COVID-19 Antibody Testing

COVID-19 Antibody Testing

ProterixBio’s test is an immunoassay intended for the (semi) quantitative* detection of COVID-19 antibodies.

Note: Antibody testing is not currently recommended to assess for immunity to COVID-19 following COVID-19 vaccination or to assess the need for vaccination in an unvaccinated person. Please refer to the FDA website for further information around antibody testing recommendations.

This test has not been approved or cleared by the FDA. This test has not been issued an Emergency Use Authorization (EUA) by the FDA.

This test does not tell you if you have an active COVID-19 infection and should not be used for the diagnosis of COVID-19.

This test requires a prescription and is not an at-home test.

For Professionals

Quantitative*
COVID-19 Serology Testing

ProterixBio offers (semi) quantitative* COVID-19 serology testing services through our high-complexity, CLIA-certified clinical testing laboratory. Our lead test measures specific antibodies that bind the spike Receptor Binding Domains (RBD) of SARS-CoV-2. Our tests are validated for serum and plasma samples, and can also be shipped as dried blood spot (DBS) sample collection kits (semi-quantitative results).

Learn more about our Serology Testing

For Patients

Know your COVID-19
Antibody Levels

ProterixBio’s COVID-19 serology test provides a numerical value that indicates whether or not you may have antibodies to SARS-CoV-2. This test requires a prescription. Please see below for additional information.

Contact your physician to order a test.

About ProterixBio COVID-19 Antibody Tests

SARS-CoV-2 (RBD) IgG Antibody test is an immunoassay intended for the (semi) quantitative* detection of antibodies binding to the SARS-CoV-2 Spike Receptor Binding Domain (RBD). Our test has been validated in serum, plasma (EDTA or heparin) and dried blood spots (DBS).

  • Antibody testing is not currently recommended to assess immunity after COVID-19 vaccination. Please refer to the FDA website for further guidance around antibody testing recommendations.
  • This test requires a prescription. Contact your physician to order a test.
  • This test has not been reviewed by the FDA.
  • This test is not an at-home test.
  • This test does not tell you if you have an active COVID-19 infection. If infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • After infection, it typically takes at least 10 days after the onset of symptoms for IgG levels to be detectable.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
  • Clinical specimens used in the test’s evaluation were collected in the United States of America prior to 2021. Clinical performance has not been established in all circulating variants, and performance may vary depending on the variants, and their prevalence, circulating at the time of patient testing. 

 

 

ProterixBio is a licensed high-complexity clinical testing laboratory (CLIA #22D2189261) located in Billerica, MA.

*Quantitative results are reported for serum and plasma samples;
these are calibrated to the First WHO International Standard for anti-SARS-CoV-2 Immunoglobulin.
Semi-quantitative results are reported for Dried Blood Spot samples.

For more information: