scholarly journals DuPont Qualicon BAX® System Assay for Genus Listeria 24E

2011 ◽  
Vol 94 (3) ◽  
pp. 863-871
Author(s):  
F Morgan Wallace ◽  
Dawn Fallon ◽  
Daniel DeMarco ◽  
Stephen Varkey
Keyword(s):  
False Negative ◽  
Method Comparison ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
Service Culture ◽  
Steel Surfaces ◽  
Consistent Performance ◽  
Inspection Service ◽  
Positive Results ◽  
The U.S

Abstract The new BAX® System PCR Assay for Genus Listeria 24E was evaluated for detecting Listeria spp. in frankfurters, spinach, cooked shrimp, queso fresco cheese, and on stainless steel surfaces with a single-stage enrichment in BAX System 24 Listeria Enrichment Broth (24 LEB). Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent or superior to the U.S. Food and Drug Administration's Bacteriological Analytical Manual and the U.S. Department of Agriculture-Food Safety and Inspection Service culture methods, but with a significantly shorter time to result. Tests to evaluate inclusivity and exclusivity returned no false-negative and no false-positive results on a diverse panel of isolates, and tests for lot-to-lot variability and tablet stability demonstrated consistent performance. Ruggedness studies determined that none of the factors examined, within the range of deviations from specified parameters examined, affect the performance of the assay.

scholarly journals Evaluation of DuPont Qualicon BAX System PCR Assay for Yeast and Mold

2010 ◽  
Vol 93 (3) ◽  
pp. 928-935
Author(s):  
F Morgan Wallace ◽  
Frank Burns ◽  
Lois Fleck ◽  
Bridget Andaloro ◽  
Andrew Farnum ◽  
...  
Keyword(s):  
Corn Starch ◽  
False Negative ◽  
Method Comparison ◽  
Culture Method ◽  
Powdered Infant Formula ◽  
Pcr Assay ◽  
Consistent Performance ◽  
Positive Results ◽  
Formula Method ◽  
The U.S

Abstract Evaluations were conducted to test the performance of the BAX System PCR assay which was certified as Performance Tested MethodSM 010902 for screening yeast and mold in yogurt, corn starch, and milk-based powdered infant formula. Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent to the U.S. Food and Drug Administration's Bacteriological Analytical Manual culture method, but with a significantly shorter time to obtain results. Tests to evaluate inclusivity and exclusivity returned no false-negative and no false-positive results on a diverse panel of isolates, and tests for lot-to-lot variability and tablet stability demonstrated consistent performance. Ruggedness studies determined that none of the factors examined affected the performance of the assay.

Deoxyribonucleic Acid Hybridization Method for the Detection of Listeria in Dairy Products, Seafoods, and Meats: Collaborative Study

1994 ◽  
Vol 77 (3) ◽  
pp. 602-617 ◽  
Author(s):  
Michael S Curiale ◽  
Terri Sons ◽  
Luanne Fanning ◽  
Wendy Lepper ◽  
Dawn Mclver ◽  
...  
Keyword(s):  
Dairy Products ◽  
Deoxyribonucleic Acid ◽  
Collaborative Study ◽  
Culture Method ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
Ribosomal Ribonucleic Acid ◽  
Administration Method ◽  
Inspection Service ◽  
The U.S

Abstract The method is based on the hybridization of synthetic deoxyribonucleic acid probes to ribosomal ribonucleic acid sequences unique to Listeria. This method was compared to 2 culture methods: the U.S. Food and Drug Administration method for the detection of Listeria in dairy products and sea-foods and the U.S. Department of Agriculture, Food Safety and Inspection Service method for Listeria in meats. Six food types with replicate samples containing various concentrations of Listeria were analyzed by the collaborating laboratories. Listeria was detected in 774 samples using the DNAH method and in 772 samples using a culture method. The DNAH and culture methods were in agreement for 668 samples containing Listeria and 306 samples without Listeria. The overall rate of agreement between methods was 82.3%. The method has been adopted first action by AOAC INTERNATIONAL.

