Decentralized clinical trial design using blood microsampling technology for serum bioanalysis DOI
Dana Lee,

C. Rapp,

Joseph Loureiro

et al.

Bioanalysis, Journal Year: 2023, Volume and Issue: 15(21), P. 1287 - 1303

Published: Oct. 19, 2023

Background: Alternatives to phlebotomy in clinical trials increase options for patients and clinicians by simplifying increasing accessibility trials. The authors investigated the technical logistical considerations of one technology compared with phlebotomy. Methodology: Paired samples were collected from 16 donors via a second-generation serum gel microsampling device conventional Microsamples subject alternative sample handling conditions evaluated quality, testing proteome profiling. Results: Timely centrifugation blood microsamples largely preserved analyte stability. Conclusion: Centrifugation timing impacts quality specific chemistry protein biomarkers. Microsampling devices remote refrigerated shipping can decrease patient burden, expand trial populations aid decisions.

Language: Английский

Revolutionizing Blood Collection: Innovations, Applications, and the Potential of Microsampling Technologies for Monitoring Metabolites and Lipids DOI Creative Commons
E Bossi,

Elena Limo,

Lisa Pagani

et al.

Metabolites, Journal Year: 2024, Volume and Issue: 14(1), P. 46 - 46

Published: Jan. 11, 2024

Blood serves as the primary global biological matrix for health surveillance, disease diagnosis, and response to drug treatment, holding significant promise personalized medicine. The diverse array of lipids metabolites in blood provides a snapshot both physiological pathological processes, with many routinely monitored during conventional wellness checks. method involves intravenous collection, extracting few milliliters via venipuncture, technique limited clinical settings due its dependence on trained personnel. Microsampling methods have evolved be less invasive (collecting ≤150 µL capillary blood), user-friendly (enabling self-collection), suitable remote collection longitudinal studies. Dried spot (DBS), pioneering microsampling technique, dominates research domains. Recent advancements device technology address critical limitations classical DBS, specifically variations hematocrit volume. This review presents comprehensive overview state-of-the-art devices, emphasizing their applications potential monitoring blood. scope extends areas, encompassing population studies, nutritional investigations, discovery, sports medicine, multi-omics research.

Language: Английский

Citations

13

Blood self-sampling devices: innovation, interpretation and implementation in total lab automation DOI Creative Commons

Dennis C.W. Poland,

Christa M. Cobbaert

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2024, Volume and Issue: unknown

Published: June 24, 2024

Abstract The introduction of the vacuum tube in 1949 revolutionized blood collection, significantly improving sample quality and patient comfort. Over past 75 years, laboratory diagnostics have evolved drastically, from manual to automated processes, reducing required test volumes by over 1,000 times. Despite these advancements, venous collection presents logistical challenges, including centralized scheduling a large volume biological waste due imbalance between needed (often very little) collected excess). COVID-19 pandemic further emphasized need for decentralized healthcare solutions empowerment. Capillary widely used point-of-care testing, offers promising alternative, particularly patients facing frequently, or difficulties with, sampling. Leiden University Medical Center Netherlands experienced 15 % reduction tests during after pandemic, attributed preference local testing. To address self-sampling devices are emerging, empowering streamlining logistics. However, challenges such as cost, transportation regulations, adequacy persists. Robust tailored total lab automation sustainable practices crucial widespread adoption. hurdles, integration into diagnostic processes is inevitable, heralding shift towards patient-centered, proactive healthcare. Practical recommendations include robust device design, ease use, affordability, sustainability, sufficient acceptability seamless workflows. Although obstacles remain, represents future diagnostics, offering convenience, cost-effectiveness, interoperability

Language: Английский

Citations

5

A Bioinspired and Cost‐Effective Device for Minimally Invasive Blood Sampling DOI Creative Commons
Nicole Zoratto,

David Klein‐Cerrejon,

Daniel Gao

et al.

