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 701–800 of 1530, newest first.
2023
In 102 samples, quantitative TSH by Finecare LFIA showed strong correlation (r approximately 0.93) and excellent agreement (Cohen's kappa 0.85) with the Roche CobasPro reference; using serum, sensitivity was 90.5% and specificity 96.3% for diagnosing thyroid abnormalities, supporting fingerstick and whole-blood use for decentralised TSH testing.
High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) — Shurbaji et al., Heliyon
- blood
- liquid
- capillary
- validation
- venous-agreement
- hormones
2023
The study found that smartwatch-based adherence monitoring showed consistent concordance over time and may be more reliable than app or pill count methods in measuring treatment adherence in a decentralised setting. This supports the use of wearable devices as objective tools in patient-centric monitoring for decentralised clinical trials.
Exploration of smart adherence-monitoring methods in vitamin D-deficient patients: A pilot feasibility clinical study — Huh et al., Clinical and translational science
- blood
- dct
- wearable
- digital-biomarker
- multimodal
2023
University branding increased trust and confidence in results, plain packaging promoted discretion, and colour‑coded bags with matching instructions reduced confusion; participants recommended instructional videos, tailored test options, real‑time introductions and personalised reminders to maximise return rates.
Lessons Learned From the Implementation of a Pilot Study on Self-collected Specimen Return by Sexual Minority Men (Project Caboodle!): Qualitative Exploration — Sallabank et al., JMIR formative research
- blood
- urine
- capillary
- self-collection
- acceptability
- sti
2023
This study externally validated salivary pepsin as a noninvasive diagnostic for gastroesophageal reflux disease, with 20 adults self-collecting saliva across fasting, post-prandial and bedtime time points over four days, using endoscopy and wireless pH monitoring as reference standards to determine optimal collection protocols and diagnostic thresholds.
Diagnostic thresholds and optimal collection protocol of salivary pepsin for gastroesophageal reflux disease — Ma et al., Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus (paywalled)
- saliva
- self-collection
- validation
2023
The study found that self-collected saliva samples showed high concordance with nasopharyngeal swabs for SARS-CoV-2 detection across multiple commercial assays, with 100% agreement in two kits and 93% in the third. This supports saliva as a reliable, patient-centric alternative for decentralised diagnostics, particularly in settings where ease of collection and infection control are priorities.
SARS-CoV-2 Detection via RT-PCR in Matched Saliva and Nasopharyngeal Samples Reveals High Concordance in Different Commercial Assays — de Sousa et al., Diagnostics
- saliva
- self-collection
- validation
- serology
2023
The study demonstrated that qPCR-based epigenetic immune cell counting from capillary dried blood spots agreed with venous blood and conventional flow cytometry in healthy donors, and then identified lymphopenia, neutrophilia and a lowered lymphocyte-to-neutrophil ratio in 103 COVID-19 patients versus 113 healthy controls, with naive B cell frequency tracking disease severity, suggesting that filter-paper blood collection could enable remote immune monitoring in home-isolated patients.
Epigenetic immune monitoring for COVID-19 disease course prognosis — Samans et al., Frontiers in immunology
- blood
- liquid
- dried
- capillary
- validation
- venous-agreement
- serology
2023
In kidney transplant recipients, home capillary blood self-testing of creatinine using a handheld analyser showed good agreement with clinic venous laboratory results, whereas potassium showed poorer agreement; patient self-use of the device was not a significant source of the potassium difference.
Patient Self-Testing of Kidney Function at Home, a Prospective Clinical Feasibility Study in Kidney Transplant Recipients — Murray et al., Kidney international reports
- blood
- liquid
- capillary
- self-collection
- venous-agreement
2023
The Ser-Col dried blood device with automated elution matched plasma gold-standard results for HIV and showed comparable performance to conventional DBS for HBV, HCV and syphilis across 378 miners at remote sites in French Guiana, with full HIV concordance and 87 per cent sensitivity for treponemal antibodies, supporting automated dried blood testing for large-scale infectious disease screening in remote populations.
Automated and combined HIV, HBV, HCV, and syphilis testing among illegal gold miners in French Guiana using a standardized dried blood device — Pisoni et al., Acta tropica (paywalled)
- blood
- dried
- dbs
- validation
- venous-agreement
- serology
- sti
2023
The study found that congenital cytomegalovirus infection is significantly associated with asymmetric bilateral and profound sensorineural hearing loss in children, based on retrospective analysis of dried blood spot testing. This supports the use of decentralised microsampling for early identification of at-risk children, enabling timely intervention.
Factors associated with congenital cytomegalovirus infection detected by dried blood spot testing in children with hearing loss — Liao et al., International journal of pediatric otorhinolaryngology (paywalled)
- blood
- dried
- dbs
- pediatric
- serology
2023
Optimisation of a commercial PCR assay for macrolide resistance in Mycoplasmoides genitalium achieved 100% specificity and 90.9% concordance with sequencing. The assay detected resistance in 67% of positive clinical specimens, with comparable performance from first-void urine and swabs, supporting its use for decentralised STI diagnostics and targeted antibiotic therapy.
Optimization and Clinical Evaluation of an Automated Commercial Analyte-Specific Reagent Assay for <i>Mycoplasmoides genitalium</i> Macrolide Resistance Detection in Primary Clinical Specimens — Munson et al., Journal of clinical microbiology
- urine
- first-void
- validation
- sti
2023
Early at-home VAMS samples allowed Bayesian forecasting of steady-state adalimumab concentrations with modest bias (mean prediction error -2.6%) and acceptable precision (normalised RMSE 24.0%), correctly classifying 75% of predictions within the therapeutic window and identifying 8.3% of patients who developed anti-adalimumab antibodies, supporting decentralised precision dosing during induction.
Early At-Home Measurement of Adalimumab Concentrations to Guide Anti-TNF Precision Dosing: A Pilot Study — de Klaver et al., European journal of drug metabolism and pharmacokinetics (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- self-collection
- tdm
- biologics
2023
The study found that blood concentrations of padsevonil measured using Mitra devices can reliably predict plasma concentrations with less than 9% mean bias, supporting the use of VAMS as a patient-centric alternative to venous sampling in decentralised trials. This validation strengthens confidence in microsampling for therapeutic drug monitoring where venous draws are impractical.
Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development — Kramer et al., The AAPS journal (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
- tdm
- dct
2023
A UHPLC-MS/MS method for measuring Fabry disease biomarkers in dried blood spots was validated using both conventional cards and Capitainer B devices. Capillary blood gave similar results to venous blood across a wide haematocrit range, supporting decentralised screening and longitudinal monitoring of patients.
