patient-centric sampling in Poland: two case studies
by James Rudge, PhD, Microsampling Technical Director on Dec 26, 2023 9:00:00 AM
A company called LabExperts and their collaborators in Poland published two key posters on the analysis of drugs from blood samples collected using Mitra® devices based on VAMS® technology. The posters describe successful validations for two different and highly relevant applications of dried blood microsampling.
The first poster demonstrates a method for the sensitive multiplex detection of 27 drugs of abuse and their metabolites in line with published cut-offs from the DRUID (driving under the influence of alcohol and medicines) study. The second poster reports on a research and development project (CardioCarePack) to monitor drug levels among patients taking medication for cardiac arrhythmias.
This blog reviews the processes and outcomes of both posters from LabExperts...
Research Poster 1: Microsampling for DRUID Monitoring
The European Union’s Research on Driving Under the Influence of Drugs, Alcohol and Medicines — the DRUID Project.
The DRUID project was commissioned by the European Union in 2007 to help to standardize regulations on the analysis of biological samples collected from people who were driving under the influence. This project examined a range of experimental, epidemiological and related studies which took place across 18 countries over 5 years, producing over 50 reports. Among the many findings gathered via tests performed on 50,000 drivers in13 countries across Europe, alcohol was present in 3.48%, and illicit drugs were present in 1.9%.
The final DRUID report (published in 2012) also discussed the advantages of using dried blood spot (DBS) sampling with a finger-prick instead of traditional whole blood sampling with venipuncture to screen for these substances. The report included the following statement:
“The evaluation data showed no significant differences in precision: all substances investigated in the presented studies could be determined in a DBS as reliably as in a whole blood specimen. Thus, the project demonstrated that DBS drug analysis can be regarded as a valuable and inexpensive alternative to the determination of substances in whole blood. Such use of DBS could greatly facilitate blood analysis in drug-driving cases in the near future.”
A poster was presented at the IATDMCT 2023 meeting entitled “How sure can you be of the results of quantification of psychoactive compounds in blood?” by Anna Lenbartowtiz et al at three companies: LabExperts sp. Z o. o, Bioanalytic sp. Z o. o, and Lab4Tox sp. Z o. o in Poland. The poster reported on validating an LC-MS/MS assay to measure 27 analytes listed in the DRUID program report.
From this validated assay they achieved limit of detection (LODs) below the analytical cut-off for all analytes listed. They also obtained linearity of R ≥ 0.995, a working range of 0.1/0.5-50 ng mL, repeatability of ≤ 15% CV, and accuracy of ≤ 80-120%. This was achieved using 20 µL Mitra® devices based on VAMS® technology and comparing dried blood samples collected with these devices to traditionally collected plasma samples.
Conclusion on the DRUID Study Poster
Given the many reported benefits the Mitra microsampling method has over the DBS method in terms of analytical performance, user experience and sample quality, Anna Lenbartowtiz et al demonstrated excellent analytical performance from Mitra extracts. As a result, we can imagine that Mitra could be used instead of DBS as a more effective tool in monitoring people who may be driving under the influence of drugs and/or alcohol.
Research Poster 2: CardioCarePack
Improving the lives of patients suffering from cardiac arrythmias
Cardiac arrythmia, which affects 12.6% of people over the age of 65, can be a fatal condition, accounting for around 80% of sudden cardiac deaths. Cardiac arrythmia describes perturbations in the normal heart rhythm / rate. This results in reduced oxygenated blood circulating through the body, leading to dizziness and fainting. If left untreated, the condition can lead to stroke, cardiomyopathy, cardiac arrest and, ultimately, death. Thankfully, there are several treatments for cardiac arrythmia, such as pacemakers, as well as non-invasive pharmaceutical treatments, including sodium channel blockers, beta blockers, potassium channel blockers, and calcium channel blockers.
Therapeutic drug monitoring (TDM) of certain medications is an important component in the care plan for patients taking such drugs. The benefits of TDM include improved self-reported drug adherence in transplant patients, as one example. In a poster presented by Maciej Stopa et al at the ASMS 2023 meeting, the group highlighted that TDM is also important in the following scenarios:
- narrow therapeutic windows
- risk of serious drug reactions
- long elimination times
- formation of metabolites, which can be pharmacologically active [v].
The poster by Maciej Stopa et al from 3 institutions in Poland is entitled “CardioCarePack – personalized medicine system to improve live [life] quality of patients suffering from cardiac arrhythmias.” It reports on a successful 2-year study monitoring 300 patients receiving drug treatment for cardiac arrhythmias. The study highlights a successful validated method for measure 15 drugs used to treat this cardiac condition. During the study, paired capillary blood using Mitra and venous blood (for serum conversion) was collected every 6 months, where serum to Mitra ratios were evaluated for the drugs tested.
The poster also introduced the CardioCarePack, which explored the use of at-home patient sampling with Mitra coupled with a smartphone app. Features of the smartphone app included sample tracking, results history (TDM and Cardiograms), autonomous verification of therapeutic index tracking / flagging, and dosing.
The researchers used the LC-MS/MS method to measure 15 drugs and their metabolites.
Conclusion on the CardioCarePack Study Poster
We are beginning to see a trend in combining home sample collection with digital apps and other digital health solutions. From smartwatches to phone apps, these solutions are designed to track or augment data, from measuring blood sugars to biomarkers, and acting as early warning systems of impending health issues. These digital technologies, coupled with remote blood sampling, can help care providers to monitor drug levels as a remote telehealth complement traditional care pathways. As we move towards longitudinal personalized healthcare, well-care solutions such as the CardioCarePack will be vital to enable this advancement.
The work conducted by LabExperts and their collaborators shows two excellent use-case scenarios where remote sampling assists in furthering the field and, hopefully, improving lives.
View the DRUID poster here.
View the CardioCarePack poster here.
Image Credits: LabExperts, Bioanalytic
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