Low Lactose ERP - Review Book

AOAC SMPR ERPs - 2019 METHOD REVIEW FORM

Submission Date

2019-09-04 09:46:24

Name

Martine van Gool

E-mail

martine.vangool@frieslandcampina.com

Organization

FrieslandCampina

Title of Method

LactoSense®R

AOAC Candidate Method Number (e.g. ALN-01)

LAC-004

Applicable SMPR

SMPR 2018.009

I. Summary of the Method

The method is based on a biosensor assay kit. An immobilized enzyme on a disposable test strip oxidizes the lactose in the sample. The resulting electrons are detected amperometrically by the specific software. This signal is converted to a lactose concentration according to the factory-set calibration function. The applicability as stated in the SMPR is met partially. The method is suitable for liquid, semi solid and solid dairy products but is excluding dried products (amongst which infant formula and adult nutritionals). Infant formula and adult nutritionals were in scope for the applicability of the method and therefore it is only partially met. The SMPR for infant formula is not met due to limited applicability. The SMPR for milk, milk products and products containing dairy in the two analytical ranges are mostly met (some outliers, not known whether these are real statistical outliers or just outside of the acceptable range). A lot of samples were included and results look promising. Most of the definitions specified in the SMPR are used, however there is no information in the summary about LOD and LOQ. This has been tested and is written at the end of the report. Could be helpful to give an overview with all performance characteristics for each concentration range in a summarizing table. Branded reagents are used. It is not known what the composition of these reagents is and whether precautions or safety aspects should be included. This has not been specified in the method protocol. No safety paragraph is included. This could be helpful also when no safety precautions are needed. Specific use of the test strips is described.

II. Review of the Method Only 1. Does the applicability of the method support the applicability of the SMPR? If not, please explain what is missing. 2. Does the analytical technique(s) used in the method meet the SMPR? If not, please specify how it differs from what is stated in the SMPR. 3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used. 4. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s).