Advanced Science, Journal Year: 2024, Volume and Issue: 11(18)

Published: March 7, 2024

Abstract Conventional venipuncture is invasive and challenging in low middle‐income countries. Conversely, point‐of‐care devices paired with fingersticks, although less invasive, suffer from high variability blood volume collection. Recently approved microsampling address some of these issues but remain cost‐prohibitive for resource‐limited settings. In this work, a cost‐effective device described the collection liquid minimal invasiveness sufficient retrieval laboratory analyses or immediate testing. Inspired by anatomy sanguivorous leeches, single‐use features storage compartment microneedle patch hidden within suction cup. Finite Element Method simulations, corroborated mechanical analyses, guide material selection fabrication design optimization. piglets, successfully collects ≈195 µL invasiveness. Additionally, tailor‐made lid adapter enable safe fluid transportation integration commercially available systems on‐site respectively. Taken together, proposed platform holds significant promise enhancing healthcare pediatric population improving patient compliance reducing risk needlestick injuries through concealed microneedles. Most importantly, given its fabrication, open‐source may have meaningful impact

Language: Английский

Citations

4

Evaluation of Patient‐Centric Sample Collection Technologies for Pharmacokinetic Assessment of Large and Small Molecules DOI Creative Commons

Sandhya Mandlekar,

Dhruvitkumar S. Sutaria,

Xiaoyun Yang

et al.

Clinical Pharmacology & Therapeutics, Journal Year: 2024, Volume and Issue: 116(3), P. 782 - 794

Published: April 26, 2024

Low-volume sampling devices offer the promise of lower discomfort and greater convenience for patients, potentially reducing patient burden enabling decentralized clinical trials. In this study, we determined whether low-volume produce pharmacokinetic (PK) data comparable to conventional venipuncture a diverse set monoclonal antibodies (mAbs) small molecules. We adopted an open-label, non-randomized, parallel-group, single-site study design, with four cohorts 10 healthy subjects per arm. The drugs, doses, routes administration included: crenezumab (15 mg/kg, intravenous infusion), etrolizumab (210 mg, subcutaneous), GDC-X (oral), hydroxychloroquine (HCQ, 200 oral). Samples were collected after single dose each drug using three capillary devices: TassoOne Plus liquid blood, Tasso-M20 dry both applied arm, Neoteryx Mitra® blood obtained from fingertips. Serum/plasma concentrations samples overlapped PK parameters all except HCQ. After applying baseline hematocrit value, two those venipuncture. For molecules, bridging strategies evaluated converting equivalent plasma concentrations. A correction and/or linear regression-based was effective GDC-X, but not Additionally, bioanalytical quality comparability various collection methods, as well preference devices.

Language: Английский

Citations

4

NEW TRENDS IN BIOANALYSIS SAMPLING AND PRETREATMENT: HOW MODERN MICROSAMPLING IS REVOLUTIONISING THE FIELD DOI Creative Commons
Michele Protti, Elisa Milandri,

Roberta Di Lecce

et al.

Advances in Sample Preparation, Journal Year: 2025, Volume and Issue: unknown, P. 100161 - 100161

Published: Feb. 1, 2025

Language: Английский

Citations

0

A Perspective on Home-Based Sexual Health Care: Evidence, Access, and Future Directions DOI Creative Commons
Cornelia Johanna Dorothy Goense, Ymke J. Evers, Christian J. P. A. Hoebe

et al.

Current HIV/AIDS Reports, Journal Year: 2025, Volume and Issue: 22(1)

Published: Feb. 26, 2025

This perspective explores the impact of home-based sexual health services on accessibility to STI and HIV testing for priority populations. study evaluates as independent care options complementary components traditional clinic-based care. Challenges persons attend can be overcome by offering lower threshold Implementing has successfully reached populations, including previously untested men who have sex with (MSM) individuals a high exposure risk sexually transmitted infections (STI) human immunodeficiency virus (HIV), attending location-based A challenge in is ensure equitable care, such limited access digital resources or low literacy. While enhance healthcare, research into needs still underserved populations subsequent tailoring offered, needed. Continuous monitoring evaluation implementation may maximize advantages this promising type

Language: Английский

Citations

0

Using an innovative method for self-collection of capillary blood for HIV and syphilis testing among men who have sex with men who use PrEP in the Netherlands; Limburg4zero DOI Creative Commons
Cornelia Johanna Dorothy Goense, Ymke J. Evers, Inge H. M. van Loo

et al.

