New Serology Test for COVID-19 antibodies by OmniCyte
COVID-19 Serology Test
OmniCyte is a Branford, CT based Immunology Company, and we are pleased to now be offering a COVID-19 response. In collaboration with Mt Sinai Hospital in New York, we are performing a highly sensitive and specific serological assay (blood test) to detect the presence of antibodies to the COVID-19 virus. This serology test has been authorized on April 15, 2020 by FDA under an EUA for use by authorized laboratories.
The FDA states:
Serological tests can play a critical role in the fight against COVID-19 by helping healthcare professionals to identify individuals who have overcome an infection in the past and have developed an immune response. In the future, this may potentially be used to help determine, together with other clinical data, that such individuals are no longer susceptible to infection and can return to work. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. This is why Vice President Mike Pence called on the laboratory community to develop serological tests for COVID-19.
While our test will indicate if someone has been previously infected and has antibodies that may confer immunity to the virus, it does not diagnose current infections. To detect current COVID-19 infection, another test must be performed.
We are pleased to provide the COVID-19 antibody serological test to you and/or your organization. The assay requires the collection of a small amount of the employee’s blood, which can be done at your facility or a regional collection site. The sample is then taken back to our lab where the samples will be analyzed and results can be returned in 24 hours.
• This test has not been FDA cleared or approved;
• This test has been authorized on April 15, 2020 by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and,
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• To detect current COVID-19 infection, another diagnostic test must be performed.