scholarly journals Matrix Extension Study: Listeria Right Now™ Test for Detection of Listeria spp. from Selected Environmental Surfaces Without Enrichment: AOAC Performance Tested MethodSM 081802

2019 ◽  
Vol 102 (5) ◽  
pp. 1589-1594
Author(s):  
Brooke Roman ◽  
Mark Mozola ◽  
Robert Donofrio ◽  
Benjamin Bastin ◽  
Nicole Klass ◽  
...  
Keyword(s):  
Ceramic Tile ◽  
Food Industry ◽  
Probability Of Detection ◽  
Extension Study ◽  
Culture Methods ◽  
Detection Model ◽  
Detection Analysis ◽  
Environmental Surfaces ◽  
Matrix Extension ◽  
Culture Procedure

Abstract Background: Listeria Right Now™ is a novel, enrichment-free test for the detection of Listeria spp. in swab samples taken from environmental surfaces. Results are available in less than 1 h. In a previous Performance Tested MethodSM (PTM) study, the test was validated for swab samples from stainless-steel and sealed concrete surfaces. Objective: A PTM matrix extension study was conducted to validate the method for the detection of Listeria spp. in swab samples from ceramic tile, plastic, and rubber surfaces. Methods: Performance of the Listeria Right Now method was compared to that of the U.S. Food and Drug Administration Bacteriological Analytical Manual reference culture procedure for the detection of Listeria spp. in swab samples taken from inoculated ceramic tile, plastic, and rubber surfaces. Data were analyzed using a probability of detection model. Results: There were no significant differences in performance between the Listeria Right Now and reference culture methods for any of the three surfaces tested, as determined by probability of detection analysis. Conclusions: The Listeria Right Now method is an effective procedure for the detection of Listeria spp. from a variety of environmental surfaces. Highlights: Listeria Right Now provides accurate results, without enrichment, in real time. This enables food industry personnel to react swiftly to suspected Listeria contamination incidents.

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.

Evaluation of the CERTUS Environmental Listeria Species Detection Kit for the Detection of Listeria Species on Environmental Surfaces: AOAC Performance Tested MethodSM 101802

2020 ◽  
Vol 103 (3) ◽  
pp. 833-842
Author(s):  
John Bodner ◽  
Mike Toribo ◽  
Erin Carruthers ◽  
Michael Weber ◽  
Holly Urquhart ◽  
...  
Keyword(s):  
Stainless Steel ◽  
Ceramic Tile ◽  
Surface Enhanced Raman Spectroscopy ◽  
Test System ◽  
Probability Of Detection ◽  
Growth Media ◽  
Species Detection ◽  
Listeria Species ◽  
Detection Analysis ◽  
Environmental Surfaces

Abstract Background CERTUS Environmental Listeria species Detection Kit (CERTUS EL Detection Kit) is a real-time, bio-contained assay designed to accurately detect Listeria species (L. grayi, L. innocua, L. ivanovii, L. marthii, L. monocytogenes, L. seeligeri, and L. welshimeri) from environmental surface matrixes using an antibody-coupled magnetic microparticle with a Surface Enhanced Raman Spectroscopy (SERS) nanoparticle technology test system paired with proprietary CERTUS EL Selective Growth Media and CERTUS Detection Unit. Objective The method was evaluated for AOAC®Performance Tested MethodSM certification. Methods Inclusivity and exclusivity, matrix studies, product consistency and stability were conducted to evaluate the CERTUS EL Detection Kit. Results In the matrix studies, stainless steel, ceramic tile, plastic (polystyrene) and sealed concrete environmental surfaces (4 × 4” test areas) were tested. No statistically significant differences were found by Probability of Detection analysis (POD) in any of the matrixes when results were compared to the U.S. Food and Drug Administration cultural microbiology reference method for Listeria. The CERTUS EL Detection Kit correctly identified all 50 target Listeria isolates and correctly excluded all 30 non-target strains that were analyzed. Probability of Detection analysis of CERTUS EL Detection Kit robustness, product consistency (lot-to-lot) and stability studies demonstrated no statistically significant differences, and no variation was observed between instruments. Conclusions The data collected in these studies demonstrate that the CERTUS EL Detection Kit is a reliable method for the rapid and specific detection of Listeria from stainless steel, ceramic tile, plastic (polystyrene) and sealed concrete environmental surfaces.

