Mark T. Muldoon, Ph.D., SDIX, 128 Sandy Drive, Newark, DE Q Laboratories, Inc.1400 Harrison Avenue, Cincinnati, OH 45214

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1 RapidChek SELECT TM Salmonella Enteritidis Test System for the Detection of Salmonella Enteritidis in Poultry House Drag Swabs, Shell Egg Pools, and Chicken Carcass Rinsates Abstract The RapidChek SELECT TM 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 SELECT TM Salmonella (AOAC PTM License Number 0001) proprietary primary and secondary enrichment media. Following enrichment, an immunochromatographic test strip is inserted into the tube containing the secondary enrichment broth, developed for min and interpreted. Salmonella Enteritidis-inoculated samples (1 to CFU SE / analytical unit) were tested by the test method as well as the appropriate cultural reference method (FDA-BAM (drag swabs and egg pools) or USDA-FSIS (chicken carcass rinsates)). A total of 0 samples were tested by both methods in the study. Fifty-two () samples were positive by the RapidChek SELECT TM Salmonella Enteritidis method and were found positive by the respective reference method. The sensitivity of the method was 0% and the specificity was 0%. The accuracy of the test method was 1%, indicating that the method was more sensitive than the reference method. The RapidChek SELECT TM Salmonella Enteritidis method was tested with Salmonella Group D1 strains including Salmonella Enteritidis strains as well as non-salmonella Group D1 strains representing bacteria genera. The test method detected all Group D1 strains (0% sensitivity). None of the non-salmonella Group D1 or other genera of bacteria were detected, indicating a specificity of 0%. The method was shown to be highly robust and stable under control and accelerated stability conditions. Method Author Mark T. Muldoon, Ph.D., SDIX, 1 Sandy Drive, Newark, DE 11 Submitting Company SDIX, 1 Pencader Drive, Newark, DE 10 Independent Laboratory Q Laboratories, Inc.0 Harrison Avenue, Cincinnati, OH 1 Reviewers Michael Brodsky, Ph.D., Brodsky Consultants, Donnamore Crescent,Thornhill, Ontario, Canada LTK Edward Richter, Ph.D., Richter International, 10 Atlas Street, Columbus, OH [RapidChek SELECT TM SE AOAC Validation Report] Page 1

2 Thomas Hammack, Ph.D., AOAC General Referee 1. Scope of method 1.1 Target organisms Salmonella Enteritidis and other Salmonella Group D1 bacteria 1. Matrices Poultry house environmental drag swabs, egg pools, chicken carcass rinsates 1. Summary of validated performance claims. RapidChek SELECT TM Salmonella Enteritidis Test System was validated for the low level detection of Salmonella Enteritidis (SE) (1- CFU/sample) in poultry house drag swabs, shell egg pools, and chicken carcass rinsates. Method sensitivity was 0% and method specificity was 0%. Accuracy of the test method was 1%.. Definitions.1 Sensitivity. Number of True Positives / (Number of True Positives + Number of False Negatives). Specificity. Number of True Negatives / (Number of False Positives + Number of True Negatives). Accuracy. Number of Confirmed Presumptive Positives for Test Method / Number of Confirmed Positives for Reference Method. Principle The RapidChek SELECT TM Salmonella Enteritidis Test Kit is designed to detect Salmonella Enteritidis (including other Group D1 serovars) in poultry house drag swabs, shell egg pool samples and chicken carcass rinsate samples. The test kit permits the presumptive detection and identification of the target pathogen in 0 or hours, dependent on sample type, when present at levels as low as 1- organisms per sample. This immunoassay test uses a double antibody sandwich format in a lateral flow test strip. It utilizes a murine monoclonal antibody specific for Salmonella Group D1 including Salmonella Enteritidis (SE). The antibody is sprayed and immobilized on the surface of a nitrocellulose membrane comprising a test line. The same monoclonal antibody is also labeled with colloidal gold and is contained within a reagent pad upstream from the test line on the membrane. As the sample moves by capillary action from the filter pad into the antibody gold pad, the antibody gold reagent specifically binds to the target organism and moves with the liquid sample onto the test membrane. The sample passes through the test line where the immobilized antibody captures the antigen antibody gold complex, causing the formation of an antibody antigen sandwich and development of red color at the test line. Antibody antigen sandwiches are not formed in the absence of the Salmonella Group D1 including SE, resulting in no red color development at the test line. Anti-mouse antibody immobilized at the control line captures excess monoclonal antibody-gold reagent passing through the test line. The presence of red color at the control line indicates that the strip has flowed correctly. Therefore, the presence of only one line (control line) on the membrane indicates a negative sample and the presence of two lines indicates a positive sample. [RapidChek SELECT TM SE AOAC Validation Report] Page

3 The immunomagnetic confirmation kit utilizes the same monoclonal antibody described above attached to magnetic particles for the purification of SE and other Group D1 serovars from a complex enriched liquid media sample. The antibody- coated magnetic particles are used to concentrate Salmonella Group D1bacteria present within an enriched sample making confirmation of the presumptive positive result much more robust and easier to interpret. Essentially, the coated magnetic particles are added to a presumptive positive enrichment. If SE is present, it will bind to the magnetic particles via the coated antibody. A magnet is then used to concentrate the bound, coated magnetic particles and the remaining enrichment is discarded leaving only magnetic particles bound to the Salmonella Group D1serovars present in the enrichment. Confirmation procedures are then continued with the concentrated sample.. General Information Salmonellosis is the most commonly occurring foodborne illness in humans and is caused by the ingestion of Salmonella-contaminated food. The Centers for Disease Control and Prevention (CDC) estimated that 1. million cases of Salmonellosis occur annually in the U.S. and results in over 00 deaths (1). Salmonella Enteritidis (SE) is one of the most frequently reported Salmonella serotypes associated with human illness. In 00, SE was the leading reported cause of Salmonella infections; accounting for 1.% of the serotypes isolated (). Most SE exposures have historically been associated with the consumption of table (shell) eggs however recently, SE infection in broiler chickens has been on the rise (). It is estimated that approximately billion shell eggs are consumed annually in the US and that. million of those are contaminated with SE (). Due to this incidence of SE found in shell eggs and the large number of shell eggs consumed in the US, the U.S. Food and Drug Administration (FDA) has implemented regulations entitled Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage and Transportation; Final Rule 1 CFR Parts 1 and (). The effective date of the Final Rule was July, 00 with implementation beginning July, 0 for most egg farms. Part of the Final Rule requires egg farms to implement an egg layer house environmental drag swab testing program. If SE is found, egg pools (representing a total of 00 eggs from a single days production at that facility) must be tested or, alternatively, the eggs diverted for the life of the flock to processing (e.g. pasteurization). Under the egg testing option, if a positive egg test result occurs, the eggs must be diverted to processing for the life of the flock or until egg pools in a row, at week intervals, are found negative. At that time, the eggs from that flock may be sold as shell eggs. Under the Final Rule, both environmental drag swab testing and egg pool testing are required by Federal regulation. The test methods under consideration here offer advantages over the existing cultural reference methods in ease-of-use and time-to-result. This latter feature is particularly important for egg testing when eggs are being diverted to processing pending the test result.. Test Kit Information [RapidChek SELECT TM SE AOAC Validation Report] Page

