Journal of AOAC International最新文献

{"title":"Utility of N-Bromosuccinimide-Water Combination as a Green Reagents for a Validated Indirect Spectrophotometric Determination of Some Antihypertensive Drugs: An Application to Their Monitoring in Marketed Tablets and Capsules.","authors":"Marwa I Helmy, Christine K Nessim","doi":"10.1093/jaoacint/qsad130","DOIUrl":"10.1093/jaoacint/qsad130","url":null,"abstract":"<p><strong>Background: </strong>Analytical tests were conducted to investigate the use of N-bromosuccinimide (NBS) as an important, safe analytical reagent for the spectrophotometric detection of therapeutically significant dihydropyridine-based calcium antagonists (DHP), namely nifedipine (NIF) and amlodipine (AML), which have been demonstrated to possess antioxidant activity in vivo and to reduce the intracellular production of reactive oxygen species (ROS). Following the reaction of DHP and NBS in acidic media, the excess NBS was evaluated for the first time by its interaction with P-aminophenol (PAP), which produced a violet-colored product that was detected at 556 nm.</p><p><strong>Objective: </strong>The analytical method was performed and validated since different variables disturbing the reaction (concentration of reagent, type and concentration of the selected acid, reaction time and the diluting solvents) were carefully studied and optimized.</p><p><strong>Methods: </strong>The stoichiometry of the applied reaction was determined by Job's method of continuous variation. Monitoring of these drug dosage forms' content uniformity is a first tool or evidence for their efficacy and safety after their administration.</p><p><strong>Results: </strong>Beer's law was obeyed in the concentration range 1.25-11.0 µg/mL for NIF and 1.25-10.0 µg/mL for AML. The calculated limit of detection (LODs) and limit of quantification (LOQs) for NIF and AML were 0.220, 0.155 µg/mL and 0.519, 0.735 µg/mL, respectively. The precision of the applied method was satisfactory; the RSDs did not exceed 2%. Two greenness assessment tools, the Green Analytical Procedure Index (GAPI) and Analytical Greenness Metric for Sample Preparation (AGREEprep) were used for measuring the environmental friendliness of the recommended method.</p><p><strong>Conclusion: </strong>The micro-determinations of content uniformity for NIF and AML in their pharmaceutical dosage forms were extremely comparable with those from official and validated procedures.</p><p><strong>Highlights: </strong>A validated indirect spectrophotometric method for accurate quantification of some 1,4-dihydropyridine drugs using NBS with the aid of PAP. Monitoring of NIF and AML dosage forms' content uniformity as a first tool or evidence for their efficacy and safety after their administration. Greenness evaluation tools, GAPI and AGREEprep, for measuring the environmental friendliness of the recommended method.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"226-233"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138471398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reverse Flow Injection Spectrophotometric Determination of Total Acidity in Beverages Using Butterfly Pea Flower Extract.","authors":"Patpitcha Deecharoenchaiyakul, Napa Tangtreamjitmun","doi":"10.1093/jaoacint/qsad126","DOIUrl":"10.1093/jaoacint/qsad126","url":null,"abstract":"<p><strong>Background: </strong>Monitoring total acidity during beverage production is crucial for quality control (QC). The standard acid-base titration, though widely used, is slow and generates hazardous waste through the use of acid-base indicators.</p><p><strong>Objective: </strong>To develop an analysis method for beverage samples to determine total acidity using a natural reagent from butterfly pea flower as the colorimetric reagent.</p><p><strong>Methods: </strong>The determination of total acidity in beverages was based on the reaction of citric acid with anthocyanin extracted from butterfly pea flowers. The decreased absorbance of anthocyanin was measured at 620 nm. A two-line reverse flow injection manifold was used to perform online dilution of samples.</p><p><strong>Results: </strong>Under optimal conditions, the calibration curve equation 1/A = 0.03782C + 0.00241 (A = absorbance and C = concentration) was linear over a range of 0.050-0.25% (w/v) citric acid. The LOD and LOQ were 0.0123 and 0.0409% (w/v), respectively. The system achieved a throughput of 120 samples per hour with comparable accuracy and precision to the standard titrimetric method.