Journal of AOAC International最新文献

{"title":"The Association between Happiness and Cognitive Function in the UK Biobank.","authors":"Xianghe Zhu, Martina Luchetti, Damaris Aschwanden, Amanda A Sesker, Yannick Stephan, Angelina R Sutin, Antonio Terracciano","doi":"10.1007/s12144-023-04446-y","DOIUrl":"10.1007/s12144-023-04446-y","url":null,"abstract":"<p><p>Feelings of happiness have been associated with better performance in creative and flexible thinking and processing. Less is known about whether happier individuals have better performance on basic cognitive functions and slower rate of cognitive decline. In a large sample from the UK Biobank (<i>N</i>=17,885; Age 40-70 years), we examine the association between baseline happiness and cognitive function (speed of processing, visuospatial memory, reasoning) over four assessment waves spanning up to 10 years of follow-up. Greater happiness was associated with better speed and visuospatial memory performance across assessments independent of vascular or depression risk factors. Happiness was associated with worse reasoning. No association was found between happiness and the rate of change over time on any of the cognitive tasks. The cognitive benefits of happiness may extend to cognitive functions such as speed and memory but not more complex processes such as reasoning, and happiness may not be predictive of the rate of cognitive decline over time. More evidence on the association between psychological well-being and different cognitive functions is needed to shed light on potential interventional efforts.</p>","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":"13 1","pages":"1816-1825"},"PeriodicalIF":2.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10954258/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83025704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simultaneous Uplc Assay for Oxitropium Bromide and Formoterol Fumarate Dihydrate in Pressurised Metered Dose Inhaler Products for Chronic Obstructive Pulmonary Disease","authors":"Serdar Seckin, Serap Saglik Aslan","doi":"10.1093/jaoacint/qsad134","DOIUrl":"https://doi.org/10.1093/jaoacint/qsad134","url":null,"abstract":"Backround Oxitropium Bromide (OB) and Formoterol Fumarate Dihydrate (FFD) are inhaler molecules that are widely used in the treatment of chronic lung diseases. Objective The goal of this work was to create a reversed phase-ultra performance liquid chromatography (RP-UPLC) technique for assay and identification of OB and FFD, as well as identification and estimate of its associated compounds in pressurised metered dose inhaler product (pMDI). Method Separation of oxitropium and formoterol peaks were enhanced on C18 (50 x 2.1 mm x 1.7 μm), UPLC column with Ethylene-Bridged-Hybrid technology, The mobile phase consists of buffer (0.07 M KH2PO4) and acetonitrile (80:20 v/v). The detector wavelength of 210 nm, flow rate of pump 0.6 mL/min and oven temperature for column were set at 25◦C. The injection volume was 10 μL. The method run time is 2 min. The mobile phase was used as the solvent. Results Retention times were 0.5 min. for OB and 1.0 min. for FFD. The assay analysis was lineear range for all analytes within the range for concentrations 0.03—14.8 µg/mL of OB, 0.01– 0.88 µg/mL of FFD. LOD values and LOQ values 0.009 µg/mL and 0.026 µg/mL for OB, 0.003 µg/mL and 0.009 µg/mL for FFD, respectively. Recoveries were obtained at 96.3% for OB and 97.2% for FFD. Precisions values were (as RSD%) ≤1.5%. Conclusions With the UPLC method developed and validated according to the current ICH guidelines, it is possible to simultaneously detect OB and FFD of assay analysis in pMDI products accurately, precisely and selectively, independent of the matrix effect. Highlights The present method is the first method in the literature based on the UPLC method for this purpose. The UPLC method is a time-saving method, it provides a faster and cheaper technique than the HPLC method.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":"79 1","pages":""},"PeriodicalIF":1.6,"publicationDate":"2023-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138742620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Greenness assessment and validation of HPLC method for simultaneous determination of Resveratrol and Vitamin E in dietary supplements","authors":"Marina Topkoska, Martina Miloshevska, Marjan Piponski, Irena Slaveska Spirevska, Natalija Nakov, Katerina Brezovska, Jelena Acevska","doi":"10.1093/jaoacint/qsad131","DOIUrl":"https://doi.org/10.1093/jaoacint/qsad131","url":null,"abstract":"Background There is an increasing interest in the use of a combination of trans-resveratrol and vitamin E in dietary supplements. Determination of the content of both components is essential for confirmation of the quality of the product. Objective To establish the applicability and ensure the greenness of the previously developed high-throughput HPLC/UV method for the simultaneous determination of trans-resveratrol and alpha-tocopherol acetate (vitamin E) in dietary supplements. Methods Separation was performed on RP C8 Select B chromatographic column, using acetonitrile and water in the mobile phase, with gradient elution. Full method validation was performed in accordance with ICH Q2(R1). The greenness of the method was assessed using the analytical eco-scale (AES) methodology and the analytical greenness metric (AGREE). Results The method is selective, linear, precise and accurate over defined concentration ranges (185—369 µg/mL of trans-resveratrol and 37—75 µg/mL of alpha-tocopherol acetate), and has a suitable sensitivity (limits of detection and quantification are 7.7 µg/mL and 23.3 µg/mL for resveratrol and 2.6 µg/mL and 7.8 µg/mL for tocopherol acetate, respectively). The obtained analytical eco-scale score of 77 and the pale green AGREE pictogram with an overall score of 0.61 confirm the method’s greenness. Conclusion The sensitivity and selectivity of the method, its short analysis time (7 minutes), the low negative environmental impact, and simple sample preparation make the method readily applicable to in-line quality control procedures. Highlights A method for simultaneously analysing vitamin E and resveratrol in dietary supplements is presented. The method is rapid, includes a simple sample preparation procedure, and has a low environmental impact.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":"31 1","pages":""},"PeriodicalIF":1.6,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138692628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of the FSTestTM Aerobic Count Plates Method for Enumeration of Aerobic Bacteria in a Variety of Matrixes and Stainless Steel Environmental Surface: AOAC Performance Tested MethodSM 112301","authors":"Yun Liu, Jun Fan, Xia Sun, Zican Zhou","doi":"10.1093/jaoacint/qsad132","DOIUrl":"https://doi.org/10.1093/jaoacint/qsad132","url":null,"abstract":"Background The FSTestTM Aerobic Count (AC) Plates are ready-to-use culture mediums containing nutrients, a cold-water-soluble gelling agent and a chromogenic indicator. Objective The objective of this study was to validate the FSTest AC plate method for the AOAC Performance Tested MethodsSM (PTM) certification for a variety of foods and stainless steel. Methods The performance of the FSTest AC plates were compared to the appropriate reference method, for the detection of total aerobic bacterial in a variety of foods matrixes (raw ground beef, raw ground pork, cooked ham, raw chicken breast, raw shrimp, frozen tuna, shredded bagged lettuce, cherry tomato, pasteurized liquid milk, nonfat milk powder) and stainless steel surface. The robustness, consistency, and stability studies of the FSTest AC plate were also conducted. Results The results of the matrix study showed the standard deviation of repeatability (sr) was similar in both the FSTest AC plate method and the reference method. The 90% confidence interval of the difference between means between the two methods was found to fall within -0.5 to 0.5 log10 for all matrixes at all levels in the method developer and independent laboratory studies. The data in the report also supports that the FSTest AC plate method is robust, manufactured in a consistent manner and can be stable for 18 months at 4–10 °C. Conclusion The FSTest AC method is validated to be equivalent to the appropriate reference methods for the enumeration of aerobic bacteria in a variety of food matrixes and stainless steel surface at 36 ± 1 °C, and 32 ± 1 °C (for dairy matrixes) in 24 ± 1 h. Highlights The FSTest AC plate method offers the advantage of saving labor, space and time, as results are available within 24 h for all tested matrixes.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":"115 1","pages":""},"PeriodicalIF":1.6,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138560721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exciting Advances in Sustainable Spectrophotometric Micro-Quantitation of an Innovative Painkiller “Tramadol and Celecoxib” Mixture in the Presence of Toxic Impurity, Promoting Greenness and Whiteness Studies","authors":"Eman A Bahgat, Hisham Hashem, Hanaa Saleh, Ebraam B Kamel, Maya S Eissa","doi":"10.1093/jaoacint/qsad133","DOIUrl":"https://doi.org/10.1093/jaoacint/qsad133","url":null,"abstract":"Background Tramadol (TRM) and celecoxib (CLX) are a novel mixture that helps relieve impetuous, acute pain when other painkillers have no action. It is also reported that the currently studied drugs, tramadol and celecoxib, are used to control COVID-19 symptoms. Objective The current work highlights three important pillars of modern pharmaceutical analysis, which are as follows; impurity profiling, greenness/whiteness studies and simplicity accompanied by sensitivity. Since 4-methyl acetophenone inhibits the human carbonyl reductase enzyme (type I), and since this compound may pose a health risk, it is crucial to regulate its concentration in all dosage forms of CLX. Methods Two simple and green spectrophotometric methods were developed, namely; Third