Clinical evaluation of BD Veritor™ SARS-CoV-2 and Flu A+B Assay for point-of-care (POC) System
| Autor: | Christensen K, Young S, Chen S, Charles K. Cooper, Huimiao Ren |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
business.industry Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) fungi Clinical performance virus diseases Rapid detection respiratory tract diseases body regions Internal medicine Point of care poc medicine Symptom onset skin and connective tissue diseases business Clinical evaluation Clearance Point of care |
| DOI: | 10.1101/2021.05.04.21256323 |
| Popis: | Differential diagnosis of COVID-19 and/or influenza (flu) at point of care is critical for efficient patient management and treatment for either of these diseases. Clinical performance of the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & FluA+B (“Veritor SARS-CoV-2/Flu”) triplex assay was characterized. The performance for SARS-CoV-2 detection was determined using two hundred and ninety-eight (298) specimens from patients reporting COVID-19 symptoms within 7 days from symptom onset (DSO) in comparison with Lyra® SARS-CoV-2 RT-PCR Assay (“Lyra SARS-CoV-2”). The Veritor SARS-CoV-2/Flu Assay met the FDA EUA acceptance criterion with 95% overall agreement for SARS-CoV-2 test when compared to Lyra SARS-CoV-2. The performance for Flu A and Flu B detection was determined using 75 influenza-positive and 40 influenza-negative retrospective specimens in comparison with the previously FDA cleared BD Veritor™ System for Rapid Detection of Flu A+B (“Veritor Flu”). The Veritor SARS-CoV-2/Flu also demonstrated 100% agreement with the Veritor Flu. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|