4 Kit Name. RapidChek SELECT TM Salmonella Enteritidis Test System; RapidChek CONFIRM TM Salmonella Enteritidis Immunomagnetic Separation (IMS) Kit. Catalog Number. 0000; 000. Ordering Information...1 USA. SDIX, 1 Pencader Drive, Newark, DE 10. Phone: Fax: techservice@sdix.com.. Test Kit Reagents and Preparation :..1.1 RapidChek SELECT TM Salmonella Enteritidis Test Strips..1. Transfer pipettes (0 L)..1. Test Tubes..1. User Guide..1. RapidChek SELECT TM Salmonella Primary Media. Twenty (0) grams of primary media base was dissolved in 1 liter of deionized water and autoclaved ( C, 1 min) or filter sterilized. Alternatively, media was rehydrated in sterile deionized water. In this manner, rehydrated media was used within hours of preparation. For chicken carcass rinsates, 0 grams of primary media base was dissolved in 1 liter of deionized water and autoclaved or filter sterilized. Alternatively, media base was rehydrated in sterile deionized water. In this manner, rehydrated media was used within hours of preparation...1. RapidChek SELECT TM Salmonella Supplement. Just prior to use, ml of supplement was added per liter of primary media base. The media was shaken to mix. For chicken carcass rinsates, 0 ml of supplement was added per liter of primary media base and shaken to mix...1. RapidChek SELECT TM Salmonella Secondary Media. Secondary media (. g) was reconstituted in 1 liter of deionized water and boiled with stirring. Alternatively, media was rehydrated in sterile deionized water. In this manner, rehydrated media was used within hours of preparation :...1 Salmonella Group D1-Specific Immunomagnetic Separation (IMS) Beads. The IMS beads are added to the enriched sample at a rate of 0.0 ml IMS beads per milliliter of sample.... Phosphate-buffered Saline-Tween (PBS-T) Packet (Sigma Cat No. P). The contents of the packet was dissolved in 1 liter of deionized water.... Sample Tubes ( ml)... User Guide [RapidChek SELECT TM SE AOAC Validation Report] Page

5 Additional Supplies and Reagents Preparation.1 Buffered Peptone Water (BPW) - (Difco Becton Dickinson). Twenty (0) grams of media was dissolved in one liter of deionized water and autoclaved for 1 min at o C.. Trypticase soy broth (TSB) - (Difco Becton Dickinson). Thirty (0) grams of media was dissolved in one liter of deionized water and autoclaved for 1 min at o C. The TSB was supplemented with mg/l ferrous sulfate for use with the FDA-BAM reference method for shell eggs.. Tetrathionate (TT) Broth (Difco Becton Dickinson). g of media was added to one liter of purified water and brought to a boil. It was allowed to cool to below 0 C prior to dispensing into sterile, ml test tubes. Just prior to use, 0. ml of iodine-iodide solution ( g iodine and g potassium iodide in 0 ml deionized water) and 0.1 ml of brilliant green solution (0.1% (w/v)) was added to each tube containing ml of media base.. Tetrathionate (Hajna) Broth (Difco Becton Dickinson). 1.g of media was added to one liter of deionized water and brought to a boil. It was allowed to cool to below 0 C prior to dispensing into sterile, ml test tubes. Just prior to use, 0. ml of iodine-iodide solution ( g iodine and g potassium iodide in 0 ml deionized water) was added to each tube containing ml of media base.. Rappaport Vassilidis broth (RV) (for FDA-BAM procedures (poultry drag swabs and egg pools)) (Difco Becton Dickinson). For these applications, RV broth was made from individual ingredients. Five () g tryptone, g sodium chloride, and 1. g potassium phosphate monobasic were dissolved in 1 L of distilled water were combined. Four hundred grams of magnesium chloride hexahydrate was dissolved in 1 L of distilled water. Malachite green oxalate (0. g) was dissolved in 0 ml of distilled water. Complete media was made by combining 00 ml broth base, 0 ml magnesium chloride solution, and ml malachite green oxalate solution (total volume of complete medium is ml). The liquid media was dispensed ( ml) into culture tubes and autoclaved for 1 min at o C.. Rappaport Vassilidis R broth (RV) (for FSIS procedure (carcass rinsates)) (Difco Becton Dickinson). To 1 L of deionized water,. g of media was added and heated gently to dissolve. The liquid media was dispensed into ml tubes and autoclaved at C for 1 min.. Brilliant green sulfa agar (BGS) (Remel) Fifty-eight () grams of media was added to 1 liter of deionized water, boiled for 1 min, and autoclaved for 1 minutes at o C. [RapidChek SELECT TM SE AOAC Validation Report] Page

