The Library
1530 papers on microsampling and monitoring, each with a finding paraphrased to our standard and labelled in one vocabulary. Every entry links to a legitimate copy; nothing is copied from an abstract.
Papers 201–300 of 1530, newest first.
2025
Plasma lipidomes from self-collected upper-arm capillary blood were statistically indistinguishable from paired venous plasma, most classes at r=0.95–0.99, validating at-home capillary self-collection for lipidomics.
Comparison of capillary and venous plasma lipidomes: validation of self-collected blood for plasma lipidomics — Hameed et al., J. Lipid Research
- venous-agreement
- blood
- self-collection
- capillary
- liquid
- validation
- biomarkers
2025
Across ~27,000 specimens, moderate over-collection of first-void urine did not meaningfully change chlamydia or gonorrhoea positivity: first-void STI detection is robust to volume variation, provided the early urethral fraction is captured.
Impact of first-void urine volume on chlamydia and gonorrhoea positivity rates — Hall et al., Microbiology Spectrum
- urine
- liquid
- first-void
- sti
2025
In a field cohort of 60 adults with diarrhoea, OMNIgene 200 and DNA/RNA shield maintained high sensitivity and concordance with fresh samples for most pathogens, while FTA cards showed low sensitivity for STEC and poor specificity for Campylobacter. This supports the use of stabilised stool media for decentralised PCR testing after prolonged ambient transport.
Prospective evaluation of different faecal preservation media for travellers' diarrhoea diagnostic application with multiplex PCR BioFire FilmArray in resource-limited settings — Toriro et al., Journal of medical microbiology
- stabilised
- dna-genotek-omnigene
- serology
- stool
2025
Taxonomic and diversity profiles differed between unstabilised swabs and stabilised OmniGene kits, with transport time disproportionately affecting swab samples; the collection method had a greater impact on taxa and diversity than transport time, highlighting the need for standardised stool collection in decentralised microbiome studies.
Stabilized and unstabilized sampling methods result in differential fecal 16S rRNA microbial sequencing results — Stamper et al., PloS one
- stabilised
- dna-genotek-omnigene
- self-collection
- microbiome
- stool
2025
In 498 women living with HIV, self-collected first-void urine and vaginal samples showed 78% high-risk HPV prevalence and good genotype concordance, kappa 0.64-0.78. Participants preferred the Colli-Pee device over the Evalyn Brush, supporting decentralised, patient-centric screening feasibility.
Feasibility of First-Void Urinary and Vaginal Self-Sampling for High-Risk Human Papillomavirus Testing Among Women Living With Human Immunodeficiency Virus in Guinea-Bissau-A Multicenter Cross-Sectional Study — Madsen et al., Journal of medical virology
- colli-pee
- acceptability
- first-void
- sti
- self-collection
- hpv
- urine
2025
This study validated a method for measuring the alcohol biomarker phosphatidylethanol using two volumetric absorptive microsampling devices, finding that the Mitra device met all validation criteria and agreed with venous sampling. The Capitainer device was deemed suitable but showed reduced accuracy at higher concentrations, with a small proportional negative bias compared to venous results.
A validated method for capillary phosphatidylethanol 16:0/18:1 quantification with two different 10-µl volumetric absorptive microsample devices in the same setup — Andreassen et al., Journal of analytical toxicology (paywalled)
- vams
- venous-agreement
- neoteryx-mitra
- blood
- dbs
- dried
- toxicology
- capillary
- validation
2025
A comparison of blood microsampling found that after 35 days, PFAS recovery changed by over 10% for five analytes using the Neoteryx hemaPEN and four using Whatman 903, but zero using the Neoteryx Mitra. The Mitra retained 45 of 49 PFAS within 70-130% recovery, showing its high stability for decentralised biomonitoring without contamination risks.
Comparison of microsampling for PFAS blood analysis: Enabling cheap high-resolution biomonitoring — Partington et al., Analytica chimica acta (paywalled)
- vams
- neoteryx-mitra
- blood
- dbs
- self-collection
- dried
- capillary
- validation
2025
The study found that VAMS devices exhibited elevated background metal concentrations that often matched or exceeded levels found in venous blood, complicating trace element analysis. Although a cleaning protocol reduced some background noise, persistent contamination limits the current efficacy of this microsampling method for environmental biomonitoring.
Evaluating the efficacy of the VAMS Mitra microsampler for whole blood trace element analysis — Ogunesan et al., Bioanalysis
- vams
- neoteryx-mitra
- blood
- dried
- validation
- biomarkers
2025
Dried saliva collected with the Mitra device correlated strongly with wet saliva but poorly with plasma unbound and total concentrations, indicating it is not a reliable substitute for plasma in routine therapeutic drug monitoring of mycophenolic acid and its glucuronide metabolite. Capillary blood collected via VAMS remains a promising alternative for long term monitoring in paediatric patients.
Volumetric Absorptive Microsampling of Saliva for Pharmacokinetic Evaluation of Mycophenolic Acid and Its Glucuronide Metabolite in Pediatric Renal Transplant Recipients: Bioanalytical Method Validation and Clinical Feasibility Evaluation — Kocur et al., Pharmaceuticals
- blood
- saliva
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- pediatric
- tdm
- immunosuppressants
2025
The study found very strong correlation between venous blood collection and capillary VAMS using Mitra devices for detecting SARS-CoV-2 spike antibodies, with samples remaining stable at room temperature for several months. This enables reliable at-home, patient-centric serological testing for large-scale community surveillance and vaccine studies.
Validation of at-home blood sampling for large scale, cost effective serological analysis for anti-viral antibody responses — Mayer et al., Journal of immunological methods (paywalled)
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- self-collection
- validation
- venous-agreement
- serology
2025
This study compared four dried blood spot devices for glucocorticoid detection, finding that the Mitra VAMS device offered the best combination of analytical recovery and user usability, whilst the HemaXis DB10 showed the least bias compared to whole blood.
Analytical and usability comparison of microsampling dried blood spot devices for glucocorticoid detection in sports using ultra-high-performance liquid chromatography-tandem mass spectrometry — Chen et al., Analytica chimica acta (paywalled)
- vams
- acceptability
- neoteryx-mitra
- doping
- blood
- dbs
- haematocrit
- dried
- toxicology
- hormones
- validation
2025
The study found a dried blood spot method for ustekinumab was linear from 3 to 12 mg/L with inter-day accuracy of 90.1 to 106%, enabling reliable capillary blood measurement for remote monitoring; the authors note the single-centre design.
