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Finding our way in the In Vitro Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum. 在体外诊断医疗器械法规中找到我们的方向：欧洲生物分析论坛的讨论文件。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-10 DOI: 10.4155/bio-2023-0262
Philip Timmerman, Anna Laurén, Robert Nelson, Matthew Barfield
{"title":"Finding our way in the <i>In Vitro</i> Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum.","authors":"Philip Timmerman, Anna Laurén, Robert Nelson, Matthew Barfield","doi":"10.4155/bio-2023-0262","DOIUrl":"10.4155/bio-2023-0262","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"117-120"},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139401631","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
Digital image colorimetry for determination of ethanol in exhaled breath condensate. 数字图像比色法测定呼出气体冷凝物中的乙醇含量。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-16 DOI: 10.4155/bio-2023-0147
Yasaman Sefid-Sefidehkhan, Maryam Khoshkam, Samineh Raha, Fariba Pourkarim, Abolghasem Jouyban, Maryam Khoubnasabjafari, Vahid Jouyban-Gharamaleki, Elaheh Rahimpour
{"title":"Digital image colorimetry for determination of ethanol in exhaled breath condensate.","authors":"Yasaman Sefid-Sefidehkhan, Maryam Khoshkam, Samineh Raha, Fariba Pourkarim, Abolghasem Jouyban, Maryam Khoubnasabjafari, Vahid Jouyban-Gharamaleki, Elaheh Rahimpour","doi":"10.4155/bio-2023-0147","DOIUrl":"10.4155/bio-2023-0147","url":null,"abstract":"<p><p><b>Aim:</b> This study aimed to develop a colorimetric approach for quantifying ethanol using smartphone image analysis. <b>Method:</b> This research presents a straightforward smartphone-based colorimetric sensor that efficiently measures ethanol levels in exhaled breath condensate (EBC) samples. The process involved changing the acidic dichromate color in an ethanolic solution, followed by image analysis. <b>Results:</b> The results showed that this method was able to estimate ethanol concentrations in the range of 300-1500 and 1600-8000 μg ml<sup>-1</sup> in EBC. <b>Conclusion:</b> This study was a follow-up study on the previous work published for the determination of ethanol in EBC samples and highlights the potential benefits of using digital images and smartphone applications for ethanol determination in biological samples.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"121-128"},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139471800","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
Expanding assay range to accommodate a monoclonal antibody therapeutic quantification in blood and cerebrospinal fluid. 扩大检测范围，以适应血液和脑脊液中单克隆抗体的治疗定量。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2023-12-13 DOI: 10.4155/bio-2023-0179
Alejandro R Foley, Gizette Sperinde, Saloumeh K Fischer
{"title":"Expanding assay range to accommodate a monoclonal antibody therapeutic quantification in blood and cerebrospinal fluid.","authors":"Alejandro R Foley, Gizette Sperinde, Saloumeh K Fischer","doi":"10.4155/bio-2023-0179","DOIUrl":"10.4155/bio-2023-0179","url":null,"abstract":"<p><p>Antibody therapeutic levels in neurodegenerative diseases are often measured in both serum and cerebrospinal fluid (CSF). Due to 0.1% drug partition from serum to CSF and the higher sensitivity needs, usually two different assays are required. The different Gyrolab Bioaffy compact discs can extend the dynamic range of assays. Here, an assay was developed and adapted on two different Gyrolab Bioaffy compact discs (200 and 4000 nl) to achieve the required sensitivity and assay dynamic range needed for the measurement of drug in both serum and CSF. This was accomplished by using the same critical reagents with minimal assay development to transition from a serum to a CSF assay.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"129-140"},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138796664","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
WRIB Poster Awards winners 2023. 2023 年 WRIB 海报奖获奖者。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-25 DOI: 10.4155/bio-2024-0012
Jennifer Getz, Shannon McGrath, Gus Hui
{"title":"WRIB Poster Awards winners 2023.","authors":"Jennifer Getz, Shannon McGrath, Gus Hui","doi":"10.4155/bio-2024-0012","DOIUrl":"10.4155/bio-2024-0012","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"185-189"},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139544846","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
LC-MS bioanalysis of protein biomarkers and protein therapeutics in formalin-fixed paraffin-embedded tissue specimens. 对福尔马林固定石蜡包埋组织标本中的蛋白质生物标记物和蛋白质疗法进行液相色谱-质谱生物分析。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-16 DOI: 10.4155/bio-2023-0210
Mashanipalya G Jagadeeshaprasad, Jianing Zeng, Naiyu Zheng