Mass Spectrometry Analysis of Globotriaosylsphingosine and Its Analogues in Dried Blood Spots — Boutin et al., International journal of molecular sciences
- blood
- dried
- capillary
- dbs
- validation
- venous-agreement
- haematocrit
- biomarkers
2023
The study found that noninternet participants in a decentralised trial were older, from more diverse backgrounds, and had worse health outcomes and higher nonadherence rates than internet participants. This matters because it shows that allowing noninternet participation increases diversity but may require additional support to maintain adherence and retention in decentralised trials.
Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study — Shen et al., Journal of the American Heart Association
- dct
2023
Most chlamydia and gonorrhoea infections in asymptomatic men who have sex with men using online self-testing were extragenital, meaning urine-only screening would miss the majority of cases; therefore, three-site testing should remain standard and free screening services should be expanded.
Three-site screening for STIs in men who have sex with men using online self-testing in an English sexual health service — Charin et al., Sexually transmitted infections (paywalled)
- urine
- self-collection
- sti
2023
The study found that dried blood spot sampling for HIV viral load monitoring achieved high coverage over 24 months in remote settings in Vietnam, with no difference in access between people who inject drugs and other patients. However, virological failure was more common in people who inject drugs, those with poor adherence and those late to clinical visits, highlighting the need for targeted support to improve outcomes in decentralised care.
Assessment of HIV viral load monitoring in remote settings in Vietnam - comparing people who inject drugs to the other patients — Lefrancois et al., PloS one
- blood
- dried
- dbs
- serology
2023
Processing stool samples with OMNIgene SPUTUM significantly improved the diagnostic yield of Mycobacterium tuberculosis using the Xpert MTB/RIF Ultra assay compared to standard methods, offering a viable alternative for patients who cannot produce sputum.
Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda — Sessolo et al., PloS one
- stool
- stabilised
- dna-genotek-omnigene
- validation
2023
The review found no consistent evidence that midstream urine collection with or without cleansing reduces contamination compared with other non-invasive methods, and only limited data suggested first-void urine had higher contamination than midstream in one study; this matters for decentralised diagnostics because it questions the universal recommendation of midstream collection and supports evaluating simpler, patient-collected methods such as first-void urine for home testing.
Best methods for urine sample collection for diagnostic accuracy in women with urinary tract infection symptoms: a systematic review — Llor et al., Family practice (paywalled)
- urine
- first-void
- validation
2023
First-void urine tested on the GeneXpert platform detected high-risk HPV DNA with 84.8 per cent sensitivity and 92.3 per cent specificity compared with clinician-collected cervical samples, with substantial agreement (kappa 0.77) and high patient acceptability among 100 HIV-positive women in Zambia, suggesting that decentralised urine self-sampling with an EDTA preservative could widen cervical cancer screening coverage where invasive methods deter uptake.
Utilizing first void urine for high-risk HPV testing for cervical cancer screening in HIV-positive women in Katete, Zambia — Kaoma et al., BMC women's health
- urine
- first-void
- validation
- acceptability
- hpv
2023
The study developed a method to separate and quantify enantiomers of novel psychoactive substances using volumetric absorptive microsampling and chiral liquid chromatography coupled to mass spectrometry. This approach allows for the precise chiral bioanalysis of these compounds from dried blood samples, which is relevant for toxicology and forensic applications.
Microsampling and enantioselective liquid chromatography coupled to mass spectrometry for chiral bioanalysis of novel psychoactive substances — Protti et al., Talanta (paywalled)
- validation
- toxicology
2023
Remote decentralised clinical trials can improve patient retention and generalisability by bringing trial activities closer to participants' homes using digital technologies. This matters for decentralised diagnostics as it supports the shift towards patient-centric models that reduce the need for on-site visits and broaden patient inclusion.
Remote decentralized clinical trials: a new opportunity for laboratory medicine — Pennestrì et al., Clinical chemistry and laboratory medicine (paywalled)
- dct
2023
The authors developed a capillary microfluidic device that captures multiple blood biomarkers at collection and dries them on-chip, enabling safe shipment to centralised laboratories for multiplexed analysis. This patient-centric approach could support remote health monitoring and decentralised trials.
Microfluidic Device for Patient-Centric Multiplexed Assays with Readout in Centralized Laboratories — Hauser et al., Analytical chemistry
- blood
- dried
- capillary
- dct
- biomarkers
2023
Healthcare professionals in underserved French regions viewed home-based HPV self-sampling as a viable solution to low screening coverage, trusting vaginal sampling while accepting urine as an alternative for women with conditions such as vaginismus. They identified kit design flaws, instruction complexity, and patient anatomical knowledge gaps as implementation barriers requiring attention in decentralised screening programmes.
Acceptability to Healthcare Professionals of Home-Based HPV Self-Sampling for Cervical Screening: A French Qualitative Study Conducted in an Area with Low Access to Health Services — Le Goff et al., Cancers
- urine
- self-collection
- acceptability
- hpv
- sti
2023
In patients with abnormal Pap smears, HPV testing on random urine achieved about 60% sensitivity compared with clinician-collected cervical samples after adjusting the detection cutoff, and about 50% sensitivity for CIN2+; urine-based HPV testing requires further development to match the performance of clinician-collected samples.
Can HPV Test on Random Urine Replace Self-HPV Test on Vaginal Self-Samples or Clinician-Collected Cervical Samples? — Shih et al., International journal of women's health
- urine
- self-collection
- validation
- hpv
- sti
2023
Repeated self-collection of saliva for steroid hormone analysis proved feasible in dementia care dyads over eight weeks, with participants providing a mean of 4.3 to 4.9 morning samples weekly during the first seven weeks, falling to 3.3 in the final week. The music intervention was associated with lower morning cortisol concentrations in caregivers, showing that home-based saliva microsampling can objectively capture intervention effects in decentralised studies.
Assessing stress using repeated saliva concentration of steroid hormones in dementia care dyads: results from a controlled pilot care music intervention — Emami et al., Upsala journal of medical sciences
- saliva
- self-collection
- hormones
- cortisol
2023
Automated dried blood spot analysis achieved clinical and analytical acceptance criteria for tacrolimus, sirolimus, everolimus and cyclosporin A after haematocrit correction. This validates a method that could enable decentralised, patient-centric therapeutic drug monitoring for transplant recipients.
