EMERYVILLE, Calif. - A non-descript warehouse-style office is now the center for the latest advancement in the battle to flatten the COVID-19 curve.
Tuesday, the Food and Drug Administration issued an emergency use authorization for the first “COVID-19 All-in-one Test Kit,” made by Emeryville-based Lucira.
“I think it could be potentially a game changer. I was very excitd when I heard of this announcement,” said immunologist Dr. Robert Quigley.
The tests are approved for people 14 years of age and older. They use a nasal swab to collect a sample, similar to other COVID tests. But with this, the sample is then placed in a vial that’s then put in the testing unit. In 30-minutes or less, the results can be read from the units display screen.
“When it was compared to a highly sensitive PCR test, it agreed with it 94% of the time with the positive cases. And 98% of the time with the negative cases. So that’s great news,” said radiologist Dr. Nicole Saphier, a medical contributor on “FOX & Friends.”
In a statement, FDA Commissioner Doctor Stephen Hahn wrote in part, “…This is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
“The more we have an idea what our status is, from an infected state to a non-infected state, the better we are to be able to control the spread of the disease,” said Quigley.
It’s unclear how long it will take to get the new, in-home test widely distributed. And there are concerns some who test positive may not do the right thing and self-isolate..
“We have to be realistic. What I do think is a majority of people, if they tested positive, would do the right thing and notify their physician. And then the physician could notify the public health agency and isolate. I don’t think people would want to take the change of potentially spreading this,” said Dr. Jake Scott, a Stanford School of Medicine infectious diseases expert.
Associated Press reported the new rapid test will require a prescription, likely limiting its initial use.
The FDA stresses efficient tracking and reporting of results is key. Nationally, 11.3 million people are infected with the novel coronavirus. In the Bay Area, six counties have dropped to the purple tier in the state’s color-code restriction list. Three are in the red tier.