Journal of AOAC International最新文献

{"title":"Screening of 152 Veterinary Drug Residues in Animal Source Foods by LC-MS/MS, Multilaboratory Validation Study: Final Action 2020.04","authors":"Aurélien Desmarchelier, Thomas Bessaire, Marie-Claude Savoy, Adrienne Tarres, Claudia Mujahid, Andrea Beck, Pascal Mottier, Xun Fu, Wai-Chinn Chan, Stéphanie Laborie, Nadine Hagenbourgerr, Gislaine Miranda, Thierry Delatour","doi":"10.1093/jaoacint/qsae032","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae032","url":null,"abstract":"Background The presence of veterinary drug residues in food-producing animals and animal products is regulated through the enforcement of maximum residue limits (MRLs). To answer the need of the food sector to monitor these substances in a wide range of food commodities, stakeholders at AOAC identified the need for a reliable confirmatory screening method. Such qualitative approach is required for compliance checking and to support product release in manufacturing. Objective Data were collected from 5 independent laboratories that applied the AOAC Official First Action Method AOAC 2020.04 to demonstrate adequate performance under reproducibility conditions. Probability of Detection (POD) was calculated in blank test samples and test samples spiked at the Screening Target Concentration (STC) level, with the objective to achieve PODs ≤ 10% and ≥ 90%, respectively. Additionally, the effectiveness of the screening method was assessed through participation to 92 proficiency test samples. Methods Four streams were optimized to screen for 152 veterinary drug residues by LC-MS/MS in a wide variety of food commodities including milk-based ingredients and related products (e.g., milk fractions, infant formula, infant cereals and baby foods), meat- and fish-based ingredients and related products (fresh, powdered, cooked, infant cereals and baby foods) and other ingredients such as eggs, animal fat and animal byproducts. The four streams covered 105 antibiotic residues, anti-inflammatory and antiparasitic agents (Stream A); 23 Beta-lactams (Stream B); 14 Aminoglycosides (Stream C) and 10 Tetracyclines (Stream D). Results The multi-laboratory validation led to PODs at the STC ≥ 94% and PODs in the blank ≤ 9%. Further application of the multi-laboratory validated method to 92 proficiency tests provided more than 99% satisfactory submitted results (n = 784). Conclusion The inter-laboratory reproducibility determined for this method met the acceptance criteria defined in AOAC SMPR 2018.010. Highlights AOAC has approved the method for Final Action Status.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140609396","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":"Enhancing the Sustainability of Eco-friendly Potentiometric Ion Selective Electrodes for Stability-Indicating Measurement of Ethamsylate: Application in Bulk and Pharmaceutical Formulations","authors":"Hany H Monir, Heba A Mohamed, Amr M Badawy, Marianne Nebsen, Christine K Nessim","doi":"10.1093/jaoacint/qsae034","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae034","url":null,"abstract":"Background Through the use of sustainable and green chemistry concepts, scientists need to decrease waste, conserve energy, and develop safe substitutes for hazardous compounds, all for protecting and benefiting society and the environment. Objective Four novel eco-friendly ion selective electrodes (ISE) were created to determine Ethamsylate (ETM) in bulk powder and different pharmaceutical formulations. The present electrodes were fabricated and evaluated to clearly distinguish ETM from a variety of inorganic, organic ions, sugars, some common drug excipients and the degradation product, hydroquinone (HQ) of ETM, and thus could be used for stability-indicating methods. Methods The electrodes fabrication was based on 2-nitrophenyl octyl ether (NPOE) that was employed as a plasticizer in electrodes 1, 2, and 3 within a polymeric matrix of polyvinyl chloride (PVC) except for electrode 4, in which dibutyl sebacate was used as a plasticizer. Electrodes 1 & 2 were fabricated using tetra dodecyl ammonium bromide as an anionic exchanger and adding 4-sulfocalix-8-arene as an ionophore only to electrode 2, but electrode 1 prepared without incorporation of an ionophore. The fabrication of electrodes 3 & 4 was based on ethamsylate-tetraphenylborate (ETM-TPB) as an ion-association complex in a PVC matrix. The environmental sustainability was assessed using Green Analytical Procedure Index (GAPI), and Analytical Greenness Metric for Sample Preparation (AGREEprep). Results Electrodes 1 & 2 had linear dynamic ranges of (10−1—10 −5) and (10−1—10 −4) respectively, with a Nernstian slope of 49.6 and 53.2 mV/decade, respectively. Electrodes 3 & 4 had linear dynamic ranges of (10−1—10 −4), with a Nernstian slope of 43.9 and 40.2 mV/decade, respectively. Conclusion The generated electrodes' selectivity coefficients showed good selectivity for ETM. The utility 4-sulfocalix-8-arene as ionophore had a significant influence on increasing the membrane sensitivity and selectivity of electrode 2 compared to other electrodes.