Bioanalysis最新文献_第5页

Comparison of SERS spectral data sets of blood serum samples of hypopharyngeal cancer using silver and gold nanoparticles as substrates. 以金纳米粒子和银纳米粒子为底物的下咽癌血清样本SERS光谱数据集的比较。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-06-30 DOI: 10.1080/17576180.2026.2693664

Muhammad Muaz Tariq, Kashif Ali, Haq Nawaz, Muhammad Irfan Majeed, Nosheen Rashid, Allah Ditta, Kinza Khan, Farzana Shamim, Rimsha Khan, Riha Zulfiqar, Aqsa Nawaz, Asmat Ullah, Mohsin Ali

{"title":"Comparison of SERS spectral data sets of blood serum samples of hypopharyngeal cancer using silver and gold nanoparticles as substrates.","authors":"Muhammad Muaz Tariq, Kashif Ali, Haq Nawaz, Muhammad Irfan Majeed, Nosheen Rashid, Allah Ditta, Kinza Khan, Farzana Shamim, Rimsha Khan, Riha Zulfiqar, Aqsa Nawaz, Asmat Ullah, Mohsin Ali","doi":"10.1080/17576180.2026.2693664","DOIUrl":"10.1080/17576180.2026.2693664","url":null,"abstract":"Background: Early detection of hypopharyngeal cancer is crucial for a good prognosis and survival, as it is mostly diagnosed at an advanced stage due to subtle early symptoms. Blood serum contains valuable diagnostic biomarkers for disease screening as it contains metabolites from various tissues and organs in the body and represents the biochemical changes occurring due to disease development.Research design and methods: Surface-enhanced Raman spectroscopy (SERS) was applied to blood serum from healthy individuals and patients at different stages of hypopharyngeal cancer. Both silver (AgNPs) and gold nanoparticles (AuNPs) were used as SERS substrates to compare their SERS features. Principal component analysis and linear discriminant analysis (PCA-LDA), along with support vector machine (SVM) were performed to analyze and differentiate the features of both substrates.Results: The analysis revealed complementary SERS spectral features associated to specific nanoparticles as a substrate for cancer diagnostics and metabolic profiling. The SVM classifier achieved an overall accuracy of >90%, with a macro-averaged AUC of 0.98. The class-wise performance metrics (precision, recall, and F1-score) approached unity, which confirms the robust discrimination across all diagnostic groups.Conclusions: The comparison of SERS spectra of both substrates identified that both substrates differentiate the healthy from cancerous ones while providing different and complementary spectral features.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"751-765"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557605/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148350419","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

Laser-printed microfluidic paper analytical device for rapid separation of whole blood and hematocrit estimation by smartphone readout. 用于全血快速分离和智能手机读数估算红细胞压积的激光打印微流控纸分析装置。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-06-23 DOI: 10.1080/17576180.2026.2692463

Adewoyin M Ogunmolasuyi, Christabel-Glory D Oloyede, Esther U Archibong, Jonathan K Irhodia, Paul I Ige

{"title":"Laser-printed microfluidic paper analytical device for rapid separation of whole blood and hematocrit estimation by smartphone readout.","authors":"Adewoyin M Ogunmolasuyi, Christabel-Glory D Oloyede, Esther U Archibong, Jonathan K Irhodia, Paul I Ige","doi":"10.1080/17576180.2026.2692463","DOIUrl":"10.1080/17576180.2026.2692463","url":null,"abstract":"In contrast to the widely used centrifugation and hematocrit method, this report presents a simple-to-fabricate paper microfluidic device (µPAD) for the estimation of RBC and hematocrit using µPAD dimensions, histogram, relative colorimetric intensity, and threshold algorithms. With laser printing (LP) technology, LP-µPAD was fabricated to fractionate freshly collected whole blood from male Wistar rats and human blood samples. Fluid flow on the LP-µPAD was tested to assess the capability of the toner-fortified hydrophobic barrier to confine fluid within designated hydrophilic regions. Taking 30 µl of different percentages of whole blood from rats, the LP-µPAD was evaluated to concentrate RBCs at sample zones to estimate hematocrit levels in rat and human blood samples. The LP-µPAD demonstrated promising capability to confine fluids within the hydrophobic barrier and separate blood samples. Whilst the histogram revealed one peak in whole blood, relative colorimetric intensity methods predicted a critical point (32.00%) useful for determining anemic condition, and the threshold algorithm was employed for the visualization of the captured RBCs at the sample zone. Likewise, with the dimension of the µPAD geometry, hematocrit levels were determined in all the samples on a par with the hematocrit method. Thus, LP-µPAD is a frugal alternative to wax printing and effective for hematocrit estimation at the point of care.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"701-709"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13449756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148300757","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