Derivative (D3) and Fourier Self Deconvulation (FSD) for resolving severely overlapped spectra of tramadol and celecoxib in the presence of 4-methyl acetophenone (4-MAP) as a process-related impurity in their novel tablet combination. Results The two approaches showed acceptable linearity with an excellent correlation coefficient. Simply, for both methods tramadol was measured when celecoxib and 4-methyl acetophenone were zero-crossing. The same procedure was applied for measuring celecoxib and its process-related impurity; 4-methyl acetophenone. Conclusion The methodologies developed were thoroughly validated in compliance with ICH guidelines. Student t and F-tests revealed no statistically substantial variation among the current methods and the reported method. Highlights No spectrophotometric methods have been published for the simultaneous analysis of TRM and CLX along with 4-MAP. As a result, the newly developed spectrophotometric approaches hold great relevance and originality in the field of pharmaceutical analysis.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":"249 1","pages":""},"PeriodicalIF":1.6,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138560474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality evaluation of gentamicin sulfate reference standards in Japanese Pharmacopoeia using hydrophilic interaction chromatography combined with tandem mass spectrometry","authors":"Keiko Maekawa, Ryuichi Sawa, Mari Matsui, Toshifumi Konda, Yumiko Kubota, Ayaka Matsuo, Akiho Maeda, Chisato Takahashi, Tsuyoshi Tanimoto, Yukari Nakagawa, Sachiyo Yoneda, Yuri Mori, Satowa Suzuki","doi":"10.1093/jaoacint/qsad135","DOIUrl":"https://doi.org/10.1093/jaoacint/qsad135","url":null,"abstract":"Background Through the recent development of analytical technology, antibiotics quantification in the Japanese Pharmacopoeia (JP) has changed from traditional microbiological assays to physicochemical methods with high specificity and precision. However, for several multicomponent antibiotics without typical UV absorption, potency cannot be directly determined using instrumental methods such as high-performance liquid chromatography; therefore, traditional microbiological assays are still used. Gentamicin sulfate (GmS), which consists of three major components, C1, C1a, and C2, is such a typical antibiotic, and its antimicrobial potency continues to be assayed using microbiological methods in JP monographs. Introduction of physicochemical assay for GmS is needed to help ensure its quality and quantity. Objective This study aimed to develop quality control measures for GmS that could be complimentary to quantitative assays and purity tests specified in the JP. Methods For each gentamicin C component (C1, C2, and C1a), theoretical potencies were determined based on the quantitative relationship between purity and potency, as measured by quantitative 1H NMR and microbiological assays, respectively. Two lots of the JP reference standard (RS) were used as test samples, with the contents of each component and impurity (sisomicin and garamine) being determined using hydrophilic interaction liquid chromatography-tandem mass spectrometry (HILIC-MS/MS). Results The ratios of theoretical potency for C1, C2, and C1a were 1.00, 1.21, and 1.80, respectively. The potencies of the GmS JP RSs, which were estimated based on the contents and theoretical potency of each C component, corresponded well with those determined through microbiological assays. Marked differences in impurities (%) between the two RS lots were highlighted by quantifying sisomicin and garamine. Conclusion The developed analytical procedure enabled the characterization of two different JP RSs in terms of content ratio, potencies, and impurities. Highlights Novel analytical procedures useful for routine quality control of GmS were developed using HILIC-MS/MS.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":"137 1","pages":""},"PeriodicalIF":1.6,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138560983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simultaneous quantification of Two Neonicotinoids using QuERChERS-LC-MS/MS in Moroccan Spearmint (Mentha Spicata.L): Qualimetry of the method by Uncertainty estimation using Generalized Pivotal Quantities approach and Monte Carlo simulation","authors":"Hicham Aaziz, Taoufiq Saffaj, Yassine Hameda Benchekroun, Bouchaib Ihssane","doi":"10.1093/jaoacint/qsad136","DOIUrl":"https://doi.org/10.1093/jaoacint/qsad136","url":null,"abstract":"Background Neonicotinoids are used for the phystosanitary treatment of Mentha Spicata.L crops, and this practice requires precise control of these harmful substances at very low concentrations. Objective The objective of this study is to apply an approach allowing simultaneously validation and evaluation of measurement uncertainty based on total error methodology, in order to accurately quantify the presence of two neonicotinoids in Mentha Spicata.L utilizing a QuEChERS-LC-MS/MS methodology. Methods