Soleris® Automated System for the Rapid Detection of Burkholderia cepacia Complex in Cosmetic Products.

BACKGROUND: Burkholderia cepacia complex (Bcc) has emerged as an important opportunistic pathogen with rising concern in pharmaceuticals and cosmetic products. The Bcc supplement (S2-BCC-S) was purposely developed and used with the Pseudomonas vial (PD-109) for the detection of Bcc through the Soleris® Next Generation automated instrument system. OBJECTIVE: This study aimed to evaluate the performance of the Soleris Bcc testing method for cosmetic products. METHOD: Inclusivity and exclusivity were assessed with the Soleris Bcc method and the United States Pharmacopeia (USP) method in three enrichment broths. Matrix testing was conducted using 28 cosmetic products to compare the equivalency of the Soleris Bcc method to that of the USP reference method. Repeatability of the Soleris Bcc assay, method robustness, product stability, and lot-to-lot consistency of the Soleris reagents were also assessed. RESULTS: Both the Soleris Bcc and the USP methods supported the growth of all 26 inclusivity strains, except the USP method missed one inclusivity strain in one broth. For exclusivity, 0-6% was presumptive positive with the Soleris Bcc method, and 42-48% was presumptive positive with the reference method. Kappa index was 0.96 for the matrix testing, indicating a good agreement between the Soleris Bcc assay and the reference method for testing Bcc in cosmetics. Repeatability results showed the coefficient of variation was less than 4%. The robustness and ruggedness study yielded detection times within 1 h differences when small variations were introduced. The lot-to-lot study showed consistent results among four lots of the Bcc reagents. CONCLUSIONS: The automated Soleris method was successfully demonstrated to be robust, sensitive, and specific for Bcc detection in cosmetic products. HIGHLIGHTS: The Soleris Bcc method is user-friendly. It shows the results in real time and generates the report automatically. Implementation of this method for detection of Bcc in cosmetics would save significant time and resources.

Validation of the Soleris® Coliform Method for Detection of Coliform Bacteria in Dried Cannabis Flower: AOAC Performance Tested MethodSM 010302.

BACKGROUND: The Soleris® Coliform Vial is a growth-based, automated method for detection of coliform bacteria in foods and other consumer products such as nutraceuticals and cosmetics. The method was granted AOAC Performance Tested MethodSM certification for select foods after successful completion of a validation study. OBJECTIVE: The objective of the current study was to validate the Soleris coliform method for use with dried cannabis flower (>0.3% delta 9-tetrahydrocannabinol). METHODS: A comparative matrix study was performed in which naturally contaminated dried cannabis flower was tested with the Soleris coliform method and with the U.S. Food and Drug Administration Bacteriological Analytical Manual solid medium method. Multiple lots of dried cannabis flower were obtained, pre-screened for coliforms, and blended to produce test materials at four different contamination levels ranging from 4.5 to 1600 CFU/g. Each material was tested at three different Soleris detection threshold levels determined by the dilution used to inoculate the Soleris vials. Probability of detection analysis was performed to determine if differences in the number of positive results obtained with the two methods were significant. RESULTS: For all four dried cannabis flower materials, at all three Soleris test thresholds, there were no significant differences in the number of positive results obtained with the Soleris and cultural plating methods as determined by probability of detection analysis at P < 0.05. CONCLUSION: The Soleris coliform test is an accurate method for detection of coliform bacteria in dried cannabis flower. HIGHLIGHTS: The Soleris coliform method provides cannabis industry QC personnel with an effective method for analysis of dried cannabis flower and produces results in 18-24 h.

Validation of the Soleris® NF-TVC Method for Detection of Aerobic, Mesophilic Microorganisms in Dried Cannabis Flower: AOAC Performance Tested MethodSM 071203.

BACKGROUND: Soleris® Non-Fermenting Total Viable Count (NF-TVC) is a growth-based, automated method for semiquantitative detection of aerobic, mesophilic microorganisms in foods and other consumer products such as nutraceuticals and cosmetics. The method was granted AOAC Performance Tested MethodSM status for select foods after successful completion of a validation study. OBJECTIVE: The objective of the current study was to validate the Soleris NF-TVC method for use with dried cannabis flower [>0.3% delta 9-tetrahydrocannabinol (THC)]. METHODS: The validation consisted of a comparative matrix study in which naturally contaminated dried cannabis flower was tested with the Soleris NF-TVC method and with the AOAC Official Methods of AnalysisSM  966.23 dilution plating method. Multiple lots of dried cannabis flower were obtained, pre-screened for total aerobic, mesophilic viable count levels, and blended to produce test materials at four different levels of contamination ranging from 1.0 × 103 to 2.2 × 105 CFU/g. Each material was tested at three different Soleris detection threshold levels determined by the dilution used to inoculate the Soleris vials. Probability of detection analysis was performed to determine if differences in the number of positive results obtained with the two methods were significant. RESULTS: For all four dried cannabis flower materials, at all three Soleris test thresholds, there were no significant differences in performance comparing the Soleris and reference dilution plating methods as determined by probability of detection analysis at P < 0.05. CONCLUSIONS: It is concluded that the Soleris NF-TVC method is an accurate and effective method for detection of aerobic, mesophilic microorganisms in dried cannabis flower. HIGHLIGHTS: The Soleris NF-TVC method provides cannabis industry quality control personnel with an effective method for analysis of dried cannabis flower and produces results in 24-48 h.

