Validated Matrices for BAX® System Assays

 

 Click here to download this full list in PDF format

 

 

Campylobacter (C. jejuni, C. coli, C. lari)

 

Assay

Approved Matrices

Validation Reference

 

BAX® System Real‐Time PCR Assay for Campylobacter jejuni/coli/lari KIT2018 (Kit #D12683449)

 

Poultry carcass rinses, processed turkey

 

AOAC PTM #040702

 

Chicken cloacae swabs

 

NordVal Certificate #39

 

For screening in poultry rinses, sponge and raw products

 

USDA FSIS MLG 41.04, 41A.00

 

 

Cronobacter (E. sakazakii)

 

Assay

Approved Matrices

Validation Reference

 

BAX® System PCR Assay for Cronobacter (E. sakazakii) KIT2001 (Kit #D11801836)

 

Powdered infant formula, dry dairy and soy ingredients, environmentals, environmental sponges

 

Internally Validated

 

Dairy (dry ingredients), environmentals (food production), powdered infant formula, soy ingredients

 

Health Canada #MFLP‐27

 

E. coli

 

Assay

Approved Matrices

Validation Reference

 

BAX® System X5 PCR Assay for

E. coli O157:H7 KIT2022 (Kit #D15407214)

Raw ground beef, beef trim, spinach and lettuce

AOAC PTM #050501

 

Raw beef meats, raw milk, fruits and vegetables, ready‐to‐eat and ready‐to‐reheat dishes, raw pork, ovine and chicken meats

AFNOR QUA 18/04 ‐ 03/08

(Validation study performed in accordance with EN ISO 16140-2)

 

BAX® System PCR Assay for

E. coli O157:H7 MP KIT2004 (Kit #D12404903)

Raw ground beef, beef trim, spinach and lettuce

AOAC PTM #050501

 

Raw beef meats, raw milk, fruits and vegetables, ready‐to‐eat and ready‐to‐reheat dishes, raw pork, ovine and chicken meats

AFNOR QUA 18/04 ‐ 03/08

(Validation study performed in accordance with EN ISO 16140-2)

 

BAX® System Real‐Time PCR Assay for

E. coli O157:H7 KIT2000 (Kit #D14203648)

Raw ground beef, beef trim, spinach and lettuce

AOAC PTM #031002

 

Raw beef meats, raw vegetables

AFNOR QUA 18/07‐07/10

(Validation study performed in accordance with EN ISO 16140-2)

Meat products and carcass and environmental sponges

 

USDA FSIS MLG 5.09/5A.04

 

BAX® System Real‐Time PCR Assay for

STEC Screening: stx and eae

KIT2021 (Kit #D14642964)

 

Raw ground beef, raw ground beef with soy, raw beef trim, flour

 

AOAC PTM #091301

 

Raw beef, raw beef mixes, beef trim, trim components, environmental sponges and carcass sponges, flour

 

USDA FSIS MLG 5B.05

 

BAX® System Real‐Time PCR Assay for

STEC Panel 1: E. coli O26, O111, and O121

KIT2008 (Kit #D14642970)

 

Raw ground beef, raw ground beef with soy, raw beef trim, flour

 

AOAC PTM #091301

 

Shiga toxin confirmation in meat products, carcass, environmental sponges

 

USDA FSIS MLG 5B.05

 

BAX® System Real‐Time PCR Assay for

STEC Panel 2: E. coli O45, O103, and O145

KIT2009 (Kit #D14642987)

 

Raw ground beef, raw ground beef with soy, raw beef trim, flour

 

AOAC PTM #091301

 

Shiga toxin confirmation in meat products and carcass and environmental sponges

 

USDA FSIS MLG 5B.05

 

Listeria

 

Assay

Approved Matrices

Validation Reference

 

BAX® System X5 PCR Assay for

Genus Listeria

KIT2024 (Kit #D15407193)

 

Environmental sponges, environmental swabs, frankfurters, smoked salmon, spinach and other vegetables, cheese

 

AOAC PTM #030502

 

All human food products and environmental samples (excluding primary production samples)

 

AFNOR QUA 18/06‐07/08

(Validation study performed in accordance with EN ISO 16140-2)

 

BAX® System PCR Assay for Genus Listeria

KIT2016 (Kit #D11000147)

 

Frankfurters, smoked salmon, spinach and other vegetables, cheese, environmental sponges, environmental swabs, multiple environmental surfaces

 

AOAC PTM #030502

Environmental sponges and swabs

Health Canada #MFLP‐15

 

BAX® System PCR Assay for Genus Listeria 24E

KIT2003 (Kit #D13608135)

 