Assay of Imidacloprid and Acetamiprid using QuEChERS extraction method coupled with LC-MS/MS to guarantee the analytical method's accuracy and control the risk of its routine use. A complete and exhaustive validation approach based on the “β-content, γ-confidence” tolerance interval was used for the uncertainty assessment, using the Generalised Pivot Quantity (GPQ) concept and Monte Carlo simulation, which avoids the need for additional data while achieving intermediate precision for each concentration level within predetermined acceptable limits. Results The validation procedure is based on the choice of a quadratic model for the two neonicotinoids, allowing the validation of Acetamiprid and Imidacloprid by LC-MS/MS assay within the range of working concentration. The flexibility of the Uncertainty Profile intervals was demonstrated with a variation in β-content values (66.7%, 80%, and 90%) and risk values (10% and 5%), which remained within the acceptability limits of 20%, and the relative expanded uncertainty did not exceed 15% and 11%. Conclusion QuEChERS- LC-MS/MS method for the analysis of two neonicotinoids has successfully been fully validated using the Uncertainty Profile strategy. Highlights Application of a full validation strategy based on the validation and uncertainty assessment for the quantification of two main Neonicotinoids in Mentha Spicata.L using QuEChERS- LC-MS/MS. This qualimetric has been conducted by computing of the measurement uncertainty of the method utilizing data from analytical validation under conditions of intermediate precision at each level of concentration without additional effort, after that we have demonstrate the flexibility of this strategy for the LC-MS/MS quantification of acetamiprid and imidacloprid, using a decision tool that enables the choice and modification of β-content and γ-confidence values.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":"152 1","pages":""},"PeriodicalIF":1.6,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138560567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stability Study and Handling Recommendations for Multiresidue Pesticide Mixes under Diverse Storage Conditions for LC-MS/MS and GC-MS/MS.","authors":"Landon A Wiest, Jana R Hepner, Jason E Fisher, Karen M Risha, John H Lidgett, Valerie N Ballarotto, Joseph D Konschnik","doi":"10.1093/jaoacint/qsad096","DOIUrl":"10.1093/jaoacint/qsad096","url":null,"abstract":"<p><strong>Background: </strong>In response to the growing global need for pesticide residue testing, laboratories must develop versatile analytical methods and workflows to produce scientifically sound results. One of the many challenges faced by food chemists is acquiring suitable pesticide certified reference materials (CRMs) to calibrate analytical equipment, monitor method performance, and confirm the identity and concentration of hundreds of pesticide residues in food samples. CRM producers invest considerable resources to ensure the stability of their products.</p><p><strong>Objective: </strong>To present proper CRM handling and storage practices as guidance to ensure stability based on the results of several multiresidue pesticide stability studies.</p><p><strong>Methods: </strong>The open ampoule and combined multiresidue mix studies were conducted under controlled conditions. New ampoules containing multiresidue pesticide CRM mixtures were opened and compared to previously opened ampoules at multiple intervals while stored under freezing and refrigerated temperatures. Both LC- and GC-amenable pesticides (>200 residues) were combined and stored under typical laboratory conditions. Studies were performed with and without celery matrix.</p><p><strong>Results: </strong>The open ampoule study showed high levels of stability for all mixtures. All GC residues remained stable over the duration of the experiment. A week after opening LC multiresidue pesticide mixtures showed minor degradation. After combination of the multiresidue pesticide mixtures, degradation occurred rapidly for both the GC and LC mixtures.</p><p><strong>Conclusion: </strong>Multiresidue pesticide mixtures are stable as ampullated until they are opened. Once the contents of a kit were opened and combined, decreasing stability was observed over time. This was true for both the LC and GC kits. Working mixtures of CRMs for instrument calibration should be made daily.</p><p><strong>Highlights: </strong>This article shows a novel approach for measuring stability of CRM mixes. In-depth analysis of multiresidue pesticide mixtures and the stability that can be expected before and after mixing under typical storage conditions is described.