Comparative Validation Study to Demonstrate the Equivalence of an Alternate Next-Day Enrichment Protocol for VIP® Gold for Salmonella Method to Culture Methods for the Detection of Salmonella in Selected Foods and Environmental Surfaces

2019 ◽  
Vol 102 (3) ◽  
pp. 815-827
Author(s):  
David E Kerr ◽  
George Shen ◽  
Andrew H Lienau ◽  
Mandeep Kaur ◽  
Amy L Immermann ◽  
...  
Keyword(s):  
Enterohemorrhagic Escherichia Coli ◽  
Official Method ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
Environmental Surfaces ◽  
Chicken Carcass ◽  
Significant Difference ◽  
Enrichment Protocol ◽  
Inspection Service ◽  
The U.S

Abstract Background: VIP® Gold for Salmonella is a lateral flow immunodetection device that was validated by AOAC in 1999 as Official Method of Analysis 999.09. It was improved upon in 2009 by introducing gold colloid as the detection method. Objective: A simple next-day enrichment protocol using modified enterohemorrhagic Escherichia coli media was developed for the VIP Gold for Salmonella to improve the time-to-results and laboratory work flow. Methods: We tested 128 Salmonella strains, representing all serotypes from A to Z and 51 to 66 as well as 50 non-Salmonella strains for inclusivity/exclusivity. Performance of the VIP using the new enrichment protocol was compared with the U.S. Department of Agriculture (USDA) Microbiology Laboratory Guidebook reference culture procedure for the detection of Salmonella in ready-to-eat poultry, roast beef, and chicken carcass rinsate. VIP performance was also compared with the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) for the detection of Salmonella from raw spinach, raw almonds, raw pasta, and environmental surfaces (stainless steel, rubber, and plastic). Results: The VIP detected all 128 of Salmonella strains and none of the 50 non-Salmonella strains. There was no statistically significant difference in the numbers of positive results with VIP Gold for Salmonella protocol compared with appropriate USDA-Food Safety and Inspection Service or FDA-BAM reference methods for any of these matrixes. Conclusions: This new enrichment protocol has met all the requirements to be approved as a Performance Tested MethodSM. Highlights: The new enrichment protocol will improve the time-to-results and allow quicker decisions about the contamination of food products.

Roka Listeria Detection Method Using Transcription Mediated Amplification to Detect Listeria Species in Select Foods and Surfaces

2012 ◽  
Vol 95 (6) ◽  
pp. 1672-1688 ◽  
Author(s):  
Hua Yang ◽  
Shannon Kaplan ◽  
Michael Reshatoff ◽  
Ernie Hu ◽  
Alexis Zukowski ◽  
...  
Keyword(s):  
Probability Of Detection ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
Detection Analysis ◽  
Reference Methods ◽  
Smoked Salmon ◽  
Environmental Surfaces ◽  
Detection Assay ◽  
Inspection Service ◽  
The U.S

Abstract The Roka Listeria Detection Assay was compared to the reference culture methods for nine select foods and three select surfaces. The Roka method used Half-Fraser Broth for enrichment at 35 ± 2°C for 24–28 h. Comparison of Roka's method to reference methods requires an unpaired approach. Each method had a total of 545 samples inoculated with a Listeria strain. Each food and surface was inoculated with a different strain of Listeria at two different levels per method. For the dairy products (Brie cheese, whole milk, and ice cream), our method was compared to AOAC Official MethodSM993.12. For the ready-to-eat meats (deli chicken, cured ham, chicken salad, and hot dogs) and environmental surfaces (sealed concrete, stainless steel, and plastic), these samples were compared to the U.S. Department of Agriculture/Food Safety and Inspection Service-Microbiology Laboratory Guidebook (USDA/FSIS-MLG) method MLG 8.07. Cold-smoked salmon and romaine lettuce were compared to the U.S. Food and Drug Administration/Bacteriological Analytical Manual, Chapter 10 (FDA/BAM) method. Roka's method had 358 positives out of 545 total inoculated samples compared to 332 positive for the reference methods. Overall the probability of detection analysis of the results showed better or equivalent performance compared to the reference methods.

