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



Elite Contact Form

"*" indicates required fields


"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