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

2019 ◽  
Vol 102 (3) ◽  
pp. 828-841
Author(s):  
David E Kerr ◽  
George Shen ◽  
Andrew H Lienau ◽  
Ta Deng ◽  
Mandeep Kaur ◽  
...  
Keyword(s):  
Enterohemorrhagic Escherichia Coli ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
Method Performance ◽  
Environmental Surfaces ◽  
Chicken Carcass ◽  
Significant Difference ◽  
Enrichment Protocol ◽  
Inspection Service ◽  
Comparative Validation

Abstract TRANSIA® PLATE Salmonella Gold is an ELISA that was validated by Association Française de Normalisation (AFNOR) in 2001 and as a Performance Tested MethodSM (PTM) by AOAC in 2006 (PTM No. 010602) as a two-step enrichment protocol requiring 48 h. A simple next-day enrichment protocol using modified Enterohemorrhagic Escherichia coli media was developed for the TRANSIA PLATE Salmonella Gold to improve the time-to-results and laboratory work flow. We tested 128 Salmonella strains, representing all serotypes from A though Z and 51–66. TRANSIA PLATE Salmonella Gold detected all 128 of these strains. None of the 50 non-Salmonella strains were detected by TRANSIA PLATE Salmonella Gold. Performance of TRANSIA PLATE Salmonella Gold using the new enrichment protocol was compared with U.S. Department of Agriculture Microbiology Laboratory Guidebook reference culture procedure for the detection of Salmonella in ready-to-eat poultry, ready-to-eat beef, and chicken carcass rinsate. In addition, TRANSIA PLATE Salmonella Gold performance was compared with 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). There was no statistically significant difference in the numbers of positive results TRANSIA PLATE Salmonella Gold protocol compared with the appropriate U.S. Department of Agriculture Food Safety and Inspection Service or FDA-BAM reference methods for any of these matrixes. Robustness testing demonstrated that the introduction of small changes in the normal assay parameters had no impact on the method performance. This new enrichment protocol has been approved as a Third Level modification to Performance Tested Method 010602.

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.

SAS™ Molecular Tests Salmonella Detection Kit

2014 ◽  
Vol 97 (3) ◽  
pp. 808-819 ◽  
Author(s):  
Chandra Bapanpally ◽  
Laura Montier ◽  
Shah Khan ◽  
Akif Kasra ◽  
Sharon L Brunelle
Keyword(s):  
Hold Time ◽  
Ground Beef ◽  
Department Of Agriculture ◽  
Test Portion ◽  
Method Performance ◽  
Molecular Tests ◽  
Amplification Method ◽  
Chicken Carcass ◽  
Inspection Service ◽  
The U.S

Abstract The SAS™ Molecular tests Salmonella Detection method, a Loop-mediated Isothermal Amplification method, performed as well as or better than the U.S. Department of Agriculture-Food Safety Inspection Service Microbiology Laboratory Guidebook and the U.S. Food and Drug Administration Bacteriological Analytical Manual reference methods for ground beef, beef trim, ground turkey, chicken carcass rinses, bagged mixed lettuce, and fresh spinach. The ground beef (30% fat, 25 g test portion), poultry matrixes and leafy greens were validated in a 6–7 h enrichment, and ground beef (30% fat, 375 g composite test portion) and beef trim (375 g composite test portion) were validated in a 16–20 h enrichment. The method performance for meat and leafy green matrixes was shown to be acceptable under conditions of co-enrichment with Escherichia coli O157. Thus, after a short 6–7 h co-enrichment step, ground beef, beef trim, lettuce, and spinach can be tested for both Salmonella and E. coli O157. Inclusivity and exclusivity testing revealed no false negatives and no false positives among the 100 Salmonella serovars and 30 non- Salmonella species examined. The method was shown to be robust when enrichment time, DNA extract hold time, and DNA volume were varied.

scholarly journals Comparative Validation Study to Demonstrate the Equivalence of a Minor Modification to AOAC Method 997.03 [Visual Immunoprecipitate (VIP®) for Listeria] to the Reference Culture Methods

2008 ◽  
Vol 91 (2) ◽  
pp. 365-369 ◽  
Author(s):  
Philip T Feldsine ◽  
David E Kerr ◽  
George S Shen ◽  
Andrew H Lienau
Keyword(s):  
Official Method ◽  
Comparison Study ◽  
Culture Methods ◽  
Environmental Surfaces ◽  
Environmental Surface ◽  
Aoac Method ◽  
Aoac Official ◽  
A Minor ◽  
Comparative Validation ◽  
Aoac Official Method

Abstract The Visual Immunoprecipitate (VIP®) for the Detection of Listeria in Foods and Environmental Surfaces, AOAC Official Method 997.03, has been modified to use a simplified housing for the device. A methods comparison study was conducted to demonstrate the equivalence of this modification to the reference culture methods. Two food matrixes and one environmental surface were analyzed. In total, valid results were obtained from 145 samples and controls. Results showed that the modified VIP for Listeria spp. is equivalent to the reference culture methods for the detection of Listeria.