{"title":"LC-MS bioanalysis of protein biomarkers and protein therapeutics in formalin-fixed paraffin-embedded tissue specimens.","authors":"Mashanipalya G Jagadeeshaprasad, Jianing Zeng, Naiyu Zheng","doi":"10.4155/bio-2023-0210","DOIUrl":"10.4155/bio-2023-0210","url":null,"abstract":"<p><p>Formalin-fixed paraffin-embedded (FFPE) is a form of preservation and preparation for biopsy specimens. FFPE tissue specimens are readily available as part of oncology studies because they are often collected for disease diagnosis or confirmation. FFPE tissue specimens could be extremely useful for retrospective studies on protein biomarkers because the samples preserved in FFPE blocks could be stable for decades. However, LC-MS bioanalysis of FFPE tissues poses significant challenges. In this Perspective, we review the benefits and recent developments in LC-MS approach for targeted protein biomarker and protein therapeutic analysis using FFPE tissues and their clinical and translational applications. We believe that LC-MS bioanalysis of protein biomarkers in FFPE tissue specimens represents a great potential for its clinical applications.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"245-258"},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139471805","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
Ocular bioanalysis of moxifloxacin and ketorolac tromethamine in rabbit lacrimal matrix using liquid chromatography-tandem mass spectrometry. 利用液相色谱-串联质谱法对兔泪液基质中的莫西沙星和酮咯酸氨丁三醇进行眼部生物分析。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-10 DOI: 10.4155/bio-2023-0233
Amol Chhatrapati Bisen, Rabi Sankar Bhatta
{"title":"Ocular bioanalysis of moxifloxacin and ketorolac tromethamine in rabbit lacrimal matrix using liquid chromatography-tandem mass spectrometry.","authors":"Amol Chhatrapati Bisen, Rabi Sankar Bhatta","doi":"10.4155/bio-2023-0233","DOIUrl":"10.4155/bio-2023-0233","url":null,"abstract":"<p><p><b>Aim:</b> The fixed-dose combination of moxifloxacin (MOXI) and ketorolac tromethamine (KTR) is widely used for the treatment of bacterial keratitis. Thus, a new LC-MS/MS method was developed to determine MOXI and KTR in lacrimal fluid. <b>Methods:</b> Bioanalysis was performed using a Shimadzu 8050 LC-MS/MS in electrospray ionization-positive mode and the method was validated per US FDA guidelines. Isocratic separation was performed with a Waters Symmetry C<sub>18</sub> column using methanol and 0.1% formic acid containing deionized water (85:15, v/v). <b>Results & conclusion:</b> An easy, quick and selective method was established and applied to assess the ocular pharmacokinetic profile of a commercially available formulation containing MOXI and KTR. Based on the pharmacokinetic data, this work describes pharmacokinetics-based dosage regimen calculations and their clinical significance.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"219-232"},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139401633","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
Free hemoglobin determination at patients' bedside to evaluate hemolysis. 床边检测游离血红蛋白评价溶血情况。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-12-05 DOI: 10.4155/bio-2023-0116
Bastien Baud, Anne Marie Dupuy, Samuel Zozor, Stéphanie Badiou, Anne Sophie Bargnoux, Olivier Mathieu, Jean Paul Cristol
{"title":"Free hemoglobin determination at patients' bedside to evaluate hemolysis.","authors":"Bastien Baud, Anne Marie Dupuy, Samuel Zozor, Stéphanie Badiou, Anne Sophie Bargnoux, Olivier Mathieu, Jean Paul Cristol","doi":"10.4155/bio-2023-0116","DOIUrl":"10.4155/bio-2023-0116","url":null,"abstract":"<p><p><b>Background:</b> The authors report the relevance of using a point of care test (Helge<sup>®</sup>) for free hemoglobin determination and concordance of the values the with Cobas<sup>®</sup> 8000 and spectrophotometer methods. <b>Results:</b> The within-run of the point of care test was <3%. Good correlations among the three methods were observed and an acceptable concordance for hemolysis index values from 50 mg/dl. An excellent agreement between the Cobas 8000 and the spectrophotometer was found. <b>Conclusion:</b> Automated methods represent methods of choice for free hemoglobin determination. An advantage of the Helge system is that it can be applied to samples experiencing a delay in evaluation due to the long distance between the collection site and the central laboratory. Another advantage is its use at the bedside, in the monitoring of extracorporeal membrane oxygenation patients.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"65-74"},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138481789","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
Challenges and current advances in the methodology of thyroglobulin measurements. 甲状腺球蛋白测量方法的挑战和当前进展。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-11-22 DOI: 10.4155/bio-2023-0149
Ilona Đorić, Sonja Šelemetjev
{"title":"Challenges and current advances in the methodology of thyroglobulin measurements.","authors":"Ilona Đorić, Sonja Šelemetjev","doi":"10.4155/bio-2023-0149","DOIUrl":"10.4155/bio-2023-0149","url":null,"abstract":"<p><p>Thyroglobulin (Tg) is a large protein secreted exclusively by the thyroid gland. In a clinical setting, it is measured for the purpose of follow-up of thyroidectomy patients. However, Tg measurements are often impeded by the presence of Tg autoantibodies and/or heterophylic antibodies that interfere with most measuring platforms. This presents a global problem in thyroid cancer patients who need to be postoperatively monitored for recurrent or residual disease. Therefore, in this paper we offer an overview of the existing methodologies and alternative approaches for Tg measurements that are a focus of research worldwide. These include Tg mRNA measurements, exosomal Tg detection, the use of alternative analytes (liquid biopsies) and the development of new approaches for preanalytical sample treatment.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"49-60"},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138290194","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 comparison of branched DNA and reverse transcriptase quantitative polymerase chain reaction methodologies for quantitation of lipid nanoparticle encapsulated mRNA. 比较支链 DNA 和逆转录酶定量聚合酶链反应方法对脂质纳米颗粒封装的 mRNA 进行定量。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-10-18 DOI: 10.1080/17576180.2024.2411914
