Thornhill, Canada
Thornhill, Canada

Time filter

Source Type

Muldoon M.T.,SDIX | Allen A.-C.O.,SDIX | Gonzalez V.,SDIX | Sutzko M.,SDIX | And 4 more authors.
Journal of AOAC International | Year: 2012

The SDIX RapidChekTM Listeria F.A.S.T. test system was validated against the U.S. Department of Agriculture-Food Safety and Inspection Service (USDA-FSIS) cultural reference method for the detection of Listeria species on stainless steel, plastic, rubber, and painted concrete. The SDIX method uses a proprietary RapidChek Listeria enrichment media for a one-step, 24-40 h enrichment at 30°C, and detects Listeria on an immunochromatographic lateral flow device in 10 min. Different Listeria species were used to spike each of the environmental surfaces. Environmental surfaces were spiked at levels ranging from 50 to 400 cfu /surface (1 in.2 swabs for painted concrete, 4 in.2 for sponge). A total of 120 spiked samples were tested by the SDIX method at 24 and 40 h and the cultural reference method. Total confirmed positives were 49, 54, and 48 for the SDIX 24 h method, the SDIX 40 h method, and the USDA-FSIS cultural reference method, respectively. Nonspiked samples from all environmental surfaces were reported as negative for Listeria spp. by all methods. The overall Chi square was 0.017 (P = 0.104) and 0.611 (P = 0.566) after a 24 and 40 h enrichment, respectively, indicating that the test method was equivalent in performance to the reference method at both enrichment times. The SDIX method was evaluated for the detection of 50 Listeria and 35 non-Listeria bacterial strains. All 50 Listeria strains were detected by the method (100% sensitivity). Five out of 35 non-Listeria species gave light test signals when grown in nonselective broth culture and tested undiluted. However, when grown in the RapidChek Listeria F.A.S.T. proprietary media, only one bacterial strain (Staphylococcus aureus) was detected, giving a very low test signal (97% specificity). The method was shown to be robust toward several alterations in testing and storage conditions. © 2012 Publishing Technology.


Montei C.,Neogen Corporation | McDougal S.,Neogen Corporation | Mozola M.,Neogen Corporation | Rice J.,Neogen Corporation | And 3 more authors.
Journal of AOAC International | Year: 2014

The Soleris Non-fermenting Total Viable Count method was previously validated for a wide variety of food products, including cocoa powder. A matrix extension study was conducted to validate the method for use with cocoa butter and cocoa liquor. Test samples included naturally contaminated cocoa liquor and cocoa butter inoculated with natural microbial flora derived from cocoa liquor. A probability of detection statistical model was used to compare Soleris results at multiple test thresholds (dilutions) with aerobic plate counts determined using the AOAC Official Method 966.23 dilution plating method. Results of the two methods were not statistically different at any dilution level in any of the three trials conducted. The Soleris method offers the advantage of results within 24 h, compared to the 48 h required by standard dilution plating methods.


Caballero O.,Neogen Corporation | Alles S.,Neogen Corporation | Gray R.L.,Neogen Corporation | Tolan J.,Neogen Corporation | And 5 more authors.
Journal of AOAC International | Year: 2014

This study represents a proposal to extend the matrix claims for the ANSR™ Salmonella test, Performance Tested MethodSM 061203. The test is based on the nicking enzyme amplification reaction (NEAR™) isothermal nucleic acid amplification technology. The assay platform features simple instrumentation, minimal labor, and following a single-step 16-24 h enrichment (depending on sample type), an extremely short assay time of 30 min including sample preparation. Detection is real-time using fluorescent molecular beacon probes. ANSR Salmonella was originally validated for detection of Salmonella spp. in chicken carcass rinse, raw ground turkey, raw ground beef, hot dogs, and oat cereal, and on stainless steel, plastic, sealed concrete, ceramic tile, and rubber surfaces. The matrixes tested in this study include pet food, ice cream, soy flour, raw almonds, peanut butter, spinach, black pepper, raw frozen shrimp, cocoa powder, and pasteurized dried egg. In unpaired comparative testing there were no statistically significant differences in the number of positive results obtained with the ANSR and the reference culture methods. Enrichment for 16 h was effective for all commodities tested except ice cream, black pepper, dried pasteurized egg, and 375 g samples of dry pet food, for which enrichment for 24 h is indicated. © 2014 Publishing Technology.


