Editor's note: As the COVID-19 situation and requirements for testing continue to evolve rapidly, please consult the US Food and Drug Administration website for the most up-to-date information on diagnostic tests.
A lack of testing capacity is one of the key hurdles currently facing the US in diagnosing and tracking cases of COVID-19. But at-home test kits for less urgent cases could soon help ease the burden as well as increase safety for health care workers and members of the public.
However, companies currently making such home-based collection kits already seem to be running into challenges of their own after the US Food and Drug Administration (FDA) said in an announcement Mar. 20 that these kits need to be FDA approved before shipping.
Everlywell had planned to start sending their tests to pharmacies and homes yesterday (Mar. 23), according to an article in Science, but has since made the decision to hold that supply for hospitals and health care providers. Carbon Health and Nurx were sending out small quantities of their home test kits, the article adds, but Nurx has currently halted new requests for its test kits (as of Mar. 23), though Carbon Health’s Coronavirus Assessment Tool was still running on its site. Once people collect samples with these kits, they then mail them to approved labs for PCR testing.
On Mar. 19, Scanwell Health announced that it “has secured exclusive rights to license and distribute a SARS-CoV-2 rapid serology test from INNOVITA for at-home use.” The US Food and Drug Administration (FDA) gave companies the go-ahead to develop serological tests on Mar. 16. Such tests measure the amount of proteins or antibodies responding to infection in a person’s blood.
Scanwell Health says its test will only take 15 minutes to complete using its smartphone app which will connect people to a nurse practitioner or doctor who will provide them with their results and advice on what they should do next. The company’s test will be distributed through its partnership with telemedicine provider Lemonaid Health.
“We recognized that a number of health care organizations are struggling to evaluate patients for COVID-19 due to testing constraints,” said Stephen Chen, founder and CEO of Scanwell Health in a press release. “While the gold standard for diagnosis is still the PCR test, given the growing shortage of swabs and reagents, a rapid serology test is beneficial in that it allows for wide-scale testing.”
“We hope that these home-use test kits will ease the burden on health care centers, so that they can focus on the highest severity cases,” Chen added.
For such home-based kits, people will answer a series of questions online or at a pharmacy or other retailer to determine whether they qualify for testing. Scanwell’s questionnaires are evaluated by a nurse practitioner or doctor who decides whether to order a test for the patient, based on CDC guidelines.
If it’s likely the patient has been exposed to COVID-19, they are mailed a test kit or can pick one up at their nearest retail location, along with instructions on how to do the test, store, and mail their sample for testing. However, Scanwell’s test does not require people to send a sample to a lab. After performing the rapid serology test at home, they use the company’s secure app to share the results with a nurse practitioner or doctor.
While Scanwell says people can expect to hear back from a nurse or doctor regarding next steps “within hours” of doing its test, Everlywell’s site says people typically get results from its test in three to five days, while Nurx’s website lists a time of two days for results of its test and Carbon Health listed a time of three to six days for test results on its website.
Late Friday, March 20, the FDA announced that all at-home tests and sample collection kits must be FDA cleared before shipping.
According to Science, Everywell has been producing thousands of their tests per day but aims to increase that to tens of thousands per day. In a statement to FierceMedTech, Everylywell said it is "working directly with the FDA to understand any additional regulatory requirements that may apply to at-home collection kits."
Scanwell is still awaiting emergency use authorization (EUA) from the FDA for its test, and says it expects its kits to be available six to eight weeks after it gains EUA. The company says it plans to ship its kits to hardest hit states first, including New York, California, and Washington.
"Scanwell Health completely agrees with the FDA that at-home tests need regulatory oversight—we began this process before we ever announced our kit, and never considered shipping kits that were not FDA cleared," said Dr. Jack Jeng, Scanwell's chief medical officer in a second press release.
It should be noted that none of the other tests mentioned in this article has yet been approved by the FDA, and it was unclear if those manufacturers are in the process of getting EUA.
In its Mar. 20 statement, the FDA warned Americans that it “has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”
The regulator added that it will take action to protect the public from companies selling fake COVID-19 tests or treatments and has already sent warning letters to companies who are doing so.