FRANKLIN LAKES, N.J.,
Sept. 9, 2020 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced the results of a new
research study that demonstrated performance of the BD Veritor™
System for Rapid Detection of SARS-CoV-2 Assay was equivalent to
that of the Quidel Sofia 2 SARS Antigen Fluorescent Immunoassay
(AFI).
In the blinded, head-to-head study, 361 patient samples
representing a cross-sectional population were tested for the
detection of SARS-CoV-2 using both the BD Veritor™ Plus system and
the Quidel Sofia 2 SARS AFI. The two testing platforms had a high
degree of agreement on testing results. When there was disagreement
between the tests (i.e. one showed positive, one showed negative),
the samples were then tested using molecular PCR (polymerase chain
reaction), which has higher sensitivity than antigen tests. The PCR
analysis of the discrepancies favored the BD Veritor™ Plus system,
which had more agreement with PCR analysis than the Quidel Sofia 2
SARS AFI. Of the seven discrepancies, PCR analysis agreed with the
BD Veritor™ Plus system on five results and agreed with the
Sofia 2 SARS AFI on two results.
Overall, the study suggests a high degree of agreement in testing
accuracy between the two systems.
"The difference in published sensitivity claims for the Quidel
Sofia SARS AFI (96.7%) versus the BD Veritor™ Plus system (84%) was
not supported by this study, probably due to the differences in
study designs and patient populations in this study versus the
Sofia EUA study," said Dr. Charles
Cooper, M.D., vice president for Medical and Scientific
Affairs at BD and a co-author of the study. "This study was
designed to assess performance in samples from patient populations
who commonly seek testing in community-based point-of-care
locations where rapid antigen tests would typically be most often
used. Other studies enrolled patients in emergency rooms and
hospitalized patients which, among other study design factors, have
the potential to influence antigen testing positive percent
agreement1. The study also suggests that the number of
symptoms in selection criteria may influence positive percent
agreement of antigen-based point-of-care testing as well."
Dr. Stephanie N. Taylor, M.D.,
Professor of Medicine, Section of Infectious Diseases at
Louisiana State University and a study
co-author said, "This study shows that EUA labeled sensitivity and
specificity should not be the sole basis for understanding antigen
assay performance. Other factors, such as clinical trial enrollment
criteria, study population characteristics, clinical setting,
reference method sensitivity, overall prevalence in the trial
population and the limit of detection for each antigen test are all
important considerations in order to arrive at a fuller
understanding of overall performance."
In addition to showing a high degree of agreement between the
two tests, the study also supports that the combination of reliable
accuracy and speed to result (about 15 minutes) of rapid antigen
tests are valuable tools to combat the COVID-19 pandemic,
particularly in decentralized health care settings where
larger-scale, molecular-based tests are not practical or would
result in significantly longer turnaround times.
As part of its emergency use authorization (EUA) for the
SARS-CoV-2 assay for the BD Veritor™ Plus system, BD completed one
of the geographically broadest U.S. clinical trials of any antigen
test on the market today, collecting and analyzing 226 samples from
21 diverse areas across the United
States. This effort was intended to reflect performance
across a range of different community-based clinical settings by
enrolling patients reflective of those typically seeking rapid
point-of-care diagnostic testing. The BD Veritor™ Plus system was
studied in care settings and patient populations most likely to
rely on rapid point-of-care tests, including ambulatory care sites,
outpatient clinics, drive-through and walk-up testing sites, and
skilled nursing facilities.
The research study authors have submitted the paper for
peer-review consideration to an infectious disease journal. The
preprint article titled "Clinical evaluation of BD Veritor™
SARS-CoV-2 point-of-care test performance compared to PCR-based
testing and versus the Sofia SARS Antigen point-of-care test" is
currently available on medRxiv.
1. Positive percent agreements shown in the EUA
instructions for use are estimates of sensitivity.
About the BD Veritor™ System for Rapid Detection of
SARS-CoV-2 Assay
The BD Veritor™ Plus System for Rapid
Detection of SARS-CoV-2 Assay has not been cleared or approved by
FDA. The test has been authorized by FDA under an EUA for use by
authorized laboratories. The test has been authorized only
for the detection of proteins from SARS-CoV-2, not for any other
viruses or pathogens; and, the test is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.
About BD
BD is one of the largest global medical
technology companies in the world and is advancing the world of
health by improving medical discovery, diagnostics and the delivery
of care. The company supports the heroes on the frontlines of
health care by developing innovative technology, services and
solutions that help advance both clinical therapy for patients and
clinical process for health care providers. BD and its 65,000
employees have a passion and commitment to help enhance the safety
and efficiency of clinicians' care delivery process, enable
laboratory scientists to accurately detect disease and advance
researchers' capabilities to develop the next generation of
diagnostics and therapeutics. BD has a presence in virtually every
country and partners with organizations around the world to address
some of the most challenging global health issues. By working in
close collaboration with customers, BD can help enhance outcomes,
lower costs, increase efficiencies, improve safety and expand
access to health care. For more information on BD, please visit
bd.com.
Contacts:
|
|
Troy
Kirkpatrick
BD Public Relations
858.617.2361
troy.kirkpatrick@bd.com
|
Kristen
Stewart
BD Investor Relations
201.847.5378
kristen.stewart@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)