It detects SARS-CoV-2 in clinical samples by amplification of a fragment of the S gene of the virus. ZARAGOZA, Spain and  FRANKLIN LAKES, N.J., March 10, 2020 /PRNewswire/ -- CerTest Biotec, along with BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the VIASURE SARS-CoV-2 Real Time PCR Detection Kit adapted for the BD MAX™ System has been CE marked to the IVD Directive (98/79/CE). 25/09/2020 CerTest & Palex, Rapid Tests and PCR for COVID-19 identification. "As we enter flu season, the ability to test for both COVID-19 and Flu at the same time will speed diagnosis and, ultimately, treatment." The BioGX SARS-CoV-2 Reagents for BD MAX™ System is only for use under the Food and Drug Administration’s Emergency Use Authorization. *VIASURE is a registered trademark of CerTest Biotec, S.L. The objective of this study was to evaluate the performance of the BD Max enteric viral panel (Max EVP) assay for identification of viral pathogens in stool specimens from individuals with symptoms of acute gastroenteritis, enteritis, or colitis. The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID … What if you could test for all three of them using the same solution? BD offers a range of solutions from collection to result for your coronavirus disease 2019 (COVID-19) testing needs, including: Swabs, tubes and needles for specimen collection; Antigen and molecular tests for detection; Solutions adapted to your testing needs. The test is a real-time reverse transcriptase polymerase chain reaction (PCR) assay for use on the fully automated BD MAX ™ System. Like the initial test for COVID-19 developed by the CDC, the vast majority of COVID-19 tests being used in the U.S. employ a common technology, called … Test Method Cycle threshold cutoffs Lab can access in EPIC Beaker SARS CoV-2 Gene targets CDC-lab developed Real-time RT-PCR <40 Yes N1, N2 Simplexa (Diasorin) Real-time RT-PCR <40 No ORF1ab, S BD Max (Becton Dickinson) Real-time RT-PCR <40 No N1, N2 … CerTest Biotec and BD Announce CE Mark for Combination COVID-19, Influenza, RSV Test on BD MAX™ Molecular Diagnostic System. We offer safe and hygienic sample collection at home by our trained technicians. It is a versatile, digitally analyzed system that removes result ambiguity and provides lab level performance with assays … 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. the BD Veritor™ Plus System The BD Veritor™ Plus System is the portable, easy-to-use testing system that delivers reliable results in just minutes. Positive results do not rule out bacterial infection or co-infection with other viruses. "The CerTest-developed kit will bring rapid COVID-19 diagnostic capabilities to many laboratories across Europe which desperately need the ability to quickly identify COVID-19 patients so that proper protocols for infection prevention can be instituted," said Nelson Fernandes, managing director of CerTest BioTec. 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. Leveraging the significant install-base of the BD MAX System in Europe and other countries, we hope this kit will greatly enhance capacity for COVID-19 testing, thereby helping clinicians rapidly diagnose patients and ultimately prevent the spread of COVID-19," said Nikos Pavlidis, vice president of molecular diagnostics and women's health and cancer for BD. 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. Results are for the identification of SARS-CoV-2 RNA. Its called BD Max … To locate an authorized BD representative or request information, visit: www.bd.com or www.certest.es. Please try new keyword. 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. C. auris is particularly problematic for healthcare institutions, its practitioners, and patients. © 2020 BD. A rapid and automated sample-to-result. Accordingly, the test comes in a tube that snaps into the test-specific position on the BD MAX™ ExK™ TNA extraction strip, which is supplied by BD. It detects SARS-CoV-2 in clinical samples by amplification of a fragment of the S gene of the virus. The BD MAX System is … VIASURE SARS-CoV-2 Real Time PCR Detection Kit for the BD MAX™ System is sold through BD's network and it is not available for sale in the United States. FDA noted that the test name is displayed on this test’s authorized fact sheets, which are supposed to be provided with test result reports. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. 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. In addition to validating the sensitivity, specificity and detection limits of these instruments, the team also validated many kinds of viral transport media and swabs to ensure … The SARS-CoV-2 RNA is generally detectable in upper respiratory samples during the acute phase of infection. On Monday, BD had announced the launch of a point-of-care COVID-19 antigen test that can detect the coronavirus in 15 minutes, the third of its COVID-19 diagnostic test. 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. The BD SARS-CoV-2 Reagents for BD MAX System results are for the identification of SARS-CoV-2 RNA. BD SARS-CoV-2Reagents for BD MAX System RT-PCR Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System RT-PCR BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV RT-PCR BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit RT-PCR Bio-Rad Laboratories, Inc Bio-Rad SARS-CoV-2 ddPCR Test RT-PCR BioFire Defense, LLC BioFire COVID-19 Test … Negative results must be combined with clinical observations, patient history, and epidemiological information. 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. As with all CerTest tests, the VIASURE SARS-CoV-2 Real Time PCR Detection Kit for the BD MAX System is offered in a lyophilized format. The conventional methodology for gastrointestinal pathogen detection remains time-consuming, expensive, and of limited sensitivity. 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. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swab samples during infection. 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. 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. 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