Are blood tests possible without seeing a doctor?

Conventional blood sampling

Conventional blood sampling/testing involves collecting blood from an individual’s vein by a needle to perform an analysis of components within the blood. The purpose of this procedure is to look for levels of specific metabolites or other biomarkers, mostly in the case of illnesses for diseased conditions. The blood is then sent to a laboratory for analysis by trained technicians. Storage and transportation of whole blood or indeed centrifuged blood is subject to specific requirements and inadequate adherence to the protocol may cause sample degradation. 

Micro blood sampling

Dried blood spot (DBS) is an alternative approach for blood sampling. The blood is simply collected by a finger or heel prick, a technique that has been used for 60 years in newborn baby screening. This method of micro blood sampling is a technique with few limitations, it is a quick and efficient method and only mildly invasive in comparison to the conventional venous sampling method. The blood is collected on specifically prepared filter card and once dried is suitable for analysis. The card can be stored at ambient temperature facilitating convenient logistics and transport. This may also reduce the possibility of human error in the processing steps required following venous whole blood collection, ensuring the reliability of results. The card is sent to the laboratory for analysis using modern detection systems including analytical, immunological and genetic. The DBS technique has proven to be reliable and results comparable to blood sampling by conventional means.

 

Blood testing without a doctor

Routine blood tests ensure that an individual’s physical health is monitored and can ensure the appropriate intervention is undertaken in the event of disease or sub-standard health presentations. The process of making an appointment and visiting a surgery can be time-consuming and, in some cases, for sick persons or those requiring repeated observations, it is highly inconvenient

Micro blood sampling through dried blood spot (DBS) enables blood sampling to be performed very quickly, and it can also be carried out without the presence of a doctor. The medical professional essentially will provide the card for blood sample collection, monitor its use, deliver results and perform follow up care. There is a pre-defined area that the blood produced by a prick to the finger will be applied. The card can then be delivered to the laboratory directly, without specialised processing of the blood sample first. 

In addition to the advantage of micro blood sampling requiring very little training and enabling greater usability and application, the newly introduced HemaXis DB10 offers volume control at the collection point. This significant detail allows for precise and accurate quantitative analysis (concentration, cut-off, range measurements), which traditional DBS doesn’t permit. It also reduces the number of manipulations by lab technicians prior to the analysis of the sample at the laboratory.

When blood sampling without a doctor may be necessary?

In some conditions such as cancer, a patient can suffer incapacitating side-effects from their treatment; however, frequent blood testing may be required to order to monitor treatment levels and correlate the efficacy while avoiding toxicity. The volumetric control in this setting is of paramount importance. In this situation, the use of the HemaXis DB10 microsampling solution can be performed quickly and easily by health care professionals or by others within the patient’s care environment; this process eliminates unnecessary inconvenience. The samples can then be sent directly for examination of the analytes of interest. 

The use of HemaXis DB10 can also provide the opportunity for large group blood sampling in one location and at a specific time point. This may be of benefit in screening for illicit drug use, in an environment such as employment, military or even prisons. This procedure can be performed rapidly, with minimal disruption and inconvenience to those involved.

It may also be necessary to address the possibility of disease in a more remote community. The ability to screen multiple people consecutively and under the same conditions may be of benefit in disease control, particularly when considering rural communities that may not have easy access to appropriate medical facilities. 

Moreover, it may be essential in some communities for newborn baby screening of many disease conditions, early detection will lead to as short a time-lapse as possible in providing the necessary treatment. Very little training is necessary for the use of micro blood sampling and the lack of requirements for cold storage and bio-hazard control; reduces the overall cost to the healthcare providers within such communities, removing the financial strain on medically resource-poor regions.

The future of DBS

Technological advancements in medicine and our increase in the understanding of the molecular mechanisms underpinning many diseased conditions have provided a fresh look at disease prevention, diagnosis and control. This has largely been by new perspectives in the fields of proteomics, metabolomics and genomics, leading to greater choices concerning healthcare management for both the global population and clinicians as a whole.

Using DBS sampling techniques, HemaXis™ DB10 is designed with maximum usability and precision in mind. Its application in the field of medicine and blood sampling of the general population is wide-reaching. By keeping abreast of medical research, HemaXis™ DB10 can be sure that the technical advantages of DBS are exploited to the benefit of the population; thus, providing maximum assurance in reliability and accuracy. The HemaXis™ DB10 leads the way in micro blood sampling with the unique feature of blood volume control, enabling fixed volume collection of blood at any time and anywhere.

 

World Anti-Doping Agency developing Dried Blood Spot testing

Volume controlled Dried Blood Spot (DBS): A key player in personalized medicine

Dried blood spot sampling and subsequent analysis is an area that is of particular interest in relation to medicine, scientific research and the pharmaceutical industries collectively. It is a field that is growing rapidly and technological advancements are made.

