ERP Micro December 2019

properly equipped laboratory under the control of trained personnel. Always follow standard laboratory safety practices, including wearing appropriate protective apparel and eye protection while handling chemicals, reagents, and contaminated samples. Avoid contact with the isolates and reagents. Dispose of isolates, chemicals, and reagents according to current local, regional, and national guidelines. The Bruker MALDI Biotyper can detect Biosafety Level 2/3 organisms. Biological samples have the potential to transmit infectious diseases. Follow all applicable local, state/provincial, and/or national regulations on disposal of biological wastes. Wear appropriate protective equipment, which includes, but is not limited to, protective eyewear, face shield, clothing/laboratory coat, and gloves. All work should be conducted in properly equipped facilities using the appropriate safety equipment (e.g., physical containment devices). Individuals should be trained in accordance with applicable regulatory and company/institution requirements before working with potentially infectious materials. Cleaning of the target plates should be conducted in a chemical fume cabinet. When testing foodborne bacterial isolates, a risk assessment should be performed for any new tests to determine the safety of the protocols and whether this procedure should be performed in a biological safety cabinet. In addition, the use of chemicals and the need to perform certain steps in a chemical fume hood should also be evaluated. When testing is complete, all materials possibly containing pathogens should be decontaminated, following current industry standards for the disposal of contaminated waste (i.e., autoclave for 30 min at 121°C). Consult the Safety Data Sheet for additional information and local regulations for disposal. To reduce risks associated with environmental contamination, follow current local, regional, and national standards for disposal of contaminated waste. See Tables 2017.09A – J for a summary of results of the interlaboratory study. A. Principle The Bruker MALDI Biotyper Method is intended to be used for the automated identification and confirmation of bacteria. Classification and identifications are based on proteomic fingerprinting using matrix-assisted laser desorption/ionization time-of-flight (MALDI- TOF) mass spectrometry (MS). First, the MALDI process transforms the proteins and peptides from the isolated microorganisms into positively charged ions. This is achieved by irradiating the matrix- sample composite with a UV laser. The matrix absorbs laser energy and transfers protons to the intact proteins or peptides in the gas phase. These ions are electrostatically accelerated and arrive in the flight tube at a mass-dependent speed. Because different proteins/ peptides have different masses, ions arrive at the detector at different times (TOF). The MALDI Biotyper System measures the time

AOAC Official Method 2017.09 Confirmation and Identification of Salmonella species, Cronobacter species, Campylobacter species, and Other Gram-Negative Organisms Bruker MALDI Biotyper® Method First Action 2017 Revised First Action 2018 (Applicable to confirmation and identification of Salmonella species, Cronobacter species, Campylobacter species, and other Gram-negative organisms from select media types.) Caution: Follow all instructions carefully. Failure to do so may lead to inaccurate results. Laser class .—The MALDI Biotyper System with a closed safety cover is a Class 1 Laser product (exempt from all beam hazard control measures). With the safety cover opened, it becomes a Class 4 Laser product (considered to be hazardous to the skin and eyes from direct and scattered radiation). It has been designed and tested in accordance with International Electrotechnical Commission (IEC) Publication 61010-1 (Pollution Degree 2), Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use . The procedure for cleaning the reusable polished stainless steel target plates with the trifluoroacetic acid should be conducted in a chemical fume hood. Do not use the MALDI Biotyper System until it has been installed by a Bruker service representative, and laboratory staff have been appropriately trained by a Bruker representative. Read the user manual for the Microflex LT/SH Smart (No. 605415) or the Microflex (No. 1831173) for operational and safety instructions before using the MALDI Biotyper System. Refer to all user manuals below for complete safety precautions: ( 1 ) Instructions for Use MBT Galaxy HCCAMatrix GPR when using the Galaxy to support the sample preparation

( 2 ) Instructions for Use MBT Biotarget 96 ( 3 ) Instructions for Use Bruker Matrix HCCA ( 4 ) Instructions for Use Bruker Bacterial Test Standard ( 5 ) User Manual MBT Subtyping Module ( 6 ) User Manual MBT Compass

( 7 ) User Manual MBT Explorer Module ( 8 ) User Manual Microflex LT/SH Smart ( 9 ) User Manual Microflex

Users should read, understand, and follow all safety information in the instructions for the Bruker method. Retain safety instructions for future reference. To reduce risks associated with exposure to chemicals and biohazards, perform microbiological testing in a

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