Frankfurters, shrimp, spinach, queso fresco cheese, stainless steel

 

AOAC PTM #050903

 

All human food products and production environmental samples (excluding primary production samples)

 

AFNOR QUA 18/06‐07/08

(Validation study performed in accordance with EN ISO 16140-2)

 

BAX® System Real‐Time PCR Assay for Genus Listeria

KIT2019 (Kit #D15131113)

 

Frankfurters, cooked shrimp, spinach, bagged lettuce, queso fresco cheese, environmental surfaces

 

AOAC PTM #081401

(Includes Actero™ Elite Enrichment Media from FoodChek™)

 

All human food products and production environmental samples (excluding primary production samples)

 

AFNOR QUA 18/09-01/19

(Validation study performed in accordance with EN ISO 16140-2)

 

Listeria monocytogenes

 

Assay

Approved Matrices

Validation Reference

 

BAX® System X5 PCR Assay for Listeria monocytogenes KIT2023 (Kit #D15407201)

 

Ground beef, ground pork, ground chicken, ground turkey, deli turkey, frankfurters, pepperoni, fish sticks, surimi, langostinos, smoked salmon,

ice cream, milk (2%), yogurt, queso fresco, cabbage slaw, peas, spinach, strawberries, apple juice, orange juice, and environmental surfaces

 

AOAC PTM #070202

 

All human food products and production environmental samples (excluding primary production samples)

 

AFNOR QUA 18/05‐07/08

(Validation study performed in accordance with EN ISO 16140-2)

 

BAX® System PCR Assay for Listeria monocytogenes KIT2017 (Kit #D11000157)

Ground beef, ground pork, ground chicken, ground turkey, deli turkey, frankfurters, pepperoni, fish sticks, surimi, langostinos, smoked salmon,

ice cream, milk (2%), yogurt, queso fresco, cabbage slaw, peas, spinach,

strawberries, apple juice, orange juice, and environmental surfaces

 

AOAC PTM #070202

Dairy products, fruits, vegetables (except radishes), seafood, raw and processed meats, and poultry

AOAC OMA 2003.12

Meat, poultry, ready‐to‐eat siluriformes and egg products, and environmental sponge samples

USDA FSIS MLG 8.10/8A.06

Raw and ready to eat meat and poultry, eggs and egg products (processed and unprocessed), seafood, dairy, chocolate/bakery products, shelf stable foods, spices, composite foods, fruits and vegetables, cereals, animal feed, environmentals

 

Health Canada #MFLP‐28

 

BAX® System PCR Assay for Listeria monocytogenes 24E KIT2002 (Kit #D13608125)

Frankfurters, shrimp, spinach, queso fresco cheese, stainless steel surfaces

AOAC PTM #080901

All human food products and production environmental samples (excluding primary production samples)

AFNOR QUA 18/05‐07/08

(Validation study performed in accordance with EN ISO 16140-2)

 

BAX® System Real‐Time PCR Assay for

Listeria monocytogenes

KIT2005 (Kit #D15134303)

Frankfurters, frozen cooked shrimp, bagged spinach, queso fresco cheese, environmental sponges (stainless steel, plastic, sealed concrete)

AOAC PTM #121402

(Includes Actero™ Elite Enrichment Media from FoodChek™)

All human food products and production environmental samples (excluding primary production samples)

AFNOR QUA 18/10-01/19

(Validation study performed in accordance with EN ISO 16140-2)

 

Salmonella

 

Assay

Approved Matrices

Validation Reference

 

BAX® System X5 PCR Assay for

Salmonella

KIT2025 (Kit #D15407187)

 

Frankfurters, chipped ham, cooked chicken, raw ground chicken, soy protein powder, liquid egg, cream cheese, peanut butter, alfalfa sprouts, chocolate, nonfat dry milk, black pepper, custard, liquid milk, chilled ready meal, cooked fish, seafood‐prawns, elbow macaroni, pizza dough, frozen peas, orange juice, dry pet food, environmental sponges (finished product areas), ground beef, beef trim, spinach and lettuce

 

AOAC PTM #100201

 

All human products, feed products, and production environmental samples (except primary production environment)

AFNOR QUA 18/03 ‐ 11/02

(Validation study performed in accordance with EN ISO 16140-2)

 

BAX® System PCR Assay for

Salmonella

KIT2012 (Kit #D14368501)

Salmonella 2 KIT2011 (Kit #D14368501)

 

