Definitions validation once an instrument or test system has been verified, validation demonstrates that it repeatedly continues to give the expected results as performed over time and continues to meet the. Becton dickinson receives fda clearance to market the bd. Fda clearance for bd max mrsa xt assay with extended. Development of a realtime pcr protocol requiring minimal. The bd max mrsa xt assay must be performed immediately after the vortexing step above specimen preparation, step 7. This document explains the environmental monitoring benefits of colorcoded 2d barcode labels on bd bb l prepared. This latest achievement further emphasizes our commitment to deliver a broad menu of molecular tests with a simplified, standardized workflow to help laboratories better meet the needs of healthcare providers, said polen. The bd max mrsa xt assay is now ce marked and available in europe for use on the bd max system. Ivd assays, research use only ruo assays and user defined protocols udp cannot be combined in the same rack. Traditional methods are slower or less sensitive, which can contribute to inappropriate or. Verification and validation in clinical microbiology. Versatility one system with the ability to provide a variety of testing options for infection control, an expanding offering to keep up with emerging diagnostic requirements, and tailored options. Bd life sciences diagnostic systems package inserts bd. Xpert mrsa gen 3 and bdmax mrsa xt j clin microbiol, 53 2015, pp.
Following enzymatic cell lysis, the released nucleic acids are captured on magnetic beads. Not all certificate types are available for all products, but examples include. Spectra mrsa is a selective medium for the screening of clinical samples for the presence of methicillinresistant staphylococcus aureus mrsa, with results available within 18 hours and no need to reincubate negatives. Automated qualitative in vitro diagnostic test for detection of methicillinresistant staphylococcus aureus mrsa dna from nasal. Laboratory evaluation of the bd max mrsa assay journal of. The bd max staphsr assay is the first and currently the only commerciallyavailable molecular assay in the united states that detects recently discovered mrsa strains with the mecc gene. Methicillinresistant staphylococcus aureus mrsa 6 methicillinsensitive staphylococcus aureus6 clostridium difficile 6 vancomycinresistant enterococci vre 7 4 bd probetec et system outside us only 5 bd affirm vpiii 6 bd geneohm mrsa, staphsr, and cdiff assays 7 bd geneohm vanr assay outside u. View and download genexpert xpert mtb rif user manual online.
Wasplab automatic detection of mrsa on chromogenic agar. Bd provides quality certificates for many products certifying that these products have been manufactured and tested in accordance with bd specifications. Hologic technology and instruments are developed with laboratorians, healthcare providers and ultimately, patients in mind. Quality certificate types offered vary by bd segment, unit, and product line. The bd max system can hold 24 samples per run supporting different samples and assays within a run. Bd max mrsa xt performance bd max mrsa xt culture pcr pos neg total pos 149 54 203 neg 11 28 2149 total 160 2192 2352 sensitivity. Camp test assay of wood smoke concentrate control strain control strain for identification evaluation of muellerhinton agar examination of dairy products media testing quality control strain reference material susceptibility disc testing enteric research water testing susceptibility. The remaining procedures were per formed according to the manufacturers instructions with automated result interpretation. An automated qualitative in vitro diagnostic test for the direct detection of methicillinresistant staphylococcus aureus mrsa dna from nasal swabs in patie.
This new assay quickly identifies instances of staphylococcus aureus sa and methicillinresistant staphylococcus aureus mrsa dna. Refer to the bd max system users manual for detailed instructions operation section. Bd bactec plus anaerobicf culture vials soybeancasein digest broth in a plastic vial. There are now more than 20 assays in the bd max systems contentrich menu pipeline. Flexible modularity offers individualized solutions to easily meet your challenging workflow needs. Objectives meticillinresistant staphylococcus aureus mrsa prevalence is high in many european countries, but remains low in the netherlands due to its search and destroy. Evaluation of the bd max mrsa xt assay for use with.
Molecular testing lab automation scalable growth hologic. Methicillinresistant staphylococcus aureus mrsa pcrmax ltd qpcr testtm 150 tests for general laboratory and research use only quantification of methicillinresistant staphylococcus aureus mrsa genomes. Mrsa fact sheet centers for disease control and prevention. The bd max mrsa xt assay with extended detection technology accurately identifies. Rid diagnostics bd imax tm mrsa xt premarket notification sample buffer tube, the bid maxtm mrsa xt unitized reagent strip and the bd maxtm poir cartridge are loaded onto the bd max tm system. Bd diagnostics, a segment of bd becton, dickinson and company, today announced it received fda clearance to market the bd max mrsa molecular test in the united states. Up to 96 samples per run up to eight patient samples one sample per run 7 is this an automated or manual. The bd max system is a fullyintegrated, automated platform that performs nucleic acid extraction and realtime pcr providing results for up to 24 samples across multiple syndromes in less than three hours. Fda only when used with bd max ivd assays, which have been cleared or approved by the fda. Up to 18% of all positive mrsa results, reported by. The bd max mrsa assay must be performed immediately after the vortexing step above specimen preparation, step 7. Bd max mrsa assay receives fda clearance infection. You can combine bd max mrsa xt testing with other assays, in the same run.