6 Brilliant green novobiocin agar (BGN). (Difco Becton Dickinson) Fifty-eight () grams of brilliant green agar was dissolved in 1 L of deionized water, boiled for 1 min, and autoclaved for 1 minutes at o C. To this was added 1 ml of a 0 mg/ml solution of novobiocin.. Xylose Lysine Tergitol agar (XLT) - (Difco Becton Dickinson) Fifty-nine () grams of media was added to 1 liter of deionized water. Then,.mL of Tergitol (Niaproof, Sigma) was added and the liquid brought to a boil for 1 min.. Xylose Lysine Deoxycholate agar (XLD) - (Difco Becton Dickinson) Fifty-five () grams of media was added to 1 liter of deionized water and the liquid brought to a boil for 1 min.. Bismuth sulfite agar (BS) - (Difco Becton Dickinson) Fifty-two () grams of media was added to 1 liter of deionized water and the liquid brought to a boil..1 Hektoen Enteric agar (HE) - (Difco Becton Dickinson) Seventy-six () grams of media was added to 1 liter of deionized water and the liquid brought to a boil..1 Triple Iron Sugar Agar Slant (TSI) - (Becton Dickinson Biosciences).1 Lysine Iron Agar Slant (LIA) (Becton Dickinson Biosciences).1 API 0E kits for identification of Enterobacteriaceae (BioMerieux).1 Salmonella Group D1 antisera (Factors 1,, 1) (Difco Becton Dickinson). Apparatus.1 Stomacher bags with filter. Stomacher bags without filter. Inoculating needles and loops. Vortex mixer. Stationary incubator Capable of holding temperature at o C+/-.0 for 0- hours.. Stationary incubator Capable of holding temperature at o C +/-.0 for 0- hours.. Stomacher Seward 00 Circulator (Seward, London, England) - for thorough mixing of food samples in enrichment broth. [RapidChek SELECT TM SE AOAC Validation Report] Page

7 Top loading balance To weigh g ( + 0.1g) test samples.. Magnetic Separation Rack- (e.g. Promega Corp. Part number CD00). Rocking Mixer Barnstead Thermolyne Speci-Mix M1 (Barnstead Thermolyne, Dubuque, IA), Fixed Speed: 1 rpm.. Circulating water bath capable of holding temperature at +/- 0. o C.. Standard Reference Materials Salmonella Enteritidis ATCC, Salmonella Enteritidis ARS, Salmonella Enteritidis ARS 1, and Salmonella Kentucky ATCC were used in various aspects of the study. Salmonella Enteritidis ATCC and Salmonella Kentucky ATCC were obtained from the American Tissue Culture Collection (ATCC, Gaithersburg, MD). Salmonella Enteritidis strains ARS and ARS 1 were obtained from the Eastern Regional Research Center, USDA-ARS, Wyndmoor, PA. Additional bacterial strains were used in the Inclusivity and Exclusivity studies and are indicated in Tables 1 and.. Safety Precautions Salmonella is a human pathogen. All test strips, pipettes and media were decontaminated by autoclave, bleach, etc., in accordance with local, state and federal regulations.. General Preparation.1 All incubators and circulating water baths were calibrated and monitored using NIST-certified thermometers.. Sample Preparation.1 Poultry house drag swabs were obtained from an egg facility in Maine. The hen house was occupied by approximately 0,000 pullets (1 weeks old) at the time of sampling. The drag swab samples were collected from the manure pits below the cage banks according to methods described in Appendix. Environmental Sampling and Detection of Salmonella In Poultry Houses US FDA, October 00. One lot of one hundred and twenty-five (1) drag swab samples were collected and shipped to SDIX for next day delivery. Upon receipt, 0 drags were subsequently shipped to the independent laboratory for next day delivery. The remaining swabs were used for the internal studies. Drag swabs were used within h of sampling and maintained at approximately C throughout shipping and storage.. Shell eggs were obtained from a local wholesale food provider. [RapidChek SELECT TM SE AOAC Validation Report] Page

8 Chicken broiler carcasses were obtained from a local grocery store. 1. Interpretation and Test Result Report The Mantel-Haenszel chi-square test for unmatched test portions was used to determine whether two methods were equivalent. A Chi-Square value of less than. indicates no significant difference (p<0.0) in the numbers of positive test portions given by the two methods being compared. The formula for determining the Mantel-Haenszel chisquare value is: (N-1)(AF (B+C+D)E) X = (A+B+C+D)(A+E)(B+C+D+F)(E+F) Where N = A + B + C + D + E + F Table. Data Table for Chi Square Analysis of Independent Samples Confirmed+ Confirmed - Alternative Presumptive + A B Method Presumptive - C D Reference Method E F Only presumptive positive results that confirm positive are considered as positive for the alternative method. All other results (presumptive positives that confirm negative, presumptive negatives that confirm negative and presumptive negatives that confirm positive) are considered as negative for the alternative method. 1. Internal Validation Studies 1.1 Poultry House Drag Swab Method Comparison Study Poultry house drag swabs were collected using standard procedures outlined in Environmental Sampling and Detection of Salmonella In Poultry Houses (US FDA, October 00) from an egg layer facility with no history of SE contamination. For spiking, a single colony isolate of Salmonella Enteritidis ARS (originally isolated from poultry feces) was grown in trypticase soy broth incubated at ºC for h. Viable cell enumeration of the inoculum was accomplished by dilution plate counting on trypticase soy agar plates supplemented with 0.% yeast extract. Individual drag swabs were inoculated at a target level of CFU/swab. Two () sets of unspiked and 0 spiked drag swab samples were acclimated at C for h, tested by either the SDIX method or the FDA BAM reference method, and the results compared. [RapidChek SELECT TM SE AOAC Validation Report] Page