Syed Ali, Matt Bruno, Caleb Celestin, Pratibha Chauhan, Marissa Mitola, Shilpa Sharma, Chiaowen Joyce Hsiao, Mengying Li, Lei Ci, Douglas Burdette, Harkewal Singh
{"title":"A comparison of branched DNA and reverse transcriptase quantitative polymerase chain reaction methodologies for quantitation of lipid nanoparticle encapsulated mRNA.","authors":"Syed Ali, Matt Bruno, Caleb Celestin, Pratibha Chauhan, Marissa Mitola, Shilpa Sharma, Chiaowen Joyce Hsiao, Mengying Li, Lei Ci, Douglas Burdette, Harkewal Singh","doi":"10.1080/17576180.2024.2411914","DOIUrl":"10.1080/17576180.2024.2411914","url":null,"abstract":"<p><p>Messenger RNA (mRNA)-based therapeutics have emerged as a promising modality for various clinical applications, necessitating robust methods for mRNA quantification. This biodistribution study compares the performance of branched DNA and reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) assays for measuring lipid nanoparticle-encapsulated mRNA. Following intravenous administration of nascent peptide imaging luciferase mRNA (1 mg/kg) to rats, mRNA levels in various tissues and serum were quantified using both assays. Statistical analyses, including Bland-Altman, Deming regression and Passing-Bablok regression, were employed to assess method comparability and reproducibility. The results indicated that mRNA pharmacokinetics measured by branched DNA and RT-qPCR were largely consistent across tissues, with RT-qPCR showing greater reproducibility across multiple laboratories. RT-qPCR also demonstrated a wider dynamic range and higher sensitivity, making it a more versatile option for large-scale studies. Despite some differences in data due to tissue types and timepoints, both methods provided comparable pharmacokinetic profiles for mRNA quantification. This study underscores the importance of selecting an appropriate quantification method based on study requirements and highlights RT-qPCR's adaptability for multisite research, especially for the clinical development of mRNA-based therapeutics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1141-1154"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11583626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Determination of drugs of abuse and metabolites in plasma microsamples by LC-MS/MS after microQuEChERS extraction. 微量 QuEChERS 萃取后通过 LC-MS/MS 测定血浆微量样本中的滥用药物和代谢物。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-09-27 DOI: 10.1080/17576180.2024.2404383
Mariana Smidt, Marcos Frank Bastiani, Roberta Zilles Hahn, Lilian de Lima Feltraco Lizot, Amanda Pacheco Bondan, Giovana Piva Peteffi, Náthaly Cbf Dos Santos, José Luiz da Costa, Rafael Lanaro, Rafael Linden
{"title":"Determination of drugs of abuse and metabolites in plasma microsamples by LC-MS/MS after microQuEChERS extraction.","authors":"Mariana Smidt, Marcos Frank Bastiani, Roberta Zilles Hahn, Lilian de Lima Feltraco Lizot, Amanda Pacheco Bondan, Giovana Piva Peteffi, Náthaly Cbf Dos Santos, José Luiz da Costa, Rafael Lanaro, Rafael Linden","doi":"10.1080/17576180.2024.2404383","DOIUrl":"10.1080/17576180.2024.2404383","url":null,"abstract":"<p><p><b>Aim:</b> Identifying drugs of abuse and their metabolites in plasma is vital in both forensic and clinical toxicology. While the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method offers an efficient approach to sample preparation, its application is complex due to the wide-ranging properties of target analytes and the challenges posed by biological matrix interferences. This study aims to develop a microQuEChERS approach for the quantification of 14 drugs of abuse and metabolites utilizing minimal sample and solvent volumes.<b>Methods:</b> The microQuEChERS method involved using 10 μl plasma samples, 25 mg of a salt mixture and 150 μl of acetonitrile. Extracts were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS), with a 7.5 min run. The assay was validated according to bioanalytical guidelines.<b>Results:</b> The accuracy was 96.8-112.4%. The within-assay precision was within 2.0-8.9% and the between-assay precision was within 3.2-8.2%. Matrix effects were found to range from -5.7 to 13.5%. The extraction yield was higher than 74.7%.<b>Conclusion:</b> This study described a microQuEChERS sample preparation approach for determining drugs of abuse and metabolites using plasma microsamples and LC-MS/MS. The approach is efficient, environmentally friendly and suitable for scenarios with limited amounts of biological samples.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1055-1065"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581147/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142340405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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