Application of a Fully Automated Dried Blood Spot Method for Therapeutic Drug Monitoring of Immunosuppressants: Another Step Toward Implementation of Dried Blood Spot Analysis — Deprez & Stove, Archives of pathology & laboratory medicine (paywalled)
- blood
- dried
- dbs
- validation
- venous-agreement
- tdm
- immunosuppressants
- haematocrit
2023
In participants 11 months after SARS-CoV-2 infection, the nano-immunoassay achieved 98.33% sensitivity and 97.62% specificity on venous serum. When combined with dried capillary microsampling, sensitivity was 95.05% with Mitra, 61.11% with repurposed glucose strips and 83.16% with HemaXis (91.49% after automated extraction), with no loss of specificity, supporting home-based sampling for serology.
Clinical sensitivity and specificity of a high-throughput microfluidic nano-immunoassay combined with capillary blood microsampling for the identification of anti-SARS-CoV-2 Spike IgG serostatus — Michielin et al., PloS one
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- venous-agreement
- serology
2023
VAMS finger-prick microsampling showed reliable agreement with venous blood sampling for measuring tacrolimus and creatinine after correction for systematic differences, supporting its use in therapeutic drug monitoring. This offers a patient-centric, decentralised alternative to frequent venipunctures in kidney transplant recipients.
Serum Creatinine and Tacrolimus Assessment With VAMS Finger-Prick Microsampling: A Diagnostic Test Study — Scuderi et al., Kidney medicine
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- venous-agreement
- tdm
- immunosuppressants
2023
VAMS capillary samples from 32 liver transplant recipients showed strong agreement with venous blood for everolimus measurement, with a correlation of r squared 0.92 and no proportional or constant bias on Bland Altman analysis. No effect of haematocrit or sampling time was observed, supporting VAMS as a virtually painless decentralised alternative to venous draws for immunosuppressant monitoring in transplant patients.
Volumetric Absorptive Microsampling for the Therapeutic Drug Monitoring of Everolimus in Patients Who Have Undergone Liver Transplant — Yoo et al., Therapeutic drug monitoring (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- venous-agreement
- tdm
- immunosuppressants
- haematocrit
2023
Researchers developed and validated a volumetric absorptive microsampling method for cariprazine therapeutic drug monitoring in psychiatric patients. The approach showed strong agreement with conventional plasma analysis, offering a minimally invasive alternative that could support decentralised monitoring programmes.
Volumetric absorptive microsampling for the therapeutic drug monitoring of psychiatric patients treated with cariprazine — Millán-Santiago et al., Journal of pharmaceutical and biomedical analysis (paywalled)
- blood
- dried
- vams
- validation
- venous-agreement
- tdm
2023
The study validated a VAMS based LC-MS/MS assay for perampanel in saliva, demonstrating linear calibration, acceptable accuracy and precision, and stability across storage conditions, and showed clinical applicability in patients with epilepsy, supporting at-home therapeutic drug monitoring.
Therapeutic Salivary Monitoring of Perampanel in Patients with Epilepsy Using a Volumetric Absorptive Microsampling Technique — Palmisani et al., Pharmaceutics
- saliva
- dried
- vams
- neoteryx-mitra
- validation
- tdm
2023
The authors validated a UHPLC-MS/MS method for quantifying four ceramide species in 10 μL quantitative dried blood spots. Ceramides remained stable at room temperature, supporting remote self-collection, and concentrations were higher in fingertip whole blood than in plasma or serum, which is relevant for at-home monitoring of cardiovascular and metabolic disease risk.
Ceramides biomarkers determination in quantitative dried blood spots by UHPLC-MS/MS — Meikopoulos et al., Analytica chimica acta (paywalled)
- blood
- dried
- capillary
- qdbs
- validation
- metabolome
- biomarkers
2023
The CHIEF-HF trial showed a fully decentralised, placebo-controlled heart failure trial can run without in-person visits, yet recruitment remained challenging: just 2.0% of 130,832 contacted people expressed interest, and 18.5% of those were enrolled. At the highest-enrolling site, electronic medical record portal messaging yielded higher opt-in rates than email alone (7.8% versus 4.4%), suggesting targeted digital channels can improve participation in decentralised diagnostic studies.
Recruitment Strategies of a Decentralized Randomized Placebo Controlled Clinical Trial: The Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) Trial — Nassif et al., Journal of cardiac failure (paywalled)
- dct
- digital-biomarker
2023
Most young women found self-collected vaginal swabs easy and acceptable for STI testing, with 60.9% preferring them to urine samples when both were offered. The method was feasible in a community-based Zimbabwean setting, with high rates of understanding, privacy, and sense of control, suggesting it could expand access to STI screening.
Acceptability of self-collected vaginal swabs for sexually transmitted infection testing among youth in a community-based setting in Zimbabwe — Rochford et al., International journal of STD & AIDS
- urine
- self-collection
- acceptability
- sti
2023
Salivary SARS-CoV-2 RNA testing showed 94.3% accuracy, 96.4% specificity and 89.2% sensitivity when benchmarked against nasopharyngeal or oropharyngeal swabs. Combining saliva with standard swabs improved detection by 3.6%, confirming saliva as a practical non-invasive option for decentralised COVID-19 screening.
Salivary SARS-CoV-2 RNA for diagnosis of COVID-19 patients: a systematic revisew and meta-analysis of diagnostic accuracy — Caixeta et al., The Japanese dental science review
- saliva
- self-collection
- validation
- serology
2023
Capillary blood in Hem-Col microtubes showed a relative bias of 1.23% against directly processed venous sampling for CEA, with samples remaining stable for up to four days after withdrawal. Home-based CEA monitoring for colorectal cancer follow-up is feasible with this method, though underfilled tubes flagged by high lithium concentrations yield less reliable results.
Reliable capillary sampling of carcinoembryonic antigen at home: the CASA feasibility study — Voigt et al., Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland (paywalled)
- blood
- liquid
- capillary
- self-collection
- validation
- venous-agreement
- colorectal
2023
Capillary blood self-collection showed acceptable agreement with venous samples for vitamin D, C-reactive protein and alkaline phosphatase even after 36-hour delays, but calcium and phosphate levels were more affected by pre-analytical conditions. This supports decentralised serology and biomarker testing while highlighting analytes that need tighter pre-analytical control.
Concordance in COVID-19 serology, bone mineralization, and inflammatory analytes between venous and self-collected capillary blood samples exposed to various pre-analytical conditions — Hosseini et al., Annals of clinical biochemistry (paywalled)
- blood
- liquid
- capillary
- validation
- venous-agreement
- serology
- biomarkers
2023
The study developed and validated an HPLC-DAD method for quantifying favipiravir in whole blood collected via VAMS, meeting FDA 2018 guidelines with a lower limit of quantification of 0.5 micrograms per millilitre. This supports the use of VAMS for therapeutic drug monitoring of favipiravir in decentralised settings.
