Buccarello AL, Soares de Souza AL, Ullmann M
… +1 more, Petit-Frere C
Bioanalysis
· 2025 Dec · PMID 41457708
·
Full text
BACKGROUND: Fresenius Kabi developed FKS518, a fully human monoclonal antibody biosimilar to denosumab, that inhibits osteoclast activation by targeting the receptor activator of nuclear factor kappa-Β ligand (RANKL). RA...BACKGROUND: Fresenius Kabi developed FKS518, a fully human monoclonal antibody biosimilar to denosumab, that inhibits osteoclast activation by targeting the receptor activator of nuclear factor kappa-Β ligand (RANKL). RANKL exists as a trimeric soluble protein (sRANKL) with high affinity for denosumab. Post-dose, sRANKL levels can rise due to drug-target complex accumulation, creating a risk of interference in bridging anti-drug antibodies (ADA) assays, particularly after acid dissociation. METHODS: We evaluated sRANKL interference in the ADA bridging assay and, to competitively block sRANKL, we introduced a specificity tier by adding osteoprotegerin (OPG). This approach enabled reanalysis of previously ADA-positive samples to confirm whether signals represented true ADA responses or artifacts caused by sRANKL interference. RESULTS: Acid dissociation significantly exacerbated target interference, resulting in ADA positivity rates of ~96-98% in clinical studies. Introducing a specificity tier corrected incidence to ≤3.9%. OPG incorporation did not change the minimum required dilution (MRD) of the assay and did not affect signals for negative/positive control, confirming assay integrity. DISCUSSION: These findings underscore the importance of early interference assessment and mitigation. A multi-tiered strategy, encompassing screening, confirmatory, and specificity tiers, provided a robust solution applicable to programs facing similar challenges.
Jones BR, Shan L, Spytko A
… +4 more, Luo R, Ayala A, Wang J, Lowes S
Bioanalysis
· 2025 Dec · PMID 41451642
·
Full text
BACKGROUND: Quantitation of adrenocorticotropic hormone (ACTH) in human plasma by clinical immunoassays is prone to selectivity challenges, whereas quantitation by mass spectrometry assays (MSA) is limited by sensitivity...BACKGROUND: Quantitation of adrenocorticotropic hormone (ACTH) in human plasma by clinical immunoassays is prone to selectivity challenges, whereas quantitation by mass spectrometry assays (MSA) is limited by sensitivity. The use of nano-liquid chromatography (nano-LC) addresses the MSA sensitivity gap but commonly suffers from poor robustness due to LC system backpressure issues, which is mitigated by incorporation of online size exclusion chromatography (SEC). RESEARCH DESIGN AND METHODS: An antibody-free, multidimensional nano-LC, high-resolution mass spectrometry method was designed and implemented to measure intact ACTH[1-39] in human plasma. Online SEC separation was performed at relatively high flow rates prior to trap and elute reversed phase separations at sub-µL/min flow rates. ACTH[1-39] was detected using a high-resolution orbitrap mass analyzer. RESULTS AND CONCLUSIONS: Nanoelectrospray allows measurement of ACTH[1-39] to a clinically relevant concentration of 3-5 pg/mL, with low bias and high precision across the concentration range interrogated. SEC reduces microfluidic backpressure effects commonly observed with the use of nano-LC for bioanalytical applications. Eliminating antibody capture reduces susceptibility to endogenous antibody interferences. This format can be readily adapted for multiplexed measurement of other low abundance peptide hormones in biological samples.
Soares de Souza AL, Buccarello AL, Berthet A
… +2 more, Ullmann M, Petit-Frere C
Bioanalysis
· 2025 Dec · PMID 41445310
·
Full text
Fresenius Kabi has developed FKS518, a fully human monoclonal antibody biosimilar to denosumab. The clinical development program included two randomized comparative trials: a PK study in healthy volunteers and a safety a...Fresenius Kabi has developed FKS518, a fully human monoclonal antibody biosimilar to denosumab. The clinical development program included two randomized comparative trials: a PK study in healthy volunteers and a safety and efficacy study in osteoporosis patients. The demonstration of similarity and equivalence between FKS518 and reference denosumab included the quantitation of the serum biomarker C-terminal cross-linking telopeptide of Type 1 collagen (CTx-1), a well-established marker of bone resorption. This paper details the development, validation, and analytical performance of the method for CTx-1 quantitation, emphasizing how the Context of Use (CoU) shaped the validation requirements. Application of the method in samples from the pharmacokinetic (PK) equivalence study allowed demonstration of pharmacodynamic (PD) similarity between FKS518 and Prolia. This publication also addresses the use of endogenous serum control (ESC) samples in monitoring assay performance. A retrospective analysis indicated that applying more flexible ranges and/or omitting ESC-based criteria for run acceptance would not have substantially changed the CTx-1 results. While recognizing the value of ESCs for stability and trending analysis and the importance of rigorous biomarker method development and validation in the assessment of biosimilarity, this paper fosters the discussion whether run acceptance based on tight ESC acceptance limits is always necessary.