scholarly journals DuPont Qualicon BAX® System Real-Time PCR Assay for Escherichia coli O157:H7

2011 ◽  
Vol 94 (4) ◽  
pp. 1117-1124 ◽  
Author(s):  
Frank Burns ◽  
Lois Fleck ◽  
Bridget Andaloro ◽  
Eugene Davis ◽  
Jeff Rohrbeck ◽  
...  
Keyword(s):  
Shelf Life ◽  
Real Time ◽  
Real Time Pcr ◽  
False Negative ◽  
Method Comparison ◽  
Pcr Assay ◽  
Culture Methods ◽  
Life Study ◽  
Test Kit ◽  
Consistent Performance

Abstract Evaluations were conducted to test the performance of the BAX® System Real-Time PCR assay, which was certified as Performance Tested MethodSM 031002 for screening E. coli O157:H7 in ground beef, beef trim, spinach, and lettuce. Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent or superior to the FDA-BAM and the USDA-FSIS culture methods, but with a significantly shorter time to result. Tests to evaluate inclusivity and exclusivity returned no false-negative and no false-positive results on a diverse panel of isolates, and tests for lot-to-lot variability and tablet stability demonstrated consistent performance. Ruggedness studies determined that none of the factors examined affect the performance of the assay. An accelerated shelf life study determined an initial 36 month shelf life for the test kit.

Detection of Listeria spp. Using ACTERO Listeria Enrichment Media

2014 ◽  
Vol 97 (4) ◽  
pp. 1127-1136
Author(s):  
David Claveau ◽  
Sergiy Olishevskyy ◽  
Michael Giuffre ◽  
Gabriela Martinez
Keyword(s):  
Stainless Steel ◽  
Environmental Samples ◽  
Incubation Temperature ◽  
Reference Method ◽  
Selective Medium ◽  
Single Step ◽  
Department Of Agriculture ◽  
Steel Surfaces ◽  
Inspection Service ◽  
The U.S

Abstract ACTERO™ Listeria Enrichment Media (ACTERO Listeria) is a selective medium developed for a single-step recovery and enrichment of Listeria spp. from environmental samples. Robustness testing of the ACTERO Listeria medium demonstrated good performance when minor changes were introduced to the incubation temperature and time. All 54 Listeria strains tested, representing the most frequently isolated Listeria species from food (L. monocytogenes, L. ivanovii, L. seeligeri, L. welshimeri, and L. grayi), were successfully enriched in ACTERO Listeria. None of the 30 nontarget strains tested in the exclusivity study was recovered after incubation in ACTERO Listeria. Recovery of Listeria was consistent across three independently produced lots of the ACTERO Listeria, and the prepared medium was stable for 45 days when stored at 4°C in the dark. Matrix studies performed with environmental sponge samples from plastic and stainless steel surfaces demonstrated similar recovery of Listeria spp. in a single-step enrichment using ACTERO Listeria from plastic, and significantly better recovery from stainless steel surfaces when compared to the U.S. Department of Agriculture-Food Safety and Inspection Service reference method. The results of this study prove that ACTERO Listeria Enrichment Media can be effectively used in replacement of the two-step enrichment suggested by the reference method without affecting the recovery of Listeria spp. from environmental samples.

scholarly journals Precollaborative Study of the GeneQuence® Salmonella Assay Using 24-Hour Enrichment Protocols for Detection of Salmonella spp. in Select Foods

2007 ◽  
Vol 90 (3) ◽  
pp. 725-737 ◽  
Author(s):  
Susan Alles ◽  
Xuan Peng ◽  
Michael Wendorf ◽  
Mark Mozola
Keyword(s):  
Collaborative Study ◽  
False Negative ◽  
False Negative Rate ◽  
Salmonella Spp ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
Chi Square ◽  
Salmonella Assay ◽  
Inspection Service ◽  
Chi Square Analysis