The discharge report will also display all patients that were still on the unit at the end of february. Turn on the bd max system and log in by entering user name and. The bd max mrsa firstgeneration, bd max staphsr, and bd max mrsaxt assays were performed according to the manufacturers instructions, with a few. Accessgudid bd max mrsa 00382904429539 bd max mrsa. Testing is performed in biodesix central laboratory where multiple patient samples can be processed on one mass spectrometry plate. System design allows for easy system reconfiguration onsite to meet the. The bd max system is designed to help address todays challenges, while preparing your laboratory for tomorrows possibilities.
Staphylococcus aureus pronounced staffillohkokus awreeus, or staph is a very common germ that about 1 out of every 3 people have on their skin or in their nose. The panther fusion system, available in the us, is a powerful molecular testing instrument that joins pcr and tma capabilities to give your lab multiple valuable chemistries on a single platform. The user will be prompted to enter a start date to. Bd diagnostics has received fda clearance to market the bd max mrsa xt assay for use on the fullyautomated bd max system. Effizientes hygienemanagement mit dem bd max system.
This is the second assay from bd diagnostics capable of detecting newly emerging mrsa strains with the novel mecc gene launched in 20, the bd max staphsr assay reports results for both staphylococus aureus sa and methicillinresistant staphylococus aureus. A comparison between the bd max mrsa and xpert mrsa assays was performed using 239 nares samples. Evaluation of xpert mrsa gen 3 and bd max mrsa xt for. Evaluation of bd max staphsr and bd max mrsaxt assays using. The opaque medium incorporates a novel chromogen that yields a blue color as a result of phosphatase activity. All lots with the expiration date january 21, 2014 or later. Of the 57,690 plates, 1,367 were scored positive by both automation and the manual reading process. Our molecular testing instruments deliver consistently reliable functionality and trusted end results. Mrsa skin infections in the early stages reduces the chances of the infection becoming severe.
Bd max molecular diagnostics system from bd diagnostics. Comparative evaluation of two pcrbased methods for detection of methicillinresistant staphylococcus aureus mrsa. Avoid cost and patient impact associated with unnecessary isolation and treatment due to meca dropouts. The bd max mrsa is the next assay to receive a moderate complexity rating. The bd max mrsa assay is intended to aid in the prevention and control of mrsa infections in healthcare settings. It is the only fullyautomated molecular assay for mrsa active. Bd viper system with xtr technology isla lab products.
Page 1 pyxis medstation 4000 system console user guide may 2011 dme. Bd plans to build on the successful launch of the bd max mrsa assay by developing additional assays for the bd max system for a broad range of disease categories. The test is unsuitable for routine use until its performance parameters can be verified. Sensitivity, specificity, and positive and negative predictive. For example bd max staphsr, bd max cdiff, and user defined protocols. Turn on the bd max system and log in by entering and.
Hologic diagnostic instruments answer the demands of todays labs with automation, efficiency and flexibility. Five out of the 12 samples positive just by the bd maxtm were also tested by an inhouse pcr test. Besides reduced manual handling, the bd max assay also proved to be cheaper. The bd max gbs assay on the bd max system is the only fully automated polymerase chain reaction method for the detection of gbs from vaginalrectal swabs after selective enrichment in lim broth. This germ does not cause any problems for most people who have it on their skin. Having direct contact with another persons infection sharing personal items, such as towels or razors, that have touched infected skin touching surfaces or items, such as used bandages, contaminated with mrsa. Ivd assays, research use only ruo assays and userdefined protocols udp cannot be combined in the same rack. Diagnosis of bloodstream infections from positive blood. The assay uses extended detection technology to accurately identify a broad range of methicillinresistant staphylococcus aureus mrsa strains from nasal swabs in patients who may be colonized with this drugresistant pathogen.
Bd max system fully integrated benchtop molecular diagnostic system the bd max system for molecular diagnostics is the next generation platform which fully automates cell lysis, nucleic acid extraction, pcr setup, amplification and detection. The assay is used with the fully automated bd max instrument bd, sparks, md, which combines nucleic acid extraction, pcr setup, and pcr. Refer to the bd max system user s manual for detailed instructions operation section. Mrsa nucleic acid ivd, kit, nucleic acid technique nat. Please use one of the following formats to cite this article in your essay, paper or report. The bd max vre pcr facilitates such diagnostic procedures by using automated pcr with minimal handling times. This fully automated sampletoresult system gives your lab the flexibility. Manual methods plus multiple instruments mean a longer time for results. Bd max is a fully automated, benchtop molecular system designed. The bd max mrsa xt kit bd, quebec, canada allows detection of methicillinresistant staphylococcus aureus mrsa dna from nasal swabs in patients at risk for nasal colonization. Laboratory evaluation of the bd max mrsa assay journal. We evaluated the new, fully automated molecular bd max methicillinresistant staphylococcus aureus mrsa assay for detection of methicillinresistant s. The assay is performed on the fullyautomated bd max system and is designed to rapidly and accurately identify patients colonized with methicillinresistant staphylococcus aureus mrsa.
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