Dutta V.,EnviroLogix Inc. | Guerrette T.,EnviroLogix Inc. | Davis A.H.,EnviroLogix Inc. | Crowley E.,Q Laboratories Inc. | And 10 more authors.
Journal of AOAC International | Year: 2014

The DNAble Salmonella detection assay utilizes single overnight culture enrichment, user-friendly sample preparation, and isothermal DNA amplification for Salmonella detection. This report describes studies performed in support of AOAC Research Institute Performance Tested MethodSM certification of the DNAble assay. Selectivity (inclusivity and exclusivity) studies were performed in the sponsor's laboratory. DNAble detected 119 out of 120 Salmonella isolates, representing 100 Salmonella serovars, in the inclusivity study while none of the 35 diverse non-Salmonella strains (32 species) tested was detected in the exclusivity study. Consistency (lot-to-lot and stability), instrument variation, and robustness studies were also conducted by the sponsor. Statistically equivalent assay performance was observed in these studies demonstrating robust assay manufacture and performance despite variation of multiple parameters in these challenges. Matrix studies, performed in an independent laboratory, evaluated DNAble assay performance in dry pet food, on stainless steel surfaces, and poultry environmental drag swab samples. Two sample sizes (25 and 375 g) and two culture volumes (9:1 and 3:1, v/w) were evaluated in separate matrix studies for dry pet food to provide multiple certified testing options for assay users. DNAble assay performance for dry pet food and stainless steel was compared to the procedures described in the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual, Chapter 5, Salmonella. Assay performance for drag swabs was compared to protocols dictated in the FDA Environmental Sampling and Detection of Salmonella in Poultry Houses guidelines. Matrix study results demonstrated statistically equivalent DNAble assay performance compared to these reference methods, ensuring that the DNAble assay provides results comparable to those of the reference methods.


Meighan P.,Unit 6 Surrey Technology Center | Chen Y.,U.S. Food and Drug Administration | Brodsky M.,Brodsky Consultants | Agin J.,Q Laboratories Inc.
Journal of AOAC International | Year: 2014

The MicroSnap Coliform and E. coli system was devised to give rapid enumeration and detection of coliforms and/or Escherichia coli strains in a sample of food within an 8 h working shift. The method measures β-galactosidase and β-glucuronidase enzymes using novel bioluminogenic substrates which develop an output light signal proportional to the concentration of enzyme discovered. The assay uses two different phases to determine the enzyme concentration. The first phase is an enrichment of the sample in a nutrientrich broth device at 37 ± 0.5°C. After 6 or 8 h, an aliquot is taken from the enrichment device and injected into the Coliform Detection Device, which is assayed in a luminometer after 10 min of incubation at 37 ± 0.5°C. Samples testing positive in the Coliform Detection Device can be subsequently assayed specifically for E. coli using the E. coli Detection Device. The relative light unit output from the detection device is proportional to the bacterial concentration when the incubation was initiated, which is proportional to the contamination level in the matrix being assessed. The MicroSnap Coliform and E. coli system was evaluated for both quantitative and qualitative analysis of coliforms and E. coli in a variety of foods. Three different luminometers were used in the analysis, each of which has different functionalities and different sensitivities. The MicroSnap method showed good correlation with the appropriate corresponding reference method for enumeration of coliforms and E. coli. A statistically significant difference was seen in detection of E. coli in milk, as reported by the independent laboratory. The reference method reported higher mean Log10 CFU counts than the MicroSnap method; however, no significant differences were seen between the MicroSnap system and reference methods for any of the other matrixes. Inclusivity testing was conducted on 25 different non-E. coli coliforms and 25 different E. coli strains, and exclusivity testing was conducted on 30 different species of nontarget organisms. Two E. coli strains were not detected in the Coliform Detection Device after 8 h on one of the instruments. All other inclusivity strains tested were detected after 8 h of incubation. None of the exclusivity strains were detected. The lot-to-lot and kit stability studies showed no statistical differences between lots or over the term of the shelf-life. Robustness studies indicate that the timing of incubation for the detection phase is critical for correct system functioning. © 2014 Publishing Technology.


Balachandran P.,CA Technologies | Cao Y.,CA Technologies | Wong L.,CA Technologies | Furtado M.R.,CA Technologies | And 5 more authors.
Journal of AOAC International | Year: 2011

Real-time PCR methods for detecting foodborne pathogens offer the advantages of simplicity and quick time-to-results compared to traditional culture methods. In this study, the MicroSEQ® real-time PCR system was evaluated for detection of Salmonella spp. in 10 different food matrixes following the AOAC Research Institute's Performance Tested MethodSM validation program. In addition, the performance of the MicroSEQ system was evaluated for the detection of Salmonella in peanut butter as a part of the Emergency Response Validation Program sponsored by the AOAC Research Institute. The system was compared to the ISO 6579 reference method using a paired-study design for detecting Salmonella spp. in raw ground beef, raw chicken, raw shrimp, Brie cheese, shell eggs, cantaloupe, chocolate, black pepper, dry infant formula, and dry pet food. For the peanut butter study, the system was compared to the U.S. Food and Drug Administration's Bacteriological Analytical Manual procedures using an unpaired-study design. No significant difference in performance was observed between the MicroSEQ Salmonella spp. detection system and the corresponding reference methods for all 11 food matrixes. The MicroSEQ system detected all Salmonella strains tested, while showing good discrimination against detection of an exclusivity panel of 30 strains, with high accuracy. © 2012 Publishing Technology.


