With the number of COVID-19 cases continuing to rise and with people social distancing and quarantining, at-home diagnostics and telehealth offer the means for doctors and patients to get vital answers and care without meeting face to face. Now, Los Angeles-based Scanwell Health has gained exclusive rights to license and distribute a rapid serology test from Innovita Biological Technology Co. Ltd., of Hebei, China, for at-home testing of SARS-CoV-2, the coronavirus that causes COVID-19.

Scanwell expects the test to be available in the U.S. within six to eight weeks of securing emergency use authorization from the FDA.

The test, which detects IgM and IgG antibodies against SARS-CoV-2 in the blood, indicating if someone has been exposed to the coronavirus, was cleared by China’s National Medical Products Administration for use in fighting that country’s COVID-19 outbreak. In a clinical trial involving 447 cases at five Chinese hospitals, 110 of 126 clinically confirmed cases were positive using the test, demonstrating 87.3% sensitivity and 100% specificity.

Antibody tests could be particularly helpful in slowing the spread of COVID-19 by helping to isolate and track asymptomatic carriers of the disease. According to the World Health Organization, 80% of infections are mild or asymptomatic.

“The lack of test kits and test facilities is a huge problem in the U.S. right now. Millions of people are likely infected and don’t know it,” Stephen Chen, Scanwell’s CEO and founder, told BioWorld.

In addition to expanding access to testing, at-home kits reduce burden on health care centers, help people maintain social distancing and allow people to get tested without putting others at risk, he said.

Partnering with telehealth

Scanwell will distribute the tests in the U.S. via its existing partnership with Lemonaid Health, which also distributes Scanwell Health’s at-home test for urinary tract infections. The San Francisco-based telemedicine provider operates in every state in the nation and ships medications nationally from its pharmacy in St. Louis.

“Patients won’t need an existing relationship with Lemonaid to use the COVID-19 at-home test,” CEO Paul Johnson told BioWorld. “Quickly increasing testing can have a big impact on managing existing cases, avoiding new infections and empowering patients with important information, so we don’t want any barriers in the way of patients who need to test.”

How it works

To perform the test, patients draw a small amount of blood using a home blood collection device included in the kit and place their blood on the test, adding a few drops of diluent that is also provided in the kit. In 15 minutes, a reaction occurs. The patient then takes a photo of the test and shares it via the Scanwell Health app with a Lemonaid doctor or nurse practitioner, who interpret the results and reach out with next steps. Lemonaid has promised to respond with results within 24 hours, but is aiming for a two-hour response time.

The prospect of at-home testing for COVID-19 comes as people are avoiding traditional health care settings, and public transport to get there, to avoid possible exposure to the coronavirus, Johnson said. In the last month, Lemonaid has seen a 30% uptick in patients seeking virtual help with anxiety and depression to deal with the stress of the situation.

And it could help to flatten the curve of new coronavirus cases and prevent hospitals and clinics from being overwhelmed.

“The patient who suspects they have the virus is the last person who should be going to a doctor’s office, traditional lab or pharmacy,” Johnson said. “The combination of home diagnostics and guidance from a telemedicine doctor on what the result means and recommending next steps in light of the patient’s specifics is a solution that removes the need for the patient to risk infecting others – particularly health care workers – by engaging with the traditional health care system.”

Added benefit

Chen said the SARS-CoV-2 at-home test has an additional advantage. While most at-home tests use sample collection kits, which must then be mailed to a lab, “the Scanwell test kits will be done completely at home – there is no need to send a sample to a lab or visit any medical facility.”

Scanwell will provide the tests at cost – $70, including next business day delivery – and is exploring options to provide it free to patients who can’t pay. The first kits will roll out in California, New York, Washington State and other hard-hit states.