Development, Validation and Application of the Dried Blood Spot Analysis Method for the Determination of Ustekinumab in Patients with Inflammatory Bowel Disease — Mingas et al., Pharmaceuticals
- blood
- dried
- capillary
- dbs
- validation
- tdm
- biologics
2025
Capillary dried blood spots yielded reference ranges for testosterone, androstenedione, 17α hydroxyprogesterone and progesterone in healthy premenopausal women, with lower concentrations in users of systemic hormonal contraceptives and cycle-related variation for 17OHP and P4. These ranges enable screening for disorders of sex development using less invasive microsampling.
Evaluation of reference ranges of four circulating sex steroids from dried blood spots in women aged 18-40 years — Wang et al., The Journal of steroid biochemistry and molecular biology (paywalled)
- blood
- dbs
- dried
- capillary
- fertility
- hormones
2025
Capillary tubes with serum separator gel gave 13% lower estradiol and 8% lower testosterone than non-gel capillary tubes, with discrepancies up to 19% and 14% versus venous tubes; other fertility hormones were unaffected. Conversion formulas were derived, but the study did not evaluate home collection workflows.
Systematic Reduction in Estradiol and Testosterone Measurements due to Serum Separator Gel in Blood Collection Tubes: Implications for At-Home Fertility Testing — Vasavan et al., The journal of applied laboratory medicine (paywalled)
- blood
- capillary
- venous-agreement
- fertility
- hormones
2025
The study validated a method for measuring cystic fibrosis drugs in dried blood spots, showing statistical equivalence to plasma concentrations, which supports their use as a less invasive alternative for therapeutic drug monitoring. It also found higher drug levels in nasal swabs, indicating localised accumulation at the disease site, which could inform more personalised treatment.
Development and application of a multimatrix LC-MS/MS method for quantifying elexacaftor-tezacaftor-ivacaftor: Expanding therapeutic drug monitoring in cystic fibrosis from systemic circulation to airways and sweat — Mucci et al., Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie (paywalled)
- venous-agreement
- sweat
- blood
- dbs
- qdbs
- tdm
- dried
- pediatric
- validation
2025
Validated on 40 adults, leptin measured from finger-prick dried blood spots agreed closely with matched serum and stayed stable at ambient and raised temperatures for 72 hours; the authors present it as a route into groups such as children that venepuncture has kept out of leptin research.
Validation of an Enzyme-Linked Immunosorbent Assay for Measuring Leptin, a Key Metabolic Hormone, in Dried Blood Spot Samples — Kim et al., American journal of human biology : the official journal of the Human Biology Council
- blood
- dried
- dbs
- validation
- venous-agreement
- hormones
2025
A simulation of decentralised clinical trial elements at 11 Chinese investigational sites with 36 researchers found high satisfaction with direct-from-patient sample collection, although challenges remain regarding system ease of use and the integration of online and offline workflows.
Insights From a User Experience-Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials — Ma et al., Clinical and translational science
- dct
- self-collection
2025
This trial found that decentralised saliva collection in care home residents with dementia is feasible, but only 66% of 1,014 samples were valid for alpha-amylase and 62% for cortisol assays. Sponsors should note the authors' caveat that future trials require improved collection protocols, such as stimulating saliva flow, to ensure data quality.
The short-term impact of music interventions on stress: Results of a multinational cluster-randomized trial using salivary cortisol and alpha-amylase assessments in care home residents with dementia — Rasing et al., Psychoneuroendocrinology (paywalled)
- dct
- cortisol
- liquid
- saliva
2025
This pilot study found that while initial household enrolment was low at 9%, remote follow-up was highly feasible, with 88% of respondents, 151 of 172, successfully returning self-collected capillary blood samples after 12 months. This shows that decentralised microsampling is viable for household cohorts when face-to-face contact is restricted.
'Bern, get ready', BEready, a household-based cohort study for pandemic preparedness research in Switzerland: pilot study — Hodel et al., BMJ open
- blood
- liquid
- capillary
- self-collection
- dct
2025
The study found that capillary microtube samples showed perfect correlation, R 1.00, and narrow limits of agreement with venous blood for IgG monitoring, making them a viable alternative. Dried blood spots showed only moderate correlation, R 0.77, and broad limits of agreement, which the authors state makes them unsuitable for routine diagnostics.
Comparison of capillary dried blood spot and capillary microtubes with venous immunoglobulin G levels for routine diagnostics — Boland et al., Clinical biochemistry (paywalled)
- venous-agreement
- blood
- dbs
- dried
- capillary
- liquid
- validation
2025
The HematoCARD cartridge autonomously collects duplicate 10 microlitre dried blood spot samples from a single finger prick and shows good analytical performance for monitoring adalimumab, with accuracy between 91 and 111 per cent, linearity R squared 0.99 and coefficient of variation at or above 0.94 compared with serum reference and commercial DBS microsampling methods.
HematoCARD: A Volumetric Duplicate Dried Blood Spot Collection Cartridge Validated for Therapeutic Drug Monitoring — Van Hileghem et al., Analytical chemistry (paywalled)
- volumetric
- biologics
- blood
- dbs
- tdm
- haematocrit
- dried
- capillary
- validation
2025
A quantitative dried blood spot method using only 10 µL of blood successfully quantified six azole antimycotics and showed samples were stable under conditions simulating postal mailing. A formula to convert dried spot results to plasma values was derived, though the authors note this is an in vitro validation and clinical studies are required for translation to patient care.
Simultaneous Quantification of Azole Antimycotics in Quantitative Dried Blood Spots: A Step Toward Home Sampling for Therapeutic Drug Monitoring — Li et al., Therapeutic drug monitoring (paywalled)
- blood
- dried
- dbs
- qdbs
- self-collection
- validation
- tdm
- antimicrobials
2025
The study determined that using self-collected dried blood spots alongside online surveys was a feasible and acceptable method for remote pre-exposure prophylaxis adherence monitoring, with 64% of participants returning at least one blood specimen.
Remote pre-exposure prophylaxis adherence monitoring among young, Black men who have sex with men: a feasibility and acceptability pilot study — Jones et al., Current psychology (paywalled)
- dct
- acceptability
- blood
- dbs
- tdm
- self-collection
- dried
2025
A study of decentralised patient-centric microsampling found that 82% of untrained participants, 47 of 57, successfully self-collected acceptable fingerstick blood in Microtainer tubes. All 46 tested samples yielded accurate HIV viral suppression results compared to venipuncture, though this remote monitoring approach is limited to US courier services and temperature conditions.
A cross-sectional analysis of fingerstick blood self-microcollection for remote HIV suppression monitoring in Atlanta, Georgia, USA: a path to expanding access to continuum of care — Johnson et al., AIDS research and therapy
- blood
- liquid
- capillary
- bd-microtainer
- self-collection
- validation
- venous-agreement
- serology
2025
This study validated a method for quantifying fluconazole using the Mitra device, demonstrating sufficient accuracy and precision for therapeutic drug monitoring in paediatric patients.
