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"Since we know that early on in the pandemic, we didn’t have enough testing to go around, there’s no way to know how many people have actually had the virus unless we go back and look for a sign that they had it two months ago or three months ago," Michelle Altrich, the company's president, said. "That is what antibody testing can do for us. It can give us an idea of what really is the prevalence of the infection and that will help managing the pandemic at a very large scale." 

The serology testing, developed in accordance with the FDA’s Emergency Use Notification process, 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.  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.  

Viracor Eurofins has been at the forefront of fighting SARS-CoV-2 in the US, having launched testing on March 13 using polymerase chain reaction (PCR) with same or next day results for PCR, and 2-4 days for blood-based antibody testing. The laboratory’s current focus is reaching out to our local communities in Kansas and Missouri that may be in need of testing. 

Fox Business discusses Eurofins' launch of coronavirus antibody testing with David Morgan, Senior Vice President of U.S. Clinical Diagnostics

Viracor will offer two types of COVID-19 tests through the company’s established contract with the GSA (U.S. General Services Administration Contract):

• NP swab-based PCR tests to determine active infection
• Blood-based antibody testing. This may become a tool to identify people who were exposed to COVID-19, may have developed some level of immunity but potentially had mild to no symptoms.

The FDA is also allowing commercial labs to run these types of tests without FDA review. Framingham-based Boston Heart Diagnostics started offering a blood test on Monday that measures COVID-19 antibodies. The test is not meant to diagnose the virus, but it can be used to determine if someone had COVID-19 in the past and whether the virus is still present.

Viracor Eurofins, one of the largest and most recognised infectious diseases testing laboratories in the U.S., was granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Clinical Diagnostics' molecular laboratory-developed test (LDT). The Viracor SARS-CoV-2 assay is a real-time polymerase chain reaction (RT-PCR) test intended for the qualitative detection of SARS-CoV-2 viral RNA in nasopharyngeal swab, nasal swab, nasopharyngeal wash, nasal wash, oropharyngeal swab and bronchoalveolar lavage from individuals suspected of COVID-19. The Viracor EUA is available on https://www.fda.gov/media/136740/download.

“We are pleased to announce that COVID-19 antibody testing will be available to NKR Member Centers by Friday, April 10th. Some centers are already planning to use the newly released antibody test for screening donors and recipients prior to surgery, in conjunction with the PCR test, and for research related to waitlisted patients and transplant recipients.” Said Garet Hil, Founder and CEO, National Kidney Registry. “We are grateful for the rapid response from Eurofins in developing this solution and we indebted to key members of our Medical Board for guiding us through this process.