Mozola M.,Neogen Corporation | Norton P.,Neogen Corporation | Alles S.,Neogen Corporation | Gray R.L.,Neogen Corporation | And 10 more authors.
Journal of AOAC International | Year: 2013

ANSRTM Salmonella is a new molecular diagnostic assay for detection of Salmonella spp. in foods and environmental samples. The test is based on the nicking enzyme amplification reaction (NEARTM) isothermal nucleic acid amplification technology. The assay platform features simple instrumentation, minimal labor, and, following a single-step 10-24 h enrichment (depending on sample type), an extremely short assay time of 30 min, including sample preparation. Detection is real-time using fluorescent molecular beacon probes. Inclusivity testing was performed using a panel of 113 strains of S. enterica and S. bongori, representing 109 serovars and all genetic subgroups. With the single exception of the rare serovar S. Weslaco, all serovars and genetic subgroups were detected. Exclusivity testing of 38 nonsalmonellae, mostly Enterobacteriaceae, yielded no evidence of cross-reactivity. In comparative testing of chicken carcass rinse, raw ground turkey, raw ground beef, hot dogs, and oat cereal, there were no statistically significant differences in the number of positive results obtained with the ANSR and the U.S. Department of Agriculture-Food Safety and Inspection Service or U.S. Food and Drug Administration/Bacteriological Analytical Manual reference culture methods. In testing of swab or sponge samples from five different environmental surfaces, four trials showed no statistically significant differences in the number of positive results by the ANSR and the U.S. Food and Drug Administration/Bacteriological Analytical Manual reference methods; in the trial with stainless steel surface, there were significantly more positive results by the ANSR method. Ruggedness experiments showed a high degree of assay robustness when deviations in reagent volumes and incubation times were introduced.


Muldoon M.T.,SDIX | Gonzalez V.,SDIX | Sutzko M.I.,SDIX | Allen A.-C.O.,SDIX | And 6 more authors.
Journal of AOAC International | Year: 2011

The RapidChek SELECTTM Salmonella Enteritidis Test System was validated for the detection of Salmonella Enteritidis (SE) in poultry house drag swabs, shell egg pools, and chicken carcass rinsates. The method utilizes RapidChek SELECTTM Salmonella (AOAC PTM License No. 080601) proprietary primary and secondary enrichment media. Following enrichment, an immunochromatographic test strip is inserted into the tube containing the secondary enrichment broth, developed for 10 min, and interpreted. Salmonella Enteritidis-inoculated samples (1-5 CFU SE/analytical unit) were tested by the test method as well as the appropriate cultural reference method U.S. Food and Drug Administration-Bacteriological Analytical Manual (drag swabs and egg pools) or U.S. Department of Agriculture-Food Safety and Inspection Service (chicken carcass rinsates). A total of 80 samples were tested by both methods in the study. Fifty-two samples were positive by the RapidChek SELECT Salmonella Enteritidis method and 38 were found positive by the respective reference method. The sensitivity of the method was 100% and the specificity was 100%. The accuracy of the test method was 137%, indicating that the method was more sensitive than the reference method. The RapidChek SELECT Salmonella Enteritidis method was tested with 82 Salmonella Group D1 strains including 63 Salmonella Enteritidis strains as well as 32 non-Salmonella Group D1 strains representing 10 bacteria genera. The test method detected all 82 Group D1 strains (100% sensitivity). None of the non-Salmonella Group D1 or other genera of bacteria were detected, indicating a specificity of 100%. The method was shown to be highly robust and stable under control and accelerated stability conditions. © 2012 Publishing Technology.


Peng L.X.,DuPont Company | Wallace M.,DuPont Company | Andaloro B.,DuPont Company | Fallon D.,DuPont Company | And 6 more authors.
Journal of AOAC International | Year: 2011

The BAX® System PCR assay for Salmonella detection in foods was previously validated as AOAC Research Institute (RI) Performance Tested MethodSM (PTM) 100201. New studies were conducted on beef and produce using the same media and protocol currently approved for the BAX System PCR assay for E. coli O157:H7 multiplex (MP). Additionally, soy protein isolate was tested for matrix extension using the U.S. Food and Drug Administration- Bacteriological Analytical Manual (FDA-BAM) enrichment protocols. The studies compared the BAX System method to the U.S. Department of Agriculture culture method for detecting Salmonella in beef and the FDA-BAM culture method for detecting Salmonella in produce and soy protein isolate. Method comparison studies on low-level inoculates showed that the BAX System assay for Salmonella performed as well as or better than the reference method for detecting Salmonella in beef and produce in 8-24 h enrichment when the BAX System E. coli O157:H7 MP media was used, and soy protein isolate in 20 h enrichment with lactose broth followed by 3 h regrowth in brain heart infusion broth. An inclusivity panel of 104 Salmonella strains with diverse serotypes was tested by the BAX System using the proprietary BAX System media and returned all positive results. Ruggedness factors involved in the enrichment phase were also evaluated by testing outside the specified parameters, and none of the factors examined affected the performance of the assay.


PubMed | BioControl Systems Inc., U.S. Food and Drug Administration, Brodsky Consultants and Q Laboratories Inc.
Type: Journal Article | Journal: Journal of AOAC International | Year: 2016

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 Method(SM) 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, Levines 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.

Loading Brodsky Consultants collaborators
Loading Brodsky Consultants collaborators