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Simultaneous determination of tramadol in earwax and urine samples: effects of age, duration time and sex. 同时测定耳屎和尿液样本中的曲马多：年龄、持续时间和性别的影响。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-21 DOI: 10.4155/bio-2023-0217
Adnan M Massadeh, Nuseer H Al-Rawi, May T Fayyad, Ali M Shotar, Mudhaffar I Al-Farras, Saif Addeen A Massadeh
{"title":"Simultaneous determination of tramadol in earwax and urine samples: effects of age, duration time and sex.","authors":"Adnan M Massadeh, Nuseer H Al-Rawi, May T Fayyad, Ali M Shotar, Mudhaffar I Al-Farras, Saif Addeen A Massadeh","doi":"10.4155/bio-2023-0217","DOIUrl":"10.4155/bio-2023-0217","url":null,"abstract":"<p><p><b>Background:</b> This study aims to determine the concentrations of tramadol in earwax (μg/g) and urine (μg/ml) samples taken from postoperative patients, to evaluate the sensitivity of earwax (cerumen) as an alternative analyte and compare it with the findings in urine samples. <b>Results:</b> The results indicated that tramadol concentrations in earwax samples were averaged 45.08 μg/g (range: 13.5-107.7 μg/g), whereas tramadol concentrations in urine samples were averaged 4.97 μg/ml (range: 1.57-10.11 μg/ml). There were significant differences when comparing age groups, duration and sex between earwax and urine samples (p < 0.05). <b>Conclusion:</b> Despite the significant differences between earwax and urine samples, earwax can be used as a bioindicator of tramadol detection.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A high-speed microscopy system based on deep learning to detect yeast-like fungi cells in blood. 基于深度学习的高速显微镜系统，用于检测血液中的酵母样真菌细胞。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0193
Ruiqi Liu, Xiaojie Li, Yingyi Liu, Lijun Du, Yingzhu Zhu, Lichuan Wu, Bo Hu
{"title":"A high-speed microscopy system based on deep learning to detect yeast-like fungi cells in blood.","authors":"Ruiqi Liu, Xiaojie Li, Yingyi Liu, Lijun Du, Yingzhu Zhu, Lichuan Wu, Bo Hu","doi":"10.4155/bio-2023-0193","DOIUrl":"10.4155/bio-2023-0193","url":null,"abstract":"<p><p><b>Background:</b> Blood-invasive fungal infections can cause the death of patients, while diagnosis of fungal infections is challenging. <b>Methods:</b> A high-speed microscopy detection system was constructed that included a microfluidic system, a microscope connected to a high-speed camera and a deep learning analysis section. <b>Results:</b> For training data, the sensitivity and specificity of the convolutional neural network model were 93.5% (92.7-94.2%) and 99.5% (99.1-99.5%), respectively. For validating data, the sensitivity and specificity were 81.3% (80.0-82.5%) and 99.4% (99.2-99.6%), respectively. Cryptococcal cells were found in 22.07% of blood samples. <b>Conclusion:</b> This high-speed microscopy system can analyze fungal pathogens in blood samples rapidly with high sensitivity and specificity and can help dramatically accelerate the diagnosis of fungal infectious diseases.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk-based approach of bioanalytical methods for clinical immunogenicity assessment of multidomain biotherapeutics. 基于风险的多域生物治疗临床免疫原性评估生物分析方法。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0250
Yan Mao, Kelly Coble
{"title":"Risk-based approach of bioanalytical methods for clinical immunogenicity assessment of multidomain biotherapeutics.","authors":"Yan Mao, Kelly Coble","doi":"10.4155/bio-2023-0250","DOIUrl":"10.4155/bio-2023-0250","url":null,"abstract":"<p><p>Tweetable abstract Risk-based bioanalytical method development for clinical antidrug antibody detection and characterization of multidomain biotherapeutics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Strategy and validation of a nonclinical generic plug-and-play antidrug antibody method for human monoclonal antibody biotherapeutics. 用于人类单克隆抗体生物治疗的非临床通用即插即用抗药抗体方法的战略和验证。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0184
Rodd Polsky, George Gunn, Kimberly J Reese, Charles Scott Hottenstein, Andrew Gehman, Ann Schwartz, Devin Root, Amy Concannon
{"title":"Strategy and validation of a nonclinical generic plug-and-play antidrug antibody method for human monoclonal antibody biotherapeutics.","authors":"Rodd Polsky, George Gunn, Kimberly J Reese, Charles Scott Hottenstein, Andrew Gehman, Ann Schwartz, Devin Root, Amy Concannon","doi":"10.4155/bio-2023-0184","DOIUrl":"10.4155/bio-2023-0184","url":null,"abstract":"<p><p>The measurement of antidrug antibodies (ADA) in nonclinical studies provides limited value because the formation and incidence of nonclinical ADA does not translate to clinical experience. The formation and presence of ADA in nonclinical species can, however, correlate to reduced drug exposure and safety observations including vasculitis and immune complex disease. Generic ADA methods for humanized monoclonal antibody biotherapeutics mitigate the need to develop bespoke ADA methods during nonclinical drug development. A drug-tolerant, sensitive, generic ADA immunoassay has been developed and validated for measuring ADA in cynomolgus monkey serum samples, allowing for immediate qualification of future monoclonal antibody biotherapeutics. This approach allows us to differentiate complexed and free ADA in a rapidly deployable manner when needed.