“We designed the test to be low-cost and simple enough that it could be used anywhere,” said Barry Lutz, a UW associate professor of bioengineering and investigator with the Brotman Baty Institute for Precision Medicine.
The Harmony COVID-19 test kit is described in a paper published in Science Advances.
Researchers developed Harmony to be simple and easy-to-use, employing ready-to-use reagents. The test uses a “PCR-like” method to detect the presence of the SARS-CoV-2 RNA genome in a nasal swab sample with the aid of a small, low-cost detector.
A smartphone is used to operate the detector and read the results. The detector can handle up to four samples at a time and would fit into a standard car’s glove compartment.
The accuracy of COVID-19 tests has been a pressing matter throughout the pandemic. Many at-home antigen kits for COVID-19, which detect pieces of the proteins the virus creates instead of its genetic material, are 80-85% accurate, though accuracy may drop with the omicron variant, which harbors a relatively high number of mutations not found in other strains.
PCR tests are generally 95% accurate or better but require expensive equipment and a long wait for results.
Initial results show that the Harmony kit is 97% accurate for nasal swabs. The Harmony kit detects three different regions of the virus’ genome. If a new variant has many mutations in one region, the new test can still detect the other two.
Though tests based on PCR or polymerase chain reaction are highly accurate, a key limitation is that PCR tests require dozens of cycles of heating and cooling to detect genetic material in a sample.
The test developed by the UW team sidesteps this issue by relying on a PCR-like method known as RT-LAMP, which doesn’t have the same stringent temperature-cycling requirements.
Researchers spun out a new company from the UW, Anavasi Diagnostics, which last year was supported by $300,000 from WE-REACH and later received $14.9 million in grants from the National Institutes of Health to develop the Harmony prototype kit into a product and scale-up manufacturing to help address the ongoing shortage of COVID-19 diagnostic tests.
Initially, the kits could be made available first for use in clinics, as well as other settings with medical oversight, such as workplaces and schools. Later, they would like to adapt the test for home use.
Source: Medindia
