OMA Consulting Protocol Review: OMACON-2019-2

8 9

40 min 30 min

2.2 mL 2.0 mL

2.2 mL 2.0 mL

Analysis 2.6.1 Sample analysis will be conducted using the 0-200 mg/L calibration range 2.6.2 Testing will be conducted in milk containing ~100 mg/L lactose. 2.6.3 Test according to the candidate method instructions for use. 2.6.4 Randomize the treatment combinations. 2.6.5 Test 2 replicates for each treatment combination. 2.6.6 Analyze data by ANOVA, multifactor regression or generalized linear model software to determine whether any parameter change affects the results. For the lot-to-lot consistency study and stability study, two separate evaluations will be performed. The first study will evaluate the stability of the Biotest under dry conditions and the second will evaluate the Biotest after being rehydrated. At least 3 lots will be evaluated. The Biotest kit, stored at 3-8°C with each electrode vacuum packed and packaged with silica gel crystals to reduce humidity, has a shelf life of 6 months before hydration. After hydration, the Biotest has a shelf life of 15 days. Lot-to-Lot Consistency and Stability Study Rehydration Stability - The study plan is to test a minimum of three lots of Biotest kit (from the beginning, middle and end of dry shelf life) at day 0, 7 and 15 after rehydration. Analysis 2.7.1 Sample analysis will be conducted using the 0-200 mg/L calibration range 2.7.2 Testing will be conducted in milk containing ~100 mg/L lactose. 2.7.3 Test according to the candidate method instructions for use. 2.7.4 Test 2 replicates for each time point or each lot of test kits. 2.7.5 Calculate the mean and s r for each time point or lot. Dry Stability - The study plan is to test a minimum of three lots of Biotest kit at 7 days, 45 days, 8 months and 14 months.

2.7

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