The pharmaceutical company Roche has gotten an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for its COVID-19 antibody test, one of 12 companies to do so, so far.
Roche says its antibody test has a specificity (true negatives) greater than 99.8% and sensitivity (true positives) of 100%, based on testing done 14 days after having patients confirmed via testing as having COVID-19. Roche says it plans to ship double-digit millions of tests this month.
In an interview, Hawaii Lt. Governor Josh Green, M. D., said that he personally is reviewing some of the antibody tests –also called serology tests– available that could be used in the state. He said those that require just a pin prick of blood are around 93% accurate. But the Roche antibody test requires a standard blood draw from a vein and has more accurate results.
The antibody tests will show if somebody had COVID-19, but it’s unclear how much immunity such a person may have, how long immunity would last, and whether they could still get other coronaviruses such as the common cold or influenza or get COVID-19 again. Even if somebody tests positive on an antibody test, showing they did have COVID-19, they still need to wear a mask when in public and stay 6 feet away from others.
The pharmaceutical company, headquartered in Switzerland, was founded in 1896.
Severin Schwan, CEO Roche Group, said ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
The FDA was initially allowing companies to introduce antibody tests and “self-certify” their validity. But there are now 200 companies offering antibody tests, and the FDA on Monday tightened the requirements and now all the companies are required to get an Emergency Use Authorization from the FDA. The FDA is also now setting performance thresholds for the antibody tess.