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140609397","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":"Determination of β-Galactooligosaccharides (GOS) in Infant Formula: Collaborative Study, Final Action 2021.01","authors":"Denis Cuany, Sean Austin","doi":"10.1093/jaoacint/qsae031","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae031","url":null,"abstract":"Background We previously published a method for the determination of β-Galactooligosaccharides (GOS) in Infant Formula and Adult Nutritionals which is currently First Action AOAC Method 2021.01. In this study, reproducibility data were collected to support the promotion of the method to Final Action. Method A collaborative study was organized, to which 14 laboratories from eight different countries participated. Initially, laboratories were requested to analyze two practice samples and request guidance from the study director in case of issues. Successful laboratories proceeded to analyze seven samples (six infant formula and one adult nutritional) received as blind duplicates. Results Thirteen laboratories reported acceptable results for practice sample 1. Practice sample 2 could only be delivered to eight of the laboratories due to restrictions at customs. The 13 laboratories successfully analyzing practice sample 1 were requested to continue with the analysis of the MLT samples. Laboratory 14 was unable to solve some technical difficulties, so their data could not be used. Out of the seven samples tested, results for six infant formula met the requirements of the AOAC SMPR 2014.003, with RSDr ranging from 1.4 to 4.7% and RSDR ranging from 8.1 to 11.6%. The adult nutritional sample returned results outside the range of SPMR, having repeatability (RSDr) of 9.9%, higher than the SMPR target of ≤ 6%, and reproducibility (RSDR) of 12.1%, just above the SMPR target of ≤ 12%.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140578309","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":"Colorimetric Concurrent Determination of Ultra-Trace Amounts of Pilocarpine and Timolol as anti-Glaucoma Drugs in Binary Mixtures Using a Multivariate Calibration Approach Based on the Aggregation of Gold Nanoparticles","authors":"Asma Zanjani, Mahmoud Reza Sohrabi, Hassan Kabiri Fard","doi":"10.1093/jaoacint/qsae030","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae030","url":null,"abstract":"Background To study the ultra-trace simultaneous determination of drugs, the colorimetric method in combination with chemometrics can be used. Objective In this study, a simple, rapid, and sensitive UV-Vis spectrophotometric method using gold nanoparticles (AuNPs) was introduced for the simultaneous determination of ultra-trace amounts of Pilocarpine (PIL) and Timolol (TIM) in binary mixtures and biological sample. Methods AuNPs interacted with components and the aggregation mode of NPs occurred and finally, the color change of the solution (red to gray) was observed with the naked eye without the most modern and expensive instruments. The characterization of AuNPs was evaluated by transmission electron microscopy (TEM) and dynamic light scattering (DLS). Results The validation of the colorimetric way was studied in the concentration range of 100–800 and 100–600 μg/L with good linearity equal to 0.9772 and 0.9891 for PIL and TIM, respectively. The limit of detection (LOD) was found to be 165.00 and 92.40 μg/L, where the limit of quantitation (LOQ) was 500.00 and 280.00 μg/L for PIL and TIM, respectively. The effect of some factors such as interaction time, the concentration of components, and the volume of buffer on absorbance was investigated. Partial least squares (PLS) as an efficient multivariate calibration method was combined with colorimetry for the simultaneous determination of PIL and TIM in binary mixtures. The optimum number of latent variables was selected by k-fold cross-validation based on minimum mean square error prediction (MSEP) and the number of components equal to 1 with MSEP of 1.085 and 0.763 was considered for PIL and TIM, respectively. The mean recovery was obtained at 100.20% and 101.55% for PIL and TIM, respectively. Conclusion The colorimetric method can be introduced as a proper option for the simultaneous determination of components in pharmaceutical formulations and other samples. Highlights A colorimetric method using AuNPs was proposed. PLS method was coupled with a colorimetric method for the ultra-trace simultaneous estimation of PIL and TIM in binary mixtures. Ultra-trace amounts of PIL and TIM were also determined in biological sample. The proposed method is simple, fast and less expensive than chromatography methods.