Potential remote measurement of C-peptide using a minimally invasive and convenient sampling technique. 潜在的远程测量c肽使用微创和方便的采样技术。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-07-24 DOI: 10.1080/17576180.2026.2690265

Kathryn Duschean, Nina Vujovic, Emad Dumar, Lili Yu, Fedelis Mutiso, Allison B Goldfine, Arkady Gusev, Dmitri Mikhailov, Arvind Kinhikar

{"title":"Potential remote measurement of C-peptide using a minimally invasive and convenient sampling technique.","authors":"Kathryn Duschean, Nina Vujovic, Emad Dumar, Lili Yu, Fedelis Mutiso, Allison B Goldfine, Arkady Gusev, Dmitri Mikhailov, Arvind Kinhikar","doi":"10.1080/17576180.2026.2690265","DOIUrl":"10.1080/17576180.2026.2690265","url":null,"abstract":"Background: In clinical research, alternatives to venipuncture can reduce participant burden and increase accessibility and sampling opportunities for biomarkers. Residual pancreatic beta-cell function is assessed in clinical research and in diabetes care using fasting and stimulated C-peptide measurements, and changes are assessed over time. Operational, technical, and acceptability considerations of utilizing Tasso+ SST devices for C-peptide collection compared to venipuncture-derived serum samples were investigated.Methodology: Samples were collected from prospectively enrolled healthy participants via Third Generation Tasso+ SST micro-sampling devices and phlebotomy. Eleven fasted Tasso+ samples collected on-site or remote underwent alternative handling conditions and were evaluated for consistency, quality, and stability. Participants responded to device acceptability questionnaires.Results: The Tasso+ SST micro-sampling device showed excellent concordance with simultaneous venipuncture-derived fasted C-Peptide, with concentration being largely conserved in healthy volunteers despite alternative sample handling. Delayed centrifugation over 72 hours caused no consequential degradation of C-peptide when kept at 4°C. Questionnaire responses indicate acceptable device usability and associated comfort levels.Conclusion: Fasting C-peptide levels can be accurately collected using micro-sampling collection techniques. Tasso+ C-peptide stability is seen when kept at 4°C. Micro-sampling devices can be used with shipping mechanisms (without centrifugation) to decrease participant burden, expand trial populations, and aid biomarker measurements.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"723-734"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148577009","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

A simple, sensitive microsample LC-MS assay for quercetin and isorhamnetin in mouse and human plasma: application to EMIQ treatment in myotonic dystrophy type 1. 小鼠和人血浆中槲皮素和异鼠李素的一种简单、灵敏的微样品LC-MS测定方法：应用EMIQ治疗1型肌强直性营养不良。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-07-03 DOI: 10.1080/17576180.2026.2695233

Purnajai Srivijay Saravanan Vanaja, Subodh Mishra, John Douglas Cleary, Masayuki Nakamori, J Andrew Berglund, Nicholas E Johnson, Phillip M Gerk

{"title":"A simple, sensitive microsample LC-MS assay for quercetin and isorhamnetin in mouse and human plasma: application to EMIQ treatment in myotonic dystrophy type 1.","authors":"Purnajai Srivijay Saravanan Vanaja, Subodh Mishra, John Douglas Cleary, Masayuki Nakamori, J Andrew Berglund, Nicholas E Johnson, Phillip M Gerk","doi":"10.1080/17576180.2026.2695233","DOIUrl":"10.1080/17576180.2026.2695233","url":null,"abstract":"Background: Quercetin, a dietary flavonoid with emerging therapeutic relevance in myotonic dystrophy type 1 (DM1), has low solubility and poor oral bioavailability. Enzymatically modified isoquercitrin (EMIQ), a water-soluble prodrug, raises systemic quercetin exposure. Pharmacokinetic studies require a sensitive assay that uses minimal sample volume.Research design and methods: We developed a single-quadrupole liquid chromatography-mass spectrometry (LC-MS) assay for free quercetin, total quercetin (after enzymatic hydrolysis of glucuronide and sulfate conjugates), and the methylated metabolite isorhamnetin in mouse and human plasma. The method used protein precipitation, 10 µL of plasma, reversed-phase C18 separation, and single-ion recording of [M+H]+ adducts. Validation followed a fit-for-purpose approach consistent with M10 guidelines, and the assay was applied to plasma from EMIQ-treated DM1 and wild-type mice (15 g/L for 6 and 12 weeks).Results: Calibration curves showed r2 > 0.99, with an LLOQ of 0.070 µM for quercetin in both matrices. The assay was successfully validated for quercetin in mouse and human plasma. Total quercetin and isorhamnetin were quantifiable in all treated mice. Exploratory analysis suggested glucuronidation as the major conjugation pathway.Conclusions: This simple, cost-effective microsampling assay suits preclinical and translational studies of EMIQ in DM1, though the conjugation findings remain exploratory.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"777-788"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13449854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148374518","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