Frankfurters, chipped ham, cooked chicken, raw ground chicken, soy protein powder, liquid egg, cream cheese, peanut butter, alfalfa sprouts, chocolate, nonfat dry milk, black pepper, custard, liquid milk, chilled ready meal, cooked fish, seafood‐prawns, elbow macaroni, pizza dough, frozen peas, orange juice, dry pet food, environmental sponges (finished product areas), ground beef, beef trim, spinach and lettuce

 

AOAC PTM #100201

Hot dogs and frankfurters, beef/raw ground beef, chicken/raw ground chicken, fish/raw frozen tilapia fish, fruit juices/orange juice, cheese/mozzarella cheese

 

AOAC OMA 2003.09

 

All human food products, feed products, and production environmental samples (except primary production environment)

AFNOR QUA 18/03 ‐ 11/02

(Validation study performed in accordancea with EN ISO 16140-2)

Drag swabs, fecal samples, dust, chick pads, meconium

NPIP

Food, animal feed and environmental samples

NORDVAL Certificate #030

Ready‐to‐eat meat, poultry, and siluriformes foods, raw poultry products, raw meat and raw beef mixed products, poultry carcass and environmental sponges, meat carcass, whole bird rinses, pasteurized liquid, frozen, or dried egg products, raw siluriformes products, fermented products, dried products

(breading mixes, dehydrated sauces, dried milk)

 

USDA FSIS MLG 4.09/4C.07

Dairy, fish and seafood, chocolate/bakery products, fruits and vegetable-based products, raw poultry, environmental surface samples

 

Health Canada MFLP‐29

 

Salmonella

 

Assay

Approved Matrices

Validation Reference

 

BAX® System Real‐Time PCR Assay for Salmonella

KIT2006 (Kit #D14306040)

 

Beef/raw ground beef, beef/ground beef with soy, beef/beef trim, hot dogs and frankfurters/frankfurters, turkey/ground turkey, chicken/chicken wings, poultry/ poultry rinse, fish/shrimp, eggs and egg products (dried whole eggs, shell eggs), cheese/cream cheese, milk/nonfat dry milk, dairy products/ice cream, infant formula/ milk‐based infant formula, vegetables/fresh bagged lettuce, frozen vegetables/peas, fruit juices/orange juice, nuts and nut products/peanut butter, cacao bean and its products/cocoa, spices and condiments/white pepper, pet foods/dry pet food, environmental surfaces (ceramic, plastic, stainless steel)

 

AOAC OMA 2013.02

Raw ground beef, poultry carcass rinse, bagged lettuce, cream cheese, dry pet food, milk chocolate, chocolate liquor, cocoa powder, shell egg,

stainless steel surfaces, plastic surfaces

 

AOAC PTM #081201

 

Dry pet food, milk chocolate, chocolate liquor, cocoa powder, shell egg, stainless steel, plastic, raw ground beef, raw ground chicken, chicken carcass rinse, dried whole egg, whole liquid egg, raw almonds, peanut butter, dried raisin,

dried parsley, whole black pepper

 

AOAC PTM #041403

(Using Actero™ Elite Enrichment Media from FoodChek™)

All human food products (excluding milk powder), pet food

and production environmental samples (except primary production environment)

AFNOR QUA 18/08‐03/15

(Validation study performed in accordance with EN ISO 16140-2)

 

Shigella

 

Assay

Approved Matrices

Validation Reference

 

BAX® System Real‐Time PCR Assay for

Shigella

KIT2007 (Kit #D14812018)

 

Frankfurters

 

Internally Validated

 

Cooked meats, raw pork, dessert gelatin, ready‐to‐eat prepared dishes, non‐fermented soy products, lunch meals, granulated white sugar

 

Internally Validated

 

Staphylococcus aureus

 

Assay

Approved Matrices

Validation Reference

 

BAX® System Real‐Time PCR Assay for Staphylococcus aureus KIT2020 (Kit #D12762689)

 

Presence/absence testing on soy and milk‐based powdered infant formula; Threshold testing on ground beef and soy protein isolate

 

AOAC PTM #120701

 

Vibrio

 

Assay

Approved Matrices

Validation Reference

 

BAX® System Real‐Time PCR Assay for

Vibrio cholerae/ parahaemolyticus/ vulnificus

KIT2010 (Kit #D12863877)

 

Tuna, shrimp and scallops (presence/absence), shrimp and scallops (MPN), oysters (MPN)

 

AOAC PTM #050902

 

Yeast & Mold

 

Assay

Approved Matrices

Validation Reference

 

BAX® System PCR Assay for Yeast & Mold

KIT2015 (Kit #D12522091)

 

Validated on using the enriched protocol for yogurt, corn starch and milk‐based powdered infant formula (for thresholds of 10‐1000 cfu/g)

 

AOAC PTM #010902

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