Abstract New enrichment protocols are described for use with a DNA hybridization (DNAH) method for detection of Salmonella spp. in select foods. GeneQuence® Salmonella, in its original version, utilized a 3-stage enrichment of minimum 42 h duration. New 2-stage procedures of 2428 h duration are described for raw poultry, raw beef, pasteurized egg products, milk chocolate, and dry pet food. In the validation study described here, a total of 345 samples were tested by the abbreviated DNAH method in parallel with either the U.S. Food and Drug Administration's Bacteriological Analytical Manual (FDA/BAM) or U.S. Department of Agriculture-Food Safety and Inspection Service (USDA-FSIS) reference culture procedures. Results showed an overall sensitivity for the DNAH method of 97.1% (false-negative rate 2.9%). There were no false-positive results by the DNAH method; therefore the specificity was 100%. Overall agreement between the DNAH and reference culture methods was 98.5%. There were no significant differences in performance between the DNAH and reference methods for any of the foods tested as determined by Chi-square analysis. It is recommended that the DNAH method be subjected to AOAC collaborative study.

scholarly journals The Validation of the VereBeef™ Detection Kit

2019 ◽  
Vol 102 (2) ◽  
pp. 508-524
Author(s):  
Dawn Qian Liu ◽  
Mitsuharu Sato ◽  
Wei Ling Tan ◽  
Grace Pei Wen Khoo ◽  
Kiel Fisher ◽  
...  
Keyword(s):  
False Negative ◽  
Method Comparison ◽  
Department Of Agriculture ◽  
Lab On Chip ◽  
E Coli ◽  
Qualitative Detection ◽  
Assay Performance ◽  
On Chip ◽  
Inspection Service ◽  
Method Comparison Study

Abstract VereBeef™ Detection Kit, incorporating both multiplex PCR and microarray technologies on a lab-on-chip platform, is intended for qualitative detection and differentiation of Escherichia coli O157:H7, E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121, E. coli O145, Shiga toxin-producing E. coli (STEC) virulence factors (stx1A, stx2A, eae), and Salmonella species in one test using raw beef trim samples. This product underwent extensive evaluations, including inclusivity-exclusivity, method comparison, robustness, lot-to-lot variability, and stability studies. The inclusivity/exclusivity study demonstrated that VereBeef Detection Kit specifically detects and identifies target analytes without occurrence of false-positive and false-negative detection. In the method comparison study, the performance of the VereBeef Detection Kit was compared with U.S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook’s methods for target organism detection in raw beef trim using E. coli O157:H7 single inoculation and Salmonella and non-O157 STEC dual inoculation. Data demonstrated equivalence in both methods. The robustness study showed that changesin the test parameters do not impact assay performance. Collectively, VereBeef Detection Kit is able to detect target pathogens in raw beef trim with a minimum enrichment time of 8 h for E. coli O157:H7 detection and 10 h for Salmonella and non-O157 STEC detection.

Contamination Revealed by Indicator Microorganism Levels during Veal Processing

2016 ◽  
Vol 79 (8) ◽  
pp. 1341-1347 ◽  
Author(s):  
JOSEPH M. BOSILEVAC ◽  
RONG WANG ◽  
BRANDON E. LUEDTKE ◽  
TOMMY L. WHEELER ◽  
MOHAMMAD KOOHMARAIE
Keyword(s):  
Escherichia Coli ◽  
Plate Count ◽  
Department Of Agriculture ◽  
E Coli ◽  
Veal Calves ◽  
Indicator Microorganism ◽  
Analysis Of Results ◽  
Aerobic Plate Count ◽  
Inspection Service ◽  
The U.S