Characterization of abatacept mediated immunogenicity using domain-specific and neutralizing antibody assays: a biosimilar perspective. 使用区域特异性和中和抗体测定阿巴接受介导的免疫原性的表征：生物类似药的观点。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-07-27 DOI: 10.1080/17576180.2026.2693653

Kamala Bhavaraju, Mansi Dhananjaya Jakhade, Aparna Kasinath

{"title":"Characterization of abatacept mediated immunogenicity using domain-specific and neutralizing antibody assays: a biosimilar perspective.","authors":"Kamala Bhavaraju, Mansi Dhananjaya Jakhade, Aparna Kasinath","doi":"10.1080/17576180.2026.2693653","DOIUrl":"10.1080/17576180.2026.2693653","url":null,"abstract":"Background: Abatacept, a CTLA-4-IgG1 Fc fusion protein, may induce anti-drug antibodies (ADAs) targeting distinct domains with varying functional and clinical implications. Antibodies directed against the CTLA-4 domain are of particular interest due to their similarity to endogenous CTLA-4, highlighting the importance of domain-specific immunogenicity assessment in biosimilar development.Research design and methods: A domain-specific, multi-tier immunogenicity strategy was applied in a Phase 1, randomized, double-blind, parallel, single-dose study comparing DRL_Abatacept with US- and EU-licensed reference products in healthy subjects. ADA detection employed a drug-tolerant electrochemiluminescence bridging assay with acid dissociation, followed by confirmatory whole-molecule abatacept and CTLA-4 domain-specific assays, titer determination, and a cell-based neutralizing antibody (NAb) assay.Results: ADA assays demonstrated high sensitivity (3.69-5.07 ng/mL), precision (≤12% CV), and drug tolerance up to 500 µg/mL, with no hook effect observed. The NAb assay showed sensitivity of 391.47 ng/mL and acceptable reproducibility (≤30% CV). ADA incidence at Day 85 was low and comparable across treatment arms, with predominantly low-titer responses and no clinically meaningful impact on safety.Conclusions: Only a subset of CTLA-4-specific binding ADAs exhibited neutralizing activity; within this Phase 1 study, domain-specific binding therefore did not consistently predict functional neutralization. A tiered, functionally anchored approach is essential for comprehensive immunogenicity assessment of complex fusion proteins.Clinical trial registration: EudraCT 2022-000926-94.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"735-750"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148590389","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

Consideration for immunogenicity assay development for oligonucleotide therapeutics. 对寡核苷酸治疗免疫原性试验发展的考虑。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-07-23 DOI: 10.1080/17576180.2026.2695220

Amily Fang-Ju Jou, Kelly M Hainline

{"title":"Consideration for immunogenicity assay development for oligonucleotide therapeutics.","authors":"Amily Fang-Ju Jou, Kelly M Hainline","doi":"10.1080/17576180.2026.2695220","DOIUrl":"10.1080/17576180.2026.2695220","url":null,"abstract":"Oligonucleotide therapeutics (ONTs) represent a rapidly expanding drug modality driven by advances in chemical modification, sequence design, and delivery technologies. These innovations have improved pharmacokinetics, tissue targeting, and clinical efficacy, but they may also introduce modality-specific challenges for immunogenicity risk assessment. Although ONTs are regulated as small molecules and routine immunogenicity testing is not universally required, anti-drug antibody (ADA) responses have been reported and may impact pharmacokinetics and safety in certain contexts. Compared with protein therapeutics, regulatory guidance, and practical experience for immunogenicity assessment of ONTs remain limited. This review summarizes the diverse oligonucleotide types, chemical modifications, and carrier modalities used in approved and emerging ONTs and examines how these attributes influence immunogenic risk and ADA assay development. Key challenges include potential nonspecific protein binding, reagent generation, immunodominance of conjugated components, and the need for specialized assay formats. Building on established principles from protein biologics while recognizing their limitations for oligonucleotides, this review highlights risk-informed strategies for ADA assay design to support immunogenicity assessment as ONT platforms continue to evolve.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"823-837"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148560664","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

