Our lab is testing a receptor-binding domain (RBD) of the S1 spike protein to detect antibodies that block the virus entry into the cells. This selection is aligned with current vaccinations in development that are targeting the spike protein.( In medical diagnosis, test sensitivity is the ability of a test to correctly identify those with the disease (true positive rate), whereas test specificity is the ability of the test to correctly identify those without the disease (true negative rate). A validation study
completed by our partner laboratory (and submitted to the FDA) showed a sensitivity of 100% and specificity of 99.8%.
Our partnered lab is the only lab in the world that is performing the Ultra Sonic COVID-19 Antibodies with Fast Track Technology which is why our sensitivity and specificity percentages are highly accurate. The lab is also a high complexity lab that is CLIA and CAP certified.
This particular test was made with specific antigens from COVID19 and was tested against other common cold strains as well (Influenza A/B, RSV, H flu, etc.), however not tested vs. other coronavirus strains. Although highly unlikely, you could potentially see cross reactivity, which is why the FDA mandated disclosure is present on all reports: “…positive results may be due to past or current infection with Non-SARS-CoV2 strains...”. At this point in this pandemic, it would be wise to practice social distancing and symptom monitoring as though you have COVID19 out of an abundance of caution.
It is also important to note that if you are on immunosuppressive medications (like chemotherapy, steroids, methotrexate or others) or have been diagnosed with cancer, your immune response may be blunted, causing a false negative of the test. Important points to remember:
Negative results do not rule out SARS-CoV-2 infection, particularly for patients who have been in contact with known infected persons or in areas with high prevalence of active infection. Follow-up testing with a molecular diagnostic test (ie PCR with a nasal swab) is necessary to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection. False positive results may rarely occur due to cross-reacting antibodies from previous infections, such as other coronaviruses, or from other causes. Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnostic determination is made.