ABSTRACT During site visits of veal processors, the U.S. Department of Agriculture, Food Safety Inspection Service (FSIS) has reported processing deficiencies that likely contribute to increased levels of veal contamination. Here, we report the results of measuring aerobic plate count bacteria (APC), Enterobacteriaceae, coliforms (CF), and Escherichia coli during eight sample collections at five veal processors to assess contamination during the harvest of bob veal and formula-fed veal before (n = 5 plants) and after (n = 3 plants) changes to interventions and processing practices. Hides of veal calves at each plant had mean log CFU/100 cm2 APC, Enterobacteriaceae, CF, and E. coli of 6.02 to 8.07, 2.95 to 5.24, 3.28 to 5.83, and 3.08 to 5.59, respectively. Preintervention carcasses had mean log CFU/100 cm2 APC, Enterobacteriaceae, CF, and E. coli of 3.08 to 5.22, 1.16 to 3.47, 0.21 to 3.06, and −0.07 to 3.10, respectively, before and 2.72 to 4.50, 0.99 to 2.76, 0.69 to 2.26, and 0.33 to 2.12, respectively, after changes were made to improve sanitary dressing procedures. Final veal carcasses had mean log CFU/100 cm2 APC, Enterobacteriaceae, CF, and E. coli of 0.36 to 2.84, −0.21 to 1.59, −0.23 to 1.59, and −0.38 to 1.45 before and 0.44 to 2.64, −0.16 to 1.33, −0.42 to 1.20, and −0.48 to 1.09 after changes were made to improve carcass-directed interventions. Whereas the improved dressing procedures resulted in improved carcass cleanliness, the changes to carcass-directed interventions were less successful, and veal processors are urged to use techniques that ensure uniform and consistent delivery of antimicrobials to carcasses. Analysis of results comparing bob veal to formula-fed veal found bob veal hides, preintervention carcasses, and final carcasses to have increased (P < 0.05) APC, Enterobacteriaceae, CF, and E. coli (with the exception of hide Enterobacteriaceae; P > 0.05) relative to formula fed veal. When both veal categories were harvested at the same plant on the same day, similar results were observed. Since identification by FSIS, the control of contamination during veal processing has started to improve, but challenges still persist.

Validation of the Reveal® 2.0 Group D1 Salmonella Test for Detection of Salmonella Enteritidis in Raw Shell Eggs and Poultry-Associated Matrixes

2016 ◽  
Vol 99 (4) ◽  
pp. 1017-1024 ◽  
Author(s):  
Mark Mozola ◽  
Preetha Biswas ◽  
Ryan Viator ◽  
Emily Feldpausch ◽  
Debra Foti ◽  
...  
Keyword(s):  
Salmonella Enteritidis ◽  
Probability Of Detection ◽  
Poultry Feed ◽  
Operating Parameters ◽  
Department Of Agriculture ◽  
Shell Eggs ◽  
Chicken Carcass ◽  
Inspection Service ◽  
The U.S ◽  
Culture Procedure

Abstract A study was conducted to assess the performance of the Reveal® 2.0 Group D1 Salmonella lateral flow immunoassay for use in detection of Salmonella Enteritidis (SE) in raw shell eggs and poultry-associated matrixes, including chicken carcass rinse and poultry feed. In inclusivity testing, the Reveal 2.0 test detected all 37 strains of SE tested. The test also detected all but one of 18 non-Enteritidis somatic group D1 Salmonella serovars examined. In exclusivity testing, none of 42 strains tested was detected. The exclusivity panel included Salmonella strains of somatic groups other than D1, as well as strains of other genera of Gram-negative bacteria. In matrix testing, performance of the Reveal 2.0 test was compared to that of the U.S. Department of Agriculture, Food Safety and Inspection Service Microbiology Laboratory Guidebook reference culture procedure for chicken carcass rinse and to that of the U.S. Food and Drug Administration Bacteriological Analytical Manual for raw shell eggs and poultry feed. For all matrixes evaluated, there were no significant differences in the ability to detect SE when comparing the Reveal 2.0 method and the appropriate reference culture procedure as determined by probability of detection statistical analysis. The ability of the Reveal 2.0 test to withstand modest perturbations to normal operating parameters was examined in robustness experiments. Results showed that the test can withstand deviations in up to three operating parameters simultaneously without significantly affecting performance. Real-time stability testing of multiple lots of Reveal 2.0 devices established the shelf life of the test device at 16 months postmanufacture.

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