key: cord-0701724-wq02ppl4
authors: Christensen, K.; Ren, H.; Chen, S.; Cooper, C. K.; Young, S.
title: Clinical evaluation of BD Veritor™ SARS-CoV-2 and Flu A+B Assay for point-of-care (POC) System
date: 2021-05-04
journal: nan
DOI: 10.1101/2021.05.04.21256323
sha: c4d542c212297905d4e7b7d0bde3215b8c17dbe2
doc_id: 701724
cord_uid: wq02ppl4

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(R) 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.

influenza B viruses from one specimen, should help reduce the workflow burden while providing 89 a differential diagnosis between COVID-19 and influenza. [8] The objective of this study was to 90 demonstrate the clinical efficacy of a new triplex test, the BD Veritor SARS-CoV-2 & Flu A+B 91 assay, to detect all three viral targets. 92 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 

Specimens and assays 94

This study was conducted as part of a US Food and Drug Administration-Emergency Use 95 Authorization (EUA) submission. Clinical performance data from the BD Veritor TM with a lower bound of the 95% CI of 85% when compared to PCR assay. The Cohen's kappa 137 coefficient was applied to gauge agreement between reference and index tests to classify results 138 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)

The copyright holder for this preprint this version posted May 4, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 into mutually exclusive categories. Κ =(P o -P e)/1-P e (<0, 0, and >0 indicating agreements worse 139 than, no better or worse than, and better than that expected by chance). The data presented in this 140 report met the criteria as defined by the FDA guidance for Veritor SARS-CoV-2/Flu against the 141 reference assays. This article was prepared according to STARD guidelines for diagnostic 142 accuracy studies reporting.

[18] The data will be available upon request. 143 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) (Table S3 ). The BD MAX SARS-CoV-2 assay was used to resolve discordant 164 results. Seven of the eight discordant specimens were positive by the BD MAX SARS-CoV-2 165 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. ; https://doi.org/10.1101/2021.05.04.21256323 doi: medRxiv preprint assay. The other one was negative by the BD MAX SARS-CoV-2 assay. One specimen positive 166 by the Veritor SARS-CoV-2/Flu assay was negative by Lyra. 167

The clinical study was conducted in the early part of the 2020-2021 flu season, therefore, the 169 concurrence of SARS-CoV-2 and influenza virus in this study was non-existent. Only one Flu A 170 positive and two Flu B positives were reported by Veritor. One Flu B positive reported by 171

Veritor was also shown as SARS-CoV-2 positive by both Veritor and Lyra reference results. 172

These three specimens were tested on MAX and resulted as negative suggesting they were false 173 positives for Flu A and Flu B. having the highest Flu A positivity ratio than other age groups (Table 4 ). However, most Flu B 186 positive samples fell in the age group ranging from 6 to 59 years old. 187 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. can flow by capillary action to initiate the antibody-antigen complex and the detection reaction. 203

Therefore, viable viral particles are required for antigen detection. [19] In contrast, PCR-based 204 assays detect viral nucleic acid, reflecting viral shedding but not active infection. Viral load and 205 analytical sensitivity of the reference RT-PCR assay heavily influence the sensitivity of the 206 antigen test. [19, 20] Thus, RT-PCR-based assays may seem more sensitive, but they do not 207 necessarily reflect infectivity of COVID-19; whereas, antigen testing is a more specific approach 208 for SARS-CoV-2 screening (compared to RT-PCR) and aligns with infectiousness of the tested 209

individual.

[21] 210 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. [25] Therefore, the accurate detection of both SARS-CoV-2 and Flu A+B impacts not only 230 the treatment plan but also the period of quarantine and resulting loss of work and school 231 attendance. The Veritor SARS-CoV-2/Flu test could provide comparable clinical outcomes to the 232 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. The test for Flu A and Flu B was conducted by using materials obtained from pre-selected frozen 247 remnants. Unbiased subjects with no confirmed diagnosis should be considered for testing. 248 249

The Veritor SARS-CoV-2/Flu assay met US FDA-EUA acceptance criteria for SARS-CoV-2 251 detection. The test sensitivity of the Veritor SARS-CoV-2/Flu assay for Flu A and B detection 252 was in agreement with the previously cleared Veritor System Flu A+B assay. Dual detection 253 capability for the etiologic agents causing COVID-19 and influenza will allow efficient 254 differentiation between the two illnesses and will inform physicians regarding diagnosis and, 255 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. ;  therefore, the proper treatment and disease management for patients exhibiting similar 256 symptoms. Dual testing may be especially important for the duration of the COVID-19 pandemic 257 as it overlaps with flu season and could have a major impact in decentralized health care settings. 258 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. ; https://doi.org/10.1101/2021.05.04.21256323 doi: medRxiv preprint Accessed December 28, 2020. https://www.cdc.gov/coronavirus/2019-348 ncov/more/scientific-brief-options-to-reduce-quarantine.html. 349 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. ; is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. The collection procedure was not consistent with the protocols utilized by other sites. The collection deviation was noted and therefore, the data was reported with and without this site.

.

It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted May 4, 2021.

A Novel Coronavirus from Patients with Pneumonia in China

Estimates of global seasonal influenza-associated respiratory 289 mortality: a modelling study

World Health Organization, Global influenza strategy 2019-2030

Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are

BD Veritor™ System for Rapid Detection of Flu A+B

BD Veritor™ System for Rapid Detection of SARS-CoV-2