IJCA - Volume 3 - Flipbook - Page 59
2024 | Volume 3, Issue 1
chooses “challenging” foods that are claimed in the
validation of the method but were not tested during
the validation study. In this context, “challenging”
refers to items with characteristics such as low
pH, low water activity, high particulate content,
etc. These factors could perhaps be inhibitory (a
challenge) to the performance of the method.
Conducting Method Veri昀椀cation—
Examples
Veri昀椀cation of a QUALITATIVE Method: Neogen
Molecular Detection Assay 2 – Salmonella
STEP 1: DEFINE THE SCOPE OF LABORATORY
APPLICATION
Suppose a laboratory intends to verify the Neogen
Molecular Detection Assay 2 – Salmonella (MDA2
SAL) for use within their facility. Initially, the
laboratory must identify the (food) items routinely
tested for Salmonella, and then determine the number
of (food) categories these items encompass, as per
the Category list outlined in Figure 1.
For example, the laboratory depicted in Figure
2 primarily tests (food) items falling within one
main (food) category: “raw poultry and ready-tocook poultry products.” Additionally, the laboratory
tests sponges collected from the manufacturing
57
environment, which fall into one of the “Other” (nonfood) categories: “Environmental samples.”
This laboratory will need to test items from both
categories to complete veri昀椀cation of this method for
use in their laboratory.
STEP 2: REVIEW METHOD VALIDATION DATA, AND
CHOOSE (FOOD) ITEMS FOR THE VERIFICATION STUDY
Next, this laboratory will need to con昀椀rm that the
food and non-food items it routinely tests have been
fully validated either through AOAC INTERNATIONAL
following Appendix J: AOAC INTERNATIONAL
Methods Committee Guidelines for Validation of
Microbiological Methods for Food and Environmental
Surfaces5 and/or a certi昀椀cation organization (such
as: NF Validation by AFNOR Certi昀椀cation or MicroVal
Certi昀椀cation) that follows the protocol de昀椀ned in
ISO 16140-2:2016 Microbiology of the food chain –
Method validation – Part 2: Protocol for the validation
of alternative (proprietary) methods against a
reference method.6
AOAC validation data
AOAC validation data for Neogen Molecular
Detection Assay 2 – Salmonella is accessed in
two parts. The comparative study data can be
found in the AOAC® Performance Tested MethodSM
Certi昀椀cate 091501 for the method, available on
THE USER LABORATORY
(FOOD) CATEGORY
Raw poultry and
ready-to-cook
poultry products
Environmental
samples
(food and feed
production)
LOCATION 1
RAW
LOCATION 2
FROZEN
LOCATION 3
READY-TO-COOK
Ground chicken
Breast
Boneless skinless
Breast, Thighs, Tenders
Ground turkey
85% lean, 93% lean
Thin sliced chicken breast
Seasoned 1, Seasoned 2,
Seasoned 3
Chicken wings
Seasoned 1, Seasoned 2,
Seasoned 3
Chicken tenders
Breaded, Seasoned 1,
Seasoned 2, Seasoned 3
Seasoned breast pieces
Fajita, Spice garlic herb,
Barbeque, Lemon pepper
Nuggets
Breaded, Seasoned 1,
Seasoned 2, Seasoned 3
Boneless skinless
Chicken breast,
Tenderloins,
Thighs, Legs
Bone/skin
Chicken breast, Thighs,
Drums, Wings, Leg
Chicken strips
Breaded, Seasoned 1,
Seasoned 2, Seasoned 3
Sponges from equipment
(EM) w/ Letheen broth
Figure 2. The “User” laboratory (food) items routinely tested for Salmonella (Qualitative method)