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140578514","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":"Analyte Extension Method Validation of Elemental Analysis Manual Method 4.7 for Six Additional Elements, Cobalt (Co), Strontium (Sr), Thallium (Tl), Tin (Sn), Uranium (U) and Vanadium (V)","authors":"Anthony Kovalenko, Dominique Stutts, Patrick J Gray","doi":"10.1093/jaoacint/qsae029","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae029","url":null,"abstract":"Background An interlaboratory study was conducted at the U.S. Food and Drug Administration’s (FDA) Northeast Food and Feed Laboratory (NFFL) and the Center for Food Safety and Applied Nutrition (CFSAN) with the purpose to expand FDA Elemental Analysis Manual (EAM) method 4.7 (Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion) to include new analytes (1). Objective The goal of the study was to demonstrate the performance of FDA EAM method 4.7 when analyzing new analytes cobalt (Co), strontium (Sr), thallium (Tl), tin (Sn), uranium (U) and vanadium (V). This analyte extension method validation of EAM 4.7 for six additional elements, Co, Sr, Tl, Sn, U and V followed all guidelines for a Level 2 or single laboratory validation and met all acceptance criteria for analyte extensions as per the Guidelines for the Validation of Chemical Methods (3). Method As per EAM 4.7 (1), this study followed the procedures and used specified equipment operated under recommended conditions. The analyte extension method validation was performed per protocol and with no deviations. Results All quality control (QC) requirements for this analyte extension method validation of EAM 4.7 passed as evidenced by the analytical data. The results presented demonstrate accuracy, linearity and precision by successful analyses of method blanks, matrix spikes, unfortified test samples and reference materials. The data analyzed met each of the validation requirements for each analyte in all representative matrices. Conclusion The study showed that the new analytes performed satisfactorily using EAM 4.7 for total acidic extractable elemental analysis of food according to FDA’s guidelines (3). Highlights The method met or exceeded the performance criteria.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140578306","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":"A Robust HPLC Approach for Quantitation of Camptothecin in Mesoporous Silica Nanoparticles Matrix and in the Presence of Its Degradation Products","authors":"Richa Dave, Neel Savaliya, Ashish Dobariya, Rashmin Patel, Mrunali Patel","doi":"10.1093/jaoacint/qsae013","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae013","url":null,"abstract":"Background Camptothecin is a potent anti-cancer drug used for the treatment of various cancers. Objective The goal of this research investigation was to develop and validate a new stability indicating HPLC technique for the quantitative assessment of camptothecin in in-house developed mesoporous silica nanoparticles, a novel nanoformulation matrix for the treatment of cancer. Method The Waters Inertsil® HPLC column (C18) was used for the chromatographic separation, with a flow rate of 1 mL/min, a column oven temperature of 40 °C, an injection volume of 10 µL, a detection wavelength of 216 nm, and a 10 min runtime overall. An isocratic blend of phosphate buffer (10 mM, pH7.0) and acetonitrile (60:40 v/v) served as the mobile phase. Various stress conditions including acid, alkali, oxidative, photolytic, thermal, and humidity environments were tested for the quantitative estimation of the camptothecin through the proposed method. Results The results demonstrated that the proposed method is specific (peak purity ≥ 0.999), accurate (99.69—100.64% w/w), precise (%RSD < 2.0), and sensitive (LOD—0.17 µg and LOQ—0.56 µg) in accordance with ICH guideline Q2(R1). Any unidentified degradation products did not interfere with the drug's estimation. Furthermore, the current method of analysis has eliminated any excipient interference from the matrix effect caused by the numerous excipients of the formulation matrix. Conclusions To quantify camptothecin for routine assay purposes, this research work offers a novel and straightforward HPLC methodology with optimized chromatographic parameters, contributing to the research and development community while ensuring an appropriate and efficient use of the drug through a variety of nanoformulation for cancer treatment. Highlights Stability-indicating HPLC method was found to be specific and suitable for routine analysis of camptothecin. The absence of any interference from excipients was confirmed by forced degradation studies.