Manufacturers scale up production as companies develop rapid at-home COVID tests

Posted at 4:39 PM, Nov 25, 2020

Holidays will look different this year for many Americans, with dinners outside, social distancing, or passing on family gatherings altogether.

But several companies developing rapid at-home COVID-19 tests are hopeful that won't be the case next year. The goal is to make inexpensive, easy-to-use COVID tests that can deliver results in minutes, just like a pregnancy test.

"For people to feel comfortable to associate with friends or family, there needs to be a testing methodology ideally that can be performed at home," said Tony Lemmo, CEO of the manufacturing company BioDot.

The company's technology is being used by over 70 manufacturers worldwide making COVID-19 antigen, antibody, and PCR tests. Their automated platforms dispense nanoliter/picoliter amounts of reagent onto the tests accurately and fast.

Lemmo says just one of their systems can support the production of roughly 100 million COVID-19 tests per year, helping to make high-volume production possible.

“We knew we were going to be called on by customers to manufacture more equipment to provide them the ability to manufacture more tests," said Lemmo.

To meet customer demand, BioDot increased staffing and built a new facility, compressing production time from months to weeks.

The FDA recently authorized the first rapid at-home test that can deliver results in 30 minutes, eliminating the need for a lab to test the sample. But the molecular single-use test will only be available to patients with a doctor's prescription who are suspected of being infected with COVID-19.

Companies developing tests hope the FDA will soon authorize another at-home testing tool: the rapid antigen test.

These inexpensive tests provide results within minutes, and companies developing them say millions could be sold without a doctor's referral.

“From what we’re hearing, it’s really just a matter of possibly months before there’s at least sufficient data to be able to support an at-home use of a test like an antigen test," said Lemmo.

Lemmo says if authorized by the FDA, manufacturers could make millions of these tests in a matter of months.

But antigen tests are less accurate, and the FDA wants to ensure they'll be simple enough for people to use at home. There are also concerns over how the data will be reported to health authorities.

“I think any at-home testing or massive rollout of a test into the communities needs to be done very carefully and with a lot of education around it," said Clinical Lab Director Melissa Miller.

Dr. Miller is a professor of pathology and laboratory medicine at the University of North Carolina Chapel Hill and Medical Director for the Clinical Microbiology Lab for the Medical Center.

She worries the inaccuracies of these tests could eventually lead the public to lose trust in all testing.

“Even at 98 percent specificity, which is very, very high. That means you’re going to have a false positive two out of every 100. If you started testing a hundred million people, this is millions of people who have a false-positive test," said Dr. Miller.

She says this could lead to healthy people isolating and missing work or school unnecessarily, and false-negative results could give people a false sense of security.

“These rapid antigen tests were pushed out to skilled nursing facilities; this is a very high-risk patient population. This is actually where you want a very accurate test," said Dr. Miller.

She says it’s unclear how well antigen tests detect the virus in asymptomatic patients but agrees more data is needed to figure that out.

“It might make more sense for K-12 schools, or even college settings, where there’s less risk for a poor outcome if you have a false positive or a false negative," said Dr. Miller.

But with a growing demand for convenient at-home testing, manufacturers are hopeful that in the months ahead, the FDA will soon open the door to new solutions.