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. 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. 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. The bd max mrsa firstgeneration, bd max staphsr, and bd max mrsaxt assays were performed according to the manufacturers instructions, with a few. Bd max molecular diagnostics system from bd diagnostics. Fda clearance for bd max mrsa xt assay with extended. Development of a realtime pcr protocol requiring minimal. Verification and validation in clinical microbiology. System design allows for easy system reconfiguration onsite to meet the. The assay is used with the fully automated bd max instrument bd, sparks, md, which combines nucleic acid extraction, pcr setup, and pcr.
Following enzymatic cell lysis, the released nucleic acids are captured on magnetic beads. 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. All lots with the expiration date january 21, 2014 or later. Besides reduced manual handling, the bd max assay also proved to be cheaper. Page 1 pyxis medstation 4000 system console user guide may 2011 dme. 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. Quality certificate types offered vary by bd segment, unit, and product line. Wasplab automatic detection of mrsa on chromogenic agar. The bd max vre pcr facilitates such diagnostic procedures by using automated pcr with minimal handling times. Comparative evaluation of two pcrbased methods for detection of methicillinresistant staphylococcus aureus mrsa. 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. Flexible modularity offers individualized solutions to easily meet your challenging workflow needs.
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. Accessgudid bd max mrsa 00382904429539 bd max mrsa. This document explains the environmental monitoring benefits of colorcoded 2d barcode labels on bd bb l prepared. This fully automated sampletoresult system gives your lab the flexibility. Bd life sciences diagnostic systems package inserts bd. Hologic technology and instruments are developed with laboratorians, healthcare providers and ultimately, patients in mind. Bd diagnostics has received fda clearance to market the bd max mrsa xt assay for use on the fullyautomated bd max system. The discharge report will also display all patients that were still on the unit at the end of february.
Diagnosis of bloodstream infections from positive blood. There are now more than 20 assays in the bd max systems contentrich menu pipeline. 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. Ivd assays, research use only ruo assays and userdefined protocols udp cannot be combined in the same rack. Molecular testing lab automation scalable growth hologic. Bd bactec plus anaerobicf culture vials soybeancasein digest broth in a plastic vial. The bd max mrsa is the next assay to receive a moderate complexity rating. Manual methods plus multiple instruments mean a longer time for results.
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. The bd max mrsa xt assay with extended detection technology accurately identifies. The bd max system can support improved patient outcomes, reduce healthcare costs, and significantly advance antimicrobial stewardship strategies. Bd viper system with xtr technology isla lab products. This new assay quickly identifies instances of staphylococcus aureus sa and methicillinresistant staphylococcus aureus mrsa dna.
The bd max mrsa xt assay is now ce marked and available in europe for use on the bd max system. Automated qualitative in vitro diagnostic test for detection of methicillinresistant staphylococcus aureus mrsa dna from nasal. This germ does not cause any problems for most people who have it on their skin. Mrsa fact sheet centers for disease control and prevention. 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. Evaluation of xpert mrsa gen 3 and bd max mrsa xt for. Laboratory evaluation of the bd max mrsa assay journal. The remaining procedures were per formed according to the manufacturers instructions with automated result interpretation. 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.
View and download genexpert xpert mtb rif user manual online. 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. Of the 57,690 plates, 1,367 were scored positive by both automation and the manual reading process. Bd max is a fully automated, benchtop molecular system designed. The user will be prompted to enter a start date to. We evaluated the new, fully automated molecular bd max methicillinresistant staphylococcus aureus mrsa assay for detection of methicillinresistant s. Fda only when used with bd max ivd assays, which have been cleared or approved by the fda. The bd max mrsa xt assay must be performed immediately after the vortexing step above specimen preparation, step 7. Up to 18% of all positive mrsa results, reported by. Up to 96 samples per run up to eight patient samples one sample per run 7 is this an automated or manual. Turn on the bd max system and log in by entering user name and. 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. Five out of the 12 samples positive just by the bd maxtm were also tested by an inhouse pcr test.
An automated qualitative in vitro diagnostic test for the direct detection of methicillinresistant staphylococcus aureus mrsa dna from nasal swabs in patie. Sensitivity, specificity, and positive and negative predictive. For example bd max staphsr, bd max cdiff, and user defined protocols. The bd max system is designed to help address todays challenges, while preparing your laboratory for tomorrows possibilities. 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. Avoid cost and patient impact associated with unnecessary isolation and treatment due to meca dropouts. Hologic diagnostic instruments answer the demands of todays labs with automation, efficiency and flexibility. Mrsa skin infections in the early stages reduces the chances of the infection becoming severe. Laboratory evaluation of the bd max mrsa assay journal of. Methicillinresistant staphylococcus aureus mrsa pcrmax ltd qpcr testtm 150 tests for general laboratory and research use only quantification of methicillinresistant staphylococcus aureus mrsa genomes. 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. 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. A comparison between the bd max mrsa and xpert mrsa assays was performed using 239 nares samples.
Turn on the bd max system and log in by entering and. Mrsa nucleic acid ivd, kit, nucleic acid technique nat. Effizientes hygienemanagement mit dem bd max system. The test is unsuitable for routine use until its performance parameters can be verified.
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. 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. Testing is performed in biodesix central laboratory where multiple patient samples can be processed on one mass spectrometry plate. Evaluation of the bd max mrsa xt assay for use with. Our molecular testing instruments deliver consistently reliable functionality and trusted end results. Refer to the bd max system user s manual for detailed instructions operation section.
Objectives meticillinresistant staphylococcus aureus mrsa prevalence is high in many european countries, but remains low in the netherlands due to its search and destroy. Bd max mrsa assay receives fda clearance infection. The bd max mrsa assay proved to be a reliable alternative for a highly automated system to detect methicillinresistant staphylococcus aureus mrsa in patient nares samples. The bd max gbs assay is the first test in a complementary menu to bds infectious diseases portfolio. 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. Xpert mrsa gen 3 and bdmax mrsa xt j clin microbiol, 53 2015, pp. 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. The bd max system can hold 24 samples per run supporting different samples and assays within a run.
The bd max mrsa assay is intended to aid in the prevention and control of mrsa infections in healthcare settings. The bd max mrsa assay must be performed immediately after the vortexing step above specimen preparation, step 7. Bd provides quality certificates for many products certifying that these products have been manufactured and tested in accordance with bd specifications. You can combine bd max mrsa xt testing with other assays, in the same run. Please use one of the following formats to cite this article in your essay, paper or report. 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. It is the only fullyautomated molecular assay for mrsa active.
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