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 301–400 of 757 labelled “validation”, newest first.
2023
A UHPLC-HRMS assay quantified 25-hydroxyvitamin D2 and D3 from 20 µL Mitra VAMS samples with accuracy under 10% and precision under 11%, LOQ 5 ng/mL: sensitive enough to flag deficiency and simple enough for untrained self-collection, enabling year-round vitamin-D monitoring.
Quantification of 25-hydroxyvitamin D2 and D3 in Mitra devices (VAMS) by UHPLC-HRMS for regular vitamin D status monitoring — Tuma et al., J. Pharmaceutical and Biomedical Analysis (paywalled)
- vams
- neoteryx-mitra
- blood
- self-collection
- dried
- capillary
- validation
- biomarkers
2023
Capillary VAMS blood covered more of the metabolome than plasma, capturing intracellular red-cell metabolites, and correlated moderately-to-well with venous, Spearman 0.66; the honest caveats are higher finger-prick replicate variability and a need for −80 °C storage within six hours.
VAMS-based blood capillary sampling for mass-spectrometry-based human metabolomics studies — Volani et al., Metabolites
- vams
- venous-agreement
- blood
- metabolome
- dried
- capillary
- validation
- biomarkers
2023
Across 18 saliva samples, mouthwash collection gave higher alpha diversity than passive drooling on both Illumina and Nanopore platforms, and three preservation methods performed alike; mouthwash and simple collection are convenient decentralised options, provided a study keeps one collection method for all participants to avoid confounding.
Factors influencing oral microbiome analysis: from saliva sampling to sequencing platforms — Bang et al., Scientific Reports
- stabilised
- microbiome
- liquid
- validation
- saliva
2023
During ACTH stimulation, salivary cortisol correlated only weakly with serum and gave modest accuracy: saliva does not reliably replace serum cortisol for adrenal insufficiency. A concrete limit.
Reliability of Salivary versus Serum Cortisol for Diagnosing Adrenal Insufficiency in Children — Ciancia et al., Children
- venous-agreement
- blood
- cortisol
- pediatric
- hormones
- liquid
- validation
- saliva
2023
TAP II capillary serum, both professionally collected and self-collected, correlated with venous serum at R > 0.9 for eight analytes including ALT, AST, cholesterol, HDL and triglycerides. Creatinine correlated acceptably but carried a consistent negative bias, and carbon dioxide, potassium and albumin did not reach acceptable agreement: the useful reading is that the panel has to be validated, not the device alone.
Maximizing microsampling: measurement of comprehensive metabolic and lipid panels using a novel capillary blood collection device — Collier et al., The Journal of Applied Laboratory Medicine (paywalled)
- venous-agreement
- blood
- self-collection
- capillary
- bd-microtainer
- liquid
- yourbio
- validation
- biomarkers
2023
Fingerstick blood self-collected into BD Microtainer tubes and posted at ambient temperature for 24 h agreed acceptably with paired serum for 11 of 12 analytes, HbA1c, lipids, creatinine, urea, urate, liver enzymes and total protein, with only AST falling outside limits.
Capillary blood stability and analytical accuracy of 12 analytes stored in Microtainers — Fontaine & Saez, Practical Laboratory Medicine
- blood
- liquid
- capillary
- bd-microtainer
- self-collection
- venous-agreement
- validation
2023
This review evaluates established and emerging capillary blood sampling techniques, comparing factors such as wound geometry and patient comfort, and identifies microneedles as a promising option for paediatric care because they can obtain samples virtually painlessly.
Minimally invasive capillary blood sampling methods — Hoffman et al., Expert review of medical devices (paywalled)
- blood
- capillary
- validation
- acceptability
- pediatric
2023
A new method using a direct mercury analyser allows for precise total mercury measurement in dried blood spot samples while controlling for sample volume. This approach facilitates minimally invasive capillary blood collection, making it highly suitable for human biomonitoring studies in vulnerable populations such as children.