</p><p><strong>Conclusion: </strong>The injection of butterfly pea flower extract into beverage samples with online dilution in a reverse flow injection system (FIS) was reported for the first time for the determination of total acidity.</p><p><strong>Highlights: </strong>Use of a green reagent in the method reflects its alignment with the principles of green analytical chemistry, providing a rapid and straightforward solution.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"260-266"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89721396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bitter-Pungent Flavor Identification Based on Ingredient Information Similarity of Chinese Herbal Medicines.","authors":"Guohui Wei, Min Qiu, Chune Li, Xiaoyan Wang, Xianjun Fu","doi":"10.1093/jaoacint/qsad125","DOIUrl":"10.1093/jaoacint/qsad125","url":null,"abstract":"<p><strong>Background: </strong>The flavor theory of Chinese herbal medicines (CHMs) is one of the core theories of traditional Chinese medicine (TCM). Accurate flavor identification of CHMs is essential to guide the clinical application of CHMs.</p><p><strong>Objective: </strong>To develop a new method for flavor identification of CHMs according to the ingredient information for CHMs.</p><p><strong>Methods: </strong>It was found that the chemical basis of medicinal flavors was CHM ingredients. We developed a bitter-pungent flavor identification scheme to build a relationship between medicinal flavors and CHM ingredients. We firstly proposed a scientific hypothesis that \"CHMs with similar flavors should have a similar chemical basis\". To test this scientific hypothesis, we then explored an intelligent algorithm for bitter-pungent flavor identification of CHMs based on the information similarity of CHM ingredients. GC was used to separate the chemical ingredients of CHMs and analyze the ingredient information of CHMs. A distance metric learning algorithm was built to measure the similarity of GC chemical fingerprints. A bitter-pungent flavor identification scheme (BPFI) was proposed to predict the bitter-pungent flavor of CHMs. Finally, a number of experiments were performed to evaluate the identification performance of our scheme.</p><p><strong>Results: </strong>Compared to classical algorithms, our proposed BPFI scheme has better flavor prediction performance. The total identification accuracy of our BPFI scheme reached 0.843. The area under ROC (receiver operating characteristic curve) curve (AUC) was 0.899.</p><p><strong>Conclusion: </strong>The experimental results confirmed our inference that the chemical basis of CHM flavors was CHM ingredients, and implied that CHMs with similar flavors had similar composition. The BPFI model proved to be effective and feasible.</p><p><strong>Highlights: </strong>Verification hypothesis: CHMs with similar flavors should have similar chemical basis.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"354-361"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89721395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to: Determination of Lactose in Lactose-Free and Low-Lactose Milk, Milk Products, and Products Containing Dairy Ingredients by the LactoSens®R Amperometry Method: Final Action 2020.01.","authors":"","doi":"10.1093/jaoacint/qsae006","DOIUrl":"10.1093/jaoacint/qsae006","url":null,"abstract":"","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"375"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139547570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Single-Laboratory Validation of a UPLC Method for Determination of Folic Acid in Various Dietary Supplement Dosage Forms.","authors":"Lusi A, Mina Fakhary, Niloufar Rahimi Gaeini, Jennifer M Solano, Mohamed Koroma","doi":"10.1093/jaoacint/qsad128","DOIUrl":"10.1093/jaoacint/qsad128","url":null,"abstract":"<p><strong>Background: </strong>Folic acid is an essential nutrient necessary for the synthesis of nucleic acids (DNA and RNA) and certain amino acids. There are no scientifically validated analytical methods for folic acid applicable to all dosage forms.</p><p><strong>Objective: </strong>A single-laboratory method was validated for the determination of folic acid content in various dietary supplement dosage forms. This method used ultra-performance liquid chromatography/diode-array detector (UPLC/PDA) to determine the folic acid content in dietary supplements in the form of tablets, two-piece capsules, powder drinks, softgels, and gummies.</p><p><strong>Method: </strong>The ultra-performance liquid chromatography/diode-array detector method was evaluated for linearity, limit of detection (LOD), limit of quantification (LOQ), repeatability, recovery, specificity, and system suitability.