Validation of the Listeria Right NowTM Test for Detection of Listeria spp. from Selected Environmental Surfaces Without Enrichment

2019 ◽  
Vol 102 (3) ◽  
pp. 926-935
Author(s):  
Quynh-Nhi Le ◽  
Susan Alles ◽  
Brooke Roman ◽  
Eric Tovar ◽  
Edan Hosking ◽  
...  
Keyword(s):  
Stainless Steel ◽  
Probability Of Detection ◽  
Nucleic Acid Amplification ◽  
Stainless Steel Surface ◽  
Bacterial Strains ◽  
Method Performance ◽  
Rna Molecules ◽  
Detection Analysis ◽  
Environmental Surfaces ◽  
Amplification Assay

Abstract Background: Listeria Right NowTM is a novel, enrichment-free molecular method for detection of Listeria spp. in swab samples from environmental surfaces. The test provides results in real time, indicating the current or recent presence of Listeria spp. in the environment. After sampling, the entire contents of the swab are subject to sample processing, releasing large quantities of target ribosomal RNA molecules into the lysate. A portion of the lysate is then tested using the ANSR® for Listeria isothermal nucleic acid amplification assay. Objective: A Performance Tested MethodSM study was conducted to validate the method for detection of Listeria spp. in swab samples from stainless steel and sealed concrete surfaces. Methods and Results: In inclusivity testing, 60 of 60 Listeria spp. strains tested positive. In exclusivity testing, 31 of 31 nontarget bacterial strains tested negative. In LOD testing, the test was able to detect as few as 2 CFU of L. monocytogenes applied to a stainless steel surface. In matrix testing of inoculated stainless steel and sealed concrete surfaces, there were no statistically significant differences in method performance comparing the Listeria Right Now and U.S. Food and Drug Administration Bacteriological Analytical Manual reference culture procedures as determined by probability of detection analysis. In robustness testing, modest changes to three assay operating parameters simultaneously did not significantly affect performance of the test. Conclusions and Highlights: Results can be obtained in less than 1 h using the Listeria Right Now test, allowing food industry personnel to take immediate corrective action in the case of Listeria contamination incidents.

Comparative Evaluation of Veriflow®Listeria Species to USDA Culture-Based Method for the Detection of Listeria spp. in Food and Environmental Samples

2017 ◽  
Vol 100 (5) ◽  
pp. 1434-1444 ◽  
Author(s):  
Adam C Joelsson ◽  
Shawn P Terkhorn ◽  
Ashley S Brown ◽  
Amrita Puri ◽  
Benjamin J Pascal ◽  
...  
Keyword(s):  
Stainless Steel ◽  
Ceramic Tile ◽  
Pcr Amplification ◽  
Reference Method ◽  
Probability Of Detection ◽  
Complex Data ◽  
Listeria Species ◽  
Environmental Surfaces ◽  
Study Results ◽  
Significant Difference

Abstract Veriflow®Listeria species (Veriflow LS) is a molecular-based assay for the presumptive detection of Listeria spp. from environmental surfaces (stainless steel, sealed concrete, plastic, and ceramic tile) and ready-to-eat (RTE) food matrixes (hot dogs and deli meat). The assay utilizes a PCRdetection method coupled with a rapid, visual, flow-based assay that develops in 3 min post-PCR amplification and requires only a 24 h enrichment for maximum sensitivity. The Veriflow LS system eliminates the need for sample purification, gel electrophoresis, or fluorophore-based detection of target amplification and does not require complex data analysis. This Performance Tested MethodSM validation study demonstrated the ability of the Veriflow LS assayto detect low levels of artificially inoculated Listeria spp. in six distinct environmental and food matrixes. In each unpaired reference comparison study, probability of detection analysis indicated that there was no significant difference between the Veriflow LS method and the U.S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guide Chapter 8.08 reference method. Fifty-one strains of various Listeria spp. were detected in the inclusivity study, and 35 nonspecific organisms went undetected in the exclusivity study. The study results show that the Veriflow LS is a sensitive, selective, and robust assay for the presumptive detection of Listeria spp. sampled from environmental surfaces (stainless steel, sealed concrete, plastic, and ceramic tile) and RTE food matrixes (hot dogs and delimeat).