Determination of Fluconazole in Children in Small Blood Volumes Using Volumetric Absorptive Microsampling (VAMS) and Isocratic High-Performance Liquid Chromatography-Ultraviolet (HPLC-UV) Detection — Zimbelmann et al., Pharmaceutics
- blood
- dried
- vams
- neoteryx-mitra
- validation
- pediatric
- tdm
- antimicrobials
2025
A comparison of three patient-centric dried blood microsampling devices, paper DBS, Mitra and Tasso-M20, found strong to excellent correlation with traditional venous plasma for measuring branched-chain amino acids and ketoacids. Participants reported high acceptability and expressed a strong willingness to use these devices for decentralised self-collection.
Quantitation of BCAA and BCKA in plasma and patient-centric dried blood microsamples in a clinical setting — Tierney et al., Bioanalysis
- vams
- venous-agreement
- acceptability
- neoteryx-mitra
- blood
- dbs
- metabolome
- dried
- validation
- biomarkers
2025
The study found volumetric absorptive microsampling showed high agreement between capillary and venous concentrations, with 94% of dasatinib and 95% of imatinib samples meeting the 20% acceptance criterion. VAMS is viable for imatinib monitoring and may allow longitudinal follow-up for dasatinib; however, VAMS results for imatinib, but not dasatinib, could be converted to plasma concentrations using prior ratios.
Toward Clinical Implementation of a Volumetric Absorptive Microsampling-Based Method for Dasatinib and Imatinib Therapeutic Drug Monitoring — Verougstraete et al., Therapeutic drug monitoring (paywalled)
- blood
- dried
- capillary
- vams
- validation
- venous-agreement
- tdm
- oncology
2025
In 277 paediatric patients, capillary microsampling with the Microsemi CRP device found close agreement with venous testing for CRP, with a mean difference of -0.25 mg/dL and 95% limits of -2.1 to 1.6 mg/dL. WBC showed a bias of -18 × 100/μL, with 95% limits of -73 to 37 × 100/μL. This supports decentralised, patient-centric screening of febrile children.
Comparison between point-of-care testing from capillary samples and conventional laboratory testing from venous samples for white blood cells and C-reactive protein in a pediatric outpatient setting — Kuniyoshi et al., Journal of general and family medicine
- venous-agreement
- blood
- capillary
- pediatric
- biomarkers
2025
In a one-week virtual home clinic with 134 participants, 86 per cent returned saliva and 84 per cent returned stool, and most components were feasible and acceptable despite device and logistical challenges. This supports decentralised, patient-centric self-collection of non-blood biospecimens for research.
Collecting at-Home Biometric Measures for Longitudinal Research From the i3C: Feasibility and Acceptability Study — Russell et al., JMIR human factors
- saliva
- stool
- self-collection
- acceptability
- dct
- microbiome
2025
While 72 per cent of participants returned self-collected dried blood spot kits, only 46 per cent provided samples adequate for a full cardiometabolic profile, with insufficient blood volume cited as the primary difficulty.
Feasibility of self-administered dried blood spot collection for cardiometabolic profile analysis in a population-based sample of young adults — Livingstone et al., PloS one
- blood
- dried
- dbs
- self-collection
- acceptability
- biomarkers
2025
Urine self-sampling for HPV showed non-inferior specificity to cervical samples, 85.19%, and found 96% of high-grade lesions. While acceptable, a survey of 1382 participants found 41.6% preferred conventional screening, showing the importance of offering choice in a decentralised, patient-centric programme.
Urine human papillomavirus testing for cervical screening in a UK general screening population: a diagnostic test accuracy study — Davies et al., The British journal of general practice : the journal of the Royal College of General Practitioners
- urine
- first-void
- colli-pee
- self-collection
- acceptability
- hpv
- sti
2025
The EUROArray HPV test achieved similar sensitivity and specificity for CIN2+ detection using first-void urine and vaginal self-samples compared with clinician-collected cervical samples, supporting the use of self-collection for cervical screening.
EUROArray HPV test accuracy for cervical precancer in self- vs. clinician-collected samples using the VALHUDES protocol — van et al., Gynecologic oncology (paywalled)
- urine
- first-void
- colli-pee
- self-collection
- validation
- hpv
2025
The study compared quantitative dried blood spot (qDBS) and volumetric absorptive microsampling (VAMS) devices for measuring ganciclovir levels in capillary blood from pediatric renal transplant recipients. This comparison provides evidence for choosing between microsampling devices in therapeutic drug monitoring, supporting decentralised sampling approaches that reduce patient burden while maintaining analytical accuracy.
The comparison of two volumetric microsampling devices (qDBS and VAMS) for determining ganciclovir levels in capillary blood using the LC-MS/MS technique in pediatric renal transplant recipients — Kocur et al., European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences (paywalled)
- vams
- volumetric
- blood
- qdbs
- tdm
- dried
- antimicrobials
- capillary
- pediatric
- validation
2025
This review summarises how volumetric absorptive microsampling facilitates self-sampling and improves stability for pharmacokinetic and toxicokinetic studies while maintaining performance comparable to standard venous blood draws.
How microsampling is impacting pharmacokinetic and toxicokinetic studies: volumetric absorptive microsampling (VAMS) — Protti et al., Bioanalysis (paywalled)
- vams
- blood
- dried
- toxicology
- validation
2025
The paper summarises that volumetric finger-prick self-sampling is suitable for monitoring immunosuppressants and biomarkers after kidney transplantation, but successful implementation requires careful design of the entire workflow, including patient training and method validation. This matters because it provides a real-world framework for moving critical monitoring from the clinic to the patient's home.
Implementation of Volumetric Finger-Prick Self-Sampling for Therapeutic Drug Monitoring of Immunosuppressants After Kidney Transplantation: Lessons Learned From the Practice — Vethe et al., Therapeutic drug monitoring (paywalled)
- vams
- volumetric
- neoteryx-mitra
- blood
- tdm
- self-collection
- immunosuppressants
- validation
- biomarkers
2025
A UHPLC-MS/MS assay using the Capitainer-qDBS device successfully quantified five antiseizure medications, showing robust 30-day stability at room temperature and no haematocrit effect between 20-70%. Although the clinical cohort was small, comparison with plasma in 30 patients showed good correlation, supporting the potential of this patient-centric microsampling method for decentralised home monitoring.
Quantitative dried blood spot microsampling for therapeutic drug monitoring of -antiseizure medications by design of experiment and UHPLC-MS/MS — Cancellerini et al., Talanta (paywalled)
- venous-agreement
- blood
- qdbs
- tdm
- haematocrit
- dried
- validation
2025
A study of 12 kidney transplant recipients providing 69 paired samples found that a VAMS-based assay for mycophenolic acid and its metabolite had 90% to 106% accuracy. Converting microsampling results to plasma concentrations met agreement criteria, supporting decentralised monitoring, though the study was small and limited to a single centre.
