Thirty-five years of offering specialized, infectious disease and emerging pathogen testing for the critically ill uniquely prepared Eurofins Viracor to take on testing for Coronavirus SARS-CoV-2.
With this long-standing history of serving hundreds of academic hospitals and over 75% of transplant centers across the U.S, we set our sights on delivering the highest standard of diagnostics:
|During this unprecedented time of high volume, the turnaround time for most Coronavirus SARS-CoV-2 (COVID-19) samples is 24 hours from receipt of specimen in the lab.
As daily volume can have an impact on workflow, we are monitoring this closely and will provide updates as the situation changes.
The turnaround time for most Pooled Coronavirus SARS-CoV-2 RT-PCR (COVID-19) samples is 24-72 hours from receipt of specimen in the lab.
If a result is a part of a positive pool, there will be an additional 24-48 hours from the time pooled testing is resulted.
In 2005, Randy Moritz was diagnosed with polycystic kidney disease.
Fifteen years later, doctors told him he needed a transplant and removed both his kidneys. His wife, Karen, was a match and the surgery was booked for March 2020.
But then COVID-19 hit.
At-Home COVID-19 Testing
SALIVA PCR NOW AVAILABLE
The saliva specimen option is available on the PCR lab test and is intended for the qualitative detection of SARS-CoV-2.
Pooled COVID-19 RT-PCR testing allows more samples to be tested at once, making it a better, cost-effective option for facilities in low risk areas.
Universities, sports teams, employers, hospitals and care centers can utilize pooled testing to monitor groups with a low prevalence of COVID-19 infection.
IN-HOME PHLEBOTOMY SERVICE
As hospitals and transplant programs remain burdened with COVID-19, transplant patients may be unable to return or want to avoid the hospital or care center for their required surveillance testing. Additionally, clinicians are aiming to reduce office visits, both to ensure patient health and safety, as well as lessen the burden on staff.
To help clinicians continue to provide routine care for critical patients without requiring them to visit their care center, Viracor is now offering safe, convenient and accurate mobile phlebotomy.
Viracor’s Labs@HOME service offers physicians the option to order from a select menu of infectious disease, transplant-related testing and routine blood labs. A COVID-19 screened, professional phlebotomist will then schedule a time to safely perform the specimen collection in the patient’s home, practicing all COVID-19 guidelines and utilizing PPE.
NKR is the largest paired exchange program in the world and serves approximately 100 transplant programs throughout the United States. NKR has relied on Eurofins’ specialty transplantation laboratories, Viracor and our sister lab VRL Eurofins, for over seven years to process mission critical tests to support NKR’s paired exchange operation.
Viracor Eurofins is thrilled to be working with NKR and believes that by combining resources we can play a pivotal role in better understanding the impact of COVID-19 on transplant donors and recipients while reducing infection risk. Given the concerns surrounding COVID-19, particularly within immunosuppressed populations, like transplant recipients, we are pleased to support the transplant community as we work through this current healthcare challenge.
Molecular detection is established as the primary method for direct detection of this virus in the early stages of infection. Serology (antibody) testing offers the promise for enhanced detection of infected or previously infected individuals, although key questions remain about the significance of serological results. A large number of antibody tests are available, both laboratory-based methods and rapid, point-of-care (POC) tests.
Given our present state of knowledge, reliance on the most accurate, reproducible diagnostic methods available will provide the most effective approach to control the virus. Serology can be an important part of SARS-CoV-2 diagnosis and control, although it is important to understand that the level and specificity of antibodies to prevent re-infection of individuals and prevent viral transmission to others has not yet been identified.
Viracor started SARS-CoV-2 PCR assay development in January as the virus was spreading throughout China. At that time, our lab was urgently searching for clinical specimens to act in accordance with the EUA template released on January 19, 2020.
On February 29, the FDA updated its guidance stating, “spiking RNA or inactivated virus” were acceptable specimens to test, allowing our lab to complete validation.
Our RT-PCR assay was released March 13. Viracor received authorization by FDA under EUA for the Coronavirus SARS-CoV-2 RT-PCR test on April 6, 2020.
Antibody testing for coronavirus SARS-CoV-2 was launched on April 6, 2020.
Early on, we partnered with our Eurofins' sister labs to ensure we had enough reagents and supplies, and to meet the unprecedented demand for orders, running testing in the labs 24/7.
We have hired more lab associates, increased and adjusted shifts, and are using qualified volunteers from other lab departments. We are also utilizing additional technology and equipment to improve capacity and turnaround time. We are now able to run 7000 PCR tests and up to 5000 antibody tests a day.
Antibody tests detect the antibodies our bodies produce to kill the virus, which we keep producing even after the virus is eliminated. These tests can reveal who has been infected even after they have recovered.
This testing involves measuring specific antibodies made against the virus. COVID-19 IgM antibody levels rapidly increase within 3-7 days after COVID-19 infection, while IgG antibody levels rise within 10-17 days and persist, indicating potential immunity to
COVID-19. A positive test is having a level of > 1.0 AU/mL for either type of antibody.
Unlike the NP swab-based PCR test, blood-based serology testing may become a tool to identify people who were exposed or may have developed some level of immunity to COVID-19, but potentially had mild to no symptoms or for those that did not have access to PCR testing at the time of clinical signs and symptoms.
Coronavirus SARS-CoV-2 IgG and IgM antibody testing could also help companies better plan for reopening and evaluating the health of their workforce. Testing is performed on serum, and recommended at least 14 days after potential exposure – giving the body the time it needs to build an immune response and produce antibodies.
Over time, antibody testing is likely to become a crucial next step in fighting the spread of the virus.
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With over 35 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor is committed to helping medical professionals, transplant teams and reference labs get results faster, when it matters most.
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