</p><p><strong>Results: </strong>Linearity of the folic acid standard was shown to be linear in the range of 0.45 µg/mL to 7.37 µg/mL. LOD and LOQ of folic acid were 0.089 and 0.268 µg/mL, respectively. The repeatability of nine samples from five matrixes resulted in 1.15-4.82% relative standard deviation (RSD). Five samples with five different matrixes spiked with 25, 50, and 100% of working standard concentration and had a recovery range of 95.48-104.72%. The chromatograms and spectra of the blank, standard, and sample solutions showed that the method was free of interference for folic acid. The system suitability results of different matrixes showed that the UPLC/PDA system is suitable for folic acid analysis. All the AOAC INTERNATIONAL SMPR® 2022.002 requirements were fulfilled.</p><p><strong>Conclusions: </strong>The ultra-performance liquid chromatography/diode-array detector method compares favorably with the requirements of AOAC SMPR 2022.002.</p><p><strong>Highlights: </strong>The UPLC/PDA method is fast and suitable for all dietary supplement matrixes studied. The method meets the requirements of SMPR 2022.002.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"277-285"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138471373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chloroplast Genome Sequences and Phylogenetic Analysis of Eight Newly Sequenced Caryophyllaceae Species.","authors":"Rongpeng Liu, Zejing Mu, Xiaolang Du, Guoyue Zhong, Xiaoyun Wang","doi":"10.1093/jaoacint/qsad129","DOIUrl":"10.1093/jaoacint/qsad129","url":null,"abstract":"<p><strong>Background: </strong>Caryophyllaceae is a big family composed of many economic and medicinal species. However, the phylogeny of the family is insufficient and genome data are lacking for many species.</p><p><strong>Objective: </strong>Using next-generation sequencing (NGS) to acquire the chloroplast (cp) genomes of Eremogone acicularis (F.N.Williams) Ikonn., E. brevipetala (Tsui & L.H.Zhou) Sadeghian & Zarre, E. bryophylla (Fernald) Pusalkar & D.K.Singh, E. kansuensis (Maxim.) Dillenb. & Kadereit, Shivparvatia glanduligera (Edgew.) Pusalkar & D.K.Singh, Silene atsaensis (Marq.) Bocquet, S. caespitella Williams, and S. lhassana (Williams) Majumdar.</p><p><strong>Methods: </strong>Bioinformatic software was used to conduct the comparative genome and phylogeny analysis of these cp genomes.</p><p><strong>Results: </strong>The eight cp genomes were 132 188-151 919 bp in length, containing 130-132 genes. A/T was dominant in simple sequence repeats (SSRs). Forward repeats and palindromic repeats were the most frequent in long terminal repeats (LTRs). Compared with the four species of Eremogone Fenzl, the inverted repeat (IR) boundaries of S. caespitella, S. atsaensis, S. lhassana, and Sh. glanduligera were significantly expanded. Four and one mutational hotspots were identified in the large single copy (LSC) region and small single copy (SSC) region, respectively. The ratio of nonsynonymous substitution to synonymous substitution (Ka/Ks ratio) showed these cp genomes may have undergone strong purifying selection. In the phylogenetic trees, both Silene L. and Eremogone were monophyletic groups. However, Sh. glanduligera was closely related to Amaranthus hypochondriacus.</p><p><strong>Conclusion: </strong>These results have provided new evidence and useful information for species identification, evolution, and genetic research on the Caryophyllaceae.</p><p><strong>Highlights: </strong>In this study, eight newly sequenced cp genomes of Caryophyllaceae species were reported for the first time.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"345-353"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138471374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Innovative UV Protocols Based on Straightforward Mathematical Filtration for Concurrent Estimation of Two Antidiabetic Drugs in Their Brand-New Combination: A Comparative Study.","authors":"Israa M Nour, Ahmed R Mohamed, Mohamed Badrawy","doi":"10.1093/jaoacint/qsad123","DOIUrl":"10.1093/jaoacint/qsad123","url":null,"abstract":"<p><strong>Background: </strong>In 2019, the U.S. Food and Drug Administration approved a brand-new combination of linagliptin and empagliflozin in a formulation called Glyxambi® tablets for managing type 2 diabetes mellitus. Nowadays, spectrophotometric techniques occupy the first place among their peers in terms of ease of application, friendliness to the environment, and low costs.