</p>","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"1550-1563"},"PeriodicalIF":1.6,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628962/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10221643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantification of Chlorate and Perchlorate in a Broad Range of Food Commodities, Including Baby Food, Nutritional Formulas, and Ingredients by LC-MS/MS: First Action AOAC 2022.06.","authors":"José Fernando Huertas-Pérez,&nbsp;Pascal Mottier,&nbsp;Erik Konings,&nbsp;Quentin Baslé,&nbsp;Shi Ying Tan,&nbsp;Monika Kopeć-Durska,&nbsp;Patrycja Zawada,&nbsp;Ashley Griffin,&nbsp;María Guadalupe Sánchez-Calderón,&nbsp;Juan Pablo Silva-Robledo,&nbsp;Lisette Rubio","doi":"10.1093/jaoacint/qsad086","DOIUrl":"10.1093/jaoacint/qsad086","url":null,"abstract":"<p><strong>Background: </strong>Chlorate is an effective herbicide, but also a byproduct of chlorinating agents used to disinfect water, which is one of the reasons why it is regularly found in food. Perchlorate is a ubiquitous contaminant, which is naturally occurring in the environment but also released from anthropogenic sources such as the industrial use of certain natural fertilizers. Chlorate affects the hematological system, and perchlorate the thyroid.</p><p><strong>Objective: </strong>Implement and validate a simple and robust analytical method for the accurate determination of chlorate and perchlorate in baby food, infant and adult formulas, and ingredients thereof, which is suited for its application in routine environments where a broad variety of food commodities must be analyzed simultaneously.</p><p><strong>Method: </strong>Typically, analytes are extracted with a mixture of water, acidified methanol, and dichloromethane. Optionally, for dairy products and byproducts, extraction can be performed with water, acidified methanol, and EDTA, followed by two steps of cleanup (freezing out and dispersive solid-phase extraction with C18 in acetonitrile). Quantitative determination is carried out by isotopic dilution liquid chromatography tandem mass spectrometry (LC-MS/MS).</p><p><strong>Results: </strong>The method was single-laboratory validated in five Nestlé Quality Assurance Centers (NQACs) in a comprehensive range of representative matrixes of different categories such as baby foods, infant/adult formulas, and ingredients, with results generally in agreement with the acceptance criteria of the Standard Method Performance Requirement (SMPR®) 2021.001 defined by AOAC INTERNATIONAL, in terms of representative matrixes validated, LOQs, trueness, and precision.The data generated during validation show that the method proposed is simple, accurate and robust enough to be implemented and applied in routine environments.</p><p><strong>Conclusion: </strong>The data generated during validation show that the method proposed is simple, accurate and robust enough to be implemented and applied in routine environments.</p><p><strong>Highlights: </strong>The AOAC Expert Review Panel approved the present method as AOAC Official First Action 2022.06.</p>","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"1505-1524"},"PeriodicalIF":1.6,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9827648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beta-Binomial Statistical Model for Validation Studies of Analytes with a Binary Response.","authors":"Robert A LaBudde,&nbsp;Paul Wehling","doi":"10.1093/jaoacint/qsad085","DOIUrl":"10.1093/jaoacint/qsad085","url":null,"abstract":"<p><strong>Background: </strong>The probability of detection (POD) model has had widespread application for statistically analyzing single and multiple collaborator validations studies with binary outcome data for a wide range of analytes over the last decade.</p><p><strong>Objective: </strong>The POD model is placed on a firm theoretical foundation, and extended to a more generalized beta-binomial model.</p><p><strong>Methods: </strong>The POD model is revisited and embedded in the beta-binomial model. This generalization includes collaborator reproducibility as a specific parameter. The new model includes only two distributional parameters: the overall across-collaborator probability of detection (LPOD) and the intraclass correlation of collaborators (ICC), measuring irreproducibility. Differences between methods are measured by the difference in LPOD values, denoted dLPOD.</p><p><strong>Results: </strong>Accurate statistical estimators and confidence intervals are provided with validation by simulation. This new beta-binomial model will be applicable to a full range of candidate methods giving binary qualitative results, including microbiological, toxin, allergen, biothreat, and botanical analytes.</p><p><strong>Conclusions: </strong>The new beta-binomial model provides easy equivalence tests to show the study clearly demonstrates (with 95% confidence) that the method differences and collaborator reproducibility are acceptable.</p><p><strong>Highlights: </strong>The validation system for qualitative binary methods using probability of detection (POD) of an analyte as the parameter of interest has been modified and further validated.</p>","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"1629-1653"},"PeriodicalIF":1.6,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9833845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}