Comparative Evaluation of Veriflow® Salmonella Species to USDA and FDA Culture-Based Methods for the Detection of Salmonella spp. in Food and Environmental Samples

2017 ◽  
Vol 100 (5) ◽  
pp. 1445-1457
Author(s):  
Amrita Puri ◽  
Adam C Joelsson ◽  
Shawn P Terkhorn ◽  
Ashley S Brown ◽  
Zara E Gaudioso ◽  
...  
Keyword(s):  
Stainless Steel ◽  
Ceramic Tile ◽  
Ground Beef ◽  
Probability Of Detection ◽  
Salmonella Spp ◽  
Raw Meat ◽  
Environmental Surfaces ◽  
Study Results ◽  
Significant Difference ◽  
The U.S

Abstract Veriflow®Salmonella species (Veriflow SS) is a molecular-based assay for the presumptive detection of Salmonella spp. from environmental surfaces (stainless steel, sealed concrete, plastic, and ceramic tile), dairy (2% milk), raw meat (20%fat ground beef), chicken carcasses, and ready-to-eat (RTE) food (hot dogs). The assay utilizes a PCR detection method coupled with a rapid, visual, flow-based assay that develops in 3 min post-PCR amplification and requires only an 18 h enrichment for maximumsensitivity. The Veriflow SS systemeliminates the need for sample purification, gel electrophoresis, or fluorophore-based detection of target amplification and does not require complex data analysis. This Performance Tested MethodSM validation study demonstrated the ability of the Veriflow SS method to detect low levels of artificially inoculated or naturally occurring Salmonella spp. in eight distinct environmental and food matrixes. Ineach reference comparison study, probability of detection analysis indicated that there was no significant difference between the Veriflow SS method and the U.S. Department of Agriculture Food Safety and Inspection Service MicrobiologyLaboratory Guidebook Chapter 4.06 and the U.S. Food and Drug Administration Bacteriological Analytical Manual Chapter 5 reference methods. A total of 104 Salmonella strains were detected in the inclusivity study, and 35 nonspecific organisms went undetected in the exclusivity study. The study results show that the Veriflow SS method is a sensitive, selective, and robust assay for the presumptive detectionof Salmonella spp. sampled from environmental surfaces (stainless steel, sealed concrete, plastic, and ceramic tile), dairy (2% milk), raw meat (20% fat ground beef), chicken carcasses, and RTE food (hot dogs).

Romer Labs RapidChek®Listeria monocytogenes Test System for the Detection of L. monocytogenes on Selected Foods and Environmental Surfaces

2018 ◽  
Vol 101 (5) ◽  
pp. 1490-1507
Author(s):  
Gregory Juck ◽  
Verapaz Gonzalez ◽  
Ann-Christine Olsson Allen ◽  
Meredith Sutzko ◽  
Kody Seward ◽  
...  
Keyword(s):  
Listeria Monocytogenes ◽  
Reference Method ◽  
Test System ◽  
Probability Of Detection ◽  
Department Of Agriculture ◽  
Detection Analysis ◽  
Media System ◽  
Reference Methods ◽  
Environmental Surfaces ◽  
Inspection Service

Abstract The Romer Labs RapidChek®Listeria monocytogenes test system (Performance Tested Method 011805) was validated against the U.S. Department of Agriculture-Food Safety and Inspection Service Microbiology Laboratory Guidebook (USDA-FSIS/MLG), U.S. Food and Drug Association Bacteriological Analytical Manual (FDA/BAM), and AOAC Official Methods of Analysis (AOAC/OMA) cultural reference methods for the detection of L. monocytogenes on selected foods including hot dogs, frozen cooked breaded chicken, frozen cooked shrimp, cured ham, and ice cream, and environmental surfaces including stainless steel and plastic in an unpaired study design. The RapidChek method uses a proprietary enrichment media system, a 44–48 h enrichment at 30 ± 1°C, and detects L. monocytogenes on an immunochromatographic lateral flow device within 10 min. Different L. monocytogenes strains were used to spike each of the matrixes. Samples were confirmed based on the reference method confirmations and an alternate confirmation method. A total of 140 low-level spiked samples were tested by the RapidChek method after enrichment for 44–48 h in parallel with the cultural reference method. There were 88 RapidChek presumptive positives. One of the presumptive positives was not confirmed culturally. Additionally, one of the culturally confirmed samples did not exhibit a presumptive positive. No difference between the alternate confirmation method and reference confirmation method was observed. The respective cultural reference methods (USDA-FSIS/MLG, FDA/BAM, and AOAC/OMA) produced a total of 63 confirmed positive results. Nonspiked samples from all foods were reported as negative for L. monocytogenes by all methods. Probability of detection analysis demonstrated no significant differences in the number of positive samples detected by the RapidChek method and the respective cultural reference method.