9 Methodology FDA Method Environmental Sampling and Detection of Salmonella in Poultry Houses () One hundred (0) ml of buffered peptone water (BPW) was added to the sterile whirl-pak bag containing the drag swab sample. The sample was shaken and incubated ± ºC for ± h. Then, 1 ml of the sample was transferred into ml TT broth and incubated at.0 ± 0.ºC for ± h in a circulating water bath. In addition, 0.1 ml was transferred into ml RV broth and incubated at.0 ± 0.ºC for ± h in a water bath. Following the secondary enrichment, a µl loop of each secondary enrichment broth was struck to XLT and BGN selective agar plates. The plates were incubated at C and examined ± h. Up to typical colonies from each set of plates were transferred to TSI and LIA slants and incubated ± 1ºC for ± h. A minimum of 1 positive TSI slant was subjected to slide agglutination serology testing for Salmonella Group D1. If positive, then the isolate was identified biochemically using BioMerieux API0E (Official Method.) RapidChek SELECT TM Salmonella Enteritidis Test System One hundred (0) ml of pre-warmed (ºC) supplemented RapidChek SELECT TM primary media was added to each sample bag containing the swab, hand massaged for 0 sec, and incubated at ± C for 1- hr. Then, 0. ml of the primary enrichment broth was transferred to a tube containing ml pre-warmed (ºC) RapidChek secondary media and incubated 1- h at ºC. Then, the tubes were gently shaken, the lateral flow test strip was inserted into the tube and developed for min. The results were recorded (Positive two red lines, Negative one red line). All samples were confirmed according to the FDA-BAM method described above using the RapidChek SELECT TM secondary enrichment broth. In addition, all samples positive by the RapidChek SELECT TM Salmonella Enteritidis test strip were tested with the RapidChek CONFIRM Salmonella Enteritidis IMS method. For this, the working stock of monoclonal antibody-magnetic particle reagent was resuspended by repeated inversion of the vial. One (1) ml of enriched sample was transferred to the a ml polypropylene centrifuge tube. Then, 0.0 ml of the IMS beads was added to the enriched sample in the tube, vortexed briefly to mix and incubated at room temperature with rocking for 1 minutes. The sample tube was placed on a magnetic separation rack for minutes after which time the liquid [RapidChek SELECT TM SE AOAC Validation Report] Page

10 was removed from the sample. The sample tubes were removed from the magnetic rack and 1 ml of wash solution (PBS-T) was added to the tube. It was vortexed briefly to mix and placed on the magnetic separation rack for minutes after which time the liquid was removed from the sample. The wash step was repeated for a total of washes. After the final wash step, the sample was reconstituted with 0.1 ml of wash solution and vortexed briefly to mix. Selective agar plates (XLT and BGN) were struck with a µl loop of the purified sample. Plates were incubated at C and examined after ± h. Typical Salmonella colonies were confirmed as described above Results The results from the study are shown in Table 1. Thirteen (1) samples were positive with the RapidChek SELECT TM SE test strip. All of the presumptive positives samples confirmed as Salmonella Group D1 positive. None of the test strip-negative samples (1) were culturally-positive by the FDA-BAM confirmation method. The FDA-BAM reference method detected positive samples. This gave an accuracy of % indicating that. times more positives were found with the RapidChek SELECT TM SE method than with the reference method. The chi-square value was.0, indicating the RapidChek method is significantly more sensitive than the reference method for the detection of SE in poultry house drag swabs. 1. Egg Pool Method Comparison Study Shell eggs were purchased from a local wholesale food distributor. Approximately 0 eggs were disinfected using established FDA-BAM procedures (0% ethanol/iodide/iodine solution). Nine hundred (00) eggs were cracked and the contents pooled. For spiking, a single colony isolate of Salmonella Enteritidis ATCC (a clinical isolate) was grown in trypticase soy broth incubated at ºC for h. Viable cell enumeration of the inoculm was accomplished by dilution plate counting on trypticase soy agar plates supplemented with 0.% yeast extract. The egg pool was spiked at a target level of. CFU/L (approximate volume of 0 egg pool). For the negative control samples, 00 disinfected eggs were cracked and pooled. One (1) liter pools were aliquoted into sterile bags and acclimated for h at C prior to analysis by the SDIX and FDA-BAM cultural reference methods. At the time of analysis, following acclimation, an aerobic plate count was conducted on the negative pool and most probable number (MPN) analysis was conducted on the spiked pool Methodology FDA-BAM Cultural Reference Method () [RapidChek SELECT TM SE AOAC Validation Report] Page

11 For the FDA-BAM method, following acclimation at C for h, eggs pools were held at room temperature (0- C) for ± h. After that time, a ml portion from each sample was removed and added to ml of sterile trypticase soy broth (TSB) supplemented with ferrous sulfate ( mg/l) and mixed well by swirling. This sample was incubated 0 ± min at room temperature. The sample was mixed by swirling and the ph was adjusted to. ± 0.. The sample was incubated ± h at C. Then, 0.1 ml was transferred to ml Rappaport-Vassiliadis (RV) broth (prepared from individual ingredients) and 1 ml to ml TT broth. The RV was incubated at 0. C for h and the TT broth at ± 0. C for h. After this incubation, the samples were mixed and then struck ( l) onto BS, XLD and HE agars. The plates were incubated at C for h. Up to typical colonies were transferred to TSI and LIA slants and incubated at C for h. A minimum of 1 positive TSI slant was subjected to slide agglutination serology testing for Salmonella Group D1. If positive, then the isolate was identified biochemically using BioMerieux API0E (Official Method.) RapidChek SELECT TM SE Test System Following acclimation at C for h, to each egg pool was added 00 ml pre-warmed (ºC) supplemented RapidChek SELECT TM primary media. The sample was mixed well and incubated at room temperature (ºC) for 0 h. At that time, 0.1 ml of the primary enrichment broth was added to a tube containing 1 ml pre-warmed (ºC) RapidChek SELECT TM secondary media. The tubes were incubated - h at ºC. The tubes were gently shaken and a RapidChek SELECT TM SE test strip was added. The test strip was developed for min and the result recorded. The results were recorded (Positive two red lines, Negative one red line). All samples were confirmed according to the FDA-BAM method described above using the RapidChek SELECT TM secondary enrichment broth. 1.. Results The results from the study are shown in Table. Seventeen (1) samples were positive with the RapidChek SELECT TM SE test strip. All of the presumptive positives samples confirmed as Salmonella Group D1 positive. None of the test strip-negative samples () were culturally-positive. The FDA- BAM reference method detected 1 positive samples. This gave an accuracy of % indicating that the RapidChek Select SE method gave nearly the same number of positives as the reference method. The chi-square value was 0.0, indicating the RapidChek method is equivalent to the FDA-BAM method for the [RapidChek SELECT TM SE AOAC Validation Report] Page

12 detection of SE in egg pools. Furthermore, the RapidChek Select SE method gave a negative result after h ( days) whereas the FDA-BAM method required 1 h ( days) for a negative result. [RapidChek SELECT TM SE AOAC Validation Report] Page 1

