GRAND RAPIDS, Mich. (WOOD) — The first clinical-grade, at-home, rapid result antibody test could be on the U.S. market by the end of the month.
The kit from California-based Scanwell Health would be available to order in the mail and would provide results in 15 minutes.
This week, the U.S. Food and Drug Administration updated a policy initially released March 16, with new rules creating a threshold for accuracy and reliability for antibody tests and requiring that any manufacturers offering them to first me have an Emergency Use Authorization first.
The chief medical officer for Scanwell, Dr. Jack Jeng, said the company expects results from its clinical trials at the end of the month. It has been working on getting a EUA from the FDA since March and Jeng expects that to come through soon after clinical trial results are in.
>>Inside woodtv.com: Antibody testing could reveal if symptoms were COVID-19
There has been a lot of attention on serology, or antibody, tests, especially in light of recent studies that show not all of them are accurate. Jeng explained that the updated policy from the FDA will help weed out any tests that have not been proven reliable.
“It has to be at least 90% sensitive and 95% specific. These are minimum performance standards that did not previously exist. A lot of the tests that are currently being used under that old guidance rule would not meet that minimum standard,” Jeng said.
The World Health Organization recently stated that there is no proof that the presence of antibodies indicates immunity to COVID-19, the disease caused by the virus labeled SARS-CoV-2, but Jeng said that’s because there simply hasn’t been enough time to gather data. The virus has only been around five or six months.
His team is going over the data coming in from China and Italy and expects to see results from that, and studies in the U.S., by the time their at-home kit is available for purchase.
“For SARS and MERS, which are also coronaviruses, people tend to have immunity for at least two years. Other types of human coronaviruses that cause the common cold, people tend to have immunity for about six months, so our best guess right now is that you should have immunity once you have antibodies for anywhere from six months to two years, or maybe longer,” he said.
Serology tests already in use have shown it’s possible for someone to have a positive result from antibodies formed against a different type of coronavirus, including the one that causes the common cold, something called “cross-reactivity.”
“The manufacturer we’re working with has done those studies and shown that there was no cross-reactivity with the common coronaviruses, but we will replicate those studies to make sure these tests are as accurate as possible,” Jeng said.
The FDA is also formalizing the due diligence that manufacturers have already been doing to make the process more standardized.
Information from serology tests could provide more useful information, including about the true mortality rate of COVID-19. Jeng said they could also ultimately help doctors make decisions about who should get a vaccine once one becomes available.
“We’re not going to be able to vaccinate our entire population right off the bat. We’re going to have to prioritize people and these antibody tests can help us triage who should get the vaccinations first,” he explained.
In West Michigan, Dr. Laurie Birkholz has started offering antibody tests at her practice near Saugatuck. She told News 8 that she has conducted 350 tests in the last three weeks and 10 have come back positive. Most of those, she said, can be traced back to travel to a coronavirus hot spot or exposure to someone with COVID-19. She said she hasn’t yet seen evidence of community spread but expects that to change in coming weeks.
“The inpatient numbers are starting to increase in the hospitals suggesting increasing prevalence in our community,” Birkholz wrote in an email.
Jeng doesn’t see the at-home test as the only tool in the toolbox, but rather something that should be used in conjunction with other tests, a vaccine and antibody testing in labs. He said his fast, cheaper at-home test could prompt someone to move forward with a more expensive lab test.
“We need all these tests because this pandemic has caused an incredible amount of suffering, shutting down our economies, causing financial strains, and until we really have all these different tools available, we’re not really going to be able to get back to what we would consider a normal way of life,” Jeng said.