HPLC-DAD quantification of favipiravir in whole blood after extraction from volumetric absorptive microsampling devices — Azzahra Rahmadhani et al., Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
- blood
- dried
- vams
- neoteryx-mitra
- validation
- tdm
- antimicrobials
2023
The study found that VAMS dried blood sampling provides blood phenylalanine measurements highly concordant with venous plasma, with over 88% of results within 20% difference, supporting its use in patient-centric monitoring. This validates a decentralised, microsampling-based approach for therapeutic drug monitoring in phenylketonuria, including in children.
Validation and application of volumetric absorptive microsampling (VAMS) dried blood method for phenylalanine measurement in patients with phenylketonuria — Gao et al., Clinical biochemistry (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
2023
Jacobs et al. validated a VAMS-based LC-HRMS/MS method for therapeutic drug monitoring of antihypertensive drugs in finger-prick blood, demonstrating acceptable accuracy and precision across haematocrit levels and stable analyte recovery for two weeks at ambient temperature. Whole-blood VAMS concentrations cannot be used interchangeably with plasma, requiring class-specific reference ranges, yet the approach is suitable for decentralised adherence assessment.
Closing the gap - development of an analytical methodology using volumetric absorptive microsampling of finger prick blood followed by LC-HRMS/MS for adherence monitoring of antihypertensive drugs — Jacobs et al., Analytical and bioanalytical chemistry
- blood
- dried
- vams
- validation
- tdm
- haematocrit
2023
Researchers developed and validated a UHPLC-MS/MS method for simultaneous quantification of favipiravir and remdesivir from VAMS blood samples, meeting FDA and EMA validation criteria. The method uses simple protein precipitation and supports therapeutic drug monitoring of COVID-19 antivirals in settings where small sample volumes and simplified processing are advantageous.
Development and validation of method for analysis of favipiravir and remdesivir in volumetric absorptive microsampling with ultra high-performance liquid chromatography-tandem mass spectrophotometry — Harahap et al., Frontiers in medicine
- blood
- dried
- vams
- validation
- tdm
- antimicrobials
2023
A qualitative study found that an online PrEP pathway incorporating postal self-sampling for HIV and STIs was highly acceptable to users and clinicians, offering convenience and service capacity benefits, though blood self-sampling was a barrier for some participants. The model suits established PrEP users with adequate digital literacy and requires integration with in-clinic support.
Delivering HIV prevention medication online: Findings from a qualitative study exploring the acceptability of an online HIV pre-exposure prophylaxis (PrEP) care pathway among service users and healthcare professionals — Kincaid et al., Digital health
- blood
- self-collection
- acceptability
- sti
2023
This pilot study of women with HPV-positive cervical swabs found urine samples detected high-risk HPV genotypes in 94% (16/17) of cases, achieving 98.8% diagnostic accuracy compared with self-collected cervical swabs. The strong agreement suggests urine testing could support decentralised cervical cancer screening, though larger studies are needed.
Comparison of Human Papillomavirus Genotype Detection in Paired Urine and Self-Collected Cervical Swabs: A Pilot Study — Patel et al., Asian Pacific journal of cancer prevention : APJCP
- urine
- self-collection
- hpv
- sti
2023
Latent profile analysis of more than 4000 saliva cortisol samples from children aged two, three-and-a-half, and five years identified three diurnal patterns: a predominant low/regular profile, a low/flat profile, and a high/fluctuating profile associated with home childcare, higher temperamental surgency, and maternal depressive symptoms. The study observed only moderate stability across the three-year follow-up, with half of children moving between groups, and highlights methodological issues in pediatric saliva sampling, supporting decentralised, longitudinal biomarker monitoring in early childhood.
Latent profile analysis of diurnal cortisol patterns at the ages of 2, 3.5, and 5 years: Associations with childcare setting, child individual characteristics, and maternal distress — Tervahartiala et al., Psychoneuroendocrinology (paywalled)
- saliva
- self-collection
- pediatric
- hormones
- cortisol
2023
The study describes a protocol for measuring the low-abundance cancer biomarker progastrin-releasing peptide in dried serum spots and volumetric absorptive microsampling devices, finding that VAMS yielded higher signal intensities than dried serum spots.
Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins — Ngo et al., Journal of visualized experiments : JoVE (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- biomarkers
2023
In 20 women providing 73 paired samples across menstrual‑cycle phases, urinary metabolites measured at home correlated strongly with serum hormone concentrations (estradiol R²=0.96, progesterone R²=0.95, LH R²=0.98). When the derived equations were applied to a separate set of 20 users, predicted serum values correlated 0.92–0.94 with actual measurements. This suggests home urine testing could substitute for clinic blood draws in routine fertility monitoring, though the cohort was limited to women with normal cycles.
Predicting serum hormone concentration by estimation of urinary hormones through a home-use device — Pattnaik et al., Human reproduction open
- blood
- urine
- self-collection
- validation
- fertility
- hormones
2023
A fully remote, randomised pilot trial of 30 people with functional constipation demonstrated geographic reach with 27% residing outside metropolitan areas. Lactobacillus supplementation increased weekly bowel movements by 0.80 and reduced defecation time by 3.94 hours versus vitamin C alone, but 33% of mobile diary entries were not completed as scheduled, highlighting the need for real-time data quality monitoring in decentralised trials.
Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms — Huh et al., Clinical and translational science
- dct
- digital-biomarker
2023
The TASSO-M20 device for self-collected capillary blood demonstrated strong agreement with liquid whole blood for phosphatidylethanol (PEth) measurement (r²=0.988) and proved feasible and acceptable during virtual alcohol monitoring, causing less discomfort than finger stick methods. In a single participant tracked over time, PEth levels from the device aligned with urinary ethyl glucuronide and self-reported alcohol consumption.
Validation of the quantification of phosphatidylethanol 16:0/18:1 concentrations in TASSO-M20 devices — Jett et al., Alcohol, clinical & experimental research (paywalled)
- blood
- dried
- capillary
- dbs
- self-collection
- validation
- venous-agreement
- acceptability
2023
Targeted DNA methylation analysis accurately estimated relative and absolute leukocyte subset counts from dried capillary blood collected with Mitra devices, showing strong correlation with conventional venous blood methods (r=0.72–0.97). This enables self-sampling by finger prick, facilitating easier access to leukocyte testing for patients with haematological disorders.