Development and Clinical Validation of a Volumetric Absorptive Capillary Microsampling Method for Quantification of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Kidney Transplant Recipients — Drevland et al., Therapeutic drug monitoring (paywalled)
- vams
- venous-agreement
- blood
- tdm
- dried
- capillary
- immunosuppressants
- validation
2025
This study found moderate to strong correlations between SARS-CoV-2 antibody levels in fingerprick dried blood spots collected using the hemaPEN device and standard venous serum samples from children and adults. The results suggest that this microsampling device offers a reliable alternative to venepuncture for serological surveillance.
Evaluation of SARS-CoV-2 Antibody Response Between Paired Fingerprick (HemaPEN<sup>®</sup>) and Venepuncture Collected Samples in Children and Adults — Mazarakis et al., Antibodies
- blood
- capillary
- dbs
- validation
- venous-agreement
- pediatric
- serology
2025
The Trials@Home RADIAL trial's regulatory record across six European countries: early and continuous engagement with regulators made the decentralised elements possible, and harmonised guidance is still needed where national legislation differs.
Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization — Gardarsdottir et al., Clinical pharmacology and therapeutics
- dct
- standards
2025
A study of 100 Brazilian women with high-grade cervical lesions found excellent concordance for high-risk HPV detection between clinician-collected samples and patient-centric, self-collected vaginal or first-void urine samples. Self-sampling was preferred for comfort, though the study's single-centre setting may limit generalisability.
Self-sampling for HPV genotyping: a study of vaginal and urine collection in Brazilian women with high-grade lesions — Castanheira et al., Clinics
- acceptability
- first-void
- sti
- self-collection
- hpv
- urine
- genotyping
2025
In a decentralised Eswatini clinic, molecular testing on the Xpert platform of self-collected urine and swabs found a 31.7% prevalence of Chlamydia, Gonorrhoea, or Trichomonas, with 20.8% of these asymptomatic. Although limited by a cross-sectional design, this shows the feasibility of patient-centric sampling for sexually transmitted infection screening in resource-limited settings.
High Burden of Symptomatic and Asymptomatic Sexually Transmitted Infections in a Routine Decentralised HIV Care Setting in Eswatini: A Cross-Sectional Study — Kerschberger et al., Tropical medicine & international health : TM & IH
- sti
- self-collection
- serology
- hpv
- urine
2025
A study of older rural US patients found that 96 to 98 per cent of self-collected dried blood spot specimens were successfully analysed for HIV viral load, with high acceptability. However, concordance between self-reported and measured viral load was only 69 to 82 per cent, highlighting the value of objective decentralised microsampling over self-reporting.
Acceptability and Feasibility of Self-Collected Dried Blood Spot Specimens for Viral Load Monitoring among Rural Older People Living with HIV — Walsh et al., AIDS and behavior (paywalled)
- dct
- acceptability
- blood
- dbs
- self-collection
- dried
- serology
2025
This study found that the HarmoniaHPV assay on first-void urine collected via Colli-Pee and vaginal self-samples showed a relative sensitivity of 0.95 for detecting CIN2+ compared to cervical samples. The VenusHPV assay showed similar accuracy but required cut-off optimisation, supporting decentralised HPV screening.
Accuracy of Liferiver HarmoniaHPV and VenusHPV Assays on Urine and Vaginal Self-Samples — Latsuzbaia et al., Journal of medical virology
- colli-pee
- first-void
- self-collection
- hpv
- urine
- validation
2025
In a Belgian colposcopy referral cohort, a study found that 66.6% of women preferred home-based first-void urine self-sampling over physician-taken samples, and 96.6% found the Colli-Pee UCM FV-5010 device easy to use. This supports patient-centric, decentralised screening, though results are limited to this specific referral population.
Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study — Hendrickx et al., Archives of public health = Archives belges de sante publique
- colli-pee
- acceptability
- first-void
- self-collection
- hpv
- liquid-biopsy
- liquid
- urine
2025
A validated LC-MS/MS method for everolimus using Mitra and Capitainer devices found excellent agreement between capillary microsamples and venous whole blood in 33 adult transplant recipients. The results showed high accuracy and negligible haematocrit effects, supporting the use of microsampling for decentralised therapeutic drug monitoring.
Therapeutic Drug Monitoring of Everolimus Using Volumetric Absorptive Microsampling and Quantitative Dried Blood Spot Methods with LC-MS/MS in Adult Solid Organ Transplant Recipients: An Analytical and Clinical Comparative Study — Kocur et al., Molecules
- vams
- venous-agreement
- neoteryx-mitra
- blood
- qdbs
- tdm
- haematocrit
- dried
- capillary
- immunosuppressants
- validation
2025
In children with SLE, VAMS finger-prick capillary blood gave haematocrit-adjusted MPA and MPAG concentrations indistinguishable from plasma, and the AUC from VAMS derived plasma-equivalent concentrations matched plasma AUC with R2 0.97. This supports accurate pharmacokinetically guided dosing of MMF using only three timed capillary microsamples.
Volumetric Absorptive Microsampling Combined with Mass Spectrometry to Support Pharmacokinetically-Guided Precision Dosing of Mycophenolate Mofetil in Pediatric Lupus Nephritis Patients — Zhao et al., The journal of applied laboratory medicine (paywalled)
- vams
- venous-agreement
- blood
- tdm
- haematocrit
- dried
- capillary
- pediatric
- immunosuppressants
- validation
2025
In the RADIAL proof-of-concept trial in type 2 diabetes, run conventionally, hybrid and fully decentralised across five European countries, sites struggled at first with technology and participant onboarding despite proactive training; the authors conclude that decentralised conduct needs firm oversight and clear contracts with third-party providers.
Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities-Findings From the Trials@Home RADIAL Proof-of-Concept Trial — Lipinska et al., Clinical pharmacology and therapeutics
- dct
2025
A study of 292 patients found that the slopes of home-collected stimulated dried blood spot C-peptide levels over six months predicted 12-month venous mixed-meal tolerance test results, P<0.001. This shows decentralised microsampling can monitor beta-cell function, though further validation is required to confirm its reliability and broader applicability.
Early Detection of β-Cell Decline Using Home Dried Blood Spot C-Peptide Levels in New-Onset Type 1 Diabetes — Hendriks et al., Diabetes care (paywalled)
- dct
- venous-agreement
- blood
- dbs
- self-collection
- dried
- pediatric
- biomarkers
2025
The study found significant gut microbiota alterations in systemic lupus erythematosus patients, with different beta diversity, p=0.001, and shifts in phyla abundance compared to controls. Specific microbial profiles were associated with clinical subgroups, though the authors note the clinical relevance of species-level alterations requires further validation.
