BD MAX™ Vaginal Panel Elevate the standard of care for Women’s Health. The agent detected may not be the definite cause of disease. BACTEC™ Lytic/10 Anaerobic/F Culture Vials Specimen collection For Rapid Detection of SARS-CoV-2 Kit configured for testing nasal swab samples freshly collected, processed and dispensed directly onto assay test device. BD Veritor™ System for Rapid Detection of SARS-CoV-2 instructions for use . Cervical cancer screening Cervical cancer screening 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 & … cobas® SARS-CoV-2 Qualitative assay for use on the cobas ... (UTM-RT) or BD™ Universal Viral Transport System (UVT). Patient monitoring and temperature management Molecular diagnostics 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. 1,2,3,4 Traditional diagnostic techniques tend to be subjective with variable sensitivity and specificity. 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. Compass stainer. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for specific detection of SARS-CoV-2 by amplifying two unique regions of the N gene (i.e., N1 and N2). The SARS-CoV-2 RNA is generally detectable in upper respiratory samples during the acute phase of infection. The NeuMoDx™ SARS-CoV-2 Assay is a rapid, automated in vitro real-time RT-PCR diagnostic test for the direct detection of SARS-CoV-2 Coronavirus RNA from nasopharyngeal, oropharyngeal and nasal swab specimens in transport medium from individuals with signs and symptoms of infection of COVID-19. Wound care, Support Type 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. This section provides answers to frequently asked questions relating to the development and performance of tests for SARS-CoV-2. Anesthesia delivery Hazardous drug safety 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. The BioGX SARS-CoV-2 Reagents for BD MAX™ System is only for use under the Food and Drug Administration’s Emergency Use Authorization. Software solutions manual, instrument manual, or reagent labeling/package insert. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for specific detection of SARS-CoV-2 by amplifying two unique regions of the N gene (i.e., N1 and N2). 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. Have confidence in your COVID-19 antibody test. Hazardous drug safety 4. Visiting. 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. Medication and supply management Vascular access Ordering Significant adverse reproductive health outcomes, including pregnancy complications, pelvic inflammatory disease and an increased risk of HIV acquisition, have been linked to TV infection. Two U.S.-based institutions – Tampa General Hospital (Tampa, Florida, USA)3 and the New York State Department of Health (New York, New York, USA)4 – have recently published their work leveraging the BD MAX™ System and the suite of BD MAX™ Open-System Reagents for rapidly identifying C. auris with an automated sample-to-answer solution: Thank You. Qualitative assay for use on the QX200™ and QXDx™ Droplet Digital™ PCR Systems Syringes and needles The BD SARS-CoV-2 Reagents for BD MAX System is only for use under the Food and Drug Administration’s Emergency Use Authorization. Negative results must be combined with clinical observations, patient history, and epidemiological information. C. auris is particularly problematic for healthcare institutions, its practitioners, and patients. Respiratory care Infection prevention The BD 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. 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. Cervista MTA System Package Inserts/IFUs. 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. BioGX COVID-19 Tests have the Coverage. Our diverse resources give you the opportunity to obtain knowledge, gain insight and read success stories on our solutions. 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. authorized materials: ARIES SARS-CoV-2 Assay Kit and ARIES SARS-CoV-2 Assay Protocol File Kit (assay protocol file and a package insert). Prostate health These questions and … Cervista HTA System Package Inserts/IFUs . Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Biosciences Abbott RealTime SARS-CoV-2 assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for COVID-19 testing. Negative results must be combined with clinical observations, patient history, and epidemiological information. 1 SARS-CoV-2 Reagents for BD MAX™ System For Emergency Use Authorization (EUA) only 445003-01 For In Vitro Diagnostic Use P0252(05) For use with the BD MAX… The BD 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 nasal, nasopharyngeal, and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. Panther Fusion Open Access is a non-IVD function that is not required to have FDA clearance or approval. BD offers a comprehensive suite of molecular solutions designed to detect healthcare-associated infections on the BD MAX™ System. Single cell multiomics Steve Back, VP, Global Quality Assurance and Regulatory Affairs . Beginning in December 2019, an outbreak of “pneumonia of unknown cause” was detected in Wuhan City, Hubei Province, China. *fda.gov: The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. Microbiology solutions The fungus can cause severe illness in hospitalized patients2, particularly as it is associated with nosocomial bloodstream and deep wound infections, which have resulted in a high mortality rate across intensive care unit (ICU) patients3. 7. Total nucleic acid (TNA) is isolated and purified using BD MAX™ ExK™ TNA-3 kit from nasal, nasopharyngeal, or oropharyngeal The BD SARS-CoV-2 Reagents for BD MAX System is only for use under the Food and Drug Administration’s Emergency Use Authorization. Bio-Rad SARS-CoV-2 ddPCR Kit . Hernia repair and fixation 2019. 