Targeted DNA Methylation Analysis Facilitates Leukocyte Counts in Dried Blood Samples — Hubens et al., Clinical chemistry (paywalled)
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- venous-agreement
- biomarkers
2023
In whole blood spiked with 90 drugs, the VAMS method using the Neoteryx Mitra device confirmed 87 compounds with identification limits below 12.5 ng/mL for 82.2% of drugs and extraction yields of 80.6 to 108.7%. In 15 poisoned patients, 98% of plasma compounds were detected in VAMS with satisfactory concordance (R2 = 0.827), supporting its use for decentralised toxicology screening.
New Trend in Toxicological Screening Using Volumetric Absorptive Microsampling (VAMS) and High-Resolution Mass Spectrometry (HR/MS) Combination — Houzé et al., Molecules
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
- toxicology
2023
Female adolescent and young adult cancer survivors frequently misestimated their infertility risk, with minimal agreement between perceived risk and objective assessment using self-collected dried blood spots for ovarian reserve testing. The study suggests ongoing counselling could align perceptions with actual risk and inform family planning.
Perceived and Objective Fertility Risk Among Female Survivors of Adolescent and Young Adult Cancer — Din et al., JAMA network open
- blood
- dried
- dbs
- self-collection
- fertility
- hormones
2023
The study found that the Premom and Easy@Home urine-based luteinizing hormone testing systems provided estimates of peak fertility that were highly correlated with the Clearblue Fertility Monitor, suggesting they are accurate tools for ovulation detection and easy to use at home.
A Comparison of Two Hormonal Fertility Monitoring Systems for Ovulation Detection: A Pilot Study — Mu & Fehring, Medicina
- urine
- self-collection
- acceptability
- fertility
- hormones
2023
The authors developed and deployed a decentralised trial platform for a Phase 2 COVID-19 study that used home-based monitoring devices and mobile applications to collect health data remotely, enabling inclusion of participants from diverse socioeconomic backgrounds and rural settings. They created a Clinical-Trial-in-a-Box tool to standardise data collection across decentralised platforms, with lessons learned applicable to Long COVID research.
From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials — Dulko et al., Journal of clinical and translational science
- dct
- rpm
2023
This protocol paper describes a decentralised HIV self-testing trial that enrolled 2093 Black and Hispanic men who have sex with men across 11 US states. The study incorporates laboratory analysis of participant-returned dried blood spot cards to verify self-reported HIV status, illustrating how patient-centric microsampling can be integrated into remote serology screening for underserved populations.
Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial — Dana et al., JMIR research protocols
- blood
- dried
- dbs
- self-collection
- dct
- serology
- sti
2023
Self collected dried blood spots gave equivalent results to venous blood for lipids, HbA1c and C reactive protein, enabling similar classification of cardiovascular risk; self collection had lower response than nurse collection but similar demographic participation.
A randomised study of nurse collected venous blood and self-collected dried blood spots for the assessment of cardiovascular risk factors in the Understanding Society Innovation Panel — Kumari et al., Scientific reports
- blood
- dried
- dbs
- self-collection
- venous-agreement
- acceptability
- biomarkers
2023
Fecal and oral microbiome samples showed high stability over two years at -80°C, with intraclass correlation coefficients of 0.70–0.99 for stool and above 0.74 for saliva across most collection methods. Stool collected without additive and saliva collected with Scope mouthwash showed lower stability for some measures, demonstrating that collection method choice affects reliability of stored samples for microbiome analysis in decentralised diagnostics.
Stability of the Fecal and Oral Microbiome over 2 Years at -80°C for Multiple Collection Methods — Zouiouich et al., Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology (paywalled)
- saliva
- stool
- stabilised
- validation
- microbiome
2023
First-void urine samples from 85 Austrian school children aged six to ten showed frequent low-level exposure to mycotoxins and phytoestrogens, with 22 percent exceeding the tolerable daily intake for deoxynivalenol and some facing possible health risks from ochratoxin A. The results support urine microsampling for decentralised exposome monitoring in paediatric populations.
The Austrian children's biomonitoring survey 2020 Part B: Mycotoxins, phytotoxins, phytoestrogens and food processing contaminants — Ayeni et al., Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association (paywalled)
- urine
- first-void
- pediatric
- toxicology
- biomarkers
2023
Researchers validated a microsampling method for measuring baricitinib levels in children aged 2–18 years using the Mitra device. The approach showed good agreement with conventional plasma sampling and was well received by clinical sites, suggesting it could support paediatric therapeutic drug monitoring and trial enrolment.
Microsampling in pediatric studies: pharmacokinetic sampling for baricitinib (Olumiant™) in global pediatric studies — Wickremsinhe et al., Bioanalysis (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- pediatric
- tdm
2023
This review surveys published LC-MS/MS methods that use dried blood microsampling for therapeutic drug monitoring of immunosuppressants in transplantation, chemotherapy and autoimmune disease, finding that volumetric dried blood samples can replace conventional venous draws for home sampling and improve patient quality of life. The authors discuss pre-analytical considerations, clinical applicability, cost-effectiveness, harmonisation gaps and patient perception, concluding that obstacles to routine clinical implementation remain despite growing methodological maturity.
Dried blood microsampling-assisted therapeutic drug monitoring of immunosuppressants: An overview — Deprez & Stove, Journal of chromatography. A (paywalled)
- blood
- dried
- dbs
- volumetric
- validation
- acceptability
- tdm
- immunosuppressants
- economics
2023
Decentralised monitoring of people with type 2 diabetes using continuous glucose monitoring and a hybrid smartwatch was feasible, with high participant retention and successful collection of glucose, heart rate, activity, sleep and GPS data via a study app.
Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial — Ali et al., Journal of diabetes science and technology (paywalled)
- dct
- wearable
- rpm
- cgm
- digital-biomarker
- actigraphy
2023
The electrochemical sensor detected SARS-CoV-2 antibodies in under ten minutes from 1.5 μL patient samples with 100% sensitivity and specificity across 93 clinical specimens. Dried blood spots enabled self-collection and ambient-temperature transport, supporting remote serological surveillance and point-of-care assessment of humoral responses to vaccination or infection.
Rapid quantitation of SARS-CoV-2 antibodies in clinical samples with an electrochemical sensor — Timilsina et al., Biosensors & bioelectronics
- blood
- dried
- dbs
- validation
- serology
2023
In adult kidney transplant patients, fingerprick VAMS and dried blood spot microsampling achieved accurate simultaneous measurement of tacrolimus, mycophenolic acid, and prednisolone compared with venepuncture. The authors noted an overall preference for VAMS over conventional dried blood spots.