Association of Gut Dysbiosis with Disease Phenotype and Treatment in Systemic Lupus Erythematosus — Medina-Martínez et al., Medical sciences
- stool
- stabilised
- dna-genotek-omnigene
- microbiome
2025
A validated offline SPE-LC-MS/MS method using the Mitra microsampling device successfully quantified tacrolimus, cyclosporine A, tryptophan, kynurenine, and creatinine simultaneously. The method met EMA and FDA criteria, showing agreement between capillary and venous sampling, which could facilitate decentralised therapeutic drug monitoring and transplant follow-up through patient self-collection.
An Offline SPE-LC-MS/MS Method for Simultaneous Quantification of Tacrolimus, Cyclosporine A, Kynurenine, Tryptophan, and Creatinine Using Volumetric Absorptive Microsampling Device Mitra — Nierychlewski et al., Therapeutic drug monitoring
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- tdm
- immunosuppressants
- biomarkers
2025
This study found that 80% of Middle Eastern-North African women preferred urine HPV self-sampling over clinician-directed screening, and 73% favoured home collection. 80% reported this decentralised method would positively impact future screening intent.
Acceptability of Home-Based Urine Self-Collection for Cervical Cancer Screening Among Women Receiving Care at the Arab Community Center for Economic and Social Services in Michigan — Guetterman et al., Cancer medicine
- urine
- self-collection
- acceptability
- hpv
2025
The Egoo Phe system showed strong concordance with dried blood spot testing across 100 paired samples, with median phenylalanine 274 versus 270 μmol/L and readings a mean 4.6% higher, and high caregiver acceptance; the small sample size limits generalisability and further validation in larger cohorts is required.
Point-of-Care Testing in PKU: A New ERA of Blood Phenylalanine Monitoring — Pinto et al., Nutrients
- acceptability
- blood
- dbs
- self-collection
- pediatric
- validation
2025
This study established conversion methods for estimating plasma concentrations from whole blood VAMS samples for seven out of ten oral anticancer drugs, finding good agreement between capillary and venous samples. Patients reported a positive experience with home sampling using this microsampling technique.
Clinical Application of Volumetric Absorptive Microsampling for Therapeutic Drug Monitoring of Oral Targeted Anticancer Drugs — Meertens et al., Therapeutic drug monitoring
- vams
- venous-agreement
- acceptability
- blood
- tdm
- self-collection
- oncology
- capillary
- validation
2025
A 2025 review from China finds decentralised trials still far from standard practice despite the enthusiasm of regulators and industry, and names the operational gaps that keep them so: technology, oversight and data quality.
Understanding the gap between expectations and reality in decentralized clinical trials — Jiang et al., NPJ digital medicine
- dct
2025
A prospective study of 109 subjects found that 250 μl capillary whole blood microsampling is stable for five hours in a microtainer. This patient-centric, decentralised method successfully detected most HCV genotypes at defined limits using the Xpert HCV test on the GeneXpert Xpress system and the cobas HCV platform.
Independent assessment of a point of care HCV RNA test by laboratory analytical testing and a prospective field study in the U.S — Miller et al., PloS one
- blood
- liquid
- capillary
- bd-microtainer
- validation
- serology
2025
The authors found that a single microdose of recombinant EPO was detectable up to 72 hours using ITP and CP methods, though the Tasso microsampling device showed lower sensitivity than Mitra and Capitainer. Additionally, isotope ratio mass spectrometry successfully detected testosterone micro-dosing in all analysed samples, supported by serum testosterone levels.
Detection of a Single Microdose of Testosterone and Recombinant EPO in Healthy Volunteers — Heiland et al., Drug testing and analysis
- neoteryx-mitra
- doping
- blood
- dbs
- dried
- steroids
- capillary
- hormones
- urine
- validation
2025
The paper highlights that while self-collection microsampling devices for blood and other matrices are advancing decentralised testing, standardisation of sample collection and integration into clinical workflows is critical for reliable results. This matters because it identifies key hurdles that must be overcome for patient-centric sampling to be widely adopted in healthcare.
Standardization of Microsampling Technologies for Accurate Sensing and Reliable Diagnostics — Mora & Mace, ACS sensors (paywalled)
- blood
- standards
- self-collection
- haematocrit
- validation
- saliva
2025
This meta-analysis found strong agreement between self-collected capillary blood and venous samples for laboratory results. Capillary sampling was associated with significantly lower pain scores than venipuncture, particularly when using upper arm devices rather than fingerprick methods.
Comparison of laboratory results and pain perception in self-sampled capillary blood versus venous blood sampling: a systematic review and meta-analysis — Schröder et al., Clinical biochemistry (paywalled)
- venous-agreement
- acceptability
- blood
- self-collection
- capillary
- liquid
- validation
2025
HPV DNA testing on first-void urine collected at home performed as well as clinician-collected cervical samples for detecting CIN2+ using Roche cobas 4800 and 6800 systems, with good to excellent agreement between paired samples. This supports the use of home-collected first-void urine for cervical cancer screening programmes.
Equivalent Clinical Accuracy of Human Papillomavirus DNA Testing Using Cobas 4800 and 6800 Human Papillomavirus Systems in Paired Urine and Cervical Samples — Van Keer et al., The Journal of molecular diagnostics : JMD (paywalled)
- urine
- first-void
- self-collection
- validation
- hpv
2025
Using the Novosanis Colli-Pee Small Volumes device, this study found that self-collected first-void urine had slightly lower sensitivity for detecting high-grade cervical intraepithelial neoplasia than cervical samples, CIN2+ ratio 0.91, 95% CI 0.83-0.99, with comparable specificity. This patient-centric, decentralised approach offers a feasible screening alternative despite a marginal reduction in sensitivity.
Clinical and Analytical Evaluation of the Abbott Alinity m HR HPV Assay in a New Generation First-Void Urine Collector — Van Keer et al., Journal of medical virology (paywalled)
- urine
- first-void
- colli-pee
- self-collection
- validation
- hpv
2025
The study validated the Allplex HPV28 assay for use with first-void urine samples collected using a Colli-Pee device, finding good agreement with a reference method and that it works without pre-centrifugation. This provides a reliable, non-invasive option for HPV screening and vaccine monitoring, which is important for increasing participation in decentralised settings.