13 Table 1. Results from the Poultry House Drag Swab Method Comparison Study-Internal Validation. Matrix Analyte Method Number of Samples Inoculation Level, CFU/sample Presumptive Positives Confirmed Positives Reference Method Positives Chi square a Sensitivity Rate b False Negative Rate c Specificity Rate d False Positive Rate e Accuracy f a Mantel-Haenszel Chi-square analysis. b Sensitivity Rate = (No. of test method presumptive positives)/(no. of test method confirmed positives) x 0. c False Negative Rate = 0 - Sensitivity Rate. d Specificity Rate = (No. of test method negatives)/(no. of confirmed test method negatives) x 0. e False Positive Rate = 0 - Specificity Rate. f Accuracy = (No. of test method positives)/(no. of reference method positives) x 0. Table. Results from the Egg Pool Method Comparison Study-Internal Validation. a Mantel-Haenszel Chi-square analysis. b Sensitivity Rate = (No. of test method presumptive positives)/(no. of test method confirmed positives) x 0. c False Negative Rate = 0 - Sensitivity Rate. d Specificity Rate = (No. of test method negatives)/(no. of confirmed test method negatives) x 0. e False Positive Rate = 0 - Specificity Rate. f Accuracy = (No. of test method positives)/(no. of reference method positives) x Table. Results from the Chicken Carcass Rinsate Method Comparison Study-Internal Validation. 1 1 a Mantel-Haenszel Chi-square analysis. b Sensitivity Rate = (No. of test method presumptive positives)/(no. of test method confirmed positives) x 0. 1 c False Negative Rate = 0 - Sensitivity Rate. d Specificity Rate = (No. of test method negatives)/(no. of confirmed test method negatives) x 0. e False Positive Rate = 0 - Specificity Rate. f Accuracy = (No. of test method positives)/(no. of reference method positives) x 0. 1 Poultry House Drag Swabs S. Enteritidis ARS RapidChek SELECT Matrix Analyte Method Egg Pools S. Enteritidis ATCC RapidChek SELECT Matrix Analyte Method Chicken Carcass Rinsates S. Enteritidis ARS RapidChek SELECT Number of Samples MPN, CFU/sample Presumptive Positives Confirmed Positives Reference Method Positives < Number of Samples Inoculation Level, CFU/sample Presumptive Positives Confirmed Positives Reference Method Positives [RapidChek SELECT TM SE AOAC Validation Report] Page % 0.0% 0.0% 0.0%.0% Chi square a Sensitivity Rate b False Negative Rate c Specificity Rate d False Positive Rate e Accuracy f % 0.0% 0.0% 0.0%.% Chi square a Sensitivity Rate b % False Negative Rate c Specificity Rate d False Positive Rate e Accuracy f 0.0% 0.0% 0.0%.%

14 Chicken Carcass Rinsate Method Comparison Study Whole (broiler) chicken carcasses () were obtained from a local grocery store. They were asceptically drained of excess liquid and transferred to a large sterile bag. For spiking, a single colony isolate of Salmonella Enteritidis ARS (originally isolated from poultry feces) was grown in trypticase soy broth incubated at ºC for h. Viable cell enumeration of the inoculum was accomplished by dilution plate counting on trypticase soy agar plates supplemented with 0.% yeast extract. Individual carcasses were inoculated at a target level of 1. CFU/carcass or 1 CFU/0 ml rinsate (analytical unit). Four hundred (00) ml of BPW was poured into the cavity of the carcass contained in the bag. The bird was rinsed inside and out with a rocking motion for one minute Methodology USDA-FSIS Cultural Reference Method () Thirty (0) ml of the sample rinse fluid obtained above was transferred to a sterile stomacher bag followed by 0 ml of sterile BPW and mixed well. The sample was incubated at ± C for 0- h. Then, 0. ± 0.0 ml of this was transferred into ml TT (Hajna) broth and 0.1 ± 0.0 ml into ml mrv broth and incubated at ± 0. C for - h. Following incubation, the broths were struck ( µl) to XLT and BGS agar plates. The plates were incubated at ± C for 1- h at which time typical colonies were picked for confirmation. If negative, plates were re-incubated for an additional 1- h and re-examined. Up to typical colonies were transferred to TSI and LIA slants and incubated at C for h. A minimum of 1 positive TSI slant was subjected to slide agglutination serology testing for Salmonella Group D1. If positive, then the isolate was identified biochemically using BioMerieux API0E (Official Method.) RapidChek SELECT SE Test System Thirty (0) ml of the sample rinse fluid obtained above was transferred to a sterile stomacher bag followed by 0 ml of prewarmed (ºC) X RapidChek SELECT TM primary media containing X supplement and mixed well. The sample was incubated at ± C for 1- hr. Then, 0.1 ml of the primary enrichment broth was transferred to a tube containing 1 ml pre-warmed (ºC) RapidChek SELECT TM secondary media and incubated 1- h at ºC. Then, the tubes were gently shaken, the lateral flow test strip was inserted into the tube and developed for min. The results were recorded (Positive two red lines, Negative one red line). All samples were confirmed according to the USDA-FSIS method [RapidChek SELECT TM SE AOAC Validation Report] Page 1

15 described above using the RapidChek SELECT TM secondary enrichment broth. 1.. Results The results from the study are shown in Table. Eleven () samples were positive with the RapidChek SELECT TM SE test strip. All of the presumptive positives samples confirmed as Salmonella Group D1 positive. None of the test strip-negative samples (1) were culturally-positive. The USDA-FSIS reference method detected 1 positive samples. This gave an accuracy of % indicating that the RapidChek SELECT TM SE method gave nearly the same number of positives as the reference method. The chi-square value was 0.0, indicating the RapidChek method is equivalent to the USDA-FSIS cultural reference method for the detection of SE in chicken carcass rinsates. 1. Test Strip Inclusivity Study 1..1 Methodology Salmonella single colony isolates were cultured in ml of RapidChek SELECT TM primary enrichment media for 1- hr at C. Then, 0.1 ml of the primary broth was transferred to 1 ml of RapidChek SELECT TM secondary enrichment media. This was incubated at C for 1- hr. Following enrichment, a test strip was inserted into the tube and developed for min after which time the test strip was read and interpreted as previously described. 1.. Results The results from the test inclusivity study are shown in Table. Eighty-two () Salmonella Group D1 strains including SE strains were grown in the complete RapidChek SELECT TM Salmonella media system and tested with the test strip. All of the Salmonella Group D1 strains gave a positive result with the method. This indicated a method sensitivity of 0%. [RapidChek SELECT TM SE AOAC Validation Report] Page 1

