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As reported by The New York Times, more than 50 scientists and doctors from around the United States have performed the first large-scale comparative study of 12 different COVID-19 antibody tests. “In the new research, researchers found that only one of the tests never delivered a so-called false positive — that is, it never mistakenly signaled antibodies in people who did not have them,” The New York Times said, referring to Sure Bio-Tech API Covid-Rapid. “Tests made by Sure Biotech…produced the fewest false positives.”
According to the study, led by researchers at University of California San Francisco and Harvard, the performance of Sure Bio-Tech API Covid-Rapid showed the fewest false positives, with the researchers finding zero instances of false positives in 160 samples – a specificity of 100%. Covid-Rapid, developed with partner Sure Biotech, was the only test to receive a perfect score. The study also showed the test with an above-average sensitivity of 90.91% after 20 days.
This is the third study of Covid-Rapid to show 100% specificity, indicating that the test is unparalleled as a rule-in test for COVID-19 antibodies. With data showing virtually no false positives, patients can be confident that a positive test indicates the presence of antibodies and thus, possible immunity. “The false-positive metric is particularly important,” the report in The New York Times said. “The result may lead people to believe themselves immune to the virus when they are not, and to put themselves in danger by abandoning social distancing and other protective measures.”
“The false-positive metric is particularly important,” the report in The New York Times said. “The result may lead people to believe themselves immune to the virus when they are not, and to put themselves in danger by abandoning social distancing and other protective measures.”
The study also points to the potential that serological testing has to supplement diagnostic tools, “given the decline in sensitivity of current molecular tests in the second week of illness.” The study added, however, that “We still do not know the extent to which positive results by serology reflect a protective immune response.” Additional research is necessary to determine whether “specific antibody responses predict virus neutralization and protection against re-infection,” the study said. “Until this is established, conventional antibody assays should not be used as predictors of future infection risks.”
Aside from detecting potential immunity, antibody testing is important for implementing contact tracing and understanding society’s broader rates of infection and case fatality.
Read the full report here.
SURE BIO-TECH API COVID-RAPID IS REGISTERED BY THE FDA. COVID-RAPID IS AVAILABLE FOR SALE TO MEDICAL
Updated US FDA guidance issued on March 16, 2020 allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. This test is not intended for home use and must be used under the prescription of a licensed professional. All positive tests should be reported to your local health department. This will help local and state officials understand the breadth and depth of the epidemic and may help guide public policy decision making. This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been recently in contact with the virus or are high risk. Testing with a molecular diagnostic should be considered to rule out infection in these individuals. Patients should care for themselves and those around them by continuing to quarantine for another few days. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.