Optimization and analytical validation of the Allplex HPV28 genotyping assay for use in first-void urine samples — Bell et al., Journal of clinical microbiology
- colli-pee
- first-void
- sti
- hpv
- urine
- validation
- genotyping
2025
A Danish study found that first-void urine testing using the 10-mL Colli-Pee device had similar sensitivity to cervical sampling for detecting CIN2+, ratio 0.97, and CIN3+, ratio 0.95, though specificity was lower. This patient-centric, decentralised microsampling method shows promise, but further clinical accuracy and acceptability data in under-screened populations are needed before implementation.
High-risk human papillomavirus testing in first-void urine as a novel and non-invasive cervical cancer screening modality-a Danish diagnostic test accuracy study — Tranberg et al., BMC medicine
- urine
- first-void
- colli-pee
- validation
- hpv
2025
Microsampling, particularly VAMS and quantitative DBS, can enable patient-centric therapeutic drug monitoring of immunosuppressants after transplantation, allowing home self-sampling and long-term monitoring when patients live far from transplant centres. These volumetric dried formats have largely overcome the haematocrit effect and sample heterogeneity that limit conventional dried blood spots.
Microsampling techniques and patient-centric therapeutic drug monitoring of immunosuppressants — Kocur & Pawiński, Bioanalysis (paywalled)
- vams
- venous-agreement
- blood
- qdbs
- tdm
- self-collection
- haematocrit
- dried
- capillary
- immunosuppressants
2025
In an untargeted metabolomics study, microsampling devices, particularly the Mitra and Capitainer, yielded metabolic profiles comparable or superior to plasma in feature number and intensity, and in the precision and stability of some metabolites. This supports their potential for large-scale, decentralised metabolic profiling, though the captured metabolite profile was application-dependent.
LC-MS-Based Global Metabolic Profiles of Alternative Blood Specimens Collected by Microsampling — Thaitumu et al., Metabolites
- vams
- neoteryx-mitra
- blood
- dbs
- qdbs
- metabolome
- dried
- validation
- biomarkers
2025
Self-collected oral and stool samples revealed distinct microbiome compositions in patients with endometriosis compared to controls, with Fusobacterium enrichment specifically observed in oral samples from moderate to severe cases. These results support the feasibility of decentralised self-collection for non-invasive biomarker screening in reproductive health.
Oral, Vaginal, and Stool Microbial Signatures in Patients With Endometriosis as Potential Diagnostic Non-Invasive Biomarkers: A Prospective Cohort Study — Hicks et al., BJOG : an international journal of obstetrics and gynaecology
- self-collection
- microbiome
- fertility
- stool
- saliva
- biomarkers
2025
This study found that stool samples self-collected on cards showed high correlation and agreement with ethanol-fixed samples for metagenomic sequencing, with negligible differences in microbial diversity. The results support the use of stool cards as a cost-effective alternative for decentralised sampling in epidemiologic studies, despite minor variations in individual species abundance.
Comparing the Metagenomic Performance of Stools Collected from Custom Cards and 95% Ethanol in Epidemiologic Studies — Kuntz et al., Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology (paywalled)
- stool
- dried
- self-collection
- validation
- microbiome
- colorectal
2025
Self-collection of vaginal samples achieved 100% sensitivity and 100% specificity, while first-void urine achieved 90% sensitivity and 99% specificity, compared with cervical brushing for detecting Chlamydia trachomatis; these results support the use of self-collected samples for decentralised STI testing.
Accuracy of self-collection versus cervical sampling for the molecular diagnosis of <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> in women attending gynecological services — Vasco et al., Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia
- first-void
- sti
- self-collection
- urine
- validation
2025
An online self-sampling intervention for chlamydia and gonorrhoea using urine kits achieved a 20.7% positivity rate, with 90% of infections being extragenital, and linked 81% of positive cases to treatment, indicating high acceptability and feasibility for decentralised STI testing.
TESTATE STI project: an online chlamydia and gonorrhoea self-sampling strategy for gay, bisexual and other men who have sex with men and trans people in Catalonia (Spain) — Martínez-Riveros et al., Sexually transmitted infections (paywalled)
- acceptability
- sti
- self-collection
- liquid
- urine
2025
The cross-sectional study of women of reproductive age in the Southern US found notable prevalence of genital and extragenital chlamydia, gonorrhoea and trichomoniasis, with no difference by HIV status. These results highlight the importance of extragenital STI testing in decentralised, patient-centric settings to improve detection and reproductive health outcomes.
Prevalence of genital and extragenital sexually transmitted infections among women of reproductive age with and without HIV in the Southern US: results from the study of treatment and reproductive outcomes — Nogueira et al., Frontiers in medicine
- urine
- self-collection
- sti
2025
This review summarises how incorporating saliva and urine into home-based point-of-care systems expands diagnostic accessibility for dengue virus, aligning with the WHO REASSURED framework for affordable and rapid testing.
Integrative Advances in Dengue Virus Diagnostics: From Technological Innovation to Tiered Diagnostic Systems — Shi et al., Journal of medical virology (paywalled)
- saliva
- urine
- self-collection
- validation
- serology
2025
Cortisol dynamic range measured from participant-led saliva collection was feasible and associated with higher perceived stress and anxiety in African American women, suggesting saliva self-collection can serve as a decentralised biomarker of chronic stress.
A Community-Engaged Approach for Assessment of Cortisol Dynamic Range and Multilevel Chronic Stress in African Americans: FAITH! Heart Health+ Ancillary Study — Ortiz et al., Journal of participatory medicine
- cortisol
- self-collection
- hormones
- saliva
- biomarkers
2025
This survey found that whilst consumers were optimistic about using saliva for periodontitis diagnosis, many clinicians remained uncertain about the accuracy of the method. The results indicate a need for further evidence and education to support the adoption of decentralised saliva sampling workflows.
A survey of Australian consumers' and dentists' perceptions of saliva as a biofluid for periodontitis diagnosis — Sun et al., BMC oral health
- saliva
- self-collection
- acceptability
2025
This study of acutely ill older adults found that in-home point-of-care testing provided clinically reliable results, with strong correlations observed between on-site analysis and routine laboratory testing. While venous samples showed lower misclassification rates, capillary blood offered a pragmatic alternative for decentralised diagnostics despite higher variation.
Validation of point-of-care tests used at in-home assessments among older adults in primary care — Smedemark et al., Scandinavian journal of primary health care
- blood
- liquid
- capillary
- validation
- venous-agreement
2025
This study found that self-collected capillary blood using the Topper system provided reliable results for most clinical chemistry analytes compared to venous sampling, with 94% of participants successfully obtaining a sample. While glucose and uncorrected AST failed to meet bias criteria, analytes such as lipids and enzymes demonstrated optimal agreement, supporting the use of this decentralised microsampling method for home testing.