A simple method for direct mercury analysis in dried blood spots (DBS) samples for human biomonitoring studies — González-Rubio et al., Environment international (paywalled)
- blood
- dried
- dbs
- validation
- pediatric
- toxicology
2023
A validated LC-MS/MS method successfully quantified vincristine in paediatric patient-centric whole blood collected via VAMS microsampling, spanning 1 to 50 ng/mL with intra- and inter-accuracy and precision within ±10.3% and ≤7.3%. Whole blood concentrations showed a non-linear relationship to plasma concentrations, which was described by a saturable binding model.
A sensitive liquid chromatographic-mass spectrometry method for the quantification of vincristine in whole blood collected with volumetric absorptive microsampling — van et al., Journal of pharmaceutical and biomedical analysis (paywalled)
- blood
- vams
- validation
- pediatric
- tdm
- oncology
2023
A study of 50 paediatric renal transplant recipients found that a UHPLC-MS/MS method successfully quantified mycophenolic acid in VAMS microsampling samples over a 0.10-15 µg/mL range. However, converting microsampling results to plasma equivalents using haematocrit-based regression is required for clinical interpretation, supporting patient-centric decentralised monitoring.
Therapeutic drug monitoring of mycophenolic acid (MPA) using volumetric absorptive microsampling (VAMS) in pediatric renal transplant recipients: ultra-high-performance liquid chromatography-tandem mass spectrometry analytical method development, cross-validation, and clinical application — Kocur et al., Pharmacological reports : PR
- vams
- venous-agreement
- blood
- tdm
- haematocrit
- dried
- capillary
- pediatric
- immunosuppressants
- validation
2023
A study of 37 kidney transplant recipients found Capitainer and Mitra microsampling feasible for decentralised monitoring. Capitainer showed consistent sampling success, 92%-96%, and higher analytical accuracy than Mitra, 52%-88% success. Proportions within ±15% of venous reference for creatinine and haemoglobin were 92%-100% and 93%-100% for Capitainer, versus 79%-96% and 67%-92% for Mitra, despite small cohorts.
Clinical performance of volumetric finger-prick sampling for the monitoring of tacrolimus, creatinine and haemoglobin in kidney transplant recipients — Vethe et al., British journal of clinical pharmacology (paywalled)
- blood
- capillary
- qdbs
- volumetric
- neoteryx-mitra
- self-collection
- validation
- venous-agreement
- tdm
- immunosuppressants
2023
The study found that combining the Oragene saliva collector with the miRNeasy kit gave the most sensitive detection of seven saliva miRNAs, and that different collector-kit combinations can be selected to suit different study needs.
Obtaining miRNA from Saliva-Comparison of Sampling and Purification Methods — Urbizu et al., International journal of molecular sciences
- saliva
- liquid
- dna-genotek-oragene
- validation
- biomarkers
2023
The Tasso+ capillary blood collection device showed substantial to almost perfect concordance with standard venipuncture for measuring abnormal liver function tests including ALT, ALP, AST and total bilirubin, and patient feedback indicated a very favourable experience, supporting its use for more frequent and convenient testing outside the clinic.
Standard Venipuncture vs a Capillary Blood Collection Device for the Prospective Determination of Abnormal Liver Chemistry — Wickremsinhe et al., The journal of applied laboratory medicine (paywalled)
- blood
- capillary
- validation
- venous-agreement
- acceptability
2023
Saliva offers a non-invasive specimen matrix for detecting both oral and systemic conditions at the point of care. Although home collection and diagnostic biosensors show strong clinical and economic utility, technical challenges remain in standardisation and device integration before widespread point-of-care adoption.
A Review on Saliva-Based Health Diagnostics: Biomarker Selection and Future Directions — Kumari et al., Biomedical materials & devices
- saliva
- self-collection
- validation
- biomarkers
2023
Saliva self-collection for SARS-CoV-2 RNA detection showed 81.5% sensitivity and 76.4% specificity against nasopharyngeal swabs in 153 patients. Performance was highest four to seven days after symptom onset, supporting saliva as a viable decentralised diagnostic specimen during the first week of illness.
