AOAC ERP MICRO AUGUST 2018

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

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Inclusivity and Exclusivity Studies

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The inclusivity and exclusivity evaluation was conducted at Q Laboratories. All test materials

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required for the Peel Plate EB method were provided by Charm Sciences, Inc.

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Methodology . For the inclusivity evaluation of the Peel Plate EB, 50 Enterobacteriaceae were

cultured in BPW (ISO) broth at 37 ± 1⁰C for 24 ± 2 h. The 30 exclusivity organisms were cultured in Brain 247

Heart Infusion (BHI) broth at 37 ± 1⁰C for 24 ± 2 h. The inclusivity and exclusivity organisms were serially 248

diluted in 0.1% BPW to approximately 100 CFU/mL. All samples were blind-coded and randomized and 249

analyzed by the Peel Plate EB method and ISO 21528-2. One milliliter of each culture was plated in 250

duplicate. All plates were incubated at 37 ± 1⁰C for 24 and 48 h. Colonies were enumerated. 251

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Inclusivity/Exclusivity Results and Discussion . Table 1 presents the details of the inclusivity study

bacterial strains and Table 2 the details of the exclusivity study strains. Table 1 demonstrates that of 50 253

Enterobacteriaceae inclusivity isolates evaluated, 50 were correctly detected with enumerated values 254

similar to the ISO method. Shown in Table 2 of the 30 exclusivity strains evaluated, 30 were correctly 255

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excluded by both the reference and alternative methods.

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Precollaborative Matrix Study

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Precollaborative matrix studies were conducted at Q Laboratories and at Charm Sciences. In these ERP Use Only outline adhered to the Official Methods of Analysis of AOAC International; Appendix J (12). Each food 262 matrix was purchased from a local distributor, prescreened for natural contamination of the target 263 260 studies, each claimed matrix was evaluated naturally and at three contamination levels. The study 261

analyte by the ISO 21528-2:2017 reference method. Following the screening, each matrix tested by the 264

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