OMA Consulting Protocol Review: OMACON-2019-2

the enzyme), alcohol sugars, ascorbic acid and sorbic acid as examples of antioxidant molecules that could interfere with the detection system, and OMEGA3, oleic oil and some vitamins normally present in commercial enriched milk. 2.4.1 Prepare samples by diluting potential cross-reactive compounds to levels typically found in milk. Compounds include:

2.4.1.1 Glucose – 40 g/L 2.4.1.2 Fructose – 40 g/L 2.4.1.3 Galactose – 40 g/L 2.4.1.4 Sacarose – 40 g/L 2.4.1.5 Allolactose – 1 g/L 2.4.1.6 Lactulose – 1 g/L 2.4.1.7 Epilactose - 1 g/L 2.4.1.8 Ascorbic Acid - 0.25 g/L 2.4.1.9 Sorbic Acid – 0.25 g/L 2.4.1.10 OMEGA3 – 1.5 g/L 2.4.1.11 Oleic Oil – 12.5 g/L 2.4.1.12 Vitamin B12 - 0.003 g/L 2.4.1.13 Vitamin B6 – 0.012 g/L

2.4.1.14 Glycerol – 50 g/L 2.4.1.15 Sorbitol – 50 g/L 2.4.1.16 Mannitol – 50 g/L 2.4.1.17 Lactitol – 50 g/L 2.4.2 Stock solutions of each analyte will be prepared at levels typically found in dairy products. 2.4.3 Sample analysis will be conducted using the 0-200 mg/L calibration range 2.4.4 Testing will be conducted in milk containing ~40 mg/L lactose. 2.4.5 Randomize and blind-code samples. 2.4.6 Test according to the candidate method instructions for use. 2.4.7 Decode results and report any positive or negative interference.

2.5

Matrix Studies

The matrix study will determine the bias, recovery, repeatability precision, LOD, and LOQ. The following matrices will be evaluated: Whole UHT milk, Yogurt (normal, flavored, liquid flavored and Greek), cream, chocolate milk shake, spreadable soft cheese, infant formula, protein powder, ice cream.

15