Validation of the ANSR®Listeria Method for Detection of Listeria spp. in Selected Foods

2015 ◽  
Vol 98 (5) ◽  
pp. 1290-1300 ◽  
Author(s):  
Oscar Caballero ◽  
Susan Alles ◽  
Michael Wendorf ◽  
R Lucas Gray ◽  
Kayla Walton ◽  
...  
Keyword(s):  
Culture Method ◽  
Cross Reactivity ◽  
Single Step ◽  
Probability Of Detection ◽  
Nucleic Acid Amplification ◽  
Culture Methods ◽  
Detection Model ◽  
Smoked Salmon ◽  
Standard Culture ◽  
Nicking Enzyme

Abstract ANSR®Listeria was previously certified as Performance Tested MethodSM 101202 for detection of Listeria spp. on selected environmental surfaces. This study proposes a matrix extension to the method for detection of Listeria spp. in selected food matrixes. The method is an isothermal nucleic acid amplification assay based on the nicking enzyme amplification reaction technology. Following single-step sample enrichment for 16–24 h, the assay is completed in less than 50 min, requiring only simple instrumentation. Inclusivity testing was performed using a panel of 51 strains of Listeria spp., representing the species L. grayi, L. innocua, L. ivanovii, L. monocytogenes, L. seeligeri, and L. welshimeri. All strains tested were detected by the ANSR assay. Exclusivity testing of 30 strains representing non-Listeria Gram-positive bacteria yielded no evidence of cross-reactivity. Performance of the ANSR method for detection of Listeria spp. was compared to that of reference culture procedures for pasteurized liquid egg, pasteurized 2% milk, Mexican-style cheese, ice cream, smoked salmon, lettuce, cantaloupe, and guacamole. Data obtained in these unpaired studies and analyzed using a probability of detection model demonstrated that there were no statistically significant differences in results between the ANSR and reference culture methods, except for milk at 16 h and cantaloupe. In milk and smoked salmon, ANSR sensitivity was low at 16 h and therefore the recommended incubation time is 24 h. In cantaloupe, ANSR was found to be more sensitive than the reference culture method at both 16 and 24 h in independent aboratory testing. The ANSR Listeria method can be used as an accurate, rapid, and simple alternative to standard culture methods for detection of Listeria spp. in selected food types.

Atlas™ Salmonella Detection Method Using Transcription Mediated Amplification (TMA) to Detect Salmonella enterica in a Variety of Foods and Select Surfaces

2013 ◽  
Vol 96 (4) ◽  
pp. 822-841 ◽  
Author(s):  
William Kwong ◽  
Kristin Livezey ◽  
Michael Reshatoff ◽  
Steve Vaughn ◽  
Anna Freed ◽  
...  
Keyword(s):  
Detection Method ◽  
Sample Volume ◽  
Probability Of Detection ◽  
Culture Methods ◽  
Department Of Agriculture ◽  
Detection Analysis ◽  
Reference Methods ◽  
Detection Assay ◽  
Atlas Method ◽  
Inspection Service

Abstract The Atlas™ Salmonella detection assay was compared to the reference culture methods for 12 foods and three surfaces. Comparison of the Atlas method to the U.S. Food and Drug Administration Bacteriological Analytical Manual (FDA/BAM) and U.S. Department of Agriculture-Food Safety and Inspection Service/Microbiology Laboratory Guidebook (USDA-FSIS/MLG) reference methods required an unpaired approach. Each method had a total of 320 samples inoculated with an S. enterica strain. Each food and surface was inoculated with a different strain of S. enterica at two different levels/method. Meat and egg products were compared to the USDA-FSIS/MLG 4.05 method. All other foods were compared to the FDA/BAM-5 method. The Atlas method had 148 positives out of 320 total inoculated samples, compared to 119 positives for the reference methods. Overall, the probability of detection analysis of the results showed equivalent or better performance by the Atlas Salmonella detection method compared to the reference methods. The Atlas Salmonella detection assay detected all 100 inclusive organisms and none of the 30 exclusive organisms. The lot-to-lot and kit stability studies showed no statistical differences between lots or over the term of the shelf-life. Instrument-to-instrument testing showed no statistical difference between instruments. Finally, the robustness study showed no difference when the sample volume added to the Atlas Salmonella detection assay varied by 10%, storage time was extended up to 5 days before analysis, or enrichment times were varied from 12 to 24 h.