Reference values for urinary 2-phenyl-2-propanol as a biomarker of cumene exposure in a non-occupationally exposed population determined by GC-MS. 用气相色谱-质谱法测定非职业暴露人群尿中2-苯基-2-丙醇作为异丙烯暴露生物标志物的参考值。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-07-16 DOI: 10.1080/17576180.2026.2698605

Stefano Dugheri, Giovanni Cappelli, Niccolò Fanfani, Ilaria Rapi, Sara Pierattini, Michele Santillo, Antonio Baldassarre, Nicola Mucci

{"title":"Reference values for urinary 2-phenyl-2-propanol as a biomarker of cumene exposure in a non-occupationally exposed population determined by GC-MS.","authors":"Stefano Dugheri, Giovanni Cappelli, Niccolò Fanfani, Ilaria Rapi, Sara Pierattini, Michele Santillo, Antonio Baldassarre, Nicola Mucci","doi":"10.1080/17576180.2026.2698605","DOIUrl":"10.1080/17576180.2026.2698605","url":null,"abstract":"Background: Cumene is a high-production volume aromatic hydrocarbon recently reclassified as a Category 1B carcinogen, and 2-Phenyl-2-Propanol (2P2P) is its primary urinary metabolite. Highly sensitive analytical methods, required to detect the low-level exposures typical of the non- occupationally exposed general population, are not available for this compound in literature to this day.Research design and methods: This research details the development and validation of a fully automated Gas Chromatography-Mass Spectrometry (GC-MS) method using SPME extraction to quantify 2P2P at ng/L levels.Results: The study established reference values by analyzing 242 non-exposed workers, yielding a background range of 31.6-652.7 ng/L (5th-95th percentiles). The literature review encompassed global production trends, environmental ubiquity, and human metabolism. Furthermore, the study utilized biomarkers like cotinine and S-Phenyl Mercapturic Acid (SPMA) to statistically evaluate smoking as a potential confounder.Conclusion: This method fills a significant technical gap by providing a noninvasive, highly sensitive tool for health surveillance. Establishing empirical background reference values is essential for accurately distinguishing between environmental and occupational exposure. Critically, statistical analysis confirms that cigarette smoking is not a significant confounding factor for urinary 2P2P levels, reinforcing its reliability as a specific biomarker for cumene.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"789-796"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557600/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148454483","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

Development and preliminary clinical application of a time-resolved fluoroimmunoassay for anti-rituximab antibodies in membranous nephropathy. 膜性肾病中抗利妥昔单抗的时间分辨氟免疫测定法的开发和初步临床应用。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-06-25 DOI: 10.1080/17576180.2026.2693651

Shangbin Kao, Dian Li, Mingze Xin, Dongwei Liu, Tianyu Zheng, Yuan Qin, Xiumei Zhou, Nenghua Zhang, Liang Wang, Biao Huang

{"title":"Development and preliminary clinical application of a time-resolved fluoroimmunoassay for anti-rituximab antibodies in membranous nephropathy.","authors":"Shangbin Kao, Dian Li, Mingze Xin, Dongwei Liu, Tianyu Zheng, Yuan Qin, Xiumei Zhou, Nenghua Zhang, Liang Wang, Biao Huang","doi":"10.1080/17576180.2026.2693651","DOIUrl":"10.1080/17576180.2026.2693651","url":null,"abstract":"Objective: In some patients with membranous nephropathy (MN) receiving rituximab therapy, treatment failure may be partly related to the development of anti-rituximab antibodies (ADAs). This study aimed to establish a highly sensitive time-resolved fluoroimmunoassay (TRFIA) for detecting ADAs in these patients.Method: A streptavidin-coated microplate was used as the solid phase, with biotinylated rituximab as the capture antibody and Eu3+ -labeled rituximab as the detection antibody. A bridging assay was developed to detect ADAs, and the method was optimized, validated, and preliminarily applied in clinical testing.Results: The developed TRFIA exhibited a linear detection range of 12.5 ng/mL to 800 ng/mL, with a detection limit (LOD) of 3.93 ng/mL. The intra‑assay coefficient of variation (CV) ranged from 3.07% to 7.90%, and the inter‑assay CV ranged from 2.57% to 11.32%. Recovery rates spanned 87.06% to 104.11%, and no cross‑reactivity was detected with anti‑obinutuzumab or anti‑eculizumab. Compared to enzyme‑linked immunosorbent assay (ELISA), the TRFIA showed superior sensitivity (3.9 ng/mL vs. 10 ng/mL) and maintained strong agreement in sample detection (p < 0.0001).Conclusion: This assay demonstrates specific potential clinical utility in monitoring resistance to rituximab, providing valuable guidance for optimizing anti-CD20 monoclonal antibody therapy and developing personalized treatment plans.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"767-775"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148315600","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