Validation of the Soleris®Enterobacteriaceae Method for Detection of Enterobacteriaceae in Dried Cannabis Flower: AOAC Performance Tested MethodSM 121901.

BACKGROUND: The Soleris®Enterobacteriaceae vial is a growth-based, automated method for detection of bacteria of the family Enterobacteriaceae in foods and other sample types including nutraceuticals and cosmetics. The Soleris method is used in a "dilute-to-specification" or threshold manner, in which a result is scored as positive or negative around a predetermined cutoff (in CFU/g) established by the dilution and volume of sample homogenate tested. The Soleris method was granted AOAC Performance Tested MethodSM (PTM) status for select foods after successful completion of a validation study (PTM 121901). OBJECTIVE: The objective of this study was to validate the method for the detection of Enterobacteriaceae in dried cannabis flower [>0.3% delta-9-tetrahydrocannabinol (THC)]. METHODS: The matrix study included comparison of Soleris method presumptive results to confirmation from the Soleris vials, and comparison of the Soleris confirmed results to those of the ISO 21528-2:2017 colony count method. Test materials at four different levels of contamination ranging from 7.8 to 3500 CFU/g were tested at three dilutions, corresponding to test thresholds. RESULTS: Probability of detection analysis at P < 0.05 showed there were no significant differences between Soleris presumptive and confirmed results, and no significant differences between Soleris confirmed and ISO 21528-2:2017 results. CONCLUSION: The results provided evidence that the Soleris Enterobacteriaceae test is an accurate method for detection of Enterobacteriaceae in dried cannabis flower. HIGHLIGHTS: The Soleris Enterobacteriaceae method provides cannabis industry QC personnel with an effective method for analysis of dried cannabis flower and produces results in 20-24 h.

Emergency Response Validation of the Soleris® Direct Yeast and Mold Method for Detection of Yeast and Mold in Dried Cannabis Flower: AOAC Performance Tested MethodSM 051301.

BACKGROUND: Soleris® Direct Yeast and Mold (DYM) is a growth-based, automated method for detection of yeast and mold in select foods and other sample types including nutraceuticals and cosmetics. The Soleris method is used in a "dilute-to-specification" or threshold manner in which a result is scored as positive or negative around a predetermined cutoff (in CFU/g) established by the dilution and volume of sample homogenate tested. OBJECTIVE: The objective of this study was to validate the method for testing of dried cannabis flower. The validation was conducted under the Emergency Response Validation program of the AOAC Research Institute. METHOD: The study included inclusivity and exclusivity testing, in particular testing of yeast and mold species associated with cannabis, and a matrix study in which Soleris method presumptive results were compared with Soleris confirmed results using Dichloran Rose-Bengal Chloramphenicol (DRBC) agar for confirmation. Samples at four different levels of natural yeast and mold contamination were tested at two test thresholds. RESULTS: In inclusivity testing, all 63 yeast and mold strains tested produced positive results within the specified test duration of 72 h. In exclusivity testing, 36 of 37 strains tested produced no detection within 72 h. In matrix testing, there were no significant differences between Soleris presumptive and confirmed results for any contamination level or test threshold as determined by probability of detection analysis. CONCLUSIONS: Results indicate that the Soleris method is an effective procedure for detection of yeast and mold in dried cannabis flower. HIGHLIGHTS: With the Soleris method, results are available within 72 h compared with the 5-7 days required for microbiological culture methods.

Validation of Modifications to the Soleris®E. coli Method for Detection and Threshold Determination of Escherichia coli in Select Foods: Level 3 Modification to AOAC Performance Tested MethodSM 101101.

BACKGROUND: Soleris®E. coli is an automated, growth-based method for detection and semi-quantitative determination of Escherichia coli in foods. The method can be used in dilute-to-specification (threshold) or presence/absence modes. OBJECTIVE: The objective of the study was to validate four modifications to the method: (1) a change in the vial detection window plug composition from agar to agarose to improve plug consistency and robustness, (2) a change in pre-enrichment incubation time for presence/absence testing from 6 h to 18-24 h, (3) a change in vial incubation temperature from 44.5 to 43.5°C, and (4) incorporation of a simple direct-from-vial confirmation test as an alternative to traditional procedures. METHODS: Elements of the study included inclusivity/exclusivity testing, matrix testing in comparison to the ISO 7251:2005 reference method, reagent stability/lot-to-lot consistency testing, and an independent laboratory study. RESULTS: In inclusivity testing, all 55 Escherichia coli strains tested produced positive results. In exclusivity testing, 30 of 31 strains of other bacterial species produced negative results, the sole exception being a strain of Enterobacter cloacae. In internal and independent laboratory matrix testing of mozzarella cheese, condensed milk, pasteurized liquid egg, and frozen green beans, results showed no significant differences in performance of the Soleris and reference methods with two exceptions, one in which the Soleris method produced more positive results, and one in which the reference method produced more positive results. CONCLUSION: Performance characteristics of the modified Soleris E. coli method are consistent with those of the original validated method. HIGHLIGHTS: The Soleris E. coli method offers improvements in ease of use and reagent robustness.

