New Portable, 30-Minute COVID-19 Test Could Enable Diagnosis at POC Without Need for Laboratory

Researchers have demonstrated a prototype of a rapid COVID-19 molecular test and a simple-to-use, portable instrument for reading the results with a smartphone in 30 minutes, which could enable point-of-care diagnosis without needing to send samples to a lab.

Researchers at the University of Illinois at Urbana-Champaign (Champaign, IL, USA) developed the test using a simpler process to analyze the viral transport media, called LAMP, which bypasses the RNA extraction and purification steps. They compared the LAMP assay with PCR, first using synthetic nasal fluid spiked with the virus and then with clinical samples. They found the results were in agreement with PCR results, and they documented the sensitivity and specificity of the LAMP test.

Then, the researchers incorporated the LAMP assay onto a small 3D-printed microfluidic cartridge that has two input slots for syringes: one for the sample-containing viral transport media, one for the LAMP chemicals. Once the two are injected, they react within the cartridge. The cartridge can be inserted into a hand-held portable instrument with a heating chamber, which heats the cartridge to 65 degrees Celsius for the duration of the reaction, and a smartphone cradle for reading the results. In approximately 30 minutes, a positive result will emit fluorescent light. The researchers demonstrated the portable device with additional clinical samples, and found the results matched those of the standard PCR lab procedure. The researchers are now exploring whether the assay would work with saliva samples to eliminate the need for nasopharyngeal swabs, and collecting more patient data as they consider next steps for regulatory approvals.

“We use modern, high speed additive manufacturing to make these cartridges. The entire thing can be quickly scaled up to hundreds of thousands of tests,” said Rashid Bashir, a professor of bioengineering and the dean of the Grainger College of Engineering at Illinois, who co-led the study. “Production scale-up is typically the biggest obstacle for commercial applications of microfluidic cartridges, and we can overcome that obstacle using this new approach. Modern additive manufacturing is elastic and scalable, and it can be ramped up very quickly compared with legacy manufacturing technologies.”

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University of Illinois at Urbana-Champaign