16 Table. Results from the Test Strip Inclusivity Study. RapidChek Select SE Test Strip Result Sample Number Serovar Strain Number RapidChek Select SE Test Strip Result Sample Number Serovar Strain Number 1 Salmonella Enteritidis ARS + Salmonella Enteritidis ISU-1-h + Salmonella Enteritidis ARS 1 + Salmonella Enteritidis ISU-1-d + Salmonella Enteritidis M1 BGA 1- + Salmonella Enteritidis ISU-1-n + Salmonella Enteritidis Tyson + Salmonella Enteritidis ISU-1-f + Salmonella Enteritidis ATCC + Salmonella Enteritidis ISU-1-g + Salmonella Enteritidis ATCC 1 + Salmonella Enteritidis ISU-1-g + Salmonella Enteritidis var. Jena ATCC 1 + Salmonella Enteritidis ISU-0-1i + Salmonella Enteritidis var. Jena ATCC + 0 Salmonella Enteritidis ISU-0-m + Salmonella Enteritidis var. Jena ATCC + 1 Salmonella Enteritidis ISU-0-n + Salmonella Enteritidis var. Essen ATCC 1 + Salmonella Enteritidis ISU-0-p + Salmonella Enteritidis var. Essen ATCC 1 + Salmonella Enteritidis ISU-0-q + 1 Salmonella Enteritidis var. Essen ATCC 0 + Salmonella Enteritidis ISU-0-r + 1 Salmonella Enteritidis var. Danysz ATCC 1 + Salmonella Enteritidis ISU-1-f + 1 Salmonella Enteritidis var. Chaco ATCC 1 + Salmonella Enteritidis ISU--a + 1 Salmonella Enteritidis var. Chaco ATCC 1 + Salmonella Enteritidis ISU--b + 1 Salmonella Enteritidis ISU-1-P + Salmonella Enteritidis ISU--e + 1 Salmonella Enteritidis ISU-1-K + Salmonella Enteritidis ISU--h + 1 Salmonella Enteritidis ISU-1-J + 0 Salmonella Enteritidis ISU--a + 1 Salmonella Enteritidis ISU-1-s + 1 Salmonella Enteritidis ISU--b + 0 Salmonella Enteritidis ISU-1-t + Salmonella Enteritidis ISU--c + 1 Salmonella Enteritidis ISU--j + Salmonella Enteritidis ISU--1f + Salmonella Enteritidis ISU--1i + Salmonella Dublin ISU--1a + Salmonella Enteritidis ISU--i + Salmonella Dublin ISU--1a + Salmonella Enteritidis ISU--f + Salmonella Dublin ISU--1a + Salmonella Enteritidis ISU--e + Salmonella Berta ISU-1-b + Salmonella Enteritidis ISU--1a + Salmonella Berta ISU-1-i + Salmonella Enteritidis ISU--1e + Salmonella Berta ISU-1-j + Salmonella Enteritidis ISU--e + 0 Salmonella Berta ISU-1-f + Salmonella Enteritidis ISU--g + 1 Salmonella Berta ISU-1-1k + 0 Salmonella Enteritidis ISU--1d + Salmonella Javiana ATCC Salmonella Enteritidis ISU--1p + Salmonella Panama Tyson + Salmonella Enteritidis ISU--a + Salmonella Pullorum ATCC + Salmonella Enteritidis ISU--f + Salmonella Pullorum ATCC 1 + Salmonella Enteritidis ISU-1-s + Salmonella,1:nonmotile ISU--a + Salmonella Enteritidis ISU-1-e + Salmonella,1:nonmotile ISU--b + Salmonella Enteritidis ISU-1-p + Salmonella,1:nonmotile ISU--c + Salmonella Enteritidis ISU-1-f + Salmonella,1:nonmotile ISU--1i + Salmonella Enteritidis ISU-1-e + Salmonella,1: poorly motile ISU--"o" + Salmonella Enteritidis ISU-1-g + 0 Salmonella,1: poorly motile ISU--n + 0 Salmonella Enteritidis ISU-1-h + 1 Salmonella,1: poorly motile ISU--1h + 1 Salmonella Enteritidis ISU-1-h + Salmonella,1: poorly motile ISU--1m + Salmonella Enteritidis ISU-1-b + [RapidChek SELECT TM SE AOAC Validation Report] Page 1

17 Test Strip Exclusivity Study 1..1 Methodology Single colony isolates of non-salmonellae as well as non-group D1 Salmonella bacteria were cultured in ml of Tryptic soy broth (TSB) that was incubated at C for h. One (1) ml of the broth culture was transferred to a 1 x mm tube and a test strip inserted into the tube. The test strip was read and interpreted as previously described. 1.. Results The results from the test exclusivity study are shown in Table. Table. Results from the Test Strip Exclusivity Study. Bacteria Strain Number RapidChek Select SE Test Strip Result Salmonella Typhimurium (B) ATCC - Salmonella Heidelberg (B) WVU F - Salmonella Montevideo (C1) ARS - Salmonella Thompson (C1) ARS 1 - Salmonella Hadar (C) ATCC 1 - Salmonella Kentucky (C) ATCC - Salmonella Albany (C) ATCC 10 - Salmonella Maarsen (D) ATCC 1 - Salmonella Muenster (E1) WVU F - Salmonella Illinois (E) ATCC - Salmonella Senftenberg (E) WVU F - Salmonella Abaetetuba (F) ATCC 0 - Salmonella Poona (G1) DSM - Salmonella Cubana (G) ATCC 0 - Salmonella Pomona (M) ATCC - Bacillus subtilis ATCC - Aeromonas veronii ATCC 1 - Citrobacter koseri ATCC 0 - Citrobacter freundii ATCC 00 - Enterobacter cloacae ATCC 0 - Enterobacter aerogenes ATCC - Escherichia coli ATCC 1 - Escherichia coli ATCC 1 - Escherichia hermannii ATCC - Escherichia hermannii ATCC 0 - Klebsiella pneumoniae ATCC 01 - Klebsiella pneumoniae ATCC - Proteus vulgaris ATCC - Proteus mirabilis ATCC 0 - Serratia liquefaciens ATCC - Vibrio parahaemolyticus ATCC 10 - Vibrio parahaemolyticus ATCC 1 - [RapidChek SELECT TM SE AOAC Validation Report] Page 1

