COVID-19 Antibody Validation

  • As of May 13, 2020, there were no COVID-19 Antibody tests approved for use in a Physician Office/Clinic without a CLIA Certificate of Accreditation/Compliance. Similarly, there were no CLIA waived POC COVID-19 (serology) tests approved by the FDA on the market, and only a handful have EUA approval.
  • However, Elite has the solution: we can help quickly upgrade your CLIA Certificate from Waived to Moderate or High Complexity in a matter of days and assist you in completing a compliant validation for the antibody test using our verified COVID-19 positive and negative antibody samples.

For only $9,250 Elite will oversee your COVID-19 Antibody test validation and provide six months of validation materials

Elite can partner with you in the following ways
to validate for COVID-19 Antibody testing


We can provide daily
controls for continued use
to ensure compliance and
accurate results.


We will coordinate
testings with a correlation
partner to ensure the
accuracy of your testing.


$9,250 for COVID-19
Antibody test validation and
6+months of validation
materials & controls.

Learn more about starting COVID-19 testing!

Click Here



"I was very impressed with the team at Elite. They helped me source instrumentation and supplies and walked my team through the validation step-by-step. The whole process as smooth from Day 1 to Go-Live."

- Michael B., Charlotte, NC

Elite is currently validating COVID 19 testing for several clients. Please let us know if you would like to hear more about our COVID validation services To learn more CLICK HERE