</p><p><strong>Objective: </strong>This research discusses the development of two very simple spectrophotometric protocols based on zero-order spectra for the determination of linagliptin and empagliflozin.</p><p><strong>Methods: </strong>The developed protocols were the induced dual-wavelength and absorption correction protocols. Linagliptin could be determined directly at 305 nm, at which the empagliflozin spectrum was zero-crossing. Empagliflozin was determined using the two developed protocols. The induced dual-wavelength technique was developed by calculating the equality factor of linagliptin to cancel its interference. The absorption correction technique was developed by measuring the correction absorption factor.</p><p><strong>Results: </strong>The concentration ranges of linagliptin and empagliflozin were 1-10 µg/mL and 3-30 µg/mL, respectively. Excellent recovery results were found in bulk, dosage form, and synthetic mixtures. Low LOD and LOQ values were obtained, indicating the high sensitivity of the protocols. The statistical Student's t-test was performed to compare the results of the applied and reported protocols, indicating no difference between them.</p><p><strong>Conclusion: </strong>The proposed protocols have the advantages of being straightforward, affordable, and requiring no sophisticated manipulations, just simple mathematical calculations. The proposed protocols are acceptable for routine usage in QC laboratories and in future research applications.</p><p><strong>Highlights: </strong>Two novel univariate methods were developed for quantitative analysis of linagliptin and empagliflozin in their pharmaceutical and laboratory mixtures, and produced satisfactory results.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"40-45"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41224067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determination of Cannabinoids in Cannabis sativa Oil and Infused Ice Cream by LC-DAD Method.","authors":"Jefree J Raslan-Jaramillo, Gisela A Ríos-Gajardo, Marcia A Avello, Marta G de Diego","doi":"10.1093/jaoacint/qsad122","DOIUrl":"10.1093/jaoacint/qsad122","url":null,"abstract":"<p><strong>Background: </strong>Cannabis sativa is known to produce a class of terpenophenolic compounds named cannabinoids. The two main ones are cannabidiol (CBD) and tetrahydrocannabinol (THC), which have therapeutic properties. In the development of cannabis-based preparations, it is important to have suitable analytical methods for the analysis of the principal cannabinoids.</p><p><strong>Objective: </strong>This study aimed to develop and validate a simple and rapid HPLC method with photodiode array detection for determination of CBD and THC in Cannabis sativa oil extract and infused ice cream, including a stability study.</p><p><strong>Method: </strong>Chromatographic separation of CBD and THC was performed with a C18 column, with a mobile phase consisting of acetonitrile and water with formic acid (80 + 20 v/v) in isocratic elution mode, with detection at 208 nm for CBD and 280 nm for THC and 1.0 mL/min flow rate.</p><p><strong>Results: </strong>The method was linear over a range of 1-5 µg/mL for CBD, and 20-100 µg/mL for THC; the relative standard deviation was <3.6%, the recovery ranged between 98.8 and 102.5% for oil and between 84 and 94% for ice cream, QL was 0.33 µg/mL for CBD and 2.30 µg/mL for THC, and the assay demonstrated adequate selectivity. CBD and THC were stable for at least 28 days under light protection at 22°C, 4°C, and -20°C in the oil and for at least 60 days at -20°C in the ice cream.</p><p><strong>Conclusions: </strong>The results showed that the method was suitable for quantitative determination of CBD and THC in Cannabis sativa oil extract and infused ice cream, and it is useful for quality control purposes.</p><p><strong>Highlights: </strong>The method is simple and fast, and it is useful for the quality control of a new product corresponding to an ice cream based on a Cannabis sativa oil extract.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"140-145"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41224056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantification of Drospirenone- and Ethinyl Estradiol-Related Impurities in a Combined Pharmaceutical Dosage Form by a Chromatography Method With a QbD Robustness Study.","authors":"Srinivasa Reddy Chinta, Vaishnavi Chintala, Vishnu Nandimalla, Rajyalakshmi Ch, Sasikiran Goud Ediga, Leela Prasad Kowtharapu, Naresh Kumar Katari","doi":"10.1093/jaoacint/qsad118","DOIUrl":"10.1093/jaoacint/qsad118","url":null,"abstract":"<p><strong>Background: </strong>The estimation of drugs containing drospirenone (DRSP) and ethinyl estradiol (EE), and their related impurities, in low-dose oral contraceptive drug products is an extremely challenging target. The proposed research sought to develop and validate a stability-indicating method for quantifying drug substances and their related impurities in tablet formulation.