News and analysis on disease research and diagnostics.
All three kits run on authorized PCR instruments and may be performed by any laboratory CLIA-certified to perform high-complexity tests.
The test is authorized for a variety of samples, including oral fluid collected with OraSure Technologies' Omnigene Oral OM-505 saliva collection device.
During evaluations of 180 randomized specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100 percent sensitivity and 98.2 percent specificity, the firm said.
More than a dozen studies have been published to date directly comparing molecular diagnostic COVID-19 tests, with some detecting differences, mostly in sensitivity.
In an interview, Marilyn Li and Douglas Stewart discuss why ACMG has put forth points that doctors and labs should consider when presumed germline findings crop up in tumor testing.
