This type of test can be used to identify large numbers of infected patients and asymptomatic carriers, ultimately supporting containment efforts and slowing the spread of the virus. Currently, the test is the only rapid serology test cleared by China's FDA, the National Medical Products Administration (NMPA), that detects and displays both IgM and IgG antibodies in the blood. To distribute the tests to individuals in the U.S., Scanwell will leverage its existing partnership with telehealth partner Lemonaid Health.
The SARS-CoV-2 test is manufactured by the Chinese biotechnology company INNOVITA and has been used extensively in China for aiding in the diagnosis of COVID-19. The test detects IgM and IgG antibodies against novel coronavirus SARS-CoV-2 in the blood, which indicates that a 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. "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 healthcare centers, so that they can focus on the highest severity cases," added Chen.
How the Scanwell Health SARS-CoV-2 Rapid Test will work:
- Patient completes online intake questionnaire to be evaluated by a Lemonaid doctor or nurse practitioner.
- If appropriate, the Lemonaid doctor or nurse practitioner will order a test for the patient (following guidelines established by the CDC) and an at-home test kit will be mailed out to the patient via next business day delivery.
- Once received, patient performs at-home test and securely shares results with a doctor or nurse practitioner via the Scanwell app. This process takes 15 minutes, and the patient can expect to hear back from the doctor or nurse practitioner within hours.
- Patient receives follow-up consultation with a Lemonaid doctor or nurse practitioner, who will advise on next steps (self-quarantine, confirmatory testing, in-person care, etc.).
The clinical trial of the IgM and IgG rapid serology test for SARS-CoV-2 from five institutions in China demonstrated 87.3% sensitivity and 100% specificity when compared to traditional tests. Though 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 also identify asymptomatic carriers (the World Health Organization reports that 80% of infections are mild or asymptomatic) and those who may have been previously infected.
While U.S. protocols for COVID-19 testing have been initially limited to PCR tests, the FDA on 3/16/2020 updated its guidance to include the use of serological tests.
"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," said Chen. "Furthermore, making this test available to U.S. 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 option of having an at-home test mailed next day to your door gives Americans nationally a new option for how to get tested without putting others at risk of infection by driving to a lab or doctor's office," said Paul Johnson, CEO and co-founder of Lemonaid Health. "Our medical team will order the test, convey the results to the patient, and help the patient understand what the test result means in terms of both the result and what to do next. The result of the test could have immediate implications for not just the patient, but their family and friends, too."
Scanwell is anticipating that the SARS-CoV-2 rapid test kits will be available within 6 to 8 weeks after Scanwell obtains Emergency Use Authorization (EUA) from the FDA for at-home use of serology tests. The service will be provided at cost ($70 including next business day delivery, no insurance required), and will first rollout in WA, CA, NY and other severely affected states. Scanwell is investigating options to provide the service for free to patients unable to pay.