Self-sampling at home using volumetric absorptive microsampling: coupling analytical evaluation to volunteers’ perception in the context of a large scale study

Uytfanghe, Katleen Van; Heughebaert, Liesl

doi:10.1515/cclm-2020-1180

Cited by 26 publications

(11 citation statements)

References 9 publications

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“…Secondly, although non‐supervised sampling inherently implies a risk, sampling can be considered reliable. This is discussed in detail elsewhere and can be concluded based on (i) the limited requests for extra sampling material, (ii) visual control of the samples (only 9% being scored as under‐ or overfilled), (iii) assessment of samples taken at the same sampling moment and (iv) a questionnaire [32]. Thirdly, by implementing VAMS as a sampling strategy, self‐sampling at home allowed the entire study to be conducted remotely.…”

Section: Discussionmentioning

confidence: 99%

Set‐up of a population‐based model to verify alcohol abstinence via monitoring of the direct alcohol marker phosphatidylethanol 16:0/18:1

et al. 2022

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Background and aims Phosphatidylethanol 16:0/18:1 (PEth) is a biomarker for alcohol intake. It has a half‐life of 7.9 days. Chronic alcohol consumption causes high PEth values. It can take weeks before PEth values fall below the decision limit for ‘alcohol abstinence’. Our aim was to validate whether alcohol abstinence can be determined based on two consecutive PEth results above the decision limit. Design Observational study. Setting Belgium, February 2019. The study was linked to a social initiative in Belgium, ‘Tournée Minérale’. Participants Adults (aged > 18 years, n = 796) with varying drinking habits who self‐reportedly refrained from alcohol consumption during the study. Measurements A validated liquid chromatography–tandem mass spectrometry method was used to quantify PEth in participants’ dried blood samples, collected at three time‐points via remote fingerprick‐based self‐sampling. Findings A population‐based algorithm to evaluate abstinence based on 95% prediction limits was developed by fitting a linear mixed‐effect model to discern patterns in PEth elimination over time. It took intra‐ and inter‐individual variability into consideration. The algorithm was included in a two‐step decision tree, assessing whether (i) PEth values fell within the prediction interval and (ii) the slope between two PEth values was consistent with no alcohol consumption. Data for 74 participants reporting no alcohol intake during the study were used for validation. With a detection limit of ‘four units spread over 14 days’, the sensitivity and specificity of the decision tree was 89%. Conclusions Claims of alcohol abstinence can be verified using a two‐step decision tree for phosphatidylethanol 16:0/18:1 values, even when those values are above the limit for ‘alcohol abstinence’.

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Section: Discussionmentioning

confidence: 99%

Set‐up of a population‐based model to verify alcohol abstinence via monitoring of the direct alcohol marker phosphatidylethanol 16:0/18:1

et al. 2022

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“…The VAMS samples were sent by postal service under ambient conditions to the Dermatology Research Unit of Ghent University Hospital for processing. Upon receipt, the tips were first visually inspected for absorption efficiency [ 28 ]; i.e., if white spots were still visible we assumed less than 20 μL was absorbed and this was noted for each individual sample. Next, the VAMS tips were transferred to 1.5 mL Eppendorfs with a forceps and 480 μL superblock PBS buffer (ThermoFisher; Waltham, MA, USA) was added.…”

Section: Methodsmentioning

confidence: 99%

Promising Tools to Facilitate the Implementation of TDM of Biologics in Clinical Practice

Soenen

Stove

Capobianco³

et al. 2022

JCM

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Therapeutic drug monitoring (TDM) of biologics—encompassing the measurement of (trough) concentrations and anti-drug antibodies—is emerging as a valuable tool for clinical decision making. While this strategy needs further validation, attention on its implementation into the clinic is warranted. Rapid testing and easy sampling are key to its implementation. Here, we aimed to evaluate the feasibility and volunteers’ perception of home microsampling for quantification of adalimumab (ADM) concentrations in psoriasis patients. In addition, we compared lateral flow testing (LFT) with enzyme-linked immunosorbent assay (ELISA). Patients participating in the SUPRA-A study (clinicaltrials.gov NCT04028713) were asked to participate in a substudy where volumetric absorptive microsampling (VAMS) was performed at home. At three time points, whole blood and corresponding serum samples were collected for ADM measurement using an in-house ELISA. In addition, the patients’ perspective on microsampling was evaluated via a questionnaire. LFT-obtained ADM concentrations agreed very well with ELISA results (Pearson’s correlation = 0.95 and R2 = 0.89). ADM concentrations determined in both capillary (via finger prick) and corresponding venous blood VAMS samples correlated strongly with serum concentrations (Pearson’s correlation = 0.87). Our preliminary data (n = 7) on rapid testing and home-based microsampling are considered promising with regard to TDM implementation for adalimumab, warranting further research.

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“…This will also prevent the risk of delay in drug intake when the patient should be sampled at a medical center. However, home-sampling is only feasible if the patients are clearly instructed and received adequate training about sample collection and, importantly, are aware of the importance of a correct sample collection ( 69 , 70 , 83 , 84 ).…”

Section: Towards Home-samplingmentioning

confidence: 99%

Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitors Using Dried Blood Microsamples

et al. 2022

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Therapeutic drug monitoring (TDM) of tyrosine kinase inhibitors (TKIs) is not yet performed routinely in the standard care of oncology patients, although it offers a high potential to improve treatment outcome and minimize toxicity. TKIs are perfect candidates for TDM as they show a relatively small therapeutic window, a wide inter-patient variability in pharmacokinetics and a correlation between drug concentration and effect. Moreover, most of the available TKIs are susceptible to various drug-drug interactions and medication adherence can be checked by performing TDM. Plasma, obtained via traditional venous blood sampling, is the standard matrix for TDM of TKIs. However, the use of plasma poses some challenges related to sampling and stability. The use of dried blood microsamples can overcome these limitations. Collection of samples via finger-prick is minimally invasive and considered convenient and simple, enabling sampling by the patients themselves in their home-setting. The collection of small sample volumes is especially relevant for use in pediatric populations or in pharmacokinetic studies. Additionally, working with dried matrices improves compound stability, resulting in convenient and cost-effective transport and storage of the samples. In this review we focus on the different dried blood microsample-based methods that were used for the quantification of TKIs. Despite the many advantages associated with dried blood microsampling, quantitative analyses are also associated with some specific difficulties. Different methodological aspects of microsampling-based methods are discussed and applied to TDM of TKIs. We focus on sample preparation, analytics, internal standards, dilution of samples, external quality controls, dried blood spot specific validation parameters, stability and blood-to-plasma conversion methods. The various impacts of deviating hematocrit values on quantitative results are discussed in a separate section as this is a key issue and undoubtedly the most widely discussed issue in the analysis of dried blood microsamples. Lastly, the applicability and feasibility of performing TDM using microsamples in a real-life home-sampling context is discussed.

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Self-sampling at home using volumetric absorptive microsampling: coupling analytical evaluation to volunteers’ perception in the context of a large scale study

Cited by 26 publications

References 9 publications

Set‐up of a population‐based model to verify alcohol abstinence via monitoring of the direct alcohol marker phosphatidylethanol 16:0/18:1

Set‐up of a population‐based model to verify alcohol abstinence via monitoring of the direct alcohol marker phosphatidylethanol 16:0/18:1

Promising Tools to Facilitate the Implementation of TDM of Biologics in Clinical Practice

Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitors Using Dried Blood Microsamples

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