AOAC ERP MICRO AUGUST 2018

OMAMAN-44 A: Collaborative Study Manuscript Expert Review Panel Use Only August 2018

streaked onto Violet Red Bile Agar with Glucose (VRBAG) broth. To confirm Enterobacteriaceae, isolates 218

should be tested for oxidase activity and stabbed into glucose agar containing Bromocresol Blue and 219

covered with sterile immersion oil. Oxidase negative samples that acidify glucose agar to produce yellow 220

stab are confirmed EB. Enterobacteriaceae confirmation procedures are described in ISO protocols (5, 221

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6).

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Pre-Collaborative and Collaborative Validation Study

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This validation study was conducted under a harmonized MicroVal/AOAC Official Methods of

Analysis (OMA) design. This utilized ISO reference methods for foods, when the method existed, and the 227

AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for 228

Food and Environmental Surfaces (12). Method developer studies were conducted in the Charm 229

Sciences, Inc., Lawrence, MA and included supplemental matrix data for additional claimed matrixes, 230

product consistency and stability studies, and robustness testing. The independent precollaborative 231

laboratory study was conducted by Q Laboratories, Inc., Cincinnati, OH, and included the 232

inclusivity/exclusivity studies and matrix studies for the claimed food/and or surface matrixes. Q- 233

Laboratories prepared samples and coordinated an international eleven laboratory collaborative study 234

of powdered infant formula containing probiotics. The testing laboratories were: SGS Vanguard 235

Sciences, North Sioux City, ND; ALS Marshfield LLC, Marshfield, WI ; Nestle Research Center, Lausanne 236 ERP Use Only Switzerland; Covance Laboratories, Madison, WI; Joint Institute for Food Safety and Applied Nutrition, 237 College Park, MD; Environmental and Occupational Health Microbiology Lab, University of Washington, 238 Seattle Washington; HiPP Croatia d.o.o – Glina, Croatia; Maxxam Analytics – Mississauga, Ontario; 239

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Maxxam Analytics – Burnaby, British Columbia; Teagasc – Cork, Ireland.

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