Li M, Ma J, Ma M
… +10 more, Chen M, Dalton J, Osei-Tutu C, Wang J, Gardner C, Yuan CX, Chen J, Zhao H, Zhang L, Pelto R
Bioanalysis
· 2025 Dec · PMID 41433139
·
Full text
As outsourcing has become mainstream in the bioanalytical industry, sponsor organizations commonly develop bioanalytical assays in-house before transferring them to contract research organizations (CROs) for validation a...As outsourcing has become mainstream in the bioanalytical industry, sponsor organizations commonly develop bioanalytical assays in-house before transferring them to contract research organizations (CROs) for validation and sample testing. However, bioanalytical assay transfer processes represent one of the most challenging workflows and can consume substantial resources in terms of personnel, time, and cost. We developed and implemented a systematic approach to enhance bioanalytical assay quality and transfer efficiency, significantly reducing transfer and troubleshooting time while improving overall success rates.
Bioanalysis
· 2025 Dec · PMID 41410021
·
Full text
AIMS: The aim of the work was to develop and validate an anti-drug antibody (ADA) assay for RGB-19, a proposed biosimilar to tocilizumab, capable of detecting anti-tocilizumab antibodies in the presence of high concentra...AIMS: The aim of the work was to develop and validate an anti-drug antibody (ADA) assay for RGB-19, a proposed biosimilar to tocilizumab, capable of detecting anti-tocilizumab antibodies in the presence of high concentrations of soluble IL-6 receptor (sIL-6R), the drug's pharmacological target. METHODS: A bridging electrochemiluminescent immunoassay was applied. To mitigate target interference, sarilumab - a high-affinity anti-sIL-6R antibody - was incorporated into the sample preparation. The assay was validated per EMA and FDA guidelines. RESULTS: The assay demonstrated high sensitivity, robust precision, and selectivity across normal and diseased matrices. Drug tolerance exceeded 280 µg/mL at regulatory sensitivity thresholds, and target tolerance was confirmed up to 1000 ng/mL sIL-6R. Performance monitoring during Phase I and III clinical sample analysis confirmed stability and acceptable false-positive rates. CONCLUSION: The validated ADA assay effectively neutralized sIL-6R interference and provided reliable immunogenicity assessment for RGB-19 clinical trials. Its robustness supports biosimilarity evaluation and ensures compliance with regulatory standards. Validation of this ADA assay is essential for regulatory compliance and patient safety. By ensuring accurate ADA detection under clinically relevant conditions, it supports biosimilarity demonstration and streamlines regulatory review, ultimately facilitating timely access to cost-effective biologic therapies. CLINICAL TRIAL REGISTRATION: https://jrct.mhlw.go.jp. jRCT2031230029 and jRCT2031220512.
Sohani A, Debaje S, Guleria K
… +5 more, Sankulkar S, Gupta K, Reddy Bandi BM, Mehetre NM, Sangamwar AT
Bioanalysis
· 2025 Dec · PMID 41403234
·
Full text
AIM: To develop and validate a rapid, sensitive, and selective LC - MS/MS method for quantifying polmacoxib (POL) in rat plasma and integrating for preclinical pharmacokinetic evaluation. MATERIALS AND METHODS: POL was q...AIM: To develop and validate a rapid, sensitive, and selective LC - MS/MS method for quantifying polmacoxib (POL) in rat plasma and integrating for preclinical pharmacokinetic evaluation. MATERIALS AND METHODS: POL was quantified using LC - MS/MS on a Varian C8 column with an isocratic mobile phase of methanol and 2 mM ammonium acetate (90:10, v/v; 0.4 mL/min) with run time of 6 min. Detection employed negative ion electrospray and MRM (m/z 360 → 296 for POL; m/z 313 → 257 for rofecoxib as IS). The method was validated as per USFDA guidelines. Male Sprague - Dawley rats received a single oral dose of 10 mg/kg POL, and plasma samples were collected up to 72 h. RESULTS: The method showed linearity (1.56-800 ng/mL, r = 0.9994), LLOQ 1.56 ng/mL, and acceptable accuracy, precision, recovery, and matrix effects. Pharmacokinetics: Cmax 643 ± 32 ng/mL, Tmax 4 h, T1/2 10.4 ± 0.8 h, AUC-∞ 5326 ± 106 ng*h/mL. CONCLUSIONS: The validated assay is robust, sensitive, and suitable for pharmacokinetic, bioequivalence, and drug - drug interaction studies of POL.
