The July 2022 issue of IEEE Spectrum is here!

Close bar

Wanted: Rapid, Portable Tests for Coronavirus

New devices may diagnose the virus in as few as 5 minutes. But in some cases, the government has slowed their development

3 min read
BioMedomics rapid COVID-19 testing system.
Photo: BioMedomics

At Brigham and Women’s Hospital in Boston, a potential COVID-19 patient can now drive in to the ambulance bay, roll down their window, and ask staff to swab their nose and throat.

Those swabs will be sent to a state lab for a real-time PCR test, which amplifies any viral genetic material so it can be compared to the new coronavirus, SARS-CoV-2. But this standard test must be carried out in a certified laboratory with trained technicians, takes 3 to 4 days to deliver results, and produces some false negatives.

To speed and improve coronavirus testing, groups around the world are working to make rapid tests that can be done on-the-spot and diagnose the presence of the virus in just minutes.

Yet some companies have faced delays as they await government approval for testing or commercialization. On 29 February, the U.S. government finally released new rules that speed the approval process for new diagnostic tests, which may help the field move forward.

“The big benefit of our test over the traditional molecular PCR test is speed, and also that it can be deployed at point-of-care,” says Kent Lupino, director of marketing at BioMedomics, which has a rapid COVID-19 test currently being used in China and Europe. The test detects the body’s immune response to the virus from a few drops of blood in 15 minutes. The company is in the process of seeking approval from the U.S. Food and Drug Administration for emergency use.

Jiangsu Medomics, the China-based sister company of BioMedomics, has already sold nearly 500,000 of the rapid tests in China, where they are being used at doctor’s offices, hospitals, and screening checkpoints, such as train stations and airports, says Lupino. The company does, however, recommend that a positive result from their rapid test be confirmed with a PCR test. BioMedomics currently has capacity to produce a million tests per week and could expand quickly, says Lupino.

Cambridge, Massachusetts-based biotech E25Bio already makes a rapid diagnostic test for dengue virus. Their technology relies on gold nanoparticles covered in specialized antibodies that hook onto parts of a virus or proteins secreted by a virus, producing a result in as little as five minutes, like a pregnancy test, says Irene Bosch, co-founder and CTO of E25Bio.

When coronavirus emerged, the company spent 23 days doing a high-throughput screen of their antibody library and produced several new antibodies based on the novel virus. “We were able to quickly iterate what we do in other viruses and apply our tech to SARS-CoV-2,” says Bosch.

E25Bio now has all the components of their test ready for coronavirus diagnosis, but no access to the virus to test it. “The scientific community in Boston had not been cleared by the Department of Public Health in Massachusetts to open a vial of virus within secure facilities,” says Bosch. She has been waiting two months for access to the virus, despite running a laboratory that already works with zika, dengue, and West Nile virus, among others. The company’s manufacturer said they can shift from dengue to coronavirus and produce 100,000 coronavirus tests per day, says Bosch—once the test is ready. The Massachusetts Department of Public Health Bureau of Infectious Disease and Laboratory Sciences did not immediately respond to a request for comment.

At the University of Cincinnati, Chong Ahn and colleagues are adapting a smartphone-based rapid test for infectious diseases such as malaria. Their three-part design, published in January in the journal Microsystems & Nanoengineering, uses a custom, disposable plastic lab-on-a-chip; an optical detector that plugs into a smartphone and reads the chip; and a custom smartphone app that stores, analyzes and transmits the data.

With a single drop of blood or saliva on the chip, a smartphone will produce a result in 10 to 20 minutes, says Ahn, an electrical and biomedical engineer. His team is now adapting their platform to test for the presence of SARS-CoV-2 infection, but additional testing, clinical trials, and manufacturing could take six months to a year, he adds.

Rapid point-of-care testing will be critical for handling pandemic diseases like coronavirus now and in the future, says Ahn. In addition to detecting infections, such tests will also be valuable to measure the effectiveness of antiviral drugs and vaccines against the virus.

The Conversation (0)
A photo showing machinery in a lab

Foundries such as the Edinburgh Genome Foundry assemble fragments of synthetic DNA and send them to labs for testing in cells.

Edinburgh Genome Foundry, University of Edinburgh

In the next decade, medical science may finally advance cures for some of the most complex diseases that plague humanity. Many diseases are caused by mutations in the human genome, which can either be inherited from our parents (such as in cystic fibrosis), or acquired during life, such as most types of cancer. For some of these conditions, medical researchers have identified the exact mutations that lead to disease; but in many more, they're still seeking answers. And without understanding the cause of a problem, it's pretty tough to find a cure.

We believe that a key enabling technology in this quest is a computer-aided design (CAD) program for genome editing, which our organization is launching this week at the Genome Project-write (GP-write) conference.

With this CAD program, medical researchers will be able to quickly design hundreds of different genomes with any combination of mutations and send the genetic code to a company that manufactures strings of DNA. Those fragments of synthesized DNA can then be sent to a foundry for assembly, and finally to a lab where the designed genomes can be tested in cells. Based on how the cells grow, researchers can use the CAD program to iterate with a new batch of redesigned genomes, sharing data for collaborative efforts. Enabling fast redesign of thousands of variants can only be achieved through automation; at that scale, researchers just might identify the combinations of mutations that are causing genetic diseases. This is the first critical R&D step toward finding cures.

Keep Reading ↓Show less