Two studies were completed to determine clinical performance. BD Synapsys™ Informatics solution provides secure connectivity, integrated workflows, and on-demand actionable insights for laboratories and facilities with Clinical Laboratory Improvement Amendments (CLIA) waivers. The BD MAX System is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in … 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. Antigen testing . © 2020 BD. This kit allows BD MAX™ System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV). Ferrari Productions (www.ferrariproductions.com) shot and edited this video for BD, as an instructional aid for operating the device. Samples are capable of being analyzed start to finish in two to three hours. The BioGX SARS-CoV-2 Reagents for BD MAX ™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. The BD Synapsys™ solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor™ and/or BD MAX™ systems. Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 … The companies submitted the Emergency Use Authorization requests to FDA today. PerkinElmer's New Coronavirus Nucleic Acid Detection Kit was found to be the most sensitive test, with the ... Dickinson's BioGX SARS CoV-2 test for the BD MAX system… The BD MAX System is designed to help address today’s challenges, while preparing your laboratory for tomorrow’s possibilities. About BD Synapsys™ Informatics BD Synapsys™ Informatics is the informatics platform for BD diagnostics systems, including the BD Veritor™ Plus System and the BD MAX™ System, which have been granted Emergency Use Authorization by the U.S. Food and Drug Administration to perform SARS-CoV-2 diagnostic testing. Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. "The solution's new encrypted reporting capabilities reduce the burden associated with manual reporting. BD Statement on COVID-19 (Coronavirus) Updated November 2020. workers for COVID-19. The company has supplied health care providers globally with millions of products used in of the fight against COVID-19, including swabs for flu and COVID-19 testing, rapid molecular diagnostic tests on the BD MAX™ System, 15-minute point-of-care antigen testing on the BD Veritor™ Plus System, infusion pumps, infusion sets and catheters. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC). BioGX operates in a cGMP compliant environment certified to International Standard ISO 13485. BioGX SARS-CoV-2 Reagents for BD MAX System: Results in Table 2A: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 RT-PCR Kit : … § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in 100+ countries through its Global Distribution Network. Unless otherwise noted, BD, the BD Logo and all other trademarks are the property of Becton, Dickinson and Company or its affiliates. The test is … Each unit is capable of analyzing hundreds of samples per day. About BD All rights reserved. Used with the BD Veritor™ Plus System and/or the BD Max™ System, the BD Synapsys™ Informatics 3.84 solution allows customers to export all SARS-CoV-2 test results in a single daily report. The test has been authorized by FDA under an EUA only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection. The BD MAX ™ system offers you an efficient path to improved clinical outcomes by combining and automating extraction and thermocycling into a single platform capable of running both FDA-cleared and open system assays. The BD Veritor™ Plus System is the portable, easy-to-use testing system that delivers reliable results in just minutes. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. "The new CerTest kit will provide rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B," said Nelson Fernandes , managing director of CerTest Biotec. The CARES Act requires COVID-19 testing facilities to report testing data to local and federal health authorities daily, including the number of tests performed, results and key patient demographics. According to the company, the BD Synapsys solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor and BD MAX systems. "The new CerTest kit will provide rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B," said Nelson Fernandes , managing director of CerTest Biotec. The tests would help fill an urgent need across the U.S. for laboratories to access an easy-to-use, rapid diagnostic test to screen patients for COVID-19. The test will be run on the BD MAX System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. BD, BioGX Announce FDA Emergency Use Authorization Submissions for New COVID-19 Diagnostics for Use in U.S. New Diagnostics Have Potential to Increase Capacity of COVID-19 Testing in U.S. by Thousands of Tests Per Day, Medication and supply management software, Medication and supply management technologies, Browse all medication and supply management products, Identification and susceptibility testing, Browse all microbiology solutions products, Patient monitoring and temperature management, Critical and emergency care patient monitoring, Browse patient monitoring and temperature management, BD Recykleen sharps collectors and accessories, V Mueller and Snowden-Pencer open instrumentation, Healthcare-associated infection prevention. Of analyzing hundreds of samples per day detect any other viruses or pathogens FDA today of being analyzed start finish... For at-home use detect any other viruses or pathogens their patients. `` by FDA an! 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