What is DBS?

DBS is an alternative strategy for blood sampling that appears to be gaining momentum. It consists of applying a few drops of blood on an absorptive material and letting it dry before being used for appropriate downstream analysis. It was first introduced in 1963 by Robert Guthrie to facilitate the neonatal screening of phenylketonuria. This technique can be used for quantitative and qualitative applications; therefore, it rapidly spread to other applications such as virology, toxicology, therapeutic drug monitoring and genetics. 

DBS sampling showed excellent results when compared to conventional blood sampling methods. A recent review counted more than 2000 different parameters for which an analytical method was described in the literature, covering a wide range of medical applications [1]. This demonstrates the versatility and interest of the scientific community for this approach.

How is DBS performed?

DBS sampling is fast, cost-effective and conveniently requires only a finger or heel prick to draw capillary blood which is then collected on a filter paper card. This method is much less invasive in comparison to conventional venipuncture and patients of hospitals and labs too could benefit as it is less time consuming than conventional blood sampling (ie.venipuncture).

DBS and therapeutic drug monitoring

Tacrolimus is an immunosuppressant drug used for the treatment of graft recipients. Dose monitoring is required to ensure the patient’s exposure to the therapeutic drug is appropriate. DBS analysis was shown to be comparable to whole blood. It is consequently a suitable method for determining the overexposure or underexposure to tacrolimus, enabling the dose to be adjusted accordingly [2]. This application has a large potential in clinical applications such as the monitoring of antipsychotic drugs and antidepressants, enabling real-time analysis of plasma drug concentration levels, ensuring they are kept within the required range for an individual [3]. This personalized medicine approach to drug applications can be applied to many conditions

DBS and toxicology

Micro-sampling using DBS, in both animal and human studies has been widely used in the context of toxicology – including toxicokinetics and environmental and forensic toxicology {Reviewed in [4]. It is considered that in such applications, these can be widely used for analyte identification – such as markers to identify substance abuse [5]. 

In pre-clinical trial animal studies, pharmaceutical companies have employed DBS to monitor drug exposure in animals (toxicokinetics), this has been useful in rapidly establishing the suitable number of animals required with appropriate doses to adhere to the 3Rs in animal research [6].

Benefits of DBS

Less blood is taken from an individual in comparison to conventional methods. Samples are easily transported to analytical laboratories without the requirements for freezing or dry ice. [6] Importantly, the blood components appear to be more stable with preservation of the material of interest, this is of particular interest as RNA material has been shown to be preserved [7], considering RNA is particularly susceptible to degradation by endogenous factors.

Challenges of DBS

The low sample volume may not be suitable in some cases to reach the required sensitivity for specific molecules of interest. Concerns have been raised in relation to the effect of plasma/serum concentrations and haematocrit on spot size however, ongoing development continues to overcome this [8].

Personalized medicine

Personalized medicine can be defined as a medicine or therapy that has been specifically designed or tailored to suit the needs and requirements of the individual. We are each unique in our genetic makeup, this impacts our health in addition to lifestyle and environmental factors. The combination of information regarding our genome, along with additional clinical and/or diagnostic data, can elucidate patterns that will enable disease risk factors to be identified (earlier in principle). This will facilitate educated decisions, moving forward in relation to personalised medicines and even changes in dietary habits. DBS Systems is one of the leading organizations which provides the HemaXis DB10 devices for Labs and Hospitals across the world that can enable a bigger patient reach.

Benefits of personalized medicine

There are many benefits to personalised medicine and it can be applied across most fields of medicine. As an example, neurodegenerative conditions are on the rise as the population lives longer however, there are presently no cures for diseases such as Alzheimer’s. Advancements in metabolomic, proteomic and genomic approaches have been made [9] and research is striving to find appropriate biomarkers to help diagnose such disease conditions. The use of a test such as HemaXis DB10 in correlation with these biomarkers may provide clinicians with early diagnostic criteria to slow the progression or halt the disease. The key is early intervention.

Genomics and personalized medicine – what everyone needs to know

Fundamentally, almost all areas of medicine are affected by genetic disease and the clarification of the role of genetics in human disease combined with improvements in sequencing technologies can provide rapid diagnosis. Two interconnected and advanced methods of biological analyses are the sequencings of the human genome and new technologies that analyze DNA. 

In the clinic, whole-exome sequencing is increasingly being used for diagnostic purposes and detection of gene variants, in particular for genetically heterogeneous diseases [10]. With the emergence and continuing advancement of bio-analytical techniques, the use of DBS is of interest as a primary test. Globally, the interest in the advantages from a retrospective and prospective stance is being explored with DBS samples being used in conjunction with newborn screening programs in conjunction with high-throughput next-generation sequencing [11] [12]. Identification of disease-related gene mutations or modifications can provide the space for the development of specific and in many cases, personalized therapeutics.