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, Browse patient monitoring and temperature management, BD Recykleen sharps collectors and accessories, V Mueller and Snowden-Pencer open instrumentation, Healthcare-associated infection prevention. Software solutions in vitro diagnostic procedures, and use of the BD MAX System. The BD SARS-CoV-2 reagents for BD MAX™ System is only for use under the FDA Emergency Use Authorization. The BD Veritor ™ System for Rapid Detection of SARS-CoV-2 is a chromatographic immunoassay for the direct and qualitative detection of SARS-CoV-2 antigens in nasal swabs from patients with signs and symptoms who are suspected of COVID-19. In the USA: For use under an Emergency Use Authorization only. Please Select, Capability Home care 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. This “Sample Procedure” is intended as a model for use by your facility to meet the needs of your laboratory. The BioGX SARS-CoV-2 Reagents for BD MAX™ System is only for use under the Food and Drug Administration’s Emergency Use Authorization. Surgical instruments Allplex™ SARS-CoV-2 Assay is a multiplex real-time PCR assay to detect 4 target genes of SARS-CoV-2, causing COVID-19 in a single tube. The BD MAX system helps redefine staff productivity with a fully integrated, automated molecular platform capable of running both FDA-cleared and open system assays efficiently and flexibly. … BD MAX™ Vaginal Panel Elevate the standard of care for Women’s Health. Molecular systems 1. The intended use of the BD Veritor™ System for Rapid Detection of SARS-CoV-2 assay only includes those who are suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms. The Xpert Xpress SARS-CoV-2 test is performed on GeneXpert Xpress System. In these uncertain times, laboratories need to have confidence in their COVID-19 antibody test results—which is why Luminex has developed a comprehensive xMAP® SARS-CoV-2 Multi-Antigen IgG Assay. Biosurgery Specimen collection A rapid and automated sample-to-result. Vascular access, Product Line Please Select Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. 12212 Technology Blvd. 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. 12013769 (10000128583) Rev. Syringes and needles Ultimately, the 2019 novel coronavirus, or SARS-CoV-2, was identified as the causative agent and subsequently isolated and sequenced. Table 1. Frenchs Forest, NSC, Australia: Pearson Australia; 2013. Technical Center Package Inserts Blood Culture. Technical Center Package Inserts Blood Culture. The assay is designed to detect RdRP, S and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2.It can be applied on Seegene’s automated system that enables high throughput testing. Due to the high analytical sensitivity of this test, extreme care should be taken to preserve the purity of all materials and reagents. BD and the BD Logo are trademarks of Becton, Dickinson and Company. Supply management Interventional specialities 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. For Rapid Detection of SARS-CoV-2 Kit configured for testing nasal swab samples freshly collected, Infection prevention An emerging fungus, Candida auris, is presently listed by the Centers for Disease Control and Prevention (CDC) as a serious global health threat due to its multidrug-resistant properties, the difficulty it poses for identifying the organism via standard laboratory methods, and its history of causing outbreaks in healthcare settings1. Drug delivery systems The BD SARS-CoV-2 Reagents for BD MAX System results are for the identification of SARS-CoV-2 RNA. Panther Fusion® … Capability Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. Good laboratory technique is essential for the proper performance of this assay. The Siemens Healthineers SARS-CoV-2 Total (COV2T) Assay* can be used effectively for broad population testing. Biosurgery Please refer to the package insert for detailed assay instructions, cautions, limitations and warnings. Drug delivery systems 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. This website contains information and package inserts for products that are targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Single cell multiomics Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. Capability 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. Bio-Rad SARS-CoV-2 ddPCR Kit . Reagents and Instruments A. The MAX assay was performed according to the manufacturer’s IFU (Becton, Dickinson and Company, BD Life Sciences—Integrated Diagnostic Solutions, Sparks, MD) ( 15 ). Positive results do not rule out bacterial infection or co-infection with other viruses. Microbiology solutions 12013769 (10000128583) Rev. Invader MTHFR 677 Assay. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Drainage The BD 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 nasal, nasopharyngeal, and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. 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. The BD MAX real-time SARS-CoV-2 PCR assay (MAX assay) was used for discordant testing on residual nasal swabs following Veritor and Lyra testing in study 1. Diabetes care Lab automation 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. 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. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. 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. BD SARS-CoV-2 Package Insert; BioGX SARS-CoV-2 Reagents for BD MAX™ System. April 3, 2020 . 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