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139969190","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":"Effect of selective enrichment storage temperature and duration time on the detection of Salmonella in food","authors":"Lijun Hu, Guodong Zhang","doi":"10.1093/jaoacint/qsae014","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae014","url":null,"abstract":"Background For pathogen detection in food, there are occasions where samples cannot be processed immediately after selective enrichment or need to be reexamined days/weeks later for confirmation or retest. Objective This study aimed to investigate the effect of different prolonged period of storage of selective enrichments of food at 4 ± 2 °C and room temperature (20—22 °C) on the detection and isolation of Salmonella. Methods This study included two experiments involving 34 types of foods to compare the effect of 4 ± 2 °C and room temperature storage on the detection of Salmonella in 204 selective enrichments [Rappaport-Vassiliadis (RV) and Tetrathionate (TT) broths] during a 42-day storage (Experiment I); and to monitor the survival of Salmonella in 300 selective enrichments (RV and TT) with different pre-enrichment broths [Lactose broth (LB) or Buffered peptone water broth (BPW)], stored at 4 °C for 60 days (Experiment II). All the samples were subjected to Salmonella analysis following FDA BAM method. Results During multiple samplings, the positive detection rate for Salmonella remained consistent through Day 42 after selective enrichment, irrespective of Salmonella serotype, storage temperature, pre-enrichment broth, or selective enrichment broth in both Experiment I and II. However, on Day 60 sampling in Experiment II, seven previously positive results turned to negatives. This data indicated that storage of RV and TT enrichments at 4 ± 2 °C or room temperature for up to 42 days after selective enrichment did not compromise the detection of Salmonella in the tested food categories, regardless of Salmonella serotypes and the broths used for pre-enrichment and selective enrichment. Conclusion At least for the specific food types studied in this experiment, the recovery of Salmonella from selective enrichments could be postponed for a limited period of time (e.g., < 42 days) if needed without adversely affecting the test results. However, the delayed analysis of TT and RV enrichments does pose a risk of reduced detection sensitivity, as evidenced by the seven negative results on Day 60 compared to previous positives. We do not recommend or endorse delaying the analysis of TT and RV enrichments. Highlights In the food matrices investigated in this experiment, the plating and isolation of Salmonella from selective TT and RV enrichments stored at 4 ± 2 °C or room temperature could be deferred for a period (up to 42 days) without any negative effect on the test results, if necessary.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139968945","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":"Molecular Interactions Leading to the Advancement in the Techniques for COVID-19 Detection: A Review","authors":"Mohammad Kashif, Swati Acharya, Adila Khalil","doi":"10.1093/jaoacint/qsae010","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae010","url":null,"abstract":"Since 2019 the world is in a combat with the highly contagious disease COVID-19 that is caused by the rapid transmission of SARS-CoV-2 virus (severe acute respiratory syndrome- coronavirus-2). Detection of this disease in an early stage helps to control its spread and management. To combat this epidemic with one-time effective medication improved quick analytical procedures must be developed and validated. The requirement of accurate and precise analytical methods for the diagnosis of the virus and antibodies in infected patients has been a matter of concern. The global impact of this virus has motivated scientists and researchers to investigate and develop various analytical diagnostic techniques. This review includes the study of standard methods which are reliable and accredited for the analytical recognition of the said virus. For early detection of SARS-CoV-2 RNA, RT-PCR is an accurate method among other methods and thus, considered as “gold standard” technique. Here, we outline the most extensively used analytical methods for diagnosing COVID-19, along with a brief description of each technique and its analytical aspects/perspective.