Kęsy-Siwik E, Chappell J, Jaros D
… +2 more, Urbaniak M, Sakowicz A
Bioanalysis
· 2025 Dec · PMID 41399870
·
Full text
AIM: Anti-drug antibodies (ADAs) can impact drug efficacy and safety, necessitating sensitive and drug-tolerant assays for accurate detection. The main goal of the study was re-optimization of the Gyrolab immunoassay int...AIM: Anti-drug antibodies (ADAs) can impact drug efficacy and safety, necessitating sensitive and drug-tolerant assays for accurate detection. The main goal of the study was re-optimization of the Gyrolab immunoassay intended to detect ADAs against MabionCD20 (rituximab biosimilar) in rheumatoid arthritis patient serum. The study focused on eliminating a nonspecific interaction that impacted assay repeatability. RESULTS: The nonspecific interactions were mitigated by evaluating numerous method modification strategies including additional washing steps, increasing buffer ionic strength, and step-by-step modification of the assay protocol to isolate the one responsible for the observed issue. Reducing molarity and increasing pH of neutralization buffer resulted in elimination of unwanted interactions between assay components and effectively improved assay performance in repeatability and drug tolerance parameters, supporting the assay's suitability for validation. CONCLUSION: Careful optimization of assay conditions, particularly buffer composition and pH successfully resolved issues related to the nonspecific interactions and enhanced assay robustness. Optimized Gyrolab-based immunoassay provided a reliable method for ADA detection, supporting immunogenicity assessment in a clinical development program.
Maxwell JR, Ohls RK, An G
… +4 more, Winter D, Beauman S, Buhrman J, Jantzie LL
Bioanalysis
· 2025 Dec · PMID 41392547
·
Full text
BACKGROUND: The erythropoiesis stimulating agents (ESAs), erythropoietin (Epo) and darbepoetin (Darbe), are administered clinically to preterm infants to stimulate red cell production and decrease red blood cell transfus...BACKGROUND: The erythropoiesis stimulating agents (ESAs), erythropoietin (Epo) and darbepoetin (Darbe), are administered clinically to preterm infants to stimulate red cell production and decrease red blood cell transfusions. Darbe is longer acting compared to Epo, allowing for weekly administration; however, Darbe does not have a specific assay to allow for serum measurements. RESEARCH DESIGN AND METHODS: We developed a sensitive and specific electrochemiluminescent assay for future reliable measurement of serum and plasma Darbe concentrations in samples from preterm infants participating in the multicenter randomized Phase III Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants. A multi-array electrochemiluminescence platform was used to develop an immunoassay to quantitatively measure Darbe concentrations in biological fluids. RESULTS: Capture and detection antibodies were identified, evaluated, and optimized. Assay sensitivity, intra- and inter-plate reproducibility, and specificity were assessed to verify the utility of the assay for the purpose of accurately measuring Darbe in these samples. CONCLUSIONS: A reliable and accurate assay to measure Darbe concentrations in serum or plasma was developed and validated on a clinically translatable platform. This method will be applied to quantify Darbe serum concentrations in extremely premature infants and to perform population pharmacokinetic analyses. https://clinicaltrials.gov/study/NCT03169881. Identifier is NCT03169881.