Normalizing genetic testing into routine medical practices along with plans to entrench whole-genome sequencing within the NHS has brought to the forefront the importance of genomics to clinicians [13]. In this regard, the use of DBS has huge potential for genomics and personalized medicine to work hand in hand. Genomic medicine could transform healthcare.

Pharmacogenomics and personalized medicine 

New technologies have led to the transformation of different fields of medicine; including medicinal therapeutics, now encompassing personalized medicine using a pharmacogenetic approach. Pharmacogenetics is a relatively new area of pharmacology – investigating the relationship between an individual’s genetic makeup and the ability for the individual to metabolize specific drugs [14]. DBS will enable rapid detection of levels of drugs in capillary samples at a given time point.

The future for DBS 

The advancements in technological advancements and our greater understanding now mean that there will be more focus on personalized medicine companies and any new personalized medicine initiatives. These new applications will have the ability to present greater choices in relation to healthcare management for both the population and clinicians as a whole. Volumetric DBS offers many advantages, including the ability to control the volume of blood drawn. This can improve not only the accuracy of DBS analysis but uses minimal exploitable blood volume. Furthermore, the increase in volumetric DBS precision enables repeatability, important for consecutive and subsequent analyses.


References

  1. Freeman, J. D., et al., State of the Science in Dried Blood Spots, Clinical Chemistry, 2018. 64(4).
  2. Zwart, T..C., et al., Therapeutic drug monitoring of tacrolimus and mycophenolic acid in outpatient renal transplant recipients using a volumetric dried blood spot sampling device. British Journal of Clinical Pharmacology, 2018. 84(12): p. 2889-2902. 
  3. Geers, L.M., et al., Dried Blood Spot Analysis for Therapeutic Drug Monitoring of Clozapine. J Clin Psychiatry, 2017. 78(9): p. e1211-e1218.
  4. Stove, C.P., et al., Dried blood spots in toxicology: from the cradle to the grave? Crit Rev Toxicol, 2012. 42(3): p. 230-43.
  5. Velghe, S., R. De Troyer, and C. Stove, Dried blood spots in therapeutic drug monitoring and toxicology. Expert Opinion on Drug Metabolism & Toxicology, 2018. 14(1): p. 1-3.
  6. Spooner, N., R. Lad, and M. Barfield, Dried blood spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method. Anal Chem, 2009. 81(4): p. 1557-63.
  7. Aitken, S.C., et al., Stability of HIV-1 Nucleic Acids in Dried Blood Spot Samples for HIV-1 Drug Resistance Genotyping. PLoS One, 2015. 10(7): p. e0131541.
  8. Wilhelm, A.J., J.C.G. den Burger, and E.L. Swart, Therapeutic drug monitoring by dried blood spot: progress to date and future directions. Clinical pharmacokinetics, 2014. 53(11): p. 961-973.
  9. Gotovac, K., et al., Personalized Medicine in Neurodegenerative Diseases: How Far Away? Molecular Diagnosis & Therapy, 2014. 18(1): p. 17-24.
  10. Yang, Y., et al., Molecular findings among patients referred for clinical whole-exome sequencing. JAMA, 2014. 312(18): p. 1870-1879.
  11. Boemer, F., et al., A next-generation newborn screening pilot study: NGS on dried blood spots detects causal mutations in patients with inherited metabolic diseases. Scientific Reports, 2017. 7(1): p. 17641.
  12. Poulsen, J.B., et al., High-Quality Exome Sequencing of Whole-Genome Amplified Neonatal Dried Blood Spot DNA. PLoS One, 2016. 11(4): p. e0153253.
  13. Brittain, H.K., R. Scott, and E. Thomas, The rise of the genome and personalised medicine. Clin Med (Lond), 2017. 17(6): p. 545-551.
  14. Topić, E., 5. Pharmacogenomics and Personalized Medicine. EJIFCC, 2008. 19(1): p. 31-41.

Cansford Laboratories turns to HemaXis DB 10 for sampling in their PEth testing program

HemaXis DB 10 is Cansford Laboratories Ltd. solution for microsampling in their new PEth testing service. We are so proud to be part of this and contribute to improving patients health! 

Cansford Laboratories offers the UK’s fastest hair drug and alcohol testing service, while investing in research and development and contributing to conferences and symposia to drive up industry standards.

