ERP Micro December 2019

2.2 Safety Protocols for E . coli O157:H7

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2.2.1 To prevent transmission, disposable gloves should be worn when working with this organism. Hands should be washed immediately following removal of gloves. Direct and indirect contact of intact or broken skin with cultures and/or contaminated laboratory surfaces, accidental parenteral inoculation, and rarely, exposure to infectious aerosols are the primary hazards to laboratory personnel. Staff should apply safety procedures used for pathogens when handling all

samples.

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2.2.2 E . coli O157:H7 is a BSL-2 pathogen and all procedures should be performed in

laboratories that use, at a minimum, BSL-2 practices.

2.2.3 A Class II BSC is recommended for sample manipulations where the risk of aerosol

production is high. Production of aerosols should be avoided.

2.2.4 The analyst must know and observe normal safety procedures required in a microbiology laboratory. These procedures must be followed while preparing, using and disposing of media, cultures, reagents, and materials, and while

operating sterilization equipment.

3.03 Method Developer Studies 19 20 The Method Developer Studies are the responsibility of BioControl Systems and may be carried out in the 21 method developer’s laboratory or contracted by BioControl Systems to another laboratory.

3.1

Inclusivity /Exclusivity Study: Screening Protocol

This protocol examines the ability of the GDS O157 to detect a variety of the claimed E. coli O157:H7 and to distinguish those strains from closely related E. coli non-O157:H7 strains and non- E. coli species through sample enrichment as directed by the GDS O157 DFU. Inclusivity and

exclusivity were previously performed for GDS O157 assay.

For a minor modification including a new instrument (PPMX), inclusivity and exclusivity are also required to be analyzed. Since exclusivity is performed with direct cultural analysis rather than

IMS concentration, the PPMX will perform inclusivity ( with IMS method ) only.

Inclusivity and Exclusivity of E . coli O157:H7

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