The Gyrolab platform for immunogenicity assessment and biotherapeutic and biomarker analysis: technical advances and bioanalytical applications. 用于免疫原性评估和生物治疗和生物标志物分析的Gyrolab平台：技术进步和生物分析应用。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-06-25 DOI: 10.1080/17576180.2026.2693659

Yuji Mano, Kei Nabeshima, Tomoko Kojima

{"title":"The Gyrolab platform for immunogenicity assessment and biotherapeutic and biomarker analysis: technical advances and bioanalytical applications.","authors":"Yuji Mano, Kei Nabeshima, Tomoko Kojima","doi":"10.1080/17576180.2026.2693659","DOIUrl":"10.1080/17576180.2026.2693659","url":null,"abstract":"Gyrolab is an automated ligand‑binding assay platform designed for the quantification of proteins with high sensitivity and broad dynamic range. Its low minimum required dilution and microfluidic disc format enable efficient sample processing while maintaining assay robustness, making it a valuable tool across drug‑development stages. This review summarizes published applications of Gyrolab for pharmacokinetic and toxicokinetic analysis and immunogenicity assessment through anti‑drug antibody detection. In addition, the platform's high-volume assay discs have facilitated its use in biomarker studies, allowing quantification of low‑abundance analytes. Representative examples from the literature are presented together with key assay elements, including analytes, matrices, dynamic ranges, and critical reagents. Because assay replicates remain an important consideration for Gyrolab workflows, recent publications addressing singlet versus duplicate strategies and their impact on data interpretation are also discussed. Finally, we provide real analytical data visualized using a three‑dimensional Gyrolab viewer to illustrate variability in duplicate measurements and to highlight future opportunities for improving assay reliability.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"807-821"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148325924","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

Limited agreement of cytokines and CRP through patient-centric microsampling compared to venipuncture in healthy adults. 与健康成人静脉穿刺相比，以患者为中心的微采样检测细胞因子和CRP的一致性有限。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-06-01 Epub Date: 2026-07-09 DOI: 10.1080/17576180.2026.2698413

Pirinka Georgiev Tuttle, Tiffany Hidalgo, Catherine Soderstrom, F Isik Karahanoglu, Christian Russel Reyes, Yalei Chen, Carolina Owen, Mar Santamaria, Denise E Chou, Bunmi Williams, Anna Gao, Jessica Selig, Briana Peterson, Bhavna Adhin, Xuemei Cai

{"title":"Limited agreement of cytokines and CRP through patient-centric microsampling compared to venipuncture in healthy adults.","authors":"Pirinka Georgiev Tuttle, Tiffany Hidalgo, Catherine Soderstrom, F Isik Karahanoglu, Christian Russel Reyes, Yalei Chen, Carolina Owen, Mar Santamaria, Denise E Chou, Bunmi Williams, Anna Gao, Jessica Selig, Briana Peterson, Bhavna Adhin, Xuemei Cai","doi":"10.1080/17576180.2026.2698413","DOIUrl":"10.1080/17576180.2026.2698413","url":null,"abstract":"Aim: This low-interventional study assessed the agreement of the paper DBS and Tasso-M20, two dried blood patient-centric sampling (PCS) devices used to measure C-reactive protein (CRP) and cytokine levels (TNF-α, IL-8, IL-10, IL-2, IL-6, and IFN-γ) and compared the results to venous plasma samples in the general adult population.Materials and methods: Levels of cytokines and CRP were measured with an assay for venous plasma, adapted for use with dried blood from PCS. Study participants also provided their preferences for blood sampling through a device usability questionnaire.Results: Correlations were observed for some of the selected cytokines measured with dried blood PCS devices compared to venous plasma. However, results were not always consistently and reliably measured. A subset of the cytokines could also not be detected in venous plasma. Overall, participants reported a preference for using PCS devices over venipuncture, on their own at home.Conclusion: PCS shows promise for a better patient experience; however, our results highlight that further study of cytokines and CRP using PCS is needed before it can be used in place of venipuncture. Future studies should consider measurement of analytes in specific patient populations, whole blood matrix PCS, and potentially more sensitive assays.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"691-700"},"PeriodicalIF":2.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557554/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148409997","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