Inova secures EUA for SARS-CoV-2 assay

2021 05 10 22 34 9372 Bio Flash Shadow 400

Inova Diagnostics has secured emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Quanta Flash SARS-CoV-2 immunoglobulin G (IgG) assay.

The assay is for use on the company's Bio-Flash random access chemiluminescent analyzer, which has a processing capacity of up to 60 samples per hour, according to the firm. It has shown 100% specificity for identifying SARS-CoV-2 in patients "with confounding conditions" and 100% sensitivity for COVID-19 in patients 15 days after a positive reverse transcription polymerase chain reaction (RT-PCR) result, Inova said.

Inova Diagnostics' Quanta Flash rapid response chemiluminescent assay runs on the Bio-Flash lab analyzer. Image courtesy of Inova Diagnostics.Inova Diagnostics' Quanta Flash rapid response chemiluminescent assay runs on the Bio-Flash lab analyzer. Image courtesy of Inova Diagnostics.
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