Fingerprick Microsampling Methods Can Replace Venepuncture for Simultaneous Therapeutic Drug Monitoring of Tacrolimus, Mycophenolic Acid, and Prednisolone Concentrations in Adult Kidney Transplant Patients — Scuderi et al., Therapeutic drug monitoring (paywalled)
- blood
- dried
- capillary
- vams
- dbs
- neoteryx-mitra
- validation
- venous-agreement
- tdm
- immunosuppressants
2023
Microsampling assays for immunosuppressant monitoring showed three- to fourfold higher imprecision across 14 laboratories than conventional whole-blood analysis, with coefficients of variation of 11.7 to 18.6 percent versus 3.9 to 4.9 percent. In a patient specimen, this analytical scatter produced a different clinical decision, proving that current microsampling practice lacks the standardisation required for safe home-based therapeutic drug monitoring.
Results From a Proficiency Testing Pilot for Immunosuppressant Microsampling Assays — Veenhof et al., Therapeutic drug monitoring
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- tdm
- immunosuppressants
2023
The study developed and validated a UHPLC-MS/MS method to measure eight antibiotics in quantitative dried blood spots collected from neonates using a capillary microsampling device. This patient-centric approach enables robust pharmacokinetic monitoring in children where blood volume is limited, supporting decentralised therapeutic drug monitoring.
A Validated UHPLC-MS/MS Method to Quantify Eight Antibiotics in Quantitative Dried Blood Spots in Support of Pharmacokinetic Studies in Neonates — Liu et al., Antibiotics
- blood
- dried
- qdbs
- validation
- pediatric
- tdm
- antimicrobials
2023
The narrative review identified gaps in sustainability assessment within current DCT frameworks, noting that environmental impacts such as carbon footprint and disposal of sensors and investigational medicinal products are not comprehensively addressed, highlighting a need for more complete guidance.
Design and Execution of Sustainable Decentralized Clinical Trials — Singh et al., Clinical pharmacology and therapeutics (paywalled)
- dct
- standards
2023
Sexual minority men found finger-stick blood and rectal swabs more challenging to self-collect than other specimens. Barriers to returning samples included low confidence in self-collection and concerns about transit delays, while motivators were status confirmation and limited clinic access; real-time video support could improve uptake in future decentralised testing programmes.
Perceptions and Experiences of Returning Self-collected Specimens for HIV, Bacterial STI and Potential PrEP Adherence Testing among Sexual Minority Men in the United States — Sharma et al., AIDS and behavior
- blood
- urine
- self-collection
- acceptability
- serology
- sti
2023
A colorimetric biosensor using peptidic ligands immobilised on porous nanofibers detects SARS-CoV-2 spike protein in saliva with low nanomolar sensitivity, achieving performance comparable to some FDA-approved home kits and detecting both the original strain and the Delta variant.
Discovery of Peptidic Ligands against the SARS-CoV-2 Spike Protein and Their Use in the Development of a Highly Sensitive Personal Use Colorimetric COVID-19 Biosensor — Yu et al., ACS sensors
- saliva
- self-collection
2023
Finger-stick capillary blood spotted onto filter paper and dried (DBS) provides C-reactive protein results that correlate excellently with venous plasma (R² = 0.986). The method correctly classified all 25 high cardiovascular-risk patients and 12 of 13 inflammation cases, with analyte stability demonstrated for 31 days, supporting its use for patient-centric at-home sampling in decentralised diagnostics and screening programmes.
Analysis of C-reactive protein from finger stick dried blood spot to predict high risk of cardiovascular disease — Schakelaar et al., Scientific reports
- blood
- dried
- capillary
- dbs
- self-collection
- validation
- venous-agreement
- haematocrit
- biomarkers
2023
The study developed and validated a LC-MS/MS assay for imatinib and its metabolite using volumetric absorptive microsampling, enabling reliable home blood collection by patients with chronic myeloid leukaemia. Therapeutic drug concentrations measured from VAMS were comparable across adherence groups, supporting the use of VAMS for routine decentralised monitoring of imatinib therapy.
Volumetric dried blood microsampling for monitoring imatinib mesylate therapy: Method development and clinical application in patients with chronic myeloid leukemia — Krützmann et al., Journal of pharmaceutical and biomedical analysis (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- self-collection
- validation
- tdm
- oncology
2023
Room temperature storage of dried blood on VAMS devices caused significant losses in 13 of 21 cytokine analytes after five months compared to storage at 4 °C. Storing devices at 4 °C or colder preserved the majority of tested cytokines, demonstrating that cold storage is essential for reliable longitudinal cytokine profiling in decentralised studies.
Stability of inflammation markers in human blood collected using volumetric absorptive microsampling (VAMS) under typical laboratory storage temperatures — McMahon et al., Cytokine (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- biomarkers
2023
A method for tacrolimus quantification from volumetric dried blood spots collected with a hemaPEN device was validated using automated LC-MS/MS extraction. The assay was linear from 1 to 100 µg/L and met all analytical and clinical validation criteria, enabling decentralised therapeutic drug monitoring of immunosuppressants through home-based capillary blood sampling.
New perspectives for the therapeutic drug monitoring of tacrolimus: Quantification in volumetric DBS based on an automated extraction and LC-MS/MS analysis — Rosé et al., Journal of chromatography. B, Analytical technologies in the biomedical and life sciences (paywalled)
- blood
- dried
- capillary
- dbs
- volumetric
- validation
- tdm
- immunosuppressants
2023
The Inito Fertility Monitor demonstrated strong agreement with laboratory ELISA for measuring urinary estrone-3-glucuronide, pregnanediol glucuronide and luteinising hormone, with coefficients of variation around 5%. It identified a novel ovulation confirmation criterion that distinguished ovulatory from anovulatory cycles with 100% specificity and an area under the curve of 0.98, supporting accurate decentralised fertility monitoring.
Validation of urinary reproductive hormone measurements using a novel smartphone connected reader — Pattnaik et al., Scientific reports
- urine
- self-collection
- validation
- fertility
- hormones
2023
Home-based monitoring of ovulation for timing frozen embryo transfer produced ongoing pregnancy rates of 20.8% in 732 women, which was non-inferior to the 20.9% rate with hospital-controlled monitoring (risk difference -0.14%, 90% CI -3.63 to 3.36). This randomised trial supports decentralised fertility care without compromising pregnancy outcomes.
Home-based monitoring of ovulation to time frozen embryo transfers in the Netherlands (Antarctica-2): an open-label, nationwide, randomised, non-inferiority trial — Zaat et al., Lancet (paywalled)
- fertility
- hormones
2023
First-void urine identified merely 15.8% of HPV types in circumcised men with genital warts, the lowest detection rate of six sampling methods. Combining wart biopsy with swabs from four genital anatomical sites achieved 98.9% detection, demonstrating that multi-site collection is necessary for accurate decentralised HPV screening in this population.
