CACLP - The largest IVD Expo & Conference

Cleveland Clinic Gets FDA Emergency Use Authorization for Molecular COVID-19, Flu Combo Test

Industry news | 18 April, 2022 | CACLP

Original from: Genomeweb

Image credit: Cleveland Clinic Official


The US Food and Drug Administration this week granted Emergency Use Authorization for the Cleveland Clinic's SelfCheck Cobas SARS-CoV-2 + Flu Assay.


The PCR-based test uses Roche's Cobas SARS-CoV-2 & Influenza A/B test, which received EUA from the FDA in late 2020. It is designed for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in anterior nasal swab specimens that are self-collected at home using the SelfCheck Nasal Swabbing Kit.


Use of the test is limited to the Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute, according to the FDA.


In late 2021, the Cleveland Clinic received EUA from the FDA for the SelfCheck Cobas SARS-CoV-2 Assay, which is designed to detect the SARS-CoV-2 genes in anterior nasal swab specimens self-collected using the SelfCheck COVID-19 Swabbing Kit.


Source: Cleveland Clinic Gets FDA Emergency Use Authorization for Molecular COVID-19, Flu Combo Test

Press contact CACLP - The largest IVD Expo & Conference

Stay in touch with CACLP News

We deliver the latest IVD news straight to your inbox. Stay in touch with CACLP News, sign-up for our newsletter today.

  • Name *
  • Email *
  • Company name *
  • Country *
    CACLP - The largest IVD Expo & Conference

By subscribing our newsletter, you agree to our Privacy Policy. You can unsubscribe at anytime.

Share
Opening Countdown
0 0 0

Day(s)

0 0

Hour(s)

0 0

Min(s)

Room 2201-2203 & 2205, Cloud Nine Plaza
1118 West Yan’an Road
Shanghai, China
200052

Copyright © 2024 GL events Ruihe (Shanghai) Exhibition Co., Ltd. All Rights Reserved. ( 沪ICP备12004745号-1 )

We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy & Cookies for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.

CACLP - The largest IVD Expo & Conference