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.

Validation of the ANSR® for Campylobacter Method for Detection of Thermophilic Campylobacter spp. in Chicken Carcass Rinse and Turkey Sponge Samples

2016 ◽  
Vol 99 (6) ◽  
pp. 1555-1564 ◽  
Author(s):  
Ryan Viator ◽  
Susan Alles ◽  
Quynh-Nhi Le ◽  
Edan Hosking ◽  
Preetha Biswas ◽  
...  
Keyword(s):  
Target Genes ◽  
Reference Method ◽  
Common Species ◽  
Single Step ◽  
Fluorescence Detector ◽  
Method Performance ◽  
Chicken Carcass ◽  
Inspection Service ◽  
Nicking Enzyme ◽  
Performance Validation

Abstract A performance validation of the ANSR® for Campylobacter method was conducted in selected matrixes. This assay used selective nicking enzyme amplification technology to amplify target genes. Samples were enriched for 20 to 24 h and then lysed. The assay was completed within 50 min using real-time detection in a combination incubator/fluorescence detector and software. When 50 distinct strains of Campylobacter jejuni, C. lari, or C. coli were tested for inclusivity, all 50 strains produced positive results. In exclusivity testing, 31 strains of related organisms, including seven nontarget Campylobacter strains and other common species, were evaluated. All 31 species generated negative ANSR assay results, including the nontarget Campylobacter strains. The ANSR for Campylobacter method was compared to the U.S. Department of Agriculture, Food Safety and Inspection Service Microbiology Laboratory Guidebook reference method using naturally contaminated chicken carcass rinse or turkey carcass sponge samples. ANSR method performance was not statistically different from the reference method using two different enrichment options. Equivalent results were observed at both time points (20 and 24 h) and in both atmospheres (microaerobic and aerobic) to reference methods. Method performance with chicken carcass rinse was confirmed in an independent laboratory study. Additionally, in robustness testing, small, deliberate changes to the assay parameters minimally affected ANSR method performance. Finally, accelerated stability results from three independently manufactured lots supported a shelf life of 6 months when stored at 4°C. The ANSR assay offered greater efficiency and flexibility when compared to the reference method with a 20–24 h single-step enrichment in a microaerobic or an aerobic atmosphere.

scholarly journals USDA FSIS, FDA BAM, AOAC, and ISO Culture Methods BD BBL CHROMagar Listeria Media

2009 ◽  
Vol 92 (4) ◽  
pp. 1105-1117 ◽  
Author(s):  
Vicki Ritter ◽  
Susan Kircher ◽  
Krista Sturm ◽  
Patty Warns ◽  
Nancy Dick
Keyword(s):  
Ground Beef ◽  
Food Samples ◽  
International Organization ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
False Negatives ◽  
Chi Square ◽  
Smoked Salmon ◽  
Inspection Service ◽  
Chi Square Analysis

Abstract BBL CHROMagar Listeria Media (CL) was evaluated for detection of Listeria monocytogenes in raw ground beef, smoked salmon, lettuce, and Brie cheese. The recovery of L. monocytogenes on CL was compared to the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM), U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), AOAC, and International Organization for Standardization (ISO) reference-plated media using the recommended pre-enrichments and selective enrichments. Of the 265 food samples tested, 140 were tested using BAM, USDA, or AOAC methods and 125 were tested using ISO methods. CL produced comparable results with the reference methods on all matrixes with a sensitivity of 99.3 and a specificity of 100. No false negatives were found in testing the food matrixes. There was no statistical difference in recovery based on Chi-square analysis. Known isolates were evaluated, and CL had a sensitivity and specificity of 100. The results of this study demonstrate that CL is an effective medium for the recovery and detection of L. monocytogenes in raw ground beef, smoked salmon, lettuce, and Brie cheese using FDA BAM, USDA FSIS, AOAC, and ISO culture methods.