</p><p><strong>Objective: </strong>To develop and validate a simple, specific, accurate, precise, and stability-indicating reverse-phase (RP)-HPLC method for quantification of DRSP, EE, and their impurities in accordance with International Conference on Harmonisation (ICH) guidelines.</p><p><strong>Method: </strong>The separation was achieved using an Agilent Zorbax SB C18 column (4.6 mm × 250 mm, 5 µm) with a detection wavelength of 215 nm and mobile phases A (100% acetonitrile) and B (acetonitrile-water, 1 + 3, v/v) at a flow rate of 1.3 mL/min and a column temperature of 40°C.</p><p><strong>Results: </strong>The recovery study of each impurity was conducted in the range of 24 to 72 µg/mL for DRSP-related impurities and 0.2 to 0.6 µg/mL for EE-related impurities with respect to the specification limit. A linearity study was conducted over a range of 1.5 to 90 µg/mL for DRSP and DRSP-related impurities, and 0.125 to 0.75 µg/mL for EE-related impurities. A Quality by Design (QbD) study demonstrated the method's robustness.</p><p><strong>Conclusions: </strong>As per current guidelines, a stability-indicating method has been developed for the determination of impurities in DRSP/EE film-coated tablets. A QbD-based robustness test was performed and the method was found to be robust.</p><p><strong>Highlights: </strong>An accurate, precise, stability-indicating, gradient RP-HPLC method has been developed and validated to determine DRSP, EE, and nine related impurities in tablet formulation. A QbD technique was used to establish a robustness study.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"31-39"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41173419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of PVT VIABLE® for Detection of Legionella in Potable and Non-Potable Water: AOAC Performance Tested MethodSM 082303.","authors":"Leah Wickenberg, Katherine Gabrie, Patrick McCarthy, Melissa Cain","doi":"10.1093/jaoacint/qsad112","DOIUrl":"10.1093/jaoacint/qsad112","url":null,"abstract":"<p><strong>Background: </strong>Phigenics Validation Test (PVT) VIABLE® (Viability Identification Assay by Legionella Enrichment) is a method to detect viable Legionella bacteria in building water systems.</p><p><strong>Objective: </strong>To evaluate PVT VIABLE against the ISO 11731:2017 Water Quality-Enumeration of Legionella reference method for the detection of viable Legionella species in potable and non-potable water.</p><p><strong>Methods: </strong>PVT VIABLE was tested for inclusivity (n = 50 strains of Legionella) and exclusivity (n = 30 non-target strains), robustness, and stability. A multi-laboratory instrument variation study was performed to evaluate the PCR data. The matrix study was performed on potable and non-potable water samples inoculated with Legionella pneumophila at a low (n = 20) and high fractional level (n = 5). Samples were analyzed using the PVT VIABLE and confirmed using ISO 11731:2017.</p><p><strong>Results: </strong>Statistical analysis showed no difference between PVT VIABLE and ISO 11731:2017 for 100 mL test portions of potable and non-potable water. PVT VIABLE demonstrated high levels of specificity and sensitivity in the inclusivity and exclusivity study. Results of the robustness and stability studies demonstrated the method was sufficiently robust to handle small method changes and met the method claims of stability.</p><p><strong>Conclusion: </strong>PVT VIABLE allows the end user to obtain presumptive results for viable Legionella spp. contamination of potable and non-potable water in 2-3 days.</p><p><strong>Highlights: </strong>PVT VIABLE provides viable Legionella results in 2-3 days versus 10-14 days for traditional spread plating. This novel diagnostic tool also differentiates between Legionella pneumophila sg1, Legionella pneumophila sg2-15, and Legionella spp. without the need for additional confirmation steps as outlined in ISO 11731:2017.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"120-128"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41173420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}