Evaluation of the optimal sampling approach for HPV genotyping in circumcised heterosexual men with genital warts — Sarier et al., Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy (paywalled)
- urine
- first-void
- genotyping
- hpv
- sti
2023
The review found that volumetric absorptive microsampling can reliably assay tacrolimus and mycophenolic acid for therapeutic drug monitoring, though correction factors are often required to meet regulatory agreement standards. This supports the use of microsampling for decentralised trials and dose optimisation in transplant recipients.
Volumetric Absorptive Microsampling to Enhance the Therapeutic Drug Monitoring of Tacrolimus and Mycophenolic Acid: A Systematic Review and Critical Assessment — Leino et al., Therapeutic drug monitoring (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
- tdm
- immunosuppressants
2023
Decentralised and site-less trial designs enable broader participation in rare cancer studies by mitigating travel burdens for underserved and rural populations.
Home-run trials for rare cancers: giving the right drug(s) to the right patients at the right time and in the right place — Adashek & Kurzrock, NPJ precision oncology
- oncology
- dct
2023
Daily at-home nasal antigen tests detected only 44% of infected individuals and missed up to 37% of those with high, presumably infectious viral loads. Using combined nasal-throat specimens rather than nasal swabs alone would significantly improve detection of infectious people in decentralised testing.
Daily SARS-CoV-2 Nasal Antigen Tests Miss Infected and Presumably Infectious People Due to Viral Load Differences among Specimen Types — Viloria Winnett et al., Microbiology spectrum
- saliva
- self-collection
- validation
- serology
2023
Volumetric dried blood spots from finger-prick correlated strongly with venous serum lithium concentrations (Pearson’s R=0.95, ratio 0.78) in thirty-nine patients. This patient-centric microsampling method could enable home-based therapeutic drug monitoring for bipolar disorder, improving compliance and safety where venous sampling is impractical.
Determination of lithium concentration in capillary blood using volumetric dried blood spots — Wikström et al., Journal of pharmaceutical and biomedical analysis (paywalled)
- blood
- dried
- capillary
- dbs
- volumetric
- self-collection
- venous-agreement
- tdm
2023
Lopinavir/ritonavir did not improve symptom resolution or reduce hospitalisation compared with placebo in non-hospitalised COVID-19 patients. The trial used remote daily surveys to monitor symptoms and outcomes, demonstrating the application of remote patient monitoring in a decentralised infectious-disease study.
Lopinavir/ritonavir for treatment of non-hospitalized patients with COVID-19: a randomized clinical trial — Kaizer et al., International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
- dct
2023
The Xpert HPV assay showed similar sensitivity for detecting cervical intraepithelial neoplasia grade 2 or worse on vaginal self-collected samples compared with clinician-collected cervical samples, but clinical specificity was lower when self-samples were collected with the Qvintip device.
Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples within the VALHUDES Framework — Latsuzbaia et al., The Journal of molecular diagnostics : JMD (paywalled)
- self-collection
- validation
- hpv
- sti
2023
EFT and music therapy significantly reduced anxiety and salivary cortisol levels while improving psychological growth and wellbeing in pregnant women following prenatal loss. This demonstrates that saliva sampling can be integrated into decentralised mental health interventions, supporting remote biomarker monitoring in perinatal care.
The effect of emotional freedom technique and music applied to pregnant women who experienced prenatal loss on psychological growth, well-being, and cortisol level: A randomized controlled trial — Okyay & Uçar, Archives of psychiatric nursing (paywalled)
- saliva
- fertility
- hormones
- cortisol
2023
The CandyCollect lollipop-inspired device achieved 100% concordance with commercial oral swabs and spit tubes for detecting salivary bacteria in 14 healthy adults who self-collected samples at home. Among 26 participants surveyed, the device was ranked highest for user preference, and it showed a one-year shelf life at room temperature, indicating potential for decentralised diagnostics and telemedicine applications.
At-Home Saliva Sampling in Healthy Adults Using CandyCollect, a Lollipop-Inspired Device — Tu et al., Analytical chemistry (paywalled)
- saliva
- self-collection
- validation
- acceptability
2023
Capillary blood yields comparable results to venous blood for common biochemistry and haematology parameters on routine analysers, but performance may degrade if samples are not processed within 24 hours.
Analysis of common biomarkers in capillary blood in routine clinical laboratory. Preanalytical and analytical comparison with venous blood — Maroto-García et al., Diagnosis (paywalled)
- blood
- liquid
- capillary
- validation
- venous-agreement
2023
This review surveyed the use of VAMS devices for analysing endogenous metabolites and biomarkers across the full analytical workflow, finding them reliable for biological analysis with improved analyte stability over liquid blood at ambient temperature and a straightforward acquisition model well suited to decentralised diagnostics.
Volumetric Absorptive Microsampling in the Analysis of Endogenous Metabolites — de Sá E Silva et al., Metabolites
- blood
- dried
- vams
- validation
- metabolome
- biomarkers
2023
Sexual health service providers in Ontario found self-sampling and virtual models for STBBI testing highly acceptable during COVID-19, viewing them as more convenient, accessible and safer than clinic-based testing while filling critical service gaps caused by pandemic resource reallocation. This real-world experience demonstrates the feasibility of decentralised, patient-centric STBBI testing and supports sustaining these models as essential healthcare.
Disruptions of sexually transmitted and blood borne infections testing services during the COVID-19 pandemic: accounts of service providers in Ontario, Canada — Ryu et al., BMC health services research
- self-collection
- acceptability
- sti
2023
First-void urine self-sampling for HPV screening cost £38.57 per complete screen compared with £56.81 for clinician-collected samples, with potential NHS savings of £19.2 million annually if uptake improved among non-attenders. This shows self-sampling is substantially cheaper and could expand screening reach to under-screened women, supporting decentralised diagnostic programmes.
Two self-sampling strategies for HPV primary cervical cancer screening compared with clinician-collected sampling: an economic evaluation — Huntington et al., BMJ open
- urine
- first-void
- self-collection
- economics
- hpv
- sti
2023
This review summarises progress toward integrating automated sample preparation with on-chip nucleic acid amplification for home testing of self-collected blood, urine, saliva and stool specimens. It identifies that user-friendly, combined systems may enable rapid, accurate molecular diagnostics outside central laboratories, which is relevant for decentralised infectious disease screening.
