Clinical evaluation of BD Veritor™ SARS-CoV-2 and Flu A+B Assay for point-of-care (POC) System-Reference-Cited by-同舟云学术

Clinical evaluation of BD Veritor™ SARS-CoV-2 and Flu A+B Assay for point-of-care (POC) System

Published:2021-05-04 Issue: Volume: Page:
ISSN:
Container-title:
language:
Short-container-title:

Author:

Christensen Katherine,Ren Huimiao,Chen Shirley,Cooper Charles K.,Young Stephen

Abstract

ABSTRACTDifferential 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.

Publisher

Cold Spring Harbor Laboratory

Reference25 articles.

1. A Novel Coronavirus from Patients with Pneumonia in China, 2019

2. Johns Hopkins University and Medicine, Coronavirus Resource Center, Mortality Analyses. 2020. https://coronavirus.jhu.edu/data/mortality.

3. Centers for Disease Control and Prevention, Influenza (Flu). Accessed December 16, 2020. https://www.cdc.gov/flu/about/index.html.

4. Estimates of global seasonal influenza-associated respiratory mortality: a modelling study

5. World Health Organization, Global influenza strategy 2019-2030. Geneva: 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris.

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Update of European Society of Clinical Microbiology and Infectious Diseases coronavirus disease 2019 guidelines: diagnostic testing for severe acute respiratory syndrome coronavirus 2;Clinical Microbiology and Infection;2023-07

2. Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors;PLOS Medicine;2022-05-26

3. Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: an updated systematic review and meta-analysis with meta regression analyzing influencing factors;2022-02-15

4. Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17th of August, 2021;2021-09-22