- 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
Support
We can provide daily
controls for continued use
to ensure compliance and
accurate results.
Accuracy
We will coordinate
testings with a correlation
partner to ensure the
accuracy of your testing.
Pricing
$9,250 for COVID-19
Antibody test validation and
6+months of validation
materials & controls.