Use of saliva as an alternative diagnostic method for diagnosis of COVID-19 — Ganie et al., IJID regions
- saliva
- self-collection
- validation
- serology
2023
This multisite diagnostic accuracy study evaluated pooling strategies for detecting Chlamydia trachomatis and Neisseria gonorrhoeae using self-collected first-void urine and clinician-collected swabs from 437 men who have sex with men. Both ex-ante and ex-post pooling approaches showed high sensitivity and specificity compared with single-specimen testing, with ex-post pooling achieving 100% sensitivity for gonorrhoea, supporting decentralised screening programmes.
Using pooled urogenital, anorectal and oropharyngeal specimens to detect <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> among men who have sex with men in China: a multisite diagnostic accuracy study — Jiang et al., BMJ open
- urine
- first-void
- self-collection
- validation
- sti
2023
In a 16-donor validation study, prompt centrifugation of serum microsamples maintained analyte stability and preserved clinical chemistry and protein biomarker quality. This demonstrates that remote centrifugation with refrigerated shipping can lessen patient burden and broaden participation in decentralised clinical trials.
Decentralized clinical trial design using blood microsampling technology for serum bioanalysis — Lee et al., Bioanalysis (paywalled)
- blood
- liquid
- validation
- venous-agreement
- dct
- biomarkers
2023
Antigen rapid diagnostic tests using saliva, nasal and nasopharyngeal samples showed 60% sensitivity and 98% specificity against RT-qPCR in 609 patients with suspected COVID-19. The high specificity and moderate concordance support their role as a decentralised, patient-centric triage tool to identify likely infectious individuals and guide public health measures.
Rapid antigen test as a tool for the identification of SARS-CoV-2 infection and its potential as a self-testing device — Filgueiras et al., Revista da Sociedade Brasileira de Medicina Tropical
- saliva
- self-collection
- validation
- serology
2023
Dried blood spot eluates showed high agreement with serum for SARS-CoV-2 IgG against Spike and Nucleocapsid (r≈0.96; qualitative φ≈0.98–1.0) and remained stable after 6–8 hours of storage, supporting use of capillary DBS for serosurveys and decentralised testing.
Dried blood spot eluates are suitable for testing of SARS-CoV-2 IgG antibodies targeting Spike protein 1 and Nucleocapsid protein — Guttmann et al., Biochemistry and biophysics reports
- blood
- dried
- capillary
- self-collection
- validation
- venous-agreement
- serology
2023
Volumetric absorptive microsampling of whole blood did not provide a reliable basis for calculating meropenem plasma concentrations in critically ill children, so a validated low volume plasma method was required for paediatric therapeutic drug monitoring.
Developing a Method for Quantifying Meropenem in Children-Volumetric Adsorptive Microsampling Versus Plasma Sampling — Ramadan et al., Therapeutic drug monitoring (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
- pediatric
- tdm
- antimicrobials
2023
Lead can be measured accurately in dried blood spots by ICP-MS only when matrix-matched calibrators are used; aqueous calibrators perform poorly. The three methods evaluated showed strong agreement with whole blood analysis and offer a robust option for decentralised lead screening in children, though the recognised limitations of dried blood spots remain.
Matrix-matched calibrators are necessary for robust and high-quality dried blood spots lead screening assays by inductively coupled plasma-mass spectrometry — Franco et al., Journal of mass spectrometry and advances in the clinical lab
- blood
- dried
- dbs
- validation
- venous-agreement
- pediatric
- toxicology
2023
Self-collected first-void urine showed substantial agreement with clinician-collected cervical samples for high-risk HPV detection in 54 women with confirmed cervical precancer or cancer, with a Cohen's kappa of 0.70 and 86 per cent overall agreement, supporting urine self-sampling as a potential alternative for cervical cancer screening where pelvic examination is not feasible or acceptable.
Study to Determine Concordance between High-Risk Human Papilloma Virus DNA Detection in Self Collected First Voided Urine Samples and Health-Care Worker Collected Cervical Samples in a Subset of Women with Proven Histopathological Precancerous and Cancerous Lesions of the Cervix — Purwar et al., Journal of mid-life health
- urine
- first-void
- self-collection
- validation
- hpv
- sti
2023
The review found that self-collected saliva samples had much lower sensitivity for SARS-CoV-2 rapid antigen tests compared to healthcare worker-collected nasal or nasopharyngeal samples, while specificity remained high across all strategies. This matters for decentralised diagnostics because it highlights that both sample type and collector significantly impact test accuracy in self-testing scenarios, informing protocol design for remote screening programmes.
