Hygiena AOAC-RI Operating instructions

AOAC-RI
Brand
Hygiena
Model
AOAC-RI
Type
Operating instructions
INTRODUCTION:
Process control and final product decisions based only
on prevalence have shown limitations in reducing
consumer risk. Therefore, adoption of validated
quantification methodologies with low error and wide
enumerable ranges should be utilized to make data-
driven food safety decisions.
Savannah F. Applegate1, Rossy L. Bueno Lopez2, April K. Englishbey1, Nisha Corrigan1,
Stacy K. Stoltenberg1, Tyler P. Stephens1, and Marcos X. Sanchez-Plata2
1Hygiena™, 2 Boulden Circle, New Castle, DE 19720
2Department of Animal and Food Sciences, Texas Tech University, Lubbock, TX 79409
Twenty samples per matrix were
divided into 4 inoculation levels with
Salmonella ATCC strains at low:
0.0–1.0 Log CFU/g(mL), medium:
1.5–2.5 Log CFU/g(mL), high: 2.5–
3.5 Log CFU/g(mL), or uninoculated
as negative controls, then cold-
stressed for 48-72 hours. After the
stress period, sample processing
followed the Hygiena Pathogen
Quantification Procedures Manual
with incubation at 42 ˚C for 6 or 8
hours for SalQuant with reference
method performed in parallel.
Candidate results were compared
to the reference results with
statistical equivalence within 90%
confidence intervals and mean
difference of ± 0.50 Log10
CFU/g(mL) utilizing the AOAC-RI
quantitative worksheet.
METHODOLOGY: RESULTS:
The BAX SalQuant candidate method was
comparable to the USDA-FSIS MLG MPN
reference method at all inoculation levels for
poultry rinsates, ground beef, ground pork,
beef trim, pork trim, and MicroTally for beef
and pork trim.
SIGNIFICANCE:
PURPOSE:
The aim of this certification study was to compare the
performance of the candidate method, BAX®System
Real-Time PCR Assay for Salmonella (KIT2006)
utilizing the SalQuant™methodology, to the USDA-
FSIS MLG Most Probable Number (MPN) quantitative
reference method.
AOAC-RI Validation of Hygiena™BAX®System SalQuant™Methods
for Poultry Rinsates, Ground Beef and Pork, Beef and Pork Trim,
and MicroTally™Manual Sampling Devices on Beef and Pork Trim
One Health Diagnostics
REGISTERED TRADEMARKS /
GLOBAL CERTIFICATIONS:
BAX®System Real-Time PCR Assay for Salmonella AOAC-RI Performance
Tested Methods℠Certification Number 081201
MicroTally™Manual Sample Device is a trademark of MicroTally.
Low Med High
SalQuant 0.86 2.10 3.23
MLG MPN 0.97 2.37 3.59
0.00
1.00
2.00
3.00
4.00
5.00
Log10 CFU (MPN)/g
AOAC -Ground Beef
Low Med High
SalQuant 0.99 2.28 3.32
MLG MPN 0.70 2.19 3.61
0.00
1.00
2.00
3.00
4.00
5.00
Log10 CFU (MPN)/mL
AOAC -Poultry Rinsates
This certification provides the
poultry, beef, and pork industries
with an accurate, reliable, and
validated quantification tool to
reduce product hold-times, verify
corrective actions, monitor process
control, and promote faster data-
driven diversion decisions which
ultimately reduces consumer risk
in animal protein products.
Low Med High
SalQuant 0.70 1.59 3.39
MLG MPN 0.71 1.72 3.53
0.00
1.00
2.00
3.00
4.00
5.00
Log10 CFU (MPN)/g
AOAC -Ground Pork
Low Med High
SalQuant 0.53 2.21 3.41
MLG MPN 0.69 2.48 3.49
0.00
1.00
2.00
3.00
4.00
5.00
Log10 CFU (MPN)/g
AOAC -Pork Trim
Low Med High
SalQuant 0.70 1.79 3.51
MLG MPN 0.46 2.18 3.12
-1.00
0.00
1.00
2.00
3.00
4.00
5.00
Log10 CFU (MPN)/g
AOAC -Beef Trim
Low Med High
SalQuant 0.65 2.13 3.22
MLG MPN 0.60 1.80 3.16
-1.00
0.00
1.00
2.00
3.00
4.00
5.00
Log10 CFU (MPN)/g
AOAC -Pork Trim MicroTally
Low Med High
SalQuant 0.75 2.01 3.26
MLG MPN 0.63 2.25 3.61
0.00
1.00
2.00
3.00
4.00
5.00
Log10 CFU (MPN)/g
AOAC -Beef Trim MicroTally
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Hygiena AOAC-RI Operating instructions

AOAC-RI
Brand
Hygiena
Model
AOAC-RI
Type
Operating instructions
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