Comparative Evaluation of Veriflow®Listeria monocytogenes to USDA and AOAC Culture Based Methods for the Detection of Listeria monocytogenes in Food

2015 ◽  
Vol 98 (5) ◽  
pp. 1325-1334
Author(s):  
Adam C Joelsson ◽  
Ashley S Brown ◽  
Amrita Puri ◽  
Martin P Keough ◽  
Zara E Gaudioso ◽  
...  
Keyword(s):  
Listeria Monocytogenes ◽  
Pcr Amplification ◽  
Reference Method ◽  
Probability Of Detection ◽  
Complex Data ◽  
Detection Analysis ◽  
Environmental Surfaces ◽  
Study Results ◽  
Significant Difference ◽  
Inspection Service

Abstract Veriflow®Listeria monocytogenes (LM) is a molecular based assay for the presumptive detection of Listeria monocytogenes from environmental surfaces, dairy, and ready-to-eat (RTE) food matrixes (hot dogs and deli meat). The assay utilizes a PCR detection method coupled with a rapid, visual, flow-based assay that develops in 3 min post PCR amplification and requires only 24 h of enrichment for maximum sensitivity. The Veriflow LM system eliminates the need for sample purification, gel electrophoresis, or fluorophore-based detection of target amplification, and does not require complex data analysis. This Performance Tested MethodSM validation study demonstrated the ability of the Veriflow LM method to detect low levels of artificially inoculated L. monocytogenes in seven distinct environmental and food matrixes. In each unpaired reference comparison study, probability of detection analysis indicated no significant difference between the Veriflow LM method and the U.S. Department of Agriculture, Food Safety and Inspection Service Microbiology Laboratory Guidebook 8.08 or AOAC 993.12 reference method. Fifty strains of L. monocytogenes were detected in the inclusivity study, while 39 nonspecific organisms were undetected in the exclusivity study. The study results show that Veriflow LM is a sensitive, selective, and robust assay for the presumptive detection of L. monocytogenes sampled from environmental, dairy, or RTE (hot dogs and deli meat) food matrixes.

AOAC Official MethodSM Matrix Extension Validation Study of Assurance GDSTM for the Detection of Salmonella in Selected Spices

2015 ◽  
Vol 98 (4) ◽  
pp. 930-938
Author(s):  
Philip Feldsine ◽  
Mandeep Kaur ◽  
Khyati Shah ◽  
Amy Immerman ◽  
Markus Jucker ◽  
...  
Keyword(s):  
Animal Feed ◽  
Reference Method ◽  
High Sensitivity ◽  
Official Method ◽  
Culture Methods ◽  
Environmental Surfaces ◽  
Microbiological Methods ◽  
Chili Powder ◽  
Aoac Official ◽  
Matrix Extension

Abstract Assurance GDSTM for Salmonella Tq has been validated according to the AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces for the detection of selected foods and environmental surfaces (Official Method of AnalysisSM 2009.03, Performance Tested MethodSM No. 050602). The method also completed AFNOR validation (following the ISO 16140 standard) compared to the reference method EN ISO 6579. For AFNOR, GDS was given a scope covering all human food, animal feed stuff, and environmental surfaces (Certificate No. TRA02/12-01/09). Results showed that Assurance GDS for Salmonella (GDS) has high sensitivity and is equivalent to the reference culture methods for the detection of motile and non-motile Salmonella. As part of the aforementioned validations, inclusivity and exclusivity studies, stability, and ruggedness studies were also conducted. Assurance GDS has 100% inclusivity and exclusivity among the 100 Salmonella serovars and 35 non-Salmonella organisms analyzed. To add to the scope of the Assurance GDS for Salmonella method, a matrix extension study was conducted, following the AOAC guidelines, to validate the application of the method for selected spices, specifically curry powder, cumin powder, and chili powder, for the detection of Salmonella.

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