ERP Micro December 2019

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Analytes: Matrices:

E. coli serotypes O157:H7 (motile and non-motile) Raw ground beef, beef trim, frozen finely trimmed beef, orange juice, apple juice, fresh vegetables, sprout process

water and carcass cloth

1.3

Assurance PickPen® PIPETMAX Automated Sample Preparation

The Assurance GDS PickPen PIPETMAX (PPMX), is a modular automated system to complete the routine pipetting and PickPen IMS (Immunomagnetic separation). The machine automates all reagent dispensing and PickPen IMS protocols. This improves PCR sample prep consistency and accuracy. The PPMX will be validated as an alternate sample preparation method alongside the

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standard method for GDS O157.

A smaller alternate tube size for the amplification tube has previously been developed for GDS O157 (HTP, High Throughput). The amplification contents remain unchanged, only the exterior tube size is modified. The HTP amplification tube will also be validated alongside the standard (size) amplification tube for GDS O157 for use by the PPMX by

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demonstrating consistency of the two tube formats.

2.0

Study Protocols

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2.0

2.1

Good Laboratory Practices

2.1.1 ATCC bacterial strains specified for use must either be obtained directly from ATCC or be traceable to direct procurement from ATCC. Bacterial strains should

be of foodborne origin and the source should be provided.

2.1.1

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2.1.2 If not directly obtained from ATCC (or other internationally recognizable reference source), or if the species and serotype information are not provided by the source, the identity of each strain must be determined and documented using

biochemical and serological methods.

2.1.2

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2.1.3 One or more technicians should prepare samples and a second or more

technicians should perform the assays on “blind” coded samples.

2.1.3

2.12.1.4

All samples must be fully randomized and labeled with a code so that the analyst performing the assays is unaware of the level or type of bacterial culture

present.

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