Toward Rapid and Accurate Molecular Diagnostics at Home — Liu & Lee, Advanced materials (paywalled)
- blood
- saliva
- urine
- stool
- self-collection
- validation
- serology
2023
The authors propose a systems-thinking framework for evaluating decentralized clinical trial deployments, concluding that solutions must be customised to patient needs and trial requirements while identifying implementation enablers to address new systemic demands. This matters because it offers a structured approach for planning patient-centric decentralised studies, though it calls for further empirical validation.
Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment — Betcheva et al., Therapeutic innovation & regulatory science
- dct
2023
In north-western Tanzania, self-collected cervical-vaginal swabs and urine were used for PCR detection of Female Genital Schistosomiasis; self-sampling was highly acceptable and detected more cases than operator-collected swabs, supporting its use in decentralised screening programmes.
Assessing the prevalence of Female Genital Schistosomiasis and comparing the acceptability and performance of health worker-collected and self-collected cervical-vaginal swabs using PCR testing among women in North-Western Tanzania: The ShWAB study — Ursini et al., PLoS neglected tropical diseases
- urine
- self-collection
- acceptability
2023
Profiling EBV DNA methylation in self-collected saliva distinguished nasopharyngeal carcinoma from controls with 90% sensitivity and 100% specificity by capture sequencing; a q-PCR assay targeting one CpG site achieved 78% sensitivity and 100% specificity. The methylation density fell after therapy and rose with recurrence, confirming that decentralised salivary screening can support both diagnosis and disease monitoring.
Saliva biopsy: Detecting the difference of EBV DNA methylation in the diagnosis of nasopharyngeal carcinoma — Zheng et al., International journal of cancer (paywalled)
- saliva
- self-collection
- validation
- oncology
- biomarkers
- liquid-biopsy
2023
In healthy adults, capillary blood collected with the Onflow device yielded similar chemistry results to venous blood and was rated more acceptable with lower pain than venepuncture, with high willingness to reuse and positive phlebotomist usability.
Painless Capillary Blood Collection: A Rapid Evaluation of the Onflow Device — Noble et al., Diagnostics
- blood
- liquid
- capillary
- venous-agreement
- acceptability
2023
Remote smartphone cognitive testing using the ALLFTD Mobile App was feasible and acceptable for people with frontotemporal dementia and at-risk kindreds, supporting decentralised trials and improved access to research.
Feasibility and acceptability of remote smartphone cognitive testing in frontotemporal dementia research — Taylor et al., Alzheimer's & dementia
- dct
- rpm
- digital-biomarker
2023
Electrochemical aptamer biosensors measured glucose and adenosine monophosphate in undiluted saliva with pico- to nanomolar sensitivity and remained reusable for up to seven days after storage. This noninvasive approach could support point-of-care diagnosis and at-home monitoring without the need for blood draws.
Electrochemical Aptamer-Based Biosensors for Measurements in Undiluted Human Saliva — Nguyen et al., ACS sensors (paywalled)
- saliva
- liquid
- self-collection
- validation
- biomarkers
2023
A prospective study of 1384 individuals developed an 18-small RNA signature (miLung) for lung cancer detection, achieving an area under the curve of 0.86 in discovery and 0.83 in validation cohorts. Diagnostic performance increased with tumour stage, and dried blood spot collection suggests feasibility for home self-collection.
Early Detection of Lung Cancer Using Small RNAs — Sikosek et al., Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (paywalled)
- blood
- dried
- dbs
- self-collection
- biomarkers
- liquid-biopsy
2023
Researchers developed a flexible electrochemical immunosensor with micropyramidal electrodes that detects salivary progesterone and β-estradiol at sub-femtomolar concentrations within minutes. This patient-centric approach enables decentralised, centrifuge-free monitoring of ovarian hormone cycles through simple saliva dilution, offering a practical platform for at-home reproductive health diagnostics.
Tip-Enhanced Sub-Femtomolar Steroid Immunosensing via Micropyramidal Flexible Conducting Polymer Electrodes for At-Home Monitoring of Salivary Sex Hormones — Li et al., ACS nano (paywalled)
- saliva
- self-collection
- fertility
- hormones
2023
Daily self-sampling showed SARS-CoV-2 viral loads in saliva and throat swabs rose as many as seven days earlier than in nasal swabs, with extreme differences up to ten to the ninth copies per millilitre between specimen types from the same person at the same timepoint. For decentralised diagnostics, this means single-specimen testing underestimates infectiousness and misses early infection, suggesting combined throat-nasal swabs offer superior clinical sensitivity for detecting pre-infectious and infectious individuals.
Extreme differences in SARS-CoV-2 viral loads among respiratory specimen types during presumed pre-infectious and infectious periods — Viloria Winnett et al., PNAS nexus
- saliva
- self-collection
- serology
2023
Stool samples collected in DNA/RNA Shield tubes showed better preservation of microbiome taxonomic composition and functional stability over 18 months than OMNIgene-Gut tubes. This demonstrates that ambient stabilisation enables reliable decentralised microbiome collection and long-term storage before analysis.
Long-term taxonomic and functional stability of the gut microbiome from human fecal samples — Kim et al., Scientific reports
- stool
- stabilised
- dna-genotek-omnigene
- validation
- microbiome
2023
A wireless, battery-free pathogenic infection diagnosis system achieved 100% accuracy for diagnosing SARS-CoV-2 infection and 92% accuracy for evaluating symptom severity in 42 participants using blow and breath samples within 110 s and 350 s respectively, offering rapid decentralised diagnostics for respiratory infections.
Wireless, battery-free, multifunctional integrated bioelectronics for respiratory pathogens monitoring and severity evaluation — Li et al., Nature communications
- wearable
- digital-biomarker
2023
In a colposcopy referral population, the Alinity m HR HPV assay showed similar sensitivity for CIN2+ on home-collected first-void urine and vaginal self-samples compared with clinician-collected cervical samples, with comparable specificity for first-void urine and variable specificity across vaginal devices; adjusting signal thresholds improved assay accuracy across all self-sample types.
Clinical Accuracy of Alinity m HR HPV Assay on Self- versus Clinician-Taken Samples Using the VALHUDES Protocol — Latsuzbaia et al., The Journal of molecular diagnostics : JMD (paywalled)
- urine
- first-void
- colli-pee
- self-collection
- validation
- hpv
2023
Volumetric absorptive microsampling improves precision over dried blood spots by collecting a standardised blood volume, making it suitable for pharmacokinetic studies in special populations, though each assay requires clinical validation before routine use.
Applications of Volumetric Absorptive Microsampling Technique: A Systematic Critical Review — Dodeja et al., Therapeutic drug monitoring (paywalled)
- blood
- dried
- vams
- validation
- tdm
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