Het bericht Check-Points joins amr industry alliance verscheen eerst op Check-Points Health.

The Check-Direct CPE Screen for the BD MAX assay is a real time PCR kit for the detection of CRO from rectal swabs. The Check-Direct CPE Screen for the BD MAX identifies and differentiates the presence of the four most common carbapenemase genes: KPC, NDM, VIM and OXA-48-like (including OXA-181 and OXA-232). In three prospective European studies, the assay demonstrated overall clinical sensitivity and specificity of 98.5 percent and 96.8 percent, respectively.

“We have used the Check-Direct CPE Screen for BD MAX in routine screening for nearly two years,” said John Rossen, assistant professor of medical microbiology at the University Medical Center, Groningen (UMCG) in the Netherlands and scientific secretary of the ESCMID Study Group for Genomic and Molecular Diagnostics. “The assay on the BD MAX has improved our turn-around-time for CRO screening and has shown a very positive impact in our hospital.”

Carbapenem-resistant organisms represent a global healthcare-associated infection (HAI) concern. In 2014, the average carbapenem resistance for K. pneumoniae in Europe was approximately 7.3 percent, with some countries reporting as high as 62.3 percent.¹ Rates of K. pneumoniae resistance to carbapenems range as high as 4-54{a6f6786ae64c84f269dfe21a62c200b8bf7c1cd02b320322b3de75a7f987125c} in other WHO regions.²  In addition, the spread of CRO represents a unique antimicrobial stewardship challenge, with limited effective treatments³ and mortality rates as high as 54.3 percent⁴. In response, the European Centers for Disease Control (ECDC)⁴ have launched active surveillance programs to assess CRO prevalence and monitor for outbreaks.

The Check-Direct CPE Screen for BD MAX assay is the latest offering in the BD MAX HAI portfolio, which includes IVD assays for the qualitative detection of Methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus aureus and Clostridium difficile (C. difficile).  Together with other upcoming products on the BD Phoenix^™ platform, BD will offer a comprehensive genotypic and phenotypic CRO solution to support clinical microbiology customers in their antimicrobial resistance programs.

*Product not available for sale in the U.S.

About BD

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 45,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve healthcare safety and expand access to health. For more information on BD, please visit bd.com.

About Check-Points

Check-Points (http://www.check-points.com) is a privately owned diagnostics company in Wageningen, The Netherlands and a leading developer and marketer of molecular assays for gram-negative drug-resistant bacteria. Check-Points offers a range of IVD and RUO products for the detection of carbapenemases, ESBLs and AmpCs. In addition, the Check&Trace product line allows for fast and reliable routine molecular confirmation and serotyping of Salmonella for food and veterinary diagnostics.

1 European Centre for Disease Prevention and Control. Antimicrobial resistance surveillance in Europe 2014. Annual report of the European Antimicrobial Resistance Surveillance Network (EARS-Net). Stockholm: ECDC; 2015.
² 2014 WHO Antimicrobial Resistance Global Report on Surveillance.
³ European Centre for Disease Prevention and Control. Carbapenemase-producing bacteria in Europe: interim results from the European Survey on carbapenemase-producing Enterobacteriaceae (EuSCAPE) project. Stockholm: ECDC; 2013.
⁴ Tumbarello et al (2012). Clin Infect Dis. 55 (7): 943-950.

Het bericht BD and Check-Points Announce Development and Global Distribution Agreement verscheen eerst op Check-Points Health.

In this study2 presented at the most recent ICAAC meeting in Washington DC, researchers from Mayo Clinic reported that Check-Points Health’s Check-MDR CT103 microarray assay was able to find more antibiotic resistance genes than conventional molecular techniques. Specifically, in 39{a6f6786ae64c84f269dfe21a62c200b8bf7c1cd02b320322b3de75a7f987125c} of isolates tested (42 out of 109) the highly multiplex detection offered by Check-Points Health’s microarray assay enabled the identification of additional resistance genes originally not known to be present.

“By casting such a wide net the microarray assay is a truly unprecedented tool for gaining broad insight into the molecular epidemiology of these resistant bacteria within just one working day. We believe, as the experts in Gram-negative resistance detection, that building a detailed picture of this issue is an important first step in fighting the antibiotic resistance threat. But we don’t want to stop there”, says Check-Points Health’s CEO and founder Joost Thijssen.

“To reduce the emergence and spread of carbapenem-resistant bacteria, European3 and US experts4 recommend implementing rapid and accurate methods for preventive screening of at risk patients in healthcare facilities. For this reason we have recently introduced the Check-Direct CPE, a CE-IVD marked real-time PCR assay for use in every hospital and with multiple real-time PCR systems, specifically designed to deliver rapid (2 hour) carbapenemase screening results.”

About Check-Points Health B.V. Check-Points Health is a privately held developer and manufacturer of in vitro diagnostic assays based in Wageningen, the Netherlands. Founded in 2008 as a part of Check-Points B.V., Check-Points Health aims to improve the control and prevention of antibiotic resistance in Gram-negative bacteria – such as carbapenemases, ESBLs and AmpCs – through combining its unique know-how of this field with its molecular detection technologies. The CE-IVD marked products range from a proprietary microarray system for comprehensive identification of resistance genes to assays for rapid screening in as fast as 2 hours based on real-time PCR.

Het bericht Mayo Clinic reports Check-Points microarray assay finds more antibiotic resistance genes than conventional molecular techniques. verscheen eerst op Check-Points Health.