Performance of different rapid antigen testing strategies for SARS-CoV-2: A living rapid review — Shaver et al., European journal of clinical investigation (paywalled)
- saliva
- self-collection
- validation
2023
The authors validated a simultaneous LC-MS/MS assay for hydroxychloroquine, its metabolites, and azithromycin from self-collected dried blood spots. Requiring only ten microlitres of blood and achieving a sensitivity of one nanogram per millilitre, the method enabled remote therapeutic drug monitoring in more than two thousand specimens during the COVID-19 pandemic.
Simultaneous LC-MS/MS method for the quantitation of Azithromycin, Hydroxychloroquine and its metabolites in SARS-CoV-2(-/ +) populations using dried blood spots — Chhonker et al., Scientific reports
- blood
- dried
- dbs
- self-collection
- validation
- tdm
2023
Capillary finger-stick dried blood spots yielded TSH measurements that agreed strongly with venous plasma (R² 0.988) and correctly identified hypothyroidism and hypothyrotropinemia in most cases. The analyte remained stable for at least four days between -20°C and +30°C, indicating potential for at-home collection in thyroid diagnostics and monitoring.
A Preliminary Analysis of Thyrotropin Measurement from Finger Stick Dried Blood Spot with an Automated High-Throughput Immunoassay Analyzer — Schakelaar et al., Thyroid : official journal of the American Thyroid Association (paywalled)
- blood
- dried
- capillary
- dbs
- self-collection
- validation
- venous-agreement
- hormones
- haematocrit
2023
The analysis quantified 62 proteins with satisfactory analytical performance, and 48 proteins showed significant correlation between 2 µL plasma microsamples and dried blood spots, supporting the use of dried blood microsampling for home collection and predictive medicine in elderly patients.
New Perspectives of Multiplex Mass Spectrometry Blood Protein Quantification on Microsamples in Biological Monitoring of Elderly Patients — Vialaret et al., International journal of molecular sciences
- blood
- liquid
- dried
- dbs
- validation
- biomarkers
2023
The study found that serum concentrations of lacosamide and levetiracetam can be accurately estimated from dried capillary blood samples using simple ratio conversion, with high agreement to measured serum levels, supporting their use in decentralised therapeutic drug monitoring. For lamotrigine, the method is acceptable at low to medium concentrations but less reliable at higher levels, indicating a need for cautious interpretation in clinical practice.
Validation of Conversion Factors for Therapeutic Drug Monitoring of Lacosamide, Lamotrigine, and Levetiracetam in Dried Capillary Blood — Hagemann et al., Therapeutic drug monitoring (paywalled)
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- venous-agreement
- tdm
2023
In healthy Chinese adults a single oral dose of padsevonil showed rapid absorption and a favourable safety profile. VAMS dried blood concentrations of padsevonil and its metabolites were generally lower than plasma but were comparable at some time points by Passing‑Bablok regression, indicating that VAMS is promising for therapeutic drug monitoring of this novel antiepileptic drug and warrants further validation.
Pharmacokinetics and safety of Padsevonil in healthy Chinese subjects and comparison of two sampling methods for Padsevonil quantification — Li et al., European review for medical and pharmacological sciences (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
- tdm
2023
The study optimised a UHPLC-MS/MS method to measure 11 lipids in 2.74 µL blood microsamples collected with hemaPEN® devices directly from athletes on a track. Five analytes, arachidonic acid, sphingosine, lactic acid, and two lysophosphatidylcholines, showed significant exercise-induced changes, demonstrating that capillary microsampling can reliably capture metabolic responses in decentralised settings without specialist staff.
A targeted UHPLC-MS/MS method to monitor lipidomic changes during a physical effort: Optimization and application to blood microsamples from athletes — Laurent et al., Journal of pharmaceutical and biomedical analysis (paywalled)
- blood
- capillary
- validation
- metabolome
- biomarkers
2023
Capillary blood collected in microtubes yielded HbA1c results that agreed closely with venous sampling, while dried blood spots showed markedly poorer agreement. High patient acceptability and willingness to repeat suggest microtubes are a viable option for decentralised diabetes monitoring.
