AOAC-RI ERP Micro June 2016

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol OMA ERP - June 2016 ERP Use Only

1 The 3M Molecular Detection Assay 2 - Listeria monocytogenes method may generate Listeria 2 monocytogenes to levels sufficient to cause stillbirths and fatalities in pregnant women and the 3 immuno compromised, if exposed. 4 5 The user must train its personnel in current proper testing techniques: for example, Good 6 Laboratory Practices, ISO 17025 (4) , or ISO 7218 (5). 7 8 To reduce the risks associated with a false-negative result leading to the release of 9 contaminated product: 10 • Follow the protocol and perform the tests exactly as stated in the product instructions. 11 • Store the 3M Molecular Detection Assay 2 - Listeria monocytogenes as indicated on the 12 package and in the product instructions. 13 • Always use the 3M Molecular Detection Assay 2 - Listeria monocytogenes by the expiration 14 date. 15 • Use the 3M Molecular Detection Assay Listeria monocytogenes for food and environmental 16 samples that have been validated internally or by a third party. 17 • Use the 3M Molecular Detection Assay Listeria monocytogenes only for surfaces, sanitizers, 18 protocols and bacterial strains that have been validated internally or by a third party. 19 • For an environmental sample containing Neutralizing Buffer with aryl sulfonate complex, 20 perform a 1:2 dilution before testing (1 part sample into 1 part sterile enrichment broth). 21 3M™ sample handling products which include neutralizing buffer: BPPFV10NB, 22 RS96010NB, RS9604NB, SSL10NB, XSLSSL10NB, HS10NB and HS119510NB. 23 24 To reduce the risks associated with exposure to chemicals and biohazards: • It is strongly recommended that female laboratory staff be informed of the risk to a developing fetus resulting from infection of the mother through exposure to Listeria monocytogenes. • Perform pathogen testing in a properly equipped laboratory under the control of trained personnel. • Always follow standard laboratory safety practices, including wearing appropriate protective AOAC Research Institute Expert Review Panel Us Only

apparel and eye protection while handling reagents and contaminated samples. • Avoid contact with the contents of the enrichment media and reagent tubes after

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