Xun Z, Zhang L, McGee R
… +3 more, Stratford B, Wang P, Rodrigues D
Bioanalysis
· 2025 Dec · PMID 41369158
·
Full text
AIM: To develop and validate a robust LC - MS/MS method for the simultaneous quantification of endogenous deoxycholic acid (DCA), 1β-hydroxydeoxycholic acid (1β-OH-DCA), 1β-hydroxydeoxycholic acid glycine conjugate (1β-O...AIM: To develop and validate a robust LC - MS/MS method for the simultaneous quantification of endogenous deoxycholic acid (DCA), 1β-hydroxydeoxycholic acid (1β-OH-DCA), 1β-hydroxydeoxycholic acid glycine conjugate (1β-OH-G-DCA), and 1β-hydroxydeoxycholic acid taurine conjugate (1β-OH-T-DCA) in human plasma as biomarkers for the assessment of CYP3A-mediated drug-drug interactions (DDI). MATERIALS AND METHODS: A surrogate matrix was employed for the preparation of calibration standards and quality control samples. Analytical quantification was achieved using protein precipitation extraction coupled with UHPLC - MS/MS analysis. RESULTS: A multiplex LC - MS/MS assay was successfully developed and validated for the simultaneous quantification of DCA (4-2000 ng/mL), 1β-OH-DCA (0.05-100 ng/mL), 1β-OH-G-DCA (0.05-100 ng/mL), and 1β-OH-T-DCA (0.05-100 ng/mL) in human plasma. The method effectively addressed the analytical challenges associated with developing an integrated assay for endogenous analytes spanning markedly different concentration ranges and was compliant with the ICH M10 bioanalytical method validation guidance. CONCLUSION: This is the first report describing the development and validation of a 4-in-1 LC - MS/MS method for the simultaneous quantification of DCA, 1β-OH-DCA, 1β-OH-G-DCA, and 1β-OH-T-DCA in human plasma. The assay provides a robust bioanalytical platform for evaluating CYP3A-mediated DDIs and offers a methodological framework applicable to other multiplexed methods for endogenous biomarkers.
Sandelius Å, Arrowsmith C, Henderson N
… +1 more, Jackson AW
Bioanalysis
· 2025 Nov · PMID 41368817
·
Full text
AIM: Pharmacokinetic (PK) characterization and accurate quantification is critical for drug development. The broad potential for antisense oligonucleotide (ASO) drugs to target previously undruggable pathways has resulte...AIM: Pharmacokinetic (PK) characterization and accurate quantification is critical for drug development. The broad potential for antisense oligonucleotide (ASO) drugs to target previously undruggable pathways has resulted in a growing number of ASO therapeutics in development increasing the demand on bioanalysis for PK and safety characterization. METHODS: In this study, a nucleic acid nanorobot (NAN) assay based on toehold mediated strand displacement was for the first time developed for ASO bioanalysis in plasma using a timesaving and simplified 2-step procedure without need for nucleotide extraction. The assay was qualified in two different laboratories to determine precision, accuracy, dilutional linearity, and matrix interferences. RESULTS: With the ASO driving a programmable cascade of RNA-DNA interaction resulting in release of a fluorophore, the NAN assay generates fluorescent signal proportional to analyte concentration. The assay showed high accuracy and precision across the assay range and high sensitivity. The assay was successfully transferred to a 2 laboratory, utilizing different equipment and software, providing evidence of assay robustness and accuracy in mouse plasma. CONCLUSIONS: A NAN assay for ASO PK bioanalysis was for the first time assessed for performance and agreement between laboratories, demonstrating this as a viable additional alternative to current bioanalytical methodologies.
Bioanalysis
· 2025 Nov · PMID 41362950
·
Full text
BACKGROUND: Cell and Gene Therapy (CGT) utilizes a nucleic acid core, which makes quantitative PCR (qPCR) a critical tool for establishing pharmacokinetics profiles supporting preclinical and clinical studies of CGT prog...BACKGROUND: Cell and Gene Therapy (CGT) utilizes a nucleic acid core, which makes quantitative PCR (qPCR) a critical tool for establishing pharmacokinetics profiles supporting preclinical and clinical studies of CGT programs. Recently, digital PCR (dPCR) has gained traction in the CGT space. AIM: Here we report a comparison of assay performance between qPCR and a nanoplate-based digital platform in a mouse biodistribution study. METHODS: This study adapted a validated duplex qPCR method for quantifying gene therapy genome copy numbers to a nanoplate-based digital PCR method. The assay performance and bioanalysis results with both methods were compared. RESULTS: The qPCR assay exhibited a broader dynamic range (up to 1e8 copies per reaction) while dPCR covered up to 5e6 copies per reaction with dilutional linearity. Both methods showed comparable Limit of Detection and assay sensitivity. The dPCR demonstrated a superior recovery of spiked targets in matrices, including off-target tissues, with only 1/10 of the input matrix. CONCLUSIONS: Both platforms pose strengths and limitations. The dPCR offers a better option for biodistribution studies for its overall superior recovery in tissues tested. With a wider dilutional linearity, the dPCR may serve as a preferable option for preclinical biodistribution studies.
