Otogenetics COVID-19 PCR Testing
To determine whether you are actively infected with COVID-19. A Quick and Highly Sensitive Test for Detection of COVID-19 Viral RNA using FDA EUA-Approved Reagent Kit (EUA200065). Otogenetics validated test LoD using the FDA SARS-CoV-2 Reference Panel materials.
* The test is for in vitro diagnostic use in Otogenetics’ CAP-accredited clinical laboratory CLIA-certified for high complexity testing.
COVID-19 Antibody Testing
To determine whether you have antibodies against SARS-CoV-2. A Single Disposable Test for Detection of COVID-19 antibodies in 15 Minutes or Less. No equipment needed.
* The tests are for in vitro diagnostic use in clinical laboratories or point-of-care facilities CLIA-certified for moderate or high complexity testing only, following guidance from the FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 during Public Health Emergency issued on March 16, 2020 and updated on May 4, 2020. Currently, various commercially available test kits with EUA authorization are used, including Cellex qSARS-CoV-2 IgG/IgM Rapid Test. Please check the limitations, warnings, and fact sheets from Cellex (https://cellex.us/). Tests are performed for their intended use and precisely according to the user instruction insert of the testing kits.
The COVID-19 antibody test ordered by physicians and submitted to Otogenetics for testing is at $50/test. Test Inquiries: contact Support@otogenetics.com
Which Test(s) to Use?
The Otogenetics COVID-19 PCR Testing is real time PCR from purified RNA that detects the presence of viral RNA. It should be used during the active phase of infection when virus is present in the infected tissues. It is one of the most sensitive molecular tests under EUA issued by FDA. As published by FDA using FDA standard reference specimens, the test sensitivity is determined at 1800 NDU*/ml. In comparison, the published sensitivity of LabCorp COVID-19 RT-PCR test is 180,000 NDU*/ml, and the published sensitivity of Abbott ID NOW COVID-19 test is 300,000 NDU*/ml. *NDU: NAAT Detectable Units/ml for FDA standard reference specimens.
COVID-19 Antibody Testing is for the detection of antibodies against COVID-19 that develop in patients some time after COVID-19 infection. This duration, known as seroconversion, can be as short as 3 days or as long as a couple of weeks post illness onset. Only very limited knowledge is available for this new virus. It is unknown how long the antibodies remain.
The diagram below illustrates when virus is detectable from throat/nasal swabs and when the antibodies may be detected (digested from data published in Nature, April 2020).