Validation of (self-collected) capillary blood using a topper collection system as alternative for venous sampling for 15 common clinical chemistry analytes — Geujar et al., Clinical chemistry and laboratory medicine (paywalled)
- blood
- liquid
- capillary
- self-collection
- validation
- venous-agreement
2025
Capillary blood self-collected with the VAMS device showed 100 per cent agreement with serum for detecting SARS-CoV-2 S RBD antibodies in participants with known past infection, and saliva showed slightly lower but high agreement; agreement was good to almost perfect in those without known antibodies, and most participants found finger prick easy while half found the microsampler easy, supporting decentralised serosurveillance.
Performance and feasibility of self-microsampling of capillary blood and saliva for serological testing of SARS-CoV-2 — Morales et al., PloS one
- vams
- venous-agreement
- acceptability
- blood
- self-collection
- serology
- capillary
- saliva
2025
Self-collected capillary samples showed good agreement with venous samples for most safety monitoring parameters in patients with rheumatic disease, although platelet counts were less reliable and haemolysis affected some biochemistry results. Patients found the self-sampling process easy and virtually painless, suggesting it is a feasible option for decentralised monitoring.
Self-sampling of capillary blood for safety monitoring of DMARD therapy in patients with rheumatic disease: a feasibility and method-comparison study — Adelhelm et al., Scandinavian journal of clinical and laboratory investigation (paywalled)
- venous-agreement
- acceptability
- blood
- self-collection
- capillary
- liquid
2025
This study validated a method combining quantitative dried blood spots with DNA methylation analysis to monitor B-cell counts remotely, achieving 100% sensitivity and specificity for a specific clinical threshold. This decentralised approach facilitates patient-centric therapeutic drug monitoring for anti-CD20 therapies by overcoming the logistical barriers of regular venous sampling.
Home-sampling of B cells using quantitative dried blood spots to enable tailored therapeutic re-dosing of anti-CD20 therapies — Tallantyre et al., Multiple sclerosis (paywalled)
- biologics
- multimodal
- blood
- rpm
- qdbs
- tdm
- self-collection
- dried
- validation
2025
This study found that a decontamination pipeline using metagenome-assembled genomes improves the accuracy of variant calling from saliva samples, showing superior concordance with blood-derived results compared to conventional methods. These results validate the potential of self-collected oral samples for accurate personal genotyping.
Metagenome-assembled genomes enhance bacterial read decontamination and variant calling in oral samples — An et al., iScience
- venous-agreement
- blood
- microbiome
- validation
- saliva
- genotyping
2025
This study compared OMNIgene Gut tubes and FTA cards for stool collection in a deployed setting, finding that OMNIgene yielded higher nucleic acid concentrations while both methods detected the majority of microbial genera. The authors conclude that distinct microbial abundance profiles between the two methods necessitate standardised protocols for field research.
Field expedient stool collection methods for gut microbiome analysis in deployed military environments — Kok et al., mSphere
- stabilised
- dna-genotek-omnigene
- dried
- microbiome
- stool
- validation
2025
This study found that dried blood microsamples, particularly those collected with the Mitra device, provided metabolic profiles comparable or superior to conventional plasma, supporting their use as a viable alternative for untargeted metabolomics.
Toward minimally invasive metabolomics: GC-MS metabolic fingerprints of dried blood microsamples in comparison to plasma — Marques de Sá E Silva et al., The Analyst (paywalled)
- vams
- venous-agreement
- neoteryx-mitra
- blood
- dbs
- metabolome
- dried
- capillary
- validation
2025
The True Dose kit achieved a high System Usability Scale score of 82.7 and enabled 92% of participants to collect the required capillary blood volume, with a median sampling time of 10.42 minutes, indicating good usability but highlighting the need for clearer instructions and stress management to support reliable decentralised sampling.
Capillary Blood Self-Sampling for Therapeutic Drug Monitoring: A Mixed-Methods Usability Study of the True Dose<sup>®</sup> Kit — Crafoord et al., BioMed research international
- blood
- capillary
- self-collection
- acceptability
- tdm
2025
This study describes the iterative development of a novel capillary self-sampling device, demonstrating that the fourth prototype enabled 77.5% of users to successfully collect at least 500 µL of blood with high usability and acceptability scores.
The development of a novel device to aid in capillary macro blood self-sampling via an iterative study design — Herrijgers et al., Expert review of medical devices (paywalled)
- blood
- capillary
- self-collection
- acceptability
2025
The method accurately measures therapeutic antibodies in Vams samples, correlating with plasma levels, enabling reliable therapeutic drug monitoring from home-collected samples to optimise cancer treatment dosing
A novel approach for quantifying therapeutic monoclonal antibodies in blood through liquid chromatography-tandem mass spectrometry — Chi et al., Analytica chimica acta (paywalled)
- blood
- vams
- venous-agreement
- tdm
- biologics
- oncology
2025
Capillary dried blood spot concentrations of levetiracetam agreed closely with plasma, with 92.1% within 20% of the mean and no proportional bias, and capillary matched venous dried blood spot with acceptable deviations; samples remained stable during postal transit, enabling at‑home self‑sampling for therapeutic drug monitoring.
Therapeutic drug monitoring of levetiracetam - Is dried blood spot sampling suitable? — Linder et al., Clinical biochemistry (paywalled)
- venous-agreement
- blood
- dbs
- tdm
- self-collection
- dried
- capillary
- validation
2025
BD's MiniDraw capillary system, in the hands of trained staff without phlebotomy experience, was clinically equivalent to conventional capillary and venous collection for a panel of general chemistry analytes, alanine aminotransferase and chloride against the venous comparator excepted, and its serum separator tube held the analytes for 48 hours. It shows an upper-arm system reaching pharmacy-style settings with laboratory-grade results.
Evaluation of a Novel Capillary Blood Collection System for Blood Sampling in Nontraditional Settings as Compared with Currently Marketed Capillary and Venous Blood Collection Systems for Selected General Chemistry Analytes — Parikh et al., The journal of applied laboratory medicine (paywalled)
- blood
- liquid
- capillary
- venous-agreement
- validation
2025
A 2025 review maps 28 microsampling devices, from dried spots and volumetric absorptive tips to upper-arm liquid capillary collectors, and names what a laboratory must control before their results are used: the haematocrit effect in non-volumetric dried samples, interstitial fluid from finger milking, volume, haemolysis and transport stability. Regulators on both sides of the Atlantic ask for the same two things, a device the patient can use safely and a sample fit for the test.
Patient centric blood sampling and analysis for diagnostics and laboratory medicine — Spooner et al., Bioanalysis
- blood
- standards
- self-collection
- haematocrit
- dried
- capillary
- liquid
- validation
2025
In 46 women under hormone monitoring at Columbia University Fertility Center, oestradiol, LH, FSH, progesterone and hCG measured on routine immunoassays from 400 to 600 microlitres of upper-arm capillary blood collected with TAP Micro Select agreed closely with paired venous results for every analyte, with correlation and concordance high throughout. It is the evidence that puts a self-collected sample inside the daily monitoring of an IVF cycle.
