Viracor Eurofins Launches Highly Accurate Antibody Tests for Coronavirus (COVID-19) SARS-CoV-2

Publisher: The Insight Partners

 Viracor Eurofins, Inc. (Viracor) an infectious disease testing laboratory for more than 35 years, announced the launch of its antibody assays for Coronavirus (COVID-19) SARS-CoV-2.  The CAP-accredited and CLIA/NY State-certified laboratory has been at the forefront of SARS-CoV-2 testing, creating a proprietary RT-PCR test used by hundreds of hospitals nationwide. Viracor's SARS-CoV-2 PCR test, received an Emergency Use Authorization from the Food and Drug Administration (FDA) on April 6.  Viracor will begin offering IgG and IgM serology assays developed by Gold Standard Diagnostics.

The assays, developed in accordance with the FDA's Emergency Use Notification process, are based on the ELISA (Enzyme-linked Immunosorbent Assay) technique. The tests can detect IgM antibodies (typically present approximately 2-5 days post-infection) and IgG antibodies (typically present approximately 2-4 weeks post-infection). Viracor has the capacity to result more than 2,000 tests per day with a 24 hour turnaround from specimen receipt. Eurofins U.S. Clinical Diagnostics, which includes Viracor and six other laboratories, has the capacity to run up to 10,000 antibody tests per day and is expecting to triple that number by the end of this month. 

According to a preliminary study, Viracor's IgG serology assay was 100% accurate in finding antibodies in COVID-19 positive patient samples (12 days post symptom onset).  Using a wider sample group from PCR positive patients, the IgG test showed a specificity of 99.1% (9 days post symptom onset).

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.  However, reliable serology testing, when used in conjunction with the PCR assay, can help determine the timing and status of the infection.  Antibody tests can also help identify which recovered patients have antibodies to be a potential plasma donor to a critical COVID-19 patient.  Finally, as knowledge around immunity strength and duration develops, antibody testing may also provide information on the statistical likelihood of getting re-infected.