First Clinical-Grade Rapid At-Home Test to Aid in COVID-19 Crisis

Scanwell Health has secured exclusive rights to license and distribute a severe acute respiratory syndrome coronavirus (SARS-CoV-2) rapid serology test from INNOVITA for at-home use. The test takes 15 minutes using the Scanwell app, and a physician and nurse practitioner will reach out with results and next steps within hours, according to the company.

The test can be used to identify large numbers of infected patients and asymptomatic carriers, which would help support containment efforts and slow the spread of the coronavirus disease 2019 (COVID-19). Additionally, it is the only rapid serology test cleared by China’s FDA, the National Medical Products Administration, that detects and displays both IgM and IgG antibodies in the blood. Scanwell Health will be leveraging its partnership with telehealth partner Lemonaid Health to distribute the tests to individuals in the United States.

INNOVITA has been manufacturing the SARS-CoV-2 test in China to aid in the diagnosis of COVID-19. The test detects IgM and IgG antibodies against COVID-19 SARS-CoV-2 in the blood, indicating that the person has been exposed and developed antibodies against the virus.

"We recognized that a number of healthcare 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."

After the patient completes an online intake questionnaire, it is then evaluated by a Lemonaid doctor or nurse practitioner. If needed, the Lemonaid doctor or nurse practitioner will order a test for the patient and an at-home test kit will be mailed out to the patient via next business day delivery.

Once patients receive and perform the at-home test, they can share the results with their physician or nurse practitioner via the Scanwell app. A follow-up consultation will occur if appropriate, in which a doctor or nurse practitioner will advise on next steps, such as self-quarantine, in-person care, etc.

Five institutions in China demonstrated 87.3% sensitivity and 100% specificity in a clinical trial of IgM and IgG rapid serology test for SARS-CoV-2 compared with traditional tests. Although the presence of IgM and IgG antibodies can take time to develop, antibody tests are especially helpful for tracking the spread of the virus, as they can help identify asymptomatic carriers and those who may have been previously infected.

"The advantage of collaborating with INNOVITA is that they have firsthand clinical data showing how effective their IgM and IgG tests have been in managing disease outbreak in China," Chen said in a press release. "Furthermore, making this test available to US patients in the home via Lemonaid Health will allow patients to receive personalized guidance from a doctor or nurse practitioner in a safe environment while limiting exposure."

The SARS-CoV-2 rapid test kits will be available within 6 to 8 weeks after Scanwell obtains Emergency Use Authorization from the FDA for at-home use of serology tests, according to the company. The test will be provided at a cost of $70 (including next business day delivery and no insurance required), and will roll out in Washington, California, New York, and other severely affected states. Scanwell Health is also investigating options to provide the service for free to patients unable to pay.

REFERENCE

Scanwell Health to Launch First Clinical-Grade Rapid At-Home Test to Aid in COVID-19 Crisis [news release]. Los Angeles, CA; PR Newswire: March 19, 2020. https://prnmedia.prnewswire.com/news-releases/scanwell-health-to-launch-first-clinical-grade-rapid-at-home-test-to-aid-in-covid-19-crisis-301027302.html. Accessed March 23, 2020.