(SOT- DR. JOHN CHOU, MEDICAL DIRECTOR FOR ANESTHESIA DIAGNOSTICS AT SUTTER HEALTH)
"You can get the results immediately, and a test that you can offer patients at home."
California-based Lucira Health has been given emergency Food and Drug Administration approval for the first do-it-yourself COVID-19 test kit that not only lets you test at home but also get the results in less than a hour.
Dr. John Chou's team at hospital operator Sutter Health helped to clinically validate the rapid at-home test.
"Our experience with it typically yielded a positive result within 15 minutes. I think as early as 11. You can only be sure that it is not positive, or that it is negative, around 30 minutes. "The huge advancement here isn't the speed itself but the ability to have a test that is on par, or at least close to par, with what we consider the gold standard: the PCR testing, and doing it at a very rapid time.""
This week's emergency use authorization for the rapid test comes at a critical time as coronavirus infections continue to see a record surge across the country... and long lines at testing sites.
Dr. Chou explains how the test works.
"The steps are: you take the batteries out of the wrapper, insert it into the device, ensuring the orientation is correct. Unwrap the nasal swab. Swab each narry 5 times. Then take the swab, dip it into the vial, swirl it around 15 times, take the swab and discard it, close the cap, and then push the whole thing down, which will engage the process of testing. And that gets the test started."
An indicator light reveals the test results. Despite promising vaccine trial results released this week from Pfizer and Moderna - the distribution of a vaccine is still months away - leaving testing as a crucial tool in stopping the spread of the virus.
Sutter will be one of two hospitals to be the first to get their hands on the kits. Sutter hopes that will be within a month or two. But that doesn't mean the kits will be going home that quickly. The hospital operator has decided to first use the kits to help clear the testing log-jam at hospitals.
"We have patients who need immediate care, so symptomatic patients, or we have patients who have high needs in terms of things to improve their health - so surgery or people who are going to deliver babies - so our initial use will really be for patients who are at the most need until there is enough capacity to expand it. We will probably start using it within point of care setting then expand to the home use setting as we get more and more kits."
Sutter Health expects to make the test available for at-home use by prescription only for people over 14 years old - sometime in the first quarter of next year. The test’s manufacturer Lucira is planning a national rollout by Spring 2021 and says the test should cost around $50.