Home monitoring of haemoglobin A<sub>1c</sub> in diabetes: A systematic review and narrative synthesis on accuracy, reliability and patient acceptability — Colley et al., Diabetic medicine : a journal of the British Diabetic Association (paywalled)
- blood
- liquid
- capillary
- dbs
- self-collection
- validation
- venous-agreement
- acceptability
2023
Self-collected capillary blood produces serum creatinine results comparable to venous blood, and the analyte remains stable in unspun capillary samples stored at ambient temperature for three days. This supports the use of capillary microsampling for kidney function monitoring in patient-centric, decentralised settings.
Comparability and Stability of Serum Creatinine Concentration in Capillary and Venous Blood — Woolley et al., British journal of biomedical science
- blood
- liquid
- capillary
- validation
- venous-agreement
2023
In 1070 young adults, dried blood spot eluates correlated strongly with serum for anti-spike IgGAM and total IgG, IgA and IgM; labDBS achieved 82.0% sensitivity and 98.2% specificity and ssDBS 86.1% sensitivity and 96.7% specificity versus serum, with minimal difference between self and investigator collection.
Validation of dried blood spot sampling for detecting SARS-CoV-2 antibodies and total immunoglobulins in a large cohort of asymptomatic young adults — Ferentinos et al., Journal of immunological methods
- blood
- dried
- dbs
- self-collection
- validation
- venous-agreement
- serology
2023
Dried blood spot sampling shows moderate agreement with plasma for therapeutic drug monitoring across evaluated drugs, and home based DBS achieves high yield and adherence with patient preference around three quarters; DBS is a reliable and feasible option for decentralised TDM but needs careful design and evaluation before use.
Reliability and feasibility of home-based dried blood spot in therapeutic drug monitoring: a systematic review and meta-analysis — Xiaoyong et al., European journal of clinical pharmacology (paywalled)
- blood
- dried
- dbs
- self-collection
- validation
- venous-agreement
- acceptability
- tdm
2023
A VAMS method using Mitra devices for whole blood lead quantification showed no significant difference compared with the centre's routine method, supporting VAMS as a practical alternative for blood lead and other trace element analyses.
Method development for the quantification of lead levels in whole blood sampled on Mitra<sup>®</sup> with VAMS<sup>®</sup> tips by inductively coupled plasma-MS/MS — Breton et al., Bioanalysis (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
- toxicology
2023
Capillary blood collected with the Mitra® device showed correlation with venous samples for paclitaxel therapeutic drug monitoring, but wide confidence intervals suggest the methods may not be interchangeable. While plasma and whole blood concentrations were more closely aligned, the variability raises questions about using self-collected capillary samples for dose individualisation without further validation.
Paclitaxel and Therapeutic Drug Monitoring with Microsampling in Clinical Practice — Radovanovic et al., Pharmaceuticals
- blood
- liquid
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- venous-agreement
- tdm
- oncology
2023
The authors developed and validated a workflow that couples Mitra volumetric absorptive microsampling with hybridisation LC-MS/MS to quantify the antisense oligonucleotide fomivirsen in human blood. Quantitative recovery was achieved irrespective of haematocrit level or sample age, and the method demonstrated sensitivity, linearity, precision, accuracy, and four-month stability, supporting its use for therapeutic drug monitoring of biologic candidates in decentralised trials.
Volumetric absorptive microsampling coupled with hybridization LC-MS/MS for quantitation of antisense oligonucleotides — Chen et al., Bioanalysis (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- haematocrit
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
2023
In women referred to colposcopy, self-collected urine and vaginal samples showed substantial to near-perfect concordance with clinician-collected cervical samples for detecting high-risk HPV (k=0.715 and k=0.898 respectively). This supports using patient-centric self-sampling to expand cervical cancer screening coverage and aligns with WHO elimination targets.
