Patient monitoring and temperature management A rapid and automated sample-to-result. authorized materials: ARIES SARS-CoV-2 Assay Kit and ARIES SARS-CoV-2 Assay Protocol File Kit (assay protocol file and a package insert). 1. Cervista MTA System Package Inserts/IFUs. The BD SARS-CoV-2 Reagents for BD MAX System results are for the identification of SARS-CoV-2 RNA. Cervical cancer screening Hernia repair and fixation Bio-Rad SARS-CoV-2 ddPCR Kit . Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The assay protocol file and a package insert ship separately on a USB as part of the ARIES SARS-CoV-2 Assay Protocol File Kit (CN-0499-01) or can be requested from Luminex Technical Support. The MAX assay was performed according to the manufacturer’s IFU (Becton, Dickinson and Company, BD Life Sciences—Integrated Diagnostic Solutions, Sparks, MD) ( 15 ). §263a, to perform moderate and high complexity tests. GasDirect Test. Biosciences BD Veritor™ System for Rapid Detection of SARS-CoV-2 instructions for use . Quick Reference Instructions for BD Veritor™ SARS-CoV-2 Use of BD Veritor™ System for Rapid Detection of SARS-CoV-2 with the BD Veritor™ Plus Analyzer INTERPRETATION OF RESULTS Test results must NOT be read visually. Materials Provided The cobas® Influenza A/B & RSV assay tube pack (Cat # 08160104190) contains sufficient reagents to process 20 specimens or quality control samples. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Xpert® Xpress SARS-CoV-2 2 Xpert® Xpress SARS-CoV-2 302-3750, Rev. BD SARS-CoV-2 Reagents for BD MAX™ – System fact sheet for healthcare providers, BD SARS-CoV-2 Reagents for BD MAX™ – System fact sheet for patients, BioGX SARS-CoV-2 Reagents for BD MAX™ – System fact sheet for healthcare providers, BioGX SARS-CoV-2 Reagents for BD MAX™ – System fact sheet for patients. Testing … BD SARS-CoV-2 Package Insert; BioGX SARS-CoV-2 Reagents for BD MAX™ System. Syringes and needles Total nucleic acid (TNA) is isolated and purified using BD MAX™ ExK™ TNA-3 kit from nasal, nasopharyngeal, or oropharyngeal Panther Fusion Open Access is a non-IVD function that is not required to have FDA clearance or approval. April 3, 2020 . Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform moderate and high complexity tests. Infection prevention In the USA: For use under an Emergency Use Authorization only. Reagents and Instruments A. Respiratory care Patient monitoring and temperature management 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. E September 2020 5 Principle of the Procedure The Xpert Xpress SARS-CoV-2 test is an automated in vitro diagnostic test for qualitative detection of nucleic acid from SARS- CoV-2. Cervista HPV 16/18 Assay. We will review your submission and send additional information shortly. Due to the heightened awareness of the species, the CDC is currently tracking C. auris cases in the U.S., as well as across the world2. Invader Factor II Assay . Package Inserts for GenMark products are found on the Customer Resource Center, in addition to assay manuals, quick reference guides, brochures, Customer Training Presentations, and Safety Data Sheets (SDS). Visiting. The agent detected may not be the definite cause of disease. Vascular access, Product Line All rights reserved. Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. The BioGX SARS-CoV-2 Reagents for BD MAX™ System is only for use under the Food and Drug Administration’s Emergency Use Authorization. BD - Diagnostic Systems: Package Inserts. Software solutions Cervical cancer screening The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swab samples during infection. 12013769 (10000128583) Rev. Vascular surgery Learn More. Medication management Biopsy 5th ed. The RNA Internal Control, used to monitor the entire sample preparation and PCR amplification process, is introduced into each specimen during sample processing. Anesthesia delivery SARS-CoV-2 Reference Panel Comparative Data; Pooled Sample Testing and Screening Testing for COVID-19; FAQs on Viral Transport Media During COVID … All other trademarks are the property of their respective owners. Veritor™ System . Software solutions The agent detected may not be the definite cause of disease. Test and Assay Support ... Alternate transport media, not identified in the package inserts (302-4421 Xpert Xpress SARS-CoV-2 Flu RSV EUA English Package Insert, 302-5159 Xpert Xpress SARS-CoV-2 Flu RSV CE IVD English Package Insert), should not be used with Xpert® Xpress SARS-CoV-2/Flu/RSV. Biosurgery BioGX COVID-19 Tests have the Coverage. There is the potential that broad population testing for antibodies may help re-open society in a smart way. The BD SARS-CoV-2 Reagents for BD MAX System is only for use under the Food and Drug Administration’s Emergency Use Authorization. 500048916(02) 30 Determinations 256082 2020-08 English . Have confidence in your COVID-19 antibody test. Invader Factor V Assay . Due to the high analytical sensitivity of this test, extreme care should be taken to preserve the purity of all materials and reagents. BD BioGX SARS-CoV-2 for BD MAX ™ System BioGX SARS-CoV-2 HMP - N1, N2 & RNase P - High-Volume Multiplex BioGX COVID-19, Flu A, Flu B, RSV RT-PCR for BD MAX ™ New Strains. Utilizing SARS-CoV-2 droplet digital PCR (ddPCR) quantified single positive clinical specimen, we compared the analytical sensitivity of seven SARS-CoV-2 EUA-granted assays, the Abbott Molecular RealTime, the NeuMoDx™, the Roche Cobas®, the BD SARS-CoV-2 reagents for BD MAX™ system, the Hologic Aptima®, the Xpert Xpress, and the GenMark ePlex SARS-CoV-2 tests. Diabetes care The BioGX SARS-CoV-2 Reagents for BD MAX System is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR, in vitro diagnostic procedures, and use of the BD MAX System. For Rapid Detection of SARS-CoV-2 Kit configured for testing nasal swab samples freshly collected, The BioGX SARS-CoV-2 Reagents for BD MAX System utilizes multiplexed primers and probes targeting RNA from the nucleocapsid phosphoprotein gene (N1 and N2 regions) of the SARS-CoV-2 coronavirus, and the human RNase P gene. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. BD MAX™ Vaginal Panel Elevate the standard of care for Women’s Health. Using a combination of robust internal controls and highly-specific antigens, the xMAP SARS-CoV-2 antibody assay enables the rapid and … 4. Vaginal infections are among the most common reasons for which women in the United States seek medical care–resulting in approximately 10 million visits to physician offices annually. cobas® SARS-CoV-2 Qualitative assay for use on the cobas ... (UTM-RT) or BD™ Universal Viral Transport System (UVT). Molecular diagnostics Drainage BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S. BD, BioGX Announce FDA Emergency Use Authorization Submissions for New COVID-19 Diagnostics for Use in U.S. https://www.cdc.gov/fungal/candida-auris/index.html, https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html, https://www.biorxiv.org/content/10.1101/608190v1, A TaqMan Probe-Based Real-Time PCR Assay for the Rapid Identification of the Emerging Multidrug-Resistant Pathogen, Lima A, Widen R, Vestal G, Uy D, Silbert S. 2019. Select Capability Supply management The QX200™ and QXDx™ Droplet Digital™ PCR Systems 7 ultimately, the test external! 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