Videbæk N, Jørgensen L, de Lemos Rieper C
… +4 more, Hummelshøj L, Petersen SS, Wøldike DBC, Andresen LO
Bioanalysis
· 2025 Nov · PMID 41334584
·
Full text
AIM: The purpose of this work was to optimize the sensitivity and the drug tolerance of two cell-based assays for the detection of neutralizing antibodies (nAbs) to semaglutide (a GLP-1 analogue) and to endogenous GLP-1....AIM: The purpose of this work was to optimize the sensitivity and the drug tolerance of two cell-based assays for the detection of neutralizing antibodies (nAbs) to semaglutide (a GLP-1 analogue) and to endogenous GLP-1. METHODOLOGY: The two assays were developed and validated in three distinct iterations. Enhancements in sensitivity and drug tolerance were achieved through platform optimization, sample pre-treatment and the alteration of control antibodies. RESULTS: The sensitivity and drug tolerance improved gradually with the different versions of the assays. For detection of nAbs to semaglutide, sensitivity was improved from 3,400 ng to 98 ng/ml antibody, and drug tolerance was improved from 2.5 nM semaglutide when detecting 3,400 ng/ml antibodies to 4.8-5.6 nM semaglutide when detecting 1,000 ng/ml antibody. For the endogenous GLP-1 assay, sensitivity was improved from 6,900 ng/ml to 46 ng/ml antibody, and drug tolerance improved from 1.0 nM semaglutide when detecting antibody concentration of 8,800 ng/ml to 2.5 nM semaglutide when detecting 1,000 ng/ml antibody. CONCLUSION: Key factors for enhancing the sensitivity and drug tolerance of the assays included the concentration of the drug standard for receptor activation, pre-treatment of the samples, and better understanding of the binding properties of the control antibody.
Galeotti F, Zampini L, Maccari F
… +5 more, Monachesi C, Padella L, Santoro L, Gabrielli O, Volpi N
Bioanalysis
· 2025 Nov · PMID 41327820
·
Full text
BACKGROUND: Keratan sulfate (KS) is altered in several pathological conditions. We report the capillary electrophoresis-laser induced fluorescence separation and validation of KS-derived disaccharides Galβ(1-4)GlcNAc(6S)...BACKGROUND: Keratan sulfate (KS) is altered in several pathological conditions. We report the capillary electrophoresis-laser induced fluorescence separation and validation of KS-derived disaccharides Galβ(1-4)GlcNAc(6S) and Gal(6S)β(1-4)GlcNAc(6S) in human urine and plasma after keratanase II treatment and AMAC fluorotagging. RESULTS: The calibration curves of the two disaccharides from 50 to 1000 ng showed an average correlation coefficient greater than 0.9970 and the calculated LOD and LOQ were 3 and 10 ng, respectively. The inter-day precision was ~13% and the inter-day accuracy was ~10% for both disaccharides. The % recovery ranged between 88% and 106% for 200, 500, and 800 ng of each disaccharide added to biofluids. Urine and plasma of Morquio A and B subjects and of patients submitted to ERT treatment were tested. Urinary KS was ~13-16-fold more abundant in MPSIVA and plasmatic KS was significantly ~2-3-fold more than controls. No differences were observed for the disaccharides ratio between Patients and not-affected Subjects. CONCLUSION: The capillary electrophoresis separation of the two main KS disaccharides in human biofluids was found specific, sensitive, and accurate and suitable for application to Morquio syndrome early detection and progression as well as for other conditions in which KS is altered in content and structure.
O'Connor E, Lachacz E, Delmar J
… +11 more, D'souza B, Edwards S, Griffin C, Lin R, Mody N, Salas A, Schoch-Lopez N, Shah M, Shih A, van Dyk D, Xu Y
Bioanalysis
· 2025 Nov · PMID 41236920
·
Full text
INTRODUCTION: Routine conjugation protocols are typically used by bioanalytical laboratories for production of their assay critical reagents. Novel molecules can pose unique challenges to the production of high-quality c...INTRODUCTION: Routine conjugation protocols are typically used by bioanalytical laboratories for production of their assay critical reagents. Novel molecules can pose unique challenges to the production of high-quality conjugated critical reagents required for clinical bioanalytical assays. Using routine conjugation protocols, we observed gross instability of conjugated-drug surrogate material for use in antidrug antibody (ADA) assays in clinical autologous Chimeric Antigen Receptor (CAR)-T cell programs, thus halting assay development. METHODS: We highlight our approach in developing process conditions for CAR-T supporting conjugated critical reagents, where recombinant CAR scFv-hFc is the surrogate drug material to be conjugated. We show that when routine platform process approaches are not appropriate to produce conjugated novel molecule critical reagents, in-silico modeling can be used to determine conditions imparting repeatable generation of stable reagents. Implementing this modeling is advantageous as it decreases laborious efforts to develop stable novel critical reagent production methodologies. CONCLUSION: As a result of these studies herein, optimal stable conjugated critical reagents were produced which enabled successful development and validation of clinical CAR-T ADA assay. This work provides a framework that can be applied to the production of other bioanalytical assay critical reagents when platform conjugation approaches fail.
