After the preliminary data of California research groups that are testing the tests, Congress is showing dissatisfaction, alarming for lack of accuracy in the antibody tests that overflown the market.
According to Dr. Alex Marson, who is conducting the research, no one will be happy with the results. He said: “If we give people a false impression, for whatever reason, that they may be in fact protected when they’re not, that would be not only irresponsible, it would be dangerous to individuals.”
Over 150 different antibody tests are available on the U.S. market without any governmental review, which complicates further research and accuracy control.
False positive testing is what medical specialists fear the most. Almost 90 percent of test specificity means that the rest of 10 percent shows false results all the time. Test specificity indicates how many negative tests are really negative.
The industry standard for tests is between 95 and 98 percent, according to medical experts, which means that the coronavirus antibody tests are far from accurate.
Accuracy results are even worse for patients who already tested positive for COVID-19. Only one test (Jiangsu Bioperfectus Technologies) exceeded 91 percent in detecting either IgG or IgM antibodies, while other tests failed even on samples taken twenty or more days after the infection.
White House investigators are addressing a concern to FDA work, detecting a lack of staff focused on enforcement of the antibody testing policies. House Oversight Committee members found that the same FDA officials are doing two jobs – acting on violations and reviewing applications for an emergency antibody test approval.
Inaccurate antibody tests are already harming the economy and stability of the country, boosting the number of infected cases and keeping us under lockdown for much longer.