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139677475","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":"Eco-Friendly Stability-Indicating HPLC Method for Related Compounds in Pemetrexed Ditromethamine (Antineoplastic Agent) for Injection","authors":"Arjuna Rao Nekkalapudi, Srinivasu Navuluri, Sreenivas Pippalla","doi":"10.1093/jaoacint/qsae008","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae008","url":null,"abstract":"Background The Eco-friendly analytical technique was developed for intention of preserving the environment by using green chemistry principles. Pemetrexed is folate analogue indicated for treatment of advanced lung cancer. Objective Development of Green Stability indicating HPLC method for quantification of Pemetrexed (Ditromethamine) impurities in API and parenteral dosage form. Method Chromatographic separation was achieved by using Zorbax SB C18 column (150 mm x 4.6 mm inner diameter, 3.5 µ particle size) with perchlorate buffer (pH 3.0 ± 0.1, 50 mM) as a mobile phase-A and Acetonitrile—perchlorate buffer (90 + 10, v/v) as a mobile phase-B at a flow rate of 0.8 mL/minute with column temperature 40 °C ± 0.5 °C. All analytes were well resolved by gradient elution with total run time of 75 minutes and detection wavelength at UV 230 nm. Results The RP-HPLC method is capable to resolve all the degradation and process impurities for Pemetrexed Ditromethamine API and parenteral dosage form. The related compounds method was validated in accordance with ICH Q2(R1) and USP <1225> guidelines, found to be accurate, specific, precise, linear, robust and stability indicating. The precision and intermediate results shown the below < 5% CV values for all the impurities. The accuracy of all the impurities were found to be between 90% and 110%. The linearity of regression co-efficient values for all the impurities were found to be more than 0.999. Conclusion The proposed related compounds method is found suitable for the determination of process and degradation impurities of commercial formulations, stability samples in quality control analysis for Pemetrexed Ditromethamine (PDT) API and drug product. Highlights The developed liquid chromatographic method greenness and eco-friendliness were assessed by using (GAPI) green analytical procedure index, (AGREE) analytical greenness tool, and found to be green. Pemetrexed Ditromethamine detoxification procedure also developed to protect from environment pollution.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139677347","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":"Comparison of 6 aptamer-aptamer pairs on rapid detection of SARS-CoV-2 by lateral flow assay","authors":"Dilek Çam Derin, Enes Gültekin, Elif Gündüz, Barış Otlu","doi":"10.1093/jaoacint/qsae004","DOIUrl":"https://doi.org/10.1093/jaoacint/qsae004","url":null,"abstract":"Background SARS-CoV-2 is a threat for humanity. Both the Spike (S) protein and its receptor binding domain (sRBD) are extensively used for the rapid detection. Although real time reverse transcription polymerase chain reaction (rRT-PCR) is mostly used method for the molecular detection of SARS-CoV-2, rapid assays for antigenic detection is always needed. Lateral flow assays (LFAs) are the most commonly used tests for this purpose and aptamers having stability and long shelf life are used as capture reagents. Objective This study aimed to develop the LFAs based on the aptamer pairs for the antigenic detection of SARS-CoV-2 with naked eye. Methods Gold nanoparticles (AuNPs) were used as label and six sandwich models by three different aptamers were prepared using 4 μM and 8 μM probes and two kinds of membranes for developing the LFAs. Results 8 μM probe concentration and M2 membrane showed the best recognition of both the synthetic sRBD and SARS-CoV-2 coming from the naso/oropharingeal swabs by designed LFAs as 100% sensitivity and 93,3% specifity compared to the antibody detecting LFAs. Conclusions Our developed strip assays based on aptamer pairs recognized the target, directly in a 5-6 minutes with naked eye. It was also concluded that aptamer pairs, membrane types, assay buffers and probe concentrations have significant role in the detection of SARS-CoV-2 by LFAs. Highlights The detection of SARS-CoV-2 in clinical samples was demonstrated with the best aptamer pairs, sensitively and selectively among the designed 6 aptamer pairs for LFAs. Developed LFAs can be an alternative method to the conventional antibody based LFAs for SARS-CoV-2 detection.","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139462978","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}