Piper T, Geyer H, Huelsemann F
… +5 more, Mareck U, Walpurgis K, Fusshoeller G, Thomas A, Thevis M
Bioanalysis
· 2025 Nov · PMID 41200853
·
Full text
Human routine doping controls rely to a considerable extent on urine samples, and test methods have been optimized for decades to allow for comprehensive analyses with adequate analytical sensitivities. However, attempts...Human routine doping controls rely to a considerable extent on urine samples, and test methods have been optimized for decades to allow for comprehensive analyses with adequate analytical sensitivities. However, attempts of sample manipulation, presumably in order to escape an adverse analytical finding, were reported to include adulteration as well as substitution, which has revived the debate as to when a sample submitted as urine specimen for sports drug testing purposes is, indeed, to be considered as 'urine.' In consideration of selected case reports as well as analytical parameters routinely acquired with doping control urine samples, options concerning guidance in that context are discussed, as detecting and reporting urine substitution and urine adulteration require laboratory approaches that might differ considerably from protocols applied for, e.g. the confirmation of the presence of a prohibited substance. In particular, commonly monitored markers characterizing urinary specifics such as pH, specific gravity, and the presence of a human urinary steroid profile and 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) in established reference ranges could assist in defining acceptance criteria for urine samples and, thereby, guidelines when a specimen does not qualify as human urine.
Timmerman P, Barfield M, Goodwin L
… +7 more, Love I, Cowan K, Anderson L, Gaertner F, Golob M, Nelson R, Knutsson M
Bioanalysis
· 2025 Nov · PMID 41195975
·
Full text
Collaboration between pharmaceutical companies and contract research organizations is central to drug development, yet projects often stumble on well-known weaknesses: communication that does not adapt to the phase of wo...Collaboration between pharmaceutical companies and contract research organizations is central to drug development, yet projects often stumble on well-known weaknesses: communication that does not adapt to the phase of work, expectations that remain unclear, partnerships reduced to transactions, and functions working in silos. Within the European Bioanalysis Forum, two dedicated teams examined these issues in depth, focusing on communication and on building sustainable partnerships. Their reflections were calibrated through dialogue with the wider community during a Focus Workshop, and sharpened by the perspective of the Forum's leadership. This paper brings forward a number of principles that, in the view of the teams and delegates, are essential to more reliable collaboration. They are not an exhaustive list, but a structured starting point for reflection. Reliable collaboration enables science to move forward efficiently and, ultimately, to benefit the patient.
Collier BB, Brandon WC, Chappell MR
… +5 more, Iacovetti G, Tokunaga N, Schaff UY, Sommer GJ, Grant RP
Bioanalysis
· 2025 Nov · PMID 41170663
·
Full text
BACKGROUND: Despite recent advances in capillary blood collection technologies for implementation in a patient centric healthcare world, a direct comparison of various technologies has yet to be performed. RESEARCH DESIG...BACKGROUND: Despite recent advances in capillary blood collection technologies for implementation in a patient centric healthcare world, a direct comparison of various technologies has yet to be performed. RESEARCH DESIGN AND METHODS: A cross-sectional comparative study was performed by recruiting healthy subjects ( = 41) to participate in a collection comparison study consisting of four upper arm capillary collection technologies, a traditional fingerstick, and a venous collection. User experience (e.g. pain, preference), collection performance (e.g. sample volume and quality, collection time), and clinical accuracy with respect to venipuncture results were compared across technologies. In addition, healing was assessed by reaching out to subjects at two different time points following collection. RESULTS: User experience and collection performance results varied across the different capillary collection technologies and a single collection technology did not stand out as superior among those investigated. As correlative results were similar across all technologies, selection of a technology may be based on the intended use population and/or other factors. CONCLUSIONS: Although there are still advancements to be made as well as additional studies to further evaluate the analyte equivalency of capillary and venous specimens, these technologies present a promising patient-centric option to provide clinical results and improve patient care.