Sexually Transmitted Diseases, Journal Year: 2024, Volume and Issue: unknown

Published: June 11, 2024

ABSTRACT Background Home-based sampling could create accessible testing opportunities for men who have sex with (MSM) use pre-exposure prophylaxis (PrEP). Blood collection is required the most reliable laboratory results HIV and syphilis testing. An innovative blood-collection method (Tasso+) creates a vacuum semi-automatically collects larger volumes of blood from upper arm. This study aims to assess acceptability feasibility this device among PrEP-using MSM performance blood-collection. Methods Between August 2022 January 2023, 47 were recruited during their routine PrEP consultations at Dutch Centre Sexual Health. Participants tested directly after consultation, an online questionnaire determined feasibility. residual serum measured Results Of participants, 87% had positive attitude toward device, 77% would it again self-sampling home. rated as easy (96%). On average 536 μl whole (244 serum) was collected. All samples syphilis, sufficient (91%) (89%). Most (85%) 220 blood, further (e.g., confirmation). Conclusions that arm highly acceptable by users performs well in multiple tests. has promising potential home-based sexual health care MSM.

Language: Английский

Citations

3

Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyond DOI Creative Commons
Harika Dasari, Anna Smyrnova, Jing Leng

et al.

PLoS ONE, Journal Year: 2024, Volume and Issue: 19(5), P. e0304155 - e0304155

Published: May 29, 2024

Background Home blood self-collection devices can enable remote monitoring, but their implementation requires validation. Our objectives were to explore (i) the impact of sampling sites and topical analgesia on capillary volume pain perception (ii) safety, acceptability, failure among adults children using Tasso-SST device. Methods We conducted a two-phase study. The investigational phase consisted two on-site cross-sectional studies in healthy adult participants (≥ 12 years) (1–17 with accompanying parent. Adults received 4 samplings, where puncture randomized factorial design, venipuncture; (and one parent) had sampling. co-primary outcomes pain. was multicentre trials choosing visits; volume, collection failure, adverse events, satisfaction documented. Results In , 90 9 7 parents enrolled; 15 2 preschoolers participated . study, device collected median (25%, 75%) 450 (250, 550) μl no significant difference between site, analgesia, its interaction. Using reduced by 0.61 (95% CI: 0.97, 0.24; P <0.01) points 11-point scale; reduction varied lower back showing most decrease. Overall, combining all phases, 425 500) μl, rate 4.4%; minor effects reported 8.9% participants, willing use again. Conclusion Capillary self-collection, yielding slightly less than 500 proves be safe relatively painless method for children, high low rates. site do not affect could reduce

Language: Английский

Citations

2

Hospital at Home programs: Decentralized inpatient care but centralized laboratory testing? DOI
Junyan Shi,

Roy Yu-Wei Chen,

Li Wang

et al.

Clinical Biochemistry, Journal Year: 2024, Volume and Issue: 129, P. 110779 - 110779

Published: June 11, 2024

Language: Английский

Citations

0

Microfluidic-assisted Biomineralization of Calcium Phosphate: Enhancing Particle Design for Medical and Therapeutic Applications DOI Creative Commons

Carol Yazbleydy Cárdenas Rodriguez,

Nutan Shukla,

Elizaveta Mukhanova

et al.

Research Square (Research Square), Journal Year: 2024, Volume and Issue: unknown

Published: Nov. 21, 2024

Abstract Calcium phosphate (CaP) polymorphs are non-toxic and biocompatible, making them intriguing for a variety of applications, including hard tissue regeneration, medicine delivery, vaccine development. Investigating the mechanism calcium nucleation development is critical understanding disorders caused by pathological mineralization developing biomimetic materials with suitable properties. The current CaP in situ/batch biomineralization process follows crystal-formation route pre-nucleation cluster aggregation particles larger than 500 microns. However, due to their large size, synthesis methods may have limited efficiency, scalability, particle uniformity. new technologies producing nano- microparticles biomedicine interesting various reasons. In this context, microfluidic-based technology developed, distinct microfluidic parameters altered, chip architecture allows fine manipulation reaction parameters. obtained conditions yielded 20-100-micron crystal. Furthermore, approach enables straightforward encapsulation two different model dyes: methylene blue (MB) rose Bengal (RB). proposed microfluidic-aided technique provides viable future study production delivery systems.

Language: Английский

Citations

0