COVID-19 ‘spit test’ coming soon to new MN testing lab

Courtesy of FDA

The test is more comfortable to take than nasal/oral swabs

Governor Tim Walz and Lt. Governor Peggy Flanagan announced on Tuesday that Minnesota has partnered with the nation’s leading distributor of saliva testing to create plans for a new lab in the state, expanding and diversifying testing capacity for Minnesotans, creating jobs, and slowing the spread of COVID-19.

State officials are working to finalize the $14.66 million contract with Vault Health and RUCDR Infinite Biologics. Rutgers’ RUCDR Infinite Biologics holds the country’s first FDA Emergency Use Authorization PCR saliva test for COVID-19 while Vault Health provides logistics and telehealth services necessary to carry out the test. The planned lab will have the ability to more than double the state’s current test processing capacity. The contractors expect to have the lab up and running by early October. The funding is provided by the state’s federal CARES Act funding.

“Public-private partnerships are the key to success in our state’s effort to combat COVID-19,” said Governor Walz. “We’ve come a long way on testing thanks to our work with the Mayo Clinic, the University of Minnesota, and our state’s health systems, but we’re looking to make COVID-19 tests even more accessible.

“That’s why we’re excited to announce a new, innovative partnership with Vault Health and RUCDR Infinite Biologics that will further expand Minnesota’s testing capacity. This means more options for Minnesotans looking to get tested and more diverse capabilities in terms of our overall strategy should we ever run into supply shortages or other hurdles down the road.”

This new saliva lab will be capable of processing as many as 30,000 samples a day, if running three shifts. At full capacity, it would also create up to 250 jobs at its planned location in Oakdale, Minnesota. Currently, Minnesota’s testing capacity hovers between 20,000 and 22,000 tests per day. The rolling average of PCR COVID-19 tests processed daily in Minnesota labs is just under 14,000 a day.

“Minnesota continues to be a leader in responding to this pandemic and planning ahead for the people of our state,” said Lt. Governor Flanagan. “This partnership will help eliminate barriers to testing, allowing us to provide saliva testing with a quick and reliable turnaround of results.”

Minnesotans will likely have three ways to access a saliva test.

  • First, the state will set up 10 semi-permanent sites. Any Minnesotan will be able to come to these sites to perform the saliva test. Each semi-permanent location will create 15-20 temporary jobs for Minnesotans.
  • Second, the state and other partners will be able to offer the test in mobile testing events. The saliva test requires much less PPE than a traditional swab for COVID-19 because it is self-collected under the supervision of a health professional.
  • Third, Vault Health also provides logistics and telehealth services to perform the saliva test at home. The state has not yet defined the parameters of a mail-order testing program.

“We are thrilled to see Governor Walz and the state government step up for their residents and protect the entire population from COVID,” said Jason Feldman, Co-Founder and CEO of Vault Health. “The Rutgers saliva test is reliable, has a low false negative rate and is comfortable to take. Our hope is that other governments will follow suit to unlock testing for all US residents.”

The higher test capacity, when combined with masking, social distancing, and isolation when appropriate, will help Minnesota get closer to suppressing COVID-19. According to the Harvard School of Public Health, for Minnesota to effectively mitigate the virus, the state will need to do just over 17,000 tests a day. Mitigation means keeping the size of the current outbreaks from growing and requires 10% or fewer positivity rate. To effectively suppress the virus, the state needs to do more than 63,500 tests a day. Suppression means greatly reducing new infections and keeping them low enough to safely reopen public life.

“While testing alone will not suppress the virus, higher testing volumes are a central part of the state’s strategies to managing the virus,” said Minnesota Department of Health Commissioner Jan Malcolm. “We’ve been successful so far at keeping our case numbers from increasing dramatically, as many other states have seen. But we know we have much more demand for testing than available testing today. And with school reopening in coming weeks, we will see an even greater demand for testing.”

The saliva test is less prone to supply shortages than the nasal swab. It avoids the discomfort of a nasal or oral swab. Given that the saliva test can be done without in-person interactions, there is no risk or virus transmission and no need for personal protective equipment (PPE) when conducted at home. To obtain a saliva sample, a person spits into a funnel attached to a small test tube. Once enough saliva is collected, the tube is closed with a plug, which releases a preservative into the sample. This keeps the sample good for up to 2 weeks without needing refrigeration.

“Research on the efficacy of all COVID testing is ongoing,” said Kris Ehresmann, Director of Infectious Disease Epidemiology with the Minnesota Department of Health. “The recent studies on saliva testing show it to be as effective as the nasal swab testing method. There are a lot of different options on the market, but we believe this saliva test is a particularly sensitive and accurate test, based on the research results so far.”

The three methods for test delivery are:

1) At-home testing supervised by a Vault Test Administrator

Residents who are eligible (state program and eligibility still in development) will be able to log onto a state-specific Vault Health website. Once they answer two questions about exposure, one about potential symptoms, the test will be ordered to a home address by Vault MD. UPS delivers the test overnight. The individual will receive instructions in the test kit to join a Zoom waiting room to be identified and have their empty tube serial number verified. They will be guided to spit, seal & preserve the contents, then return the sample to the lab in a prepaid overnight return to the lab. Test results are emailed within 72 hours. View process here:

2) On-site testing, supervised by trained medical personnel 

The testing entity orders test kits in bulk and leverages employees, contractors or volunteers with a medical background as “test administrators.” Vault will provide training to these administrators to conduct a “supervised spit” and to collect the samples and return to the laboratory. The main difference in the process flow is that the individual will use a mobile device to scan or manually enter on the website the serial number for the test kit handed to them on-site. Test results are emailed within 48 hours. (Alternatively, kits can be handed out onsite, with ability to use the telehealth option and returned via individual overnight UPS shipping.)

3) Minnesota’s semi-permanent in-person testing locations

Vault is available to manage on-site test events at any facility where additional support or a turnkey process is required. Vault will provide an appropriately sized team to administer testing on a specified date and time conducting a specific number of tests. Vault manages large on-site workforces in government, education, factories and fulfillment centers and sports teams in their practice facilities, and works to minimize disruption or long work stoppages.

Information provided by Governor Tim Walz and Lt. Governor Peggy Flanagan.