false."

Oak Park-River Forest High School 200 officials also issued a statement following the report.

"We concur with New Trier’s statement," it said. "Legal counsel has reviewed our program, and we are confident that it is an appropriate and useful part of our multi-layered approach to mitigating the spread of COVID-19."

Campbell pointed to guidance from the Centers for Medicare and Medicaid Services, or CMS, effective Aug. 28, 2020, said the federal agency was "temporarily exercising enforcement discretion" when it comes to patient-specific COVID-19 surveillance testing programs.

Neither state or federal agencies, it said, will issue citations to non-CLIA certified labs as long as they only refer people with presumptive positive or inclusive results to a certified lab for further testing.

The February update to Illinois Department of Public Health's testing guidance for schools asks the public to report any labs that are "inappropriately reporting non-approved surveillance test results to individuals or to workplaces, schools, etc. as a diagnostic criteria to be used for quarantine decision-making" to the department's health care regulation office.

An IDPH spokesperson said the agency consulted with CMS and the Centers for Disease Control and Prevention after local health departments contacted it about schools using the testing. In response, CMS sent a letter to Safeguard late last year.

"Then in March, IDPH received two anonymous complaints to our Clinical Laboratory Improvement Amendments (CLIA) program. CMS reviewed the complaints and did not recommend an investigation," the IDPH spokesperson told Patch. "SafeGuard has since received a CLIA Certificate. Per CMS/CLIA, at this time, there is no further recommended action."

The Dec. 28 letter from CMS said no one can be given a patient-specific result from non-CLIA certified testing, but it reiterated earlier federal guidance that it would not issue any citations to labs that refer patients for further COVID-19 testing. The federal agency said Safeguard could not describe test results using the term "finding of potential clinical significance."

"We adopted that term because it was, in fact, the term that CMS officials in Wisconsin provided to David O’Connor, who was one of the pioneers of non-diagnostic surveillance testing in school settings, as the words he should use to refer a person to a diagnostic test," Campbell told Patch.

"We are not sure why Illinois CMS found issue with this term, and we did not feel that we were being 'warned' of anything. We accepted this guidance, as curious as it was, and now only state 'The following individuals should be referred to a diagnostic test in a CLIA certified laboratory,'" followed by a barcode, "to ensure we are adhering to this guidance."