FDA Releases COVID-19 Test Performance Data

IVDs from PerkinElmer and Viracor Eurofins were the most sensitive, agency says

The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.

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Newly released reference panel data from the US Food and Drug Administration shows that the most sensitive tests for SARS-CoV-2 reviewed by the agency can detect the virus at a mean lower limit of detection (LoD) of 180 NAAT detectable units per milliliter (NDU/mL).

Two products shared that level of sensitivity: the PerkinElmer Inc. New Coronavirus Nucleic Acid Detection Kit, and the Viracor SARS-CoV-2 assay from Eurofins Viracor Inc. Both collect samples...

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