The publication allows for the comparison of the sensitivity of one test to another because each was evaluated under the same conditions as the others using a single set of controlled reference samples distributed by the agency earlier in the year.
The FDA says that the limit of detection alone does not paint the full picture of how sensitive a test can be, and this is not used by itself to determine whether a test will receive an approval for Emergency Use Authorization or a regulatory clearance.
“Instead, the data gives laboratories, healthcare providers and patients a new resource on the relative performance of available tests to better inform which tests they choose to use,” the agency said in its announcement.
With a limit of detection at 180, PerkinElmer’s coronavirus detection test using nasopharyngeal swabs in viral transport media tops the list. Not far behind by a factor of three in the 540 to 600 range were ScienCell Research Laboratories, BioCore, DiaCarta, Seasun Biomaterial and Hologic. With detection limits of 1,800 PCR testing from BD, Quest Diagnostic, Helix and Roche make the list, and Abbotts; RealTime Assay and Cepheid’s Xpert Xpress rapid point of care tests were set at 5,400.
The original diagnostic panel that was supplied by the CDC was listed at 18,000. Diatherix Eurofins, Luminex, and Qiagen panels which check for COVID-19 plus a number of influenza strains, rhinovirus and respiratory syncytial virus all rounded out the listing at 180,000. The full list can be viewed here.
“Reference panels can be used in many ways to support test development and authorization, but most importantly, they are a powerful tool in monitoring test performance and ensuring that Americans have access to diagnostics they can trust,” said the agency’s device center director, Jeff Shuren.