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Western blotting: evolution of an old analytical method to a new quantitative tool for biomarker measurements. Western 印迹法：从一种古老的分析方法演变为一种新的生物标志物定量测量工具。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-13 DOI: 10.4155/bio-2023-0212
Carolina Owen, Kelly A Fader, Mohamed Hassanein
{"title":"Western blotting: evolution of an old analytical method to a new quantitative tool for biomarker measurements.","authors":"Carolina Owen, Kelly A Fader, Mohamed Hassanein","doi":"10.4155/bio-2023-0212","DOIUrl":"10.4155/bio-2023-0212","url":null,"abstract":"<p><p>Western blotting (WB) is a widely used laboratory technique for detecting specific proteins in biological matrices. Recent advances in antibody production, automation, gel and membrane manufacturing and highly sensitive detection platforms have transformed WB from a labor-intensive and qualitative method into a highly reproducible and quantitative assay suitable for biomarker detection. Despite these significant improvements in the capabilities and efficiency of WB, there remain challenges that hinder its widespread application as a research, diagnostic (in two-tiered assays like Lyme disease testing) and drug development tool. This article describes recent innovations introduced to WB methodology and the remaining challenges that prevent its wider adoption for biomarker measurements throughout the drug development process.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse. 欧洲生物分析论坛研讨会的建议和反馈：ICH M10 实施 1 年--把握脉搏。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-05 DOI: 10.4155/bio-2024-0013
Philip Timmerman, Matthew Barfield, Enric Bertran Portabella, Salvatore Calogero, Kyra Cowan, Jörg Faber, Luca Ferrari, Michaela Golob, Jo Goodman, Lee Goodwin, Mark Jean Gnoth, Richard Hughes, Tsvetelina Ivanova, Gregor Jordan, Anna Laurén, Delphine Maux, Stuart McDougall, Petya Milushewa, Robert Nelson, Gwenda Pynaert, Kamil Sklodowski, Rebecca Sleigh, Petra Struwe, Tom Verhaeghe, Robert Wheller, Steve White, Katja Zeiser
{"title":"Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse.","authors":"Philip Timmerman, Matthew Barfield, Enric Bertran Portabella, Salvatore Calogero, Kyra Cowan, Jörg Faber, Luca Ferrari, Michaela Golob, Jo Goodman, Lee Goodwin, Mark Jean Gnoth, Richard Hughes, Tsvetelina Ivanova, Gregor Jordan, Anna Laurén, Delphine Maux, Stuart McDougall, Petya Milushewa, Robert Nelson, Gwenda Pynaert, Kamil Sklodowski, Rebecca Sleigh, Petra Struwe, Tom Verhaeghe, Robert Wheller, Steve White, Katja Zeiser","doi":"10.4155/bio-2024-0013","DOIUrl":"10.4155/bio-2024-0013","url":null,"abstract":"<p><p>The ICH M10 guideline on bioanalytical method validation and sample analysis is being adopted since 2023. However, and inevitably, some paragraphs or requirements remain ambiguous and are open for different interpretations. In support of a harmonized interpretation by the industry and health authorities, the European Bioanalysis Forum organized a workshop on 14 November 2023 in Barcelona, Spain, to discuss unclear and/or ambiguous paragraphs which were identified by the European Bioanalysis Forum community and delegates of the workshop prior to the workshop. This manuscript reports back from the workshop with recommendations and aims at continuing an open scientific discussion within the industry and with regulators in support of a science-driven guideline for the bioanalytical community and in line with the ICH mission - that is, achieve greater harmonization worldwide to ensure that safe, effective and high-quality medicines are developed and registered in the most resource-efficient manner.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Highlights from the 25th International Reid Bioanalytical Forum. 第 25 届国际里德生物分析论坛花絮。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-13 DOI: 10.4155/bio-2024-0018
Neil Spooner, Sankeetha Nadarajah, Tim Sangster
{"title":"Highlights from the 25th International Reid Bioanalytical Forum.","authors":"Neil Spooner, Sankeetha Nadarajah, Tim Sangster","doi":"10.4155/bio-2024-0018","DOIUrl":"10.4155/bio-2024-0018","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interlaboratory evaluation of LC-MS-based biomarker assays. 基于液相色谱-质谱联用技术的生物标志物测定的实验室间评估。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0173
