Self Administered COVID-19 Saliva Testing

Why should your company keep on-hand and test for COVID-19?

• Security for your employees
• Protect your business and avoid possible shutdown
• Understanding the current state of exposure to your company
• Ability to plan for returning workers
• Reduce exposure to unaffected workforce
• Maintain/Improve productivity
• Planning for future waves of infections
• Practical/Non-invasive
• Test and result large populations quickly
• Helps control the spread of COVID-19 for larger society

CDC Guidance

SARS-CoV-2 Testing Strategy: Considerations for Non-Healthcare Workplaces

Public health surveillance for SARS-CoV-2 testing is considered to be surveillance when conducted to detect transmission hot spots, or to better understand disease trends in a workplace.  These goals are consistent with employer-based occupational medicine surveillance programs. Occupational medicine surveillance programs may use testing to assess the burden of SARS-CoV-2 in the workforce, assess factors that place employees at risk for workplace acquisition of SARS-CoV-2, or evaluate the effectiveness of workplace infection control programs. Surveillance should only be undertaken if the results have a reasonable likelihood of benefiting workers.

https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/testingnon-healthcare-workplaces.html#testing-5

Nova Medical Centers will provide the employer with COVID-19 Saliva Tests that can be self-administered on the job site, on-demand, and as needed.  Each package includes twenty-five (25) COVID-19 Saliva Tests to be housed and administered by the employer.

About the COVID-19 Saliva Test

• FDA Emergency Use Authorization – (EUA)
  • After meeting clinical testing requirements, the FDA issued an EUA to distribute and use the COVID-19 Saliva test on 5/7/2020 to Rutgers Clinical Genomics Laboratory (RCGL)
  • Tests made available under an EUA have not undergone the same type of review as an FDA-approved or cleared test. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved or available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that the test may be effective.
• Yale University Study
  • Independent study by Yale University, published on 4/22/2020
  • Showed saliva testing to be more sensitive than nasopharyngeal swabbed tests.
• The RCGL saliva test is designed to detect RNA in the SARS-CoV-2 virus which causes COVID-19
  • DO NOT eat, drink, smoke or chew gum 30 minutes prior to collection
  • Collection chemistry inactivates 100% of the live virus while preserving the RNA for detection on testing
  • The RCGL test has a small chance of producing an inconclusive result. (Relative Sensitivity /True Positive
  • Rate: 100%, Relative Specificity/True Negative Rate: 100%, Overall Accuracy: 99%) EUA w/ Clinical Data
  • Retesting by your PCP may be recommended if the test is positive, inconclusive or negative with symptoms

FDA Patient Factsheet

What Does the Test Include?

• Aggregate reporting of population results to Human Resources
• Employee receives their own results via email
• Shipping of test kits to your worksite (increments of 25 tests)
• Saliva collection tube
• Reagent cap w/ chemistry to stabilize and preserve
• Biohazard specimen bag
• Alcohol pads
• Kit instructions
• Return shipping (Category-B UN3373 biological)
• Results in 1-3 days (overnight shipping)
• Results in 4-5 days (2nd-day shipping)