Prevalence of Salmonella on Chicken Carcasses from Retail Markets in Vietnam

2012 ◽  
Vol 75 (10) ◽  
pp. 1851-1854 ◽  
Author(s):  
YEN T. TA ◽  
TRUNG THANH NGUYEN ◽  
PHUONG BICH TO ◽  
DA XUAN PHAM ◽  
HAO THI HONG LE ◽  
...  
Keyword(s):  
Storage Temperature ◽  
Poultry Meat ◽  
Department Of Agriculture ◽  
Retail Markets ◽  
Poultry Products ◽  
Ambient Storage ◽  
Significant Difference ◽  
Inspection Service ◽  
Wet Market ◽  
Raw Poultry

This study was conducted to estimate the prevalence of Salmonella on chicken carcasses collected from six regions in Vietnam. A total of 1,000 whole, dressed chicken carcasses were collected from five cities and seven provinces across the six regions in Vietnam. Of these, 900 samples were collected from wet markets and 100 from supermarkets. All samples were analyzed for the presence of Salmonella according to a method recommended by the U.S. Department of Agriculture, Food Safety and Inspection Service. The overall Salmonella prevalence was 45.9%. There was no significant difference (P > 0.05) in Salmonella prevalence by (i) location (Ha Noi city, 51.1%; Hai Phong city, 45.6%; Da Nang and Can Tho cities, 45.5%; Bac Ninh province and Ho Chi Minh city, 44.7%; Dong Nai province, 44.6%; Ha Tinh province, 44.4%; Phu Tho province, 43.8%; Lao Cai province, 43.5%; Kien Giang province, 41.9%; and Lam Dong province, 40.9%), (ii) market type (wet market, 46.2%; supermarket samples, 43.0%), and (iii) storage temperature at retail (ambient storage, 46.4%; chilled storage, 45.1%). Hence, Salmonella presence on poultry meat in Vietnam was not associated with a specific city or province, market type, or storage temperature at retail. Strategies to reduce Salmonella levels on raw poultry in Vietnam should be undertaken to improve the safety of poultry products and reduce the incidence of human salmonellosis from poultry consumption.

Comparison of Assurance GDS® MPX ID for Top STEC with Reference Culture Methods for the Detection of E. coli Top 6 STEC; Direct Confirmation of Top 6 STEC from Isolation Plates and Determination of Equivalence of PickPen® and FSIS OctoMACS™ Concentration Protocols

2016 ◽  
Vol 99 (2) ◽  
pp. 428-443 ◽  
Author(s):  
Philip Feldsine ◽  
Andrew H Lienau ◽  
Khyati Shah ◽  
Amy Immermann ◽  
Khanh Soliven ◽  
...  
Keyword(s):  
Stainless Steel ◽  
Laboratory Study ◽  
Screening Method ◽  
Ground Beef ◽  
Immunomagnetic Separation ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
Independent Laboratory ◽  
Environmental Surfaces ◽  
Microbiological Methods

Abstract Assurance GDS® MPX ID for Top Shiga toxin-producing Escherichia coli (STEC; MPX ID) was validated according to the AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Foods and Environmental Surfaces as (1) a secondary screening method for specific detection of the Top 6 STEC serogroups (O26, O45, O103, O111, O121, and O145) in raw beef trim, raw ground beef, raw spinach, and on stainless steel; and (2) as a confirmatory method for the identification of pure culture isolates as Top 6 STEC. MPX ID is used in conjunction with the upfront BCS Assurance GDS MPX Top 7 STEC assay. This Performance Tested MethodSM validation has two main parts: Method Developer studies and the Independent Laboratory study. A total of 180 samples and controls were analyzed. Results showed that MPX ID had no statistically significant differences with the reference culture methods for the detection of Top 6 STEC in the food matrixes (raw beef trim, raw ground beef, and raw spinach) and environmental sponges (stainless steel) studied. Inclusivity/exclusivity studies were also conducted. One hundred percent inclusivity among the 50 Top 6 STEC serovars tested and 100% exclusivity for the 30 non-Top 6 STEC organisms tested were demonstrated. For validation of MPX ID as a confirmatory method for isolated colonies, all inclusivity and exclusivity organisms were streaked for isolation onto five STEC plating media: modified rainbow agar, Levine's eosin-methylene blue (L-EMB) agar, rainbow agar with novobiocin and cefixime, and enterohemolysin agar with selective agents as well as trypticase soy agar with yeast extract. These isolated colonies were suspended and analyzed by Assurance GDS MPX Top 7 STEC and MPX ID. MPX ID was able to correctly confirm all inclusivity organisms from all plate types, except two STEC isolates from L-EMB agar plates only in the Independent Laboratory study. All exclusivity organisms were correctly determined by MPX ID as non-Top 6 STEC from the STEC plating media. An additional but separate part of these studies was a comparison of immunomagnetic separation (IMS) efficiency using the Assurance GDS procedure with a PickPen® device and the U.S. Department of Agriculture procedure using the OctoMACS™ Separator device for plating onto chromogenic agar. Results demonstrated the equivalence of the two IMS procedures for plate confirmation of Top 7 STEC.

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.

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