NEW HAVEN, Conn. (WTNH) — The latest from the U.S. Food and Drug Administration Monday — requiring antibody test makers to get FDA authorization — a move to address unproven tests flooding the market.
Granting emergency use is how the FDA responds to public health emergencies.
The latest FDA approval — an antibody test developed by Roche. The CEO said, it has a 99.8% accuracy to detect if someone was infected by the virus that causes COVID-19.
“They are reporting a very high sensitivity and specificity, one of the advantages of Roche is they have the ability to mass-produce and potentially distribute,” says infectious disease specialist Dr. Manisha Juthani with Yale Medicine.
She goes on to say, “They are expecting not as many false positives so I think it remains to be seen a little bit. There are other tests that are on the market as well that can have similar type testing ability. But I think it is promising that at least another test is coming to the market.”
Testing for antibodies appealing to people who may have been exposed but showed no symptoms.
“I think this is a very important conversation to have with your doctor,” says Dr. Juthani, “So that you understand what the test can tell you and can not tell you and I think that’s why you need to talk to your doctor and figure out where they can send you.”
The drug first developed for Ebola, also getting the okay from the FDA. Hospitals across the country will be getting the intravenous medication Remdesivir this week.
She says, “It’s certainly only for hospitalized patients but it is specifically for hospitalized patients who have more severe disease so they need oxygen in order to provide enough oxygen to their body. So if somebody does not need supplemental oxygen then they would really not be a candidate for Remdesivir.”
Getting back to antibody testing — currently — there maybe a high rate of false positives — and many of you are asking — how many times should you get tested?
Dr. Sheldon Campbell, who specializes in laboratory testing for patient care at Yale Medicine, answers, “That right now we do not recommend antibody testing except to understand COVID in the population. But eventually, a positive test might need confirmation; a good positive test and a second good positive with a different viral protein are fine, you wouldn’t need three.”
Dr. Campbell says that could change in a month, describing antibody tests, a bit Wild West right now.