Preclinical Data Find At-Home COVID-19 Test Potentially as Good as Laboratory PCR Tests

In laboratory molecular tests, scientists mix samples with assay reagents in a highly controlled process, but because the reaction conditions are tightly controlled, the tests are both sensitive and selective, according to the researchers.

Researchers at the University of Illinois Chicago (UIC) have created a high-quality assay that can be used in at-home testing for rapid COVID-19 screening. Results from an early preclinical study suggest that tests with the new assay may be as reliable as the laboratory-based molecular tests—or PCR tests—used by hospitals for clinical diagnostics, according to a UIC press release.

“Having fast and easy-to-use tests for COVID-19 is critical, especially in the communities that have low rates of vaccination and low access to health care services, including COVID-19 surveillance and diagnostic testing,” said Xiaowei Wang, UIC professor of pharmacology and bioengineering, in the press release. “The current crisis has created an unprecedented need for rapid tests that are highly sensitive and the sooner we can develop better technology and testing options, the better it will be for everyone.”

In laboratory molecular tests, scientists mix samples with assay reagents in a highly controlled process, but because the reaction conditions are tightly controlled, the tests are both sensitive and selective, according to the researchers. Additionally, laboratory tests can be expensive and are not accessible in all communities and field settings.

One method, known as loop-mediated isothermal amplification (LAMP), which uses 6 DNA primers for pathogen detection, has shown promise for other pathogens but has not been recently applied to COVID-19.

Wang and other UIC researchers who developed the new COVID-19 assay created and applied a bioinformatics algorithm to identify the best potential DNA primer combinations for reliably detecting SARS-CoV-2 with the LAMP method. Further, the researchers ran a series of simulations to optimize the conditions under which the potential DNA primer combinations worked best in the field environments, according to the press release.

The team designed specific experiments to see how each COVID-19 test performed, processing artificial samples and human samples with a standard PCR test and with the new test. The results of a comparison showed a significant improvement in the efficiency of the new test over others using the LAMP method to detect the virus and, in comparison, to more expensive gold standard PCR tests.

Further studies are needed to truly evaluate the new method, which would use a greater number of samples from real patients, according to the rearchers. If future studies validate the test, the data will then be submitted with an application to the FDA for emergency use authorization.

REFERENCE

A potential at-home COVID-19 test is just as good as laboratory PCR tests, according to preclinical data. University of Illinois Chicago Today. January 3, 2022. Accessed January 4, 2022. https://today.uic.edu/a-potential-at-home-covid-19-test-is-just-as-good-as-laboratory-pcr-tests-according-to-preclinical-data