Lab-in-a-box: Diagnosing COVID-19 with portable and affordable tests

Dr. Keith Pardee

Since the outbreak of COVID-19 (the disease caused by the SARS-CoV-2 virus), the need for reliable diagnostic testing has dominated the headlines. The gold standard for such testing uses a method called polymerase chain reaction (PCR), which requires special equipment in a lab and trained technicians to use it. This reliance on PCR has inevitably led to backlogs as the need for testing skyrockets, but it also highlights the disparities in testing ability for rural, remote, or developing areas that have fewer lab facilities available to them.

To address these testing capacity issues, Dr. Keith Pardee, a synthetic biologist at the University of Toronto, has designed a portable diagnostic kit that he calls “lab-in-a-box.” It’s a concept that he has been working on for years—and one that he was able to test-drive during the Zika crisis. With partners in Brazil, Ecuador, and Colombia, Dr. Pardee and his team were able to use the lab-in-a-box technology to diagnose Zika in patients quickly, effectively, and at a fraction of the cost of the regular PCR-based tests.

The diagnostic kit itself sounds like some of the best science fiction come to life: a freeze-dried biomolecular platform contains a gene-circuit-based sensor that detects the presence of a specific virus and then spits out an easy-to-read, paper-based result a few hours later. And the best part? The test itself doesn’t need to be run by a highly-trained technician. Instead, health care personnel take the sample from a patient and place it in a multi-well plate, which is widely available, for measurement by an electronic device about the size of a toaster. 

The Zika virus is very different from SARS-CoV-2, but the principles of the lab-in-a-box diagnostic kit remain the same. The team simply needs to swap which virus the kit’s sensors are looking for. “We just change one piece of the platform,” Dr. Pardee explains, “and then it reads the target pathogen’s genome like a barcode.”

The biggest step involved is developing the right diagnostic sensors to ensure that they can detect SARS-CoV-2—and that they only detect SARS-CoV-2 to avoid false positives—but Dr. Pardee notes that the work thus far is going well. The team’s results indicate that the sensors are sensitive enough to be tested against that PCR gold standard, and then it will be up to regulatory authorities to determine whether it can be approved for broad use.

The simplicity of the kit makes it particularly appealing for use in low- and middle-income countries, as well as rural and remote communities here at home, especially since each kit has the capacity to run 14,000 diagnostic tests. “This is about getting the diagnostic capacity into the hands of people who need it,” says Dr. Pardee. “We want to be able to ship a lab-in-a-box anywhere in Canada or internationally and contribute to testing capacity in a big way.”

After the kit receives regulatory approval, Dr. Pardee and his team plan to take the test out of the lab, scale up production, and distribute it widely. Dealing with the logistics to make that happen poses a much different challenge than developing the diagnostics in the lab, so as of late April 2020, the team is exploring the best ways to form a non-profit vehicle to meet demand.

From the outside, it looks like everything is falling into place with remarkable speed, but Dr. Pardee credits the previous support he received from CIHR and the International Development Research Centre (IDRC) with giving his team a head start. “Our lab-in-a-box is an excellent example of how long-term funding for research between crises can ensure that technology will be able to pivot when we need it to deal with the unknowns that we can’t prepare for,” he says. “Our support from CIHR and the IDRC for Zika, and now for SARS-CoV-2, has been instrumental in allowing us to respond quickly to the current pandemic—and that will ultimately help us increase diagnostic capacity here at home and abroad.” 

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