18 Thirty-two ( ) non-salmonella Group D1 bacteria from genera were tested in the exclusivity study. This included 1 Salmonella from serogroups other than D1. None of the test strains gave a positive response in the test indicating a specificity of 0%. 1. Test Strip Ruggedness Studies 1..1 Test Strip Read Time Methodology Salmonella Enteritidis ATCC and Salmonella Enteritidis ARS single colony isolates were cultured in ml of RapidChek SELECT TM primary enrichment media for 1- hr at C. Then, 0.1 ml of the primary broth was transferred to 1 ml of RapidChek SELECT TM secondary enrichment media. This was incubated at C for 1- hr. The samples were then diluted into RapidChek SELECT TM secondary media to approximately 1 x CFU/mL (approximately 1 log above the detection limit of the method). Salmonella Kentucky ATCC was grown in non-selective media (TSB) (approximately 1 x CFU/mL). Test strips were placed into replicate samples (), removed from the sample at various time points (,, 0 min) and the test strip was read and interpreted Results The results are shown in Table. Table. Results from the Test Strip Read Time Ruggedness Study. Test Strip Result, # of Positives Read Time, min Test Level, CFU/mL 0 S. Enteritidis ATCC 1 x / / / S. Enteritidis ARS 1 x / / / S. Kentucky ATCC ~1 x (Neat) 0/ 0/ 0/ There were no differences in the number of test strip positives found when test strips were interpreted after, (designated read time), or 0 min in the sample. In addition, there were no false positives found with the non-salmonella Group D1 strain. This suggested that the impact of test strip read time on the test strip result is minimal. 1.. Test Strip Sample Temperature [RapidChek SELECT TM SE AOAC Validation Report] Page 1

19 Methodology 1... Results Salmonella Enteritidis ATCC and Salmonella Enteritidis ARS single colony isolates were cultured in ml of RapidChek SELECT TM primary enrichment media for 1- hr at C. Then, 0.1 ml of the primary broth was transferred to 1 ml of RapidChek SELECT TM secondary enrichment media. This was incubated at C for 1- hr. The samples were then diluted into RapidChek SELECT TM secondary media to approximately 1 x CFU/mL (approximately 1 log above the detection limit of the method). Salmonella Kentucky ATCC was grown in non-selective media (TSB) (approximately 1 x CFU/mL). Replicate () 1 ml aliquots were left at room temperature or placed in an incubator for 1 hr in order to further acclimate the sample at various test temperatures (room temperature (0- C), C, and C). Test strips were placed into the samples while maintained under the various conditions (i.e., in the respective incubator). They were developed for min, removed and interpreted. The results are shown in Table. Table. Results from the Test Strip-Sample Temperature Ruggedness Study. S. Kentucky ATCC ~1 x (Neat) 0/ 0/ 0/ a RT, room temperature, - C Test Strip Sample Volume Methodology Test Strip Result, # of Positives Test Temperature, C Test Level, CFU/mL RT a S. Enteritidis ATCC 1 x / / / S. Enteritidis ARS 1 x / / / There were no differences in the number of test strip positives found when test strips were tested on samples that varied in temperature from room temperature (0- C) to C. In addition, there were no false positives found with the non- Salmonella Group D1 strain. This suggested that the impact of sample temperature on the test strip result is minimal. [RapidChek SELECT TM SE AOAC Validation Report] Page 1

20 Salmonella Enteritidis ATCC and Salmonella Enteritidis ARS single colony isolates were cultured in ml of RapidChek SELECT TM primary enrichment media for 1- hr at C. Then, 0.1 ml of the primary broth was transferred to 1 ml of RapidChek SELECT TM secondary enrichment media. This was incubated at C for 1- hr. The samples were then diluted into RapidChek Select secondary media to approximately 1 x CFU/mL (approximately 1 log above the detection limit of the method). Salmonella Kentucky ATCC was grown in nonselective media (TSB) (approximately 1 x CFU/mL). Replicate () aliquots of each sample type varying in sample volumes (0., 1.0,.0, and. ml) were tested. Test strips were placed into the samples, developed for min, removed and interpreted Results The results are shown in Table. Table. Results from the Test Strip-Sample Volume Ruggedness Study. Test Strip Result, # of Positives Test Volume, ml Test Level, CFU/mL S. Enteritidis ATCC 1 x / / / / S. Enteritidis ARS 1 x / / / / S. Kentucky ATCC ~1 x (Neat) 0/ 0/ 0/ 0/ There were no differences in the number of test strip positives found when test strips were tested on samples varying in sample volume. In addition, there were no false positives found with the non-salmonella Group D1 strain. This suggested that the impact of sample volume on the test strip result is minimal. 1. Test Strip Stability Study 1..1 Methodology Three lots of test strips in their final packaging (0 test strips/desiccant canister) were placed into storage at various temperatures ( C, room temperature (0- C, recommended storage condition), C (accelerated stability), and C (accelerated stability)). At day intervals, 1 test strips from each lot were removed from each storage condition and tested in replicate () with replicate samples () of Salmonella Enteritidis ATCC and Salmonella Enteritidis ARS at 1 x CFU/mL (approximately 1 log above the detection limit of the test strip) in RapidChek Select [RapidChek SELECT TM SE AOAC Validation Report] Page 0