Soleris®Enterobacteriaceae for the Detection of Enterobacteriaceae in Select Foods: AOAC Performance Tested MethodSM 121901.

BACKGROUND: Soleris®Enterobacteriaceae is a growth-based, automated method for detection of Enterobacteriaceae in food. OBJECTIVE: A study was conducted to validate the Soleris method for detection of Enterobacteriaceae in select foods (pasteurized milk, yogurt, mozzarella cheese, ice cream, dried milk, pasteurized liquid egg, frozen cooked chicken, deli ham, lettuce, and dry dog food) at a threshold of ≥ 10 CFU/g of product. METHODS: Inclusivity and exclusivity of the Soleris method were assessed by testing 55 and 38 target and non-target bacterial strains, respectively. Matrix testing was performed with one naturally contaminated and nine inoculated foods. Efficacy of the Soleris method was compared to that of the ISO 21528-2:2017 direct plating reference method using probability of detection analysis. Independent laboratory testing was conducted to verify method performance in two matrixes (yogurt and deli ham). Method robustness, stability, and lot-to-lot consistency of the Soleris reagents were also assessed. RESULTS: Inclusivity of the Soleris test was 91% and exclusivity was 100%. In matrix testing, there were no significant differences in the number of positive results obtained with the Soleris and reference methods for any of the matrixes examined. Overall, of 370 test portions, there were 176 positive results by the Soleris method and 177 positive results by the reference procedure. CONCLUSIONS: Soleris Enterobacteriaceae is an effective method for detection of Enterobacteriaceae in the foods evaluated, with performance equivalent to that of the ISO 21528-2:2017 reference method. HIGHLIGHTS: The Soleris method offers the advantages of labor savings and results within 18 h.

Rapid Automated System for the Detection of Objectionable Microorganisms in Nutraceutical and Dietary Supplements.

BACKGROUND: The U.S. Pharmacopeia (USP) established microbiological procedures to evaluate nonsterile products and nutritional and dietary supplements for objectionable microorganisms of concern in the industry. A rapid method has been developed to detect the presence of microorganisms based on real-time photometric monitoring of pH, carbon dioxide, or fluorescence indicators within a novel broth/agar combination vial and accompanying reader. OBJECTIVE: To validate the performance of the Neogen Rapid Microbiology System (NRMS) method against the USP reference method for the ability to detect presence or the absence of Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa in nutraceutical and dietary supplements. METHODS: Over 200 samples were evaluated for the presence of objectionable microorganisms. For each specified microorganism, a minimum of 23 matrices were tested uninoculated and with a low-level inoculum of <1-27.4 CFU/g, as paired samples, by NRMS and USP methods. RESULTS: In the four objectionable microorganism categories evaluated, 100% inclusivity, 97-100% exclusivity, 97-100% positive predictivity, 100% negative predictivity, and Kappa Indices of 0.97-1.0 were achieved following ISO 5725-6:1994 standards. CONCLUSIONS: The validation study demonstrates that NRMS is a rapid and effective method to detect objectionable microorganisms in a variety of nutraceutical and dietary supplements. HIGHLIGHTS: A novel method was validated against the relevant USP reference method for the detection of Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa in nutraceutical and dietary supplements. NRMS provided results statistically comparable to the USP reference method within 22 h following primary enrichment compared with 5-7 days by the reference method.

Semiquantitative determination of mesophilic, aerobic microorganisms in cocoa products using the Soleris NF-TVC method.

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.

Validation of the Soleris NF-TVC method for determination of total viable count in a variety of foods.

A study was conducted to determine the efficacy of the Soleris Non-fermenting-Total Viable Count (NF-TVC) automated growth-based method for semiquantitative detection of mesophilic, aerobic microorganisms in a variety of food products. A probability of detection (POD) statistical model was used to compare Soleris results at multiple test thresholds (dilutions) with aerobic plate counts determined using reference dilution plating procedures. Nine naturally contaminated food products were tested, with Soleris testing performed at three or four threshold levels for each food. Using the POD model, all Soleris test results were in statistical agreement with the reference plating procedures with the exception of a single threshold level in two trials with black pepper, and a single threshold level in the independent laboratory trial with cheesecake. Results of ruggedness testing showed that the Soleris method produced accurate results even when minor variances in operating parameters, including sample volume and incubation temperature, were introduced. Results of the internal and independent laboratory validation studies showed that the Soleris NF-TVC method can be used as an accurate alternative to conventional dilution plating procedures for evaluation of microbial counts at threshold levels, while saving 24 h or more in analysis time.