Company begins user study for at-home COVID-19 antibody test
The Los Angeles-based medical device company, Scanwell Health, announced on its website yesterday that it has begun user testing for its at-home antibody blood test for the novel coronavirus (COVID-19).
The company submitted its clinical trial protocol to the U.S. Food and Drug Administration (FDA) on April 8 and hopes Emergency Use Authorization will be granted by the agency. In the meantime, Scanwell researchers have partnered with scientists from Wake Forest Baptist Health in Winston-Salem, North Carolina, who have launched an 1,000-person study in which participants are mailed an at-home antibody testing kit.
Until now, testing for COVID-19 in the United States has largely centered on PCR assays of nasal swabs collected by healthcare professionals. However, lack of testing capacity, as well as shortages of nasal swab test kits, has limited testing scale-up efforts.
The limitations led scientists to look at an antibody-based serology pinprick blood test, which can deliver results in minutes. The tests work similarly to the PCR tests, diagnosing for active infection via IgM antibodies, with the added benefit of assessing immunity from prior infection through IgG antibodies.
At-home testing has been a subject of discussion in the healthcare community to help address hospital and clinic capacity and limit transmission. However, on March 20, the FDA issued guidance prohibiting the use of at-home nasal swab tests. The need for safe, convenient, efficient, and accurate testing remains, which has pointed researches towards an at-home antibody test.
The Scanwell Health test works similarly to a fingerstick blood glucose monitor and enables a testing pathway for COVID-19 to be delivered remotely. According to the company’s website, a patient completes an online intake questionnaire, which is evaluated by a medical doctor or nurse practitioner. If appropriate, the provider will order a test for the patient, following guidelines established by the U.S. Centers for Disease Control and Prevention. Once the test is ordered, it will be mailed to the patient via next business day delivery.
Once received, the patient completed the at-home test following instructions from the Scanwell mobile app. Test results will be shared back to the company. From there, the patient will receive a follow-up consultation with their provider, who will advise on next steps, whether that be self-quarantine, confirmatory testing, in person care, or similar.
The at-home tests will be provided for $70 and no insurance is required. The cost includes the online consultation the testing kit, shipping, and labor. The website did not mention whether they can accept insurance.
Healthcare professionals and researchers have expressed concerns about the validity of COVID-19 testing with the surge in emergency approvals from the FDA. The main concern is test accuracy.
The Scanwell Health team noted in its early user testing that some people are having difficulty with the blood collection process. Its medical team and engineers are working to address this and other challenges.
The clinical trial protocol is still pending approval for emergency use from the FDA at press time.