Painless, needle-free capillary blood collection for fertility hormone monitoring — Lattin et al., Fertility and sterility (paywalled)
- blood
- liquid
- capillary
- yourbio
- fertility
- hormones
- venous-agreement
- validation
2025
Circulating collagen X degradation product (CXM) remains stable in healthy adults regardless of age or sex. In patients with tibial or femoral shaft fractures, serum CXM correlates with established bone turnover markers, and finger prick collection makes it feasible for remote quantitative monitoring of fracture healing without repeated clinic visits.
Efficacy of biomarkers in the endochondral phase of fracture repair and healing in long bones: A clinical observational studys — Working et al., PLoS medicine
- blood
- capillary
- biomarkers
2025
Healthcare professionals considered a postal self-collection service for diabetes review acceptable, anticipating it would reduce missed appointments and enable more holistic use of consultation time, while cautioning that administrative burden and public perception of diminished face-to-face care would need managing. The study indicates that patient-centric microsampling can secure professional support, a prerequisite for decentralised diagnostics.
Healthcare professional views of a diabetes review postal box: A qualitative study — Colley et al., Diabetic medicine : a journal of the British Diabetic Association (paywalled)
- blood
- urine
- self-collection
- acceptability
2025
In 40 participants, dried blood spots showed excellent agreement with venous blood for HBA1c measurement (LCCC 0.982, PCC 0.990, limits of agreement -0.45 to 0.48). The method demonstrated high repeatability (CV 1.13) and clinical conformity (K 0.80), suggesting capillary DBS sampling could replace venipuncture for diabetes monitoring in decentralised settings.
Preliminary comparative study of HBA1c measurement by IEX-HPLC Bio-Rad in dried blood spot vs. whole venous blood — Hadami et al., Annales de biologie clinique (paywalled)
- blood
- dried
- capillary
- dbs
- validation
- venous-agreement
- acceptability
2025
The study found that the Test2Know postal self-sampling service was highly acceptable and usable, with nearly 90% of users willing to reuse or recommend it, and it reached individuals at risk who had not previously tested for HIV or STIs. This supports the role of decentralised, patient-centric microsampling in expanding access to sexual health testing.
Acceptability, usability, and user experiences of an online postal self-sampling approach for HIV and STI testing in Belgium: Test2Know — De Baetselier et al., International journal of STD & AIDS (paywalled)
- self-collection
- acceptability
- serology
- sti
2025
In a feasibility pilot of 29 perimenopausal women using daily saliva progesterone measured at home, a significant association was seen between short luteal phases and having more cycles under 23 days, but this did not remain after adjusting for observation count and no differences were found for other cycle characteristics, suggesting short luteal phases may not reliably indicate cycle irregularity in this population.
The role of short luteal phases on cycle regularity during the perimenopausal transition — Visby Madsen et al., Menopause (paywalled)
- saliva
- self-collection
- fertility
- hormones
2025
A survey of 146 Brazilian infertility patients found that 88.3% were willing to perform ultrasounds at home provided image quality and diagnostic accuracy matched clinic-based examinations, and identified patients already familiar with assisted reproductive technology processes as the most suitable candidates for remote fertility monitoring.
Remote fertility care: Are patients prepared to forego physician proximity in favor of accessibility? — Collado et al., JBRA assisted reproduction
- acceptability
- fertility
- rpm
2025
The Mira fertility monitor's LH surge and urine E1-3G levels correlated strongly with the ClearBlue Fertility Monitor's LH surge and low-to-high shift in both postpartum and perimenopause transitions, supporting at-home urine hormone monitoring for fertility tracking.
Validating At-Home Urinary Hormone Measurements in Postpartum and Perimenopause Fertility Transitions — Bouchard et al., Women's health reports
- urine
- self-collection
- validation
- fertility
- hormones
2025
The study found that acoustic speech features differed significantly between Android and iOS devices, with iOS recordings showing more periodic content but less high-frequency energy, while Android devices exhibited greater measurement variability. These platform-specific differences, coupled with participant experience challenges such as iOS users struggling with background noise checks, demonstrate that device choice and app instruction design materially affect data quality and trial outcomes in decentralised digital biomarker studies.
Comparing Phoneme Speech Recordings and Acoustic App Data Capture Experience for Android and iOS Mobile Device Users in the Large Decentralized AcRIS Study — Chappie et al., Journal of voice : official journal of the Voice Foundation (paywalled)
- dct
- rpm
- digital-biomarker
2025
Interviews with clinical development staff found that decentralised clinical trials improved patient access by reducing travel burdens and waiting times. Implementation challenges included local regulations, telemedicine policies, IT infrastructure, information literacy and costs, with Japan lagging behind Europe and the United States in adoption.
Considerations on the implementation of DCT: a SCAT-based analysis of fact-finding interviews in Europe and the United States, with implications for regions newly adopting DCT, including Japan — Taruno et al., Frontiers in medicine
- dct
2025
A randomised trial of 47 participants using a mobile app integrated with remote patient monitoring devices achieved a 74% biomarker submission rate over four weeks, with system usability scores of 77–94 and acceptability exceeding benchmarks, showing the platform is feasible for remote data collection in decentralised clinical trials.
Evaluation of a remote biomarker capture system integrated with REDCap: A decentralized randomized trial — Dahne et al., Journal of clinical and translational science
- acceptability
- dct
- rpm
2025
This study found that a decentralised approach using home-based sleep apnoea screening, heart rhythm monitoring and activity tracking in patients with atrial fibrillation is feasible, with high data completeness and low drop-out rates. The results support the use of patient-centric digital tools in decentralised trials for chronic cardiac conditions.
Feasibility of a decentralised trial of sleep apnoea screening in patients with atrial fibrillation — Hashiba et al., Danish medical journal (paywalled)
- dct
- wearable
- rpm
- digital-biomarker
- actigraphy
2025
Decentralised clinical trials can help overcome barriers to trial participation such as travel burdens and improve access to recommended treatments.
[Decentralized Clinical Trials in Cancer Patients] — Sasaki & Nakamura, Gan to kagaku ryoho. Cancer & chemotherapy (paywalled)
- dct
2025
This study introduces a statistical approach based on an information criterion to assess agreement between two measurement methods, evaluating six models simultaneously to provide an objective decision rule. The method is demonstrated using real data sets from patient-centric microsampling, offering a robust tool for method validation and regulatory compliance.
An Information Criterion Approach for Assessing Agreement When Comparing Two Methods of Measurement — Tan et al., Statistics in medicine (paywalled)
- validation
- standards
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