21 secondary media and Salmonella Kentucky ATCC grown in nonselective media (TSB) and tested neat (approximately 1 x CFU/mL). 1.. Results The results from this study are shown in Table. Table. Results of the Accelerated Test Strip Stability Study Temperature, C Room Temperature Lot Time, Test Level, Test Strain weeks CFU/mL / / / / / / / / / / / / / / / / / / / / / / / / / / / Salmonella / / / / / / / / / / / / Enteritidis 1 x / / / / / / / / / / / / ATCC / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / Salmonella / / / / / / / / / / / / Enteritidis 1 x / / / / / / / / / / / / ARS / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /0 0/0 0/ /0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 Salmonella 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 1 x Kentucky 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 (Neat) ATCC 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 There were no differences in test strip results for up to weeks (compared to week 0) for any of the storage conditions. This demonstrated that the test strip was very stable under accelerated stability conditions (up to C). 1. Immunomagnetic Separation (IMS) Reagent Inclusivity Study 1..1 Methodology Single colony isolates of various Group D1 Salmonella were cultured in ml of RapidChek SELECT TM primary enrichment media for 1- hr at C. Then, 0.1 ml of the primary broth was transferred to 1 ml of RapidChek SELECT TM secondary enrichment media. This was incubated at C for 1- hr. Following enrichment, 1 ml of the enriched sample was subjected to IMS as described in Section The samples ( µl) were struck to BGN and XLT plates. The plates were incubated at ± C for 1- h at which time 1 typical colony was picked for confirmation. Typical colonies were transferred to TSI and LSI slants and incubated at C for h. The positive TSI slant was subjected to slide agglutination serology testing for Salmonella Group D1. [RapidChek SELECT TM SE AOAC Validation Report] Page 1

22 Results The results of this study are shown in Table. Eighty-two () Salmonella Group D1 strains including SE strains were grown in the RapidChek Select Salmonella media and tested with the IMS method followed by independent serological colony confirmation. All of the Salmonella Group D1 strains gave a positive result with the IMS confirmation procedure. 1. Immunomagnetic Separation (IMS) Reagent Exclusivity Study 1..1 Methodology Single colony isolates of non-salmonellae as well as non-group D1 Salmonella bacteria were cultured in ml of Tryptic soy broth (TSB) incubated at C for h. Following enrichment, 1 ml of the enriched sample was subjected to IMS as described in Section The samples ( µl) were struck to BGN and XLT plates. The plates were incubated at ± C for 1- h at which time 1 typical colony was picked for confirmation. Typical colonies were transferred to TSI and LSI slants and incubated at C for h. The positive TSI slant was subjected to slide agglutination serology testing for Salmonella Group D Results The results of this study are shown in Table. [RapidChek SELECT TM SE AOAC Validation Report] Page

23 Table. Results from the Immunomagnetic Separation (IMS) Method Inclusivity Study. RapidChek Confirm SE IMS Result Sample Number Serovar Strain Number RapidChek Confirm SE IMS Result Sample Number Serovar Strain Number 1 Salmonella Enteritidis ARS + Salmonella Enteritidis ISU-1-h + Salmonella Enteritidis ARS 1 + Salmonella Enteritidis ISU-1-d + Salmonella Enteritidis M1 BGA 1- + Salmonella Enteritidis ISU-1-n + Salmonella Enteritidis Tyson + Salmonella Enteritidis ISU-1-f + Salmonella Enteritidis ATCC + Salmonella Enteritidis ISU-1-g + Salmonella Enteritidis ATCC 1 + Salmonella Enteritidis ISU-1-g + Salmonella Enteritidis var. Jena ATCC 1 + Salmonella Enteritidis ISU-0-1i + Salmonella Enteritidis var. Jena ATCC + 0 Salmonella Enteritidis ISU-0-m + Salmonella Enteritidis var. Jena ATCC + 1 Salmonella Enteritidis ISU-0-n + Salmonella Enteritidis var. Essen ATCC 1 + Salmonella Enteritidis ISU-0-p + Salmonella Enteritidis var. Essen ATCC 1 + Salmonella Enteritidis ISU-0-q + 1 Salmonella Enteritidis var. Essen ATCC 0 + Salmonella Enteritidis ISU-0-r + 1 Salmonella Enteritidis var. Danysz ATCC 1 + Salmonella Enteritidis ISU-1-f + 1 Salmonella Enteritidis var. Chaco ATCC 1 + Salmonella Enteritidis ISU--a + 1 Salmonella Enteritidis var. Chaco ATCC 1 + Salmonella Enteritidis ISU--b + 1 Salmonella Enteritidis ISU-1-P + Salmonella Enteritidis ISU--e + 1 Salmonella Enteritidis ISU-1-K + Salmonella Enteritidis ISU--h + 1 Salmonella Enteritidis ISU-1-J + 0 Salmonella Enteritidis ISU--a + 1 Salmonella Enteritidis ISU-1-s + 1 Salmonella Enteritidis ISU--b + 0 Salmonella Enteritidis ISU-1-t + Salmonella Enteritidis ISU--c + 1 Salmonella Enteritidis ISU--j + Salmonella Enteritidis ISU--1f + Salmonella Enteritidis ISU--1i + Salmonella Dublin ISU--1a + Salmonella Enteritidis ISU--i + Salmonella Dublin ISU--1a + Salmonella Enteritidis ISU--f + Salmonella Dublin ISU--1a + Salmonella Enteritidis ISU--e + Salmonella Berta ISU-1-b + Salmonella Enteritidis ISU--1a + Salmonella Berta ISU-1-i + Salmonella Enteritidis ISU--1e + Salmonella Berta ISU-1-j + Salmonella Enteritidis ISU--e + 0 Salmonella Berta ISU-1-f + Salmonella Enteritidis ISU--g + 1 Salmonella Berta ISU-1-1k + 0 Salmonella Enteritidis ISU--1d + Salmonella Javiana ATCC Salmonella Enteritidis ISU--1p + Salmonella Panama Tyson + Salmonella Enteritidis ISU--a + Salmonella Pullorum ATCC + Salmonella Enteritidis ISU--f + Salmonella Pullorum ATCC 1 + Salmonella Enteritidis ISU-1-s + Salmonella,1:nonmotile ISU--a + Salmonella Enteritidis ISU-1-e + Salmonella,1:nonmotile ISU--b + Salmonella Enteritidis ISU-1-p + Salmonella,1:nonmotile ISU--c + Salmonella Enteritidis ISU-1-f + Salmonella,1:nonmotile ISU--1i + Salmonella Enteritidis ISU-1-e + Salmonella,1: poorly motile ISU--"o" + Salmonella Enteritidis ISU-1-g + 0 Salmonella,1: poorly motile ISU--n + 0 Salmonella Enteritidis ISU-1-h + 1 Salmonella,1: poorly motile ISU--1h + 1 Salmonella Enteritidis ISU-1-h + Salmonella,1: poorly motile ISU--1m + Salmonella Enteritidis ISU-1-b + [RapidChek SELECT TM SE AOAC Validation Report] Page

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