New Head-to-Head Study Demonstrates Equivalency and Accuracy of COVID-19 Rapid Point-of-Care Tests, Despite Different Test Sensitivity Claims
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
"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.
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
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.
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.
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