OMA Consulting Protocol Review: OMACON-2019-2

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Introduction 1.1

BIOMILK 300 LAC Method

The BIOMILK 300 LAC (Appendix 1) is a compact analytical device that combines a biological component with a physicochemical transducer to detect analytes of interest. The BIOMILK 300 LAC combines the high specificity and selectivity of specific enzymes for each target analyte with an amperometric transduction of that biological signal, which is easily detectable and quantifiable. The technology is based on the Biotest, a working electrode that immobilizes the enzyme together with other electroactive components, which cause a change in electric current when analyte is present. There are two parts to the analysis. In the first phase (ADJUSTING REFERENCE), the device records the electricity signal that circulates in the electrochemical cell that is filled with Measuring Solution. In the second phase (MEASURING), a calibration standard or sample is added to the cell and the device records the electrical signal. The addition of sample or standard increases the electricity current in the cell due to the redox reaction sequence that occurs on the Biotest surface. The device uses the differences in intensities recorded before and after the addition of standard or sample to calculate a current intensity variation that correlates with the lactose concentration by means of a prior calibration of the device. The method is intended for the quantitative determination of lactose in low lactose or lactose free dairy products. The method has been developed with three separate analytical ranges. See Table 1 for specifications on the methods measurement ranges.

Table 1: Specifications of the Measurement Ranges 0-200 mg/L

0-2 g/L

0-6 g/L

Error

15%

15%

15%

Quantitative Range

50-200 mg/L

0.2-2 g/L 200 mg/L

0.5-6 g/L

LOQ

50 mg/L

0.5 g/L

Dilution Required

No

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1.2

Validation Overview

Validation study designs may vary based on several factors, including but not limited to the intended applicability of the method, the analyte being evaluated, or the validation guidelines used to design the study.

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