Pub Date : 2024-02-01Epub Date: 2024-01-10DOI: 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":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":"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}
Aim: This study aimed to develop a colorimetric approach for quantifying ethanol using smartphone image analysis. Method: 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. Results: The results showed that this method was able to estimate ethanol concentrations in the range of 300-1500 and 1600-8000 μg ml-1 in EBC. Conclusion: 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.
{"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":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":"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}
Pub Date : 2024-02-01Epub Date: 2023-12-13DOI: 10.4155/bio-2023-0179
Alejandro R Foley, Gizette Sperinde, Saloumeh K Fischer
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.
{"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":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":"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}
Pub Date : 2024-02-01Epub Date: 2024-01-16DOI: 10.4155/bio-2023-0210
Mashanipalya G Jagadeeshaprasad, Jianing Zeng, Naiyu Zheng
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.
{"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":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":"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}
Pub Date : 2024-02-01Epub Date: 2024-01-10DOI: 10.4155/bio-2023-0233
Amol Chhatrapati Bisen, Rabi Sankar Bhatta
Aim: 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. Methods: 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 C18 column using methanol and 0.1% formic acid containing deionized water (85:15, v/v). Results & conclusion: 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.
{"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":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":"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}
Pub Date : 2024-01-01Epub Date: 2023-11-22DOI: 10.4155/bio-2023-0171
John Takyi-Williams, Abbie D Leino, Ruiting Li, Kevin J Downes, Athena F Zuppa, Amanda Bwint, Bo Wen, Duxin Sun, Marc H Scheetz, Manjunath P Pai
Background: Volumetric absorptive microsamples (VAMS) can support pharmacokinetic / pharmacodynamic studies. We present the bioanalytical method development for the simultaneous quantification of ampicillin, cefepime, ceftriaxone, meropenem, piperacillin, tazobactam, and vancomycin from VAMS. Methods & results: Optimal extraction, chromatographic, and mass spectrometry conditions were identified. Maximum extraction recoveries included 100 μl of water for rehydration and methanol for protein precipitation. Chromatographic separation used Phenomenex Kinetex™ Polar C18 column with a mobile phase comprising water/acetonitrile with formic acid and was fully validated. Hematocrit effects were only observed for vancomycin. Samples were stable for 90 days at -80°C except for meropenem, which was stable for 60 days. Conclusion: Multiple antibiotics can be assayed from a single VAMS sample to facilitate pharmacokinetic/pharmacodynamic studies.
{"title":"Bioanalysis of six antibiotics from volumetric microsamples: a new tool for precision dosing in critically ill children.","authors":"John Takyi-Williams, Abbie D Leino, Ruiting Li, Kevin J Downes, Athena F Zuppa, Amanda Bwint, Bo Wen, Duxin Sun, Marc H Scheetz, Manjunath P Pai","doi":"10.4155/bio-2023-0171","DOIUrl":"10.4155/bio-2023-0171","url":null,"abstract":"<p><p><b>Background:</b> Volumetric absorptive microsamples (VAMS) can support pharmacokinetic / pharmacodynamic studies. We present the bioanalytical method development for the simultaneous quantification of ampicillin, cefepime, ceftriaxone, meropenem, piperacillin, tazobactam, and vancomycin from VAMS. <b>Methods & results:</b> Optimal extraction, chromatographic, and mass spectrometry conditions were identified. Maximum extraction recoveries included 100 μl of water for rehydration and methanol for protein precipitation. Chromatographic separation used Phenomenex Kinetex<sup>™</sup> Polar C18 column with a mobile phase comprising water/acetonitrile with formic acid and was fully validated. Hematocrit effects were only observed for vancomycin. Samples were stable for 90 days at -80°C except for meropenem, which was stable for 60 days. <b>Conclusion:</b> Multiple antibiotics can be assayed from a single VAMS sample to facilitate pharmacokinetic/pharmacodynamic studies.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10718164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138290193","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}
Pub Date : 2024-01-01Epub Date: 2023-11-22DOI: 10.4155/bio-2023-0149
Ilona Đorić, Sonja Šelemetjev
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.
{"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":null,"pages":null},"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}
Pub Date : 2024-01-01Epub Date: 2023-12-05DOI: 10.4155/bio-2023-0116
Bastien Baud, Anne Marie Dupuy, Samuel Zozor, Stéphanie Badiou, Anne Sophie Bargnoux, Olivier Mathieu, Jean Paul Cristol
Background: The authors report the relevance of using a point of care test (Helge®) for free hemoglobin determination and concordance of the values the with Cobas® 8000 and spectrophotometer methods. Results: 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. Conclusion: 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.
{"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":null,"pages":null},"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}
Pub Date : 2024-01-01Epub Date: 2024-03-26DOI: 10.4155/bio-2024-0051
Olga Begou, Artemis Lioupi, Georgina Page, Shwan Ahmed, Svenja Stiltz, Rebecca Dowell, Jack Lodge
The 25th edition of the International Reid Bioanalytical Forum (REID) was held at the Cambridge Belfry (Cambourne, UK) between 4 and 7 September 2023 and hosted approximately 100 delegates, the majority of whom were attending the event for their first time.REID encourages early-career researchers to present their work and have a bursary program to help provide them support. At the 2023 event, REID welcomed 15 bursary winners to provide them with the opportunity to participate in their first international meeting, network with their peers and make their first oral, or poster presentation. The bursary winners also had the opportunity to interview with the Bioanalysis journal and their responses to the interview questions are transcribed below in this second part of two.
{"title":"An interview with <i>Bioanalysis</i>: speaking with the 2023 Reid bursary award winners - part 2.","authors":"Olga Begou, Artemis Lioupi, Georgina Page, Shwan Ahmed, Svenja Stiltz, Rebecca Dowell, Jack Lodge","doi":"10.4155/bio-2024-0051","DOIUrl":"10.4155/bio-2024-0051","url":null,"abstract":"<p><p>The 25th edition of the International Reid Bioanalytical Forum (REID) was held at the Cambridge Belfry (Cambourne, UK) between 4 and 7 September 2023 and hosted approximately 100 delegates, the majority of whom were attending the event for their first time.REID encourages early-career researchers to present their work and have a bursary program to help provide them support. At the 2023 event, REID welcomed 15 bursary winners to provide them with the opportunity to participate in their first international meeting, network with their peers and make their first oral, or poster presentation. The bursary winners also had the opportunity to interview with the <i>Bioanalysis</i> journal and their responses to the interview questions are transcribed below in this second part of two.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11235136/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140288094","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}