Kosuke Saito, Ryoya Goda, Koji Arai, Kota Asahina, Mitsuhiko Kawabata, Hitoshi Uchiyama, Tomohiro Andou, Hisao Shimizu, Kentaro Takahara, Masaaki Kakehi, Saki Yamauchi, Shin-Ichiro Nitta, Takahiro Suga, Hisashi Fujita, Rika Ishikawa, Yoshiro Saito
{"title":"Interlaboratory evaluation of LC-MS-based biomarker assays.","authors":"Kosuke Saito, Ryoya Goda, Koji Arai, Kota Asahina, Mitsuhiko Kawabata, Hitoshi Uchiyama, Tomohiro Andou, Hisao Shimizu, Kentaro Takahara, Masaaki Kakehi, Saki Yamauchi, Shin-Ichiro Nitta, Takahiro Suga, Hisashi Fujita, Rika Ishikawa, Yoshiro Saito","doi":"10.4155/bio-2023-0173","DOIUrl":"10.4155/bio-2023-0173","url":null,"abstract":"<p><p>Validation of biomarker assays is crucial for effective drug development and clinical applications. Interlaboratory reproducibility is vital for reliable comparison and combination of data from different centers. This review summarizes interlaboratory studies of quantitative LC-MS-based biomarker assays using reference standards for calibration curves. The following points are discussed: trends in reports, reference and internal standards, evaluation of analytical validation parameters, study sample analysis and normalization of biomarker assay data. Full evaluation of these parameters in interlaboratory studies is limited, necessitating further research. Some reports suggest methods to address variations in biomarker assay data among laboratories, facilitating organized studies and data combination. Method validation across laboratories is crucial for reducing interlaboratory differences and reflecting target biomarker responses.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Validation and comprehensive analysis of Streptococcus pneumoniae IgG WHO enzyme-linked immunosorbent assay in an Indian reference laboratory. 印度参考实验室对肺炎链球菌 IgG 世卫组织酶联免疫吸附试验的验证和综合分析。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-02-05 DOI: 10.4155/bio-2023-0111
Mettingal Ramakrishnan Shincy, Govindan Vandana, Manheri Mavupadi Akhila, Ravindran Shilpa, Kadahalli Lingegowda Ravikumar
{"title":"Validation and comprehensive analysis of <i>Streptococcus pneumoniae</i> IgG WHO enzyme-linked immunosorbent assay in an Indian reference laboratory.","authors":"Mettingal Ramakrishnan Shincy, Govindan Vandana, Manheri Mavupadi Akhila, Ravindran Shilpa, Kadahalli Lingegowda Ravikumar","doi":"10.4155/bio-2023-0111","DOIUrl":"10.4155/bio-2023-0111","url":null,"abstract":"<p><p>Monitoring serotype-specific IgG levels against pneumococci is crucial for assessing immunity, vaccine efficacy, and evaluating vaccination programs. The WHO ELISA for pneumococci is a standardized assay ensuring consistency in testing and comparability of results across laboratories. It involves a rigorous testing process to confirm accurate, precise and reliable detection of antibodies. We validated the protocol for 13 pneumococcal serotypes by assessing its specificity, reproducibility (coefficient of variation ≤15%), repeatability (coefficient of variation ≤20%), accuracy, lower limit of quantification, stability, and robustness. We found these parameters were within acceptable ranges and showed excellent performance. Our findings imply that the method employed is appropriate for evaluating 13 valent pneumococcal conjugate vaccine which is introduced in the national immunization program by comparing pre-and post-vaccination IgG response.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
UHPLC-MS/MS for plasma lamotrigine analysis and comparison with a homogenous enzyme immunoassay. 用于血浆拉莫三嗪分析的超高效液相色谱-质谱/质谱法以及与同源酶免疫分析法的比较。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0183
Xiaoxu Shi, Dongjie Zhang, Zhigang Zhao, Shenghui Mei
{"title":"UHPLC-MS/MS for plasma lamotrigine analysis and comparison with a homogenous enzyme immunoassay.","authors":"Xiaoxu Shi, Dongjie Zhang, Zhigang Zhao, Shenghui Mei","doi":"10.4155/bio-2023-0183","DOIUrl":"10.4155/bio-2023-0183","url":null,"abstract":"<p><p><b>Aims:</b> To develop and validate a UHPLC-MS/MS method for lamotrigine (LTG) analysis in human plasma and evaluate its agreement with a homogenous enzyme immunoassay (HEIA). <b>Materials & methods:</b> The UHPLC-MS/MS method was developed and validated according to the USFDA/EMA guidelines. A Bland-Altman plot was used to evaluate the agreement between UHPLC-MS/MS and HEIA. <b>Results:</b> Samples were pretreated with one-step protein precipitation and separated in 2.6 min. The intra- and inter-day bias and imprecisions were -15.8 to 15.0% and less than 11.17%, respectively. The recovery and matrix factor were 98.30 to 111.97%. The mean overestimation of UHPLC-MS/MS compared with HEIA was 21.57%. <b>Conclusion:</b> A rapid, sensitive and robust UHPLC-MS/MS method for plasma LTG analysis was developed and validated and was a 21.57% overestimation compared with HEIA.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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