Accuracy of Human Papillomavirus (HPV) Testing on Urine and Vaginal Self-Samples Compared to Clinician-Collected Cervical Sample in Women Referred to Colposcopy — Martinelli et al., Viruses
- urine
- self-collection
- validation
- hpv
- sti
2023
Deprez et al. validated LC‑MS/MS methods for four immunosuppressants and creatinine from a single 10 μL quantitative dried blood spot. With biases under 10 % and CVs below 8 %, the approach enables accurate patient‑centric therapeutic drug monitoring from capillary blood at home, mitigating the haematocrit effect through volumetric collection.
Liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring of immunosuppressants and creatinine from a single dried blood spot using the Capitainer® qDBS device — Deprez et al., Analytica chimica acta (paywalled)
- blood
- dried
- capillary
- qdbs
- volumetric
- validation
- tdm
- immunosuppressants
- haematocrit
2023
First-void urine is established as a reliable self-collected specimen for human papillomavirus screening, triage, and post-vaccination surveillance. The use of specialised collection devices and advanced molecular assays supports the integration of non-invasive sampling into routine cervical cancer prevention strategies.
Testing for Human Papillomaviruses in Urine, Blood, and Oral Specimens: an Update for the Laboratory — Poljak et al., Journal of clinical microbiology
- blood
- saliva
- urine
- first-void
- self-collection
- validation
- hpv
- sti
2023
High-performing dried blood spot assays have been developed and validated for measuring environmental exposures to tobacco smoke, trace elements, and several endocrine-disrupting chemicals, confirming the method as a viable minimally invasive alternative to venous sampling for field-based public health screening and paediatric epidemiological studies. Further validation is required for cadmium, arsenic, inorganic mercury, and bisphenol A to expand the panel of reliable decentralised exposure biomarkers.
A state-of-the-science review and guide for measuring environmental exposure biomarkers in dried blood spots — Jacobson et al., Journal of exposure science & environmental epidemiology
- blood
- dried
- dbs
- validation
- pediatric
- biomarkers
2022
A systematic review of 19,704 articles, analysing 45 trials and 117 documents, found wide heterogeneity in decentralised clinical trial designs. The authors caution that there is currently insufficient evidence to confirm which decentralised methods are most effective for trial recruitment, retention, or overall cost.
A systematic review of methods used to conduct decentralised clinical trials — Rogers et al., British Journal of Clinical Pharmacology (paywalled)
- dct
- validation
2022
An IQ Consortium position paper from sponsor scientists positioning patient-centric sampling as the enabling technology for decentralised trials, and stating that a bridging study against conventional sampling “has quickly been established as a regulatory expectation”.
Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality — Maass et al., Clinical and Translational Science
- blood
- dct
- standards
- self-collection
- validation
2022
A review of dried blood microsampling for tyrosine kinase inhibitor monitoring, covering the analytical and clinical requirements for moving oral cancer-drug TDM out of hospital.
Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitors Using Dried Blood Microsamples — Verougstraete et al., Frontiers in Oncology
- blood
- dbs
- tdm
- self-collection
- haematocrit
- dried
- oncology
- pediatric
- validation
2022
A single VAMS run quantified two immunosuppressants plus creatinine with minimal haematocrit effect: combined drug-and-organ-function monitoring from one dried tip.
A VAMS UPLC-MS/MS Method for Simultaneous Quantification of Tacrolimus, Mycophenolic Acid and Creatinine in Whole Blood of Renal Transplant Recipients — Wang et al., Pharmaceutics
- vams
- venous-agreement
- acceptability
- blood
- tdm
- haematocrit
- dried
- immunosuppressants
- validation
2022
This review shows that patient-centric Mitra microsampling devices accurately collect fixed blood volumes for immunosuppressant monitoring, reducing haematocrit bias compared to classic dried blood spots. While ideal for paediatric adherence, wider decentralised adoption requires further multicentre validation and cross-laboratory harmonisation to address current analytical and cost limitations.
Volumetric Absorptive Microsampling in Therapeutic Drug Monitoring of Immunosuppressive Drugs — From Sampling and Analytical Issues to Clinical Application — Kocur & Pawiński, Int. J. Molecular Sciences
- vams
- neoteryx-mitra
- blood
- tdm
- haematocrit
- dried
- pediatric
- immunosuppressants
- validation
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