Link to Cansford blog : here

Zaragoza University uses HemaXis for Hg quantification

The group of Prof. Resano of Zaragoza University Department of Analytical Chemistry published a very interesting article about the use of HemaXis™ DB10 for the quantification of mercury in patients’ blood. The study showed excellent reproducibility for samples collected using HemaXis™ DB10. In the conclusion, the authors states that “current DBS microsampling devices show a very promising performance for Hg determination in whole blood, facilitating easy home collection”.

HemaXis™ DB10 tangibly opens the way to simpler and cheaper large population studies on heavy metal exposure!

Link to the original article

HemaXis DB 10 available at Cibesmed

If you need fully customised kits which could include device, disinfectant, lancet, plasters, envelope, etc. our partner Cibesmed (www.cibesmed.com) will be delighted to tailor a solution for you. You can send your request to

HemaXis DB 10 application presented in the German Symposium

Frank Sporkert & Cristian Palmiere will present, during the 15. Gemeinsames Symposium der Deutschen Gesellschaft für Verkehrspsychologie e. V. (DGVP) und der Deutschen Gesellschaft für Verkehrsmedizin e. V. (DGVM) in Bonn, very interesting data on Phosphatidylethanol and driving aptitude in the french-speaking part of Switzerland, measured from HemaXis DB 10.

Joining Lyonbiopôle

DBS System becomes member of Lyonbiopôle !

As a Cluster, Lyonbiopole is the gateway to healthcare innovation in the Auvergne-Rhône-Alpes region.

It’s supporting ambitious projects and innovative companies in the healthcare & life sciences’ sector. Its aim is to help innovators develop new technologies, products and services in a push toward a more personalized medicine and better treatments for patients.lyonbiopole logo

HemaXis™ DB10 samples professional cyclists in drug monitoring program

DBS System SA today announced its collaboration with the Union Cycliste Internationale (UCI) and the Center of Research and Expertise in anti-Doping sciences (REDs) to monitor the use of Tramadol in the professional peloton. Following the ban of Tramadol use on March 1, the drug has been tested on 143 samples of 117 professional riders at 11 major events on the UCI WorldTour Calendar.

Blood samples have been collected with HemaXis™ DB10, the patented blood collection device manufactured by DBS System SA, a company based in Switzerland. HemaXis DB10 generates reliable blood microsamples straight from the rider’s finger-tip in an instantaneous, user-friendly and cost-effective manner.

HemaXis™ uniquely allows the convenient collection and storage of an accurate quantity of blood in the form of dried blood spots. These standardized dried blood spots enable a dependable analysis, while reducing overall cost and logistic constraints.

“We are proud to announce that HemaXis™ contributes to the health and safety of the competitors.” said Eric Ödman, CEO of DBS System. “We firmly believe that our technology will be the way forward for much improved monitoring of drug use in sport.”

UCI press release available at https://www.uci.org/inside-uci/press-releases/misuse-of-tramadol-uci-report-on-tests-carried-out-during-the-first-part-of-the-2019-season

DBS System’s HemaXis™ DB 10 blood collection device is now CE/IVD marked

DBS System SA announced today that its blood collection device, HemaXis™ DB 10, has been registered with the Swiss Agency for Therapeutic Products (SwissMedic), and is now CE/IVD marked following the 98/79/EC In vitro Diagnostic Medical Device Directive. HemaXis DB 10 is DBS System’s first-generation device for the collection, transport and storage of a precisely metered quantity of capillary whole blood sample, through a prick at the patient’s fingertip.

DBS System, a Swiss based company, produces blood collection devices that leverage advanced microfluidic technology to simplify and reduce the cost of blood sampling without the need to significantly modify existing laboratory workflows. With the CE mark applied on HemaXis™ DB 10, DBS System will target sales to certified labs performing analysis for clinical trials, diagnostic and wellness testing to monitor health, offering a simple, less invasive and highly cost-efficient alternative to traditional blood collection, thereby overcoming the worldwide challenges blood collection has faced for decades.

DBS System’s device uniquely allows for the patient friendly and standardized collection and storage of an accurate quantity of whole blood. The integration of an industry standard filter paper card for sample storage enables fully automated extraction and analysis using existing equipment. In addition, HemaXis™ DB 10 simplifies the logistics chain because cold storage is not required, resulting in significant cost savings for labs. These benefits provide a clear advantage over traditional dried blood spot collection and competitive devices being launched in the market.

Obtaining the CE mark is a major milestone for DBS System as it will enable us to penetrate the European market by building strong partnerships and a platform for growth in Switzerland and Europe. Coupled with the already secured FDA clearance for the US market, we are now in a position to engage several major research and commercial labs across the two biggest markets of the world, in exciting and growing areas such as wellness testing for preventative care and for alcohol and drugs of abuse screening especially in context of the current opioid epidemic”, says CEO Eric Ödman.