Q & A
Q; What is Patient Centric Sampling?
A: Patient centric sampling (PCS) is a term used to describe the process of collecting a biological sample (blood, urine, saliva, etc) from a human that minimises the impact on the individual and puts their requirements at the centre of the process. For example, this might mean that you are able to collect a sample in a location that is most convenient to you, such as at home.
Q: Who can use PCS technologies?
A: Anyone as long as they are appropriately trained and do so following local regulatory requirements.
Q: In what settings can PCS technologies be used?
A: These technologies can be used wherever biological samples (blood, urine, etc) are currently collected, for example a hospital / clinical setting. However, the technology can also be used in locations that are more convenient to the patient, for example in their home, or at a pharmacy / doctors office (where local laws allow). These technologies can be used for the consumer-led healthcare market (wellness testing), pharmaceutical drug development, drug testing in sport, population health monitoring, environmental pollutant impact monitoring, etc.
Q; What is patient centric blood sampling?
A: Patient centric blood sampling (PCBS) is a means to improve compliance and lower anxiety, complexity and cost related to the blood collection process. This is accomplished by making the process more convenient and more comfortable than traditional blood sampling, through the use of next generation devices and technologies. With a PCS approach, individuals may collect their blood samples remotely by themselves or with the help of a caregiver. Where appropriate, these collections may take place in the patient’s own home.
Q: What are the issues with the traditional ways of getting blood?
A: The traditional blood draw involves trained health care practitioners, and often requires a trip to the clinic. In addition, venepuncture is not a pleasant experience for many, and it can pose the risk of needle stick. Finger or heel sticks are still quite painful. Children in particular can greatly benefit from this less invasive procedure, especially when frequent sampling is required.
Q: For which body locations can I use PCBS technologies?
A: At any bodily location as defined by the manufacturer. Possible locations may include a finger, the upper arm, thigh, buttocks, lower back, etc.
Q: What type of blood samples can be taken using these technologies?
A: A variety of sample types are available depending on the technology, including but are not limited to whole blood, separated blood, dried blood spot, dried plasma.
Q: How much would PCS cost?
A: The cost of PCS technologies is often higher than the sample collection technologies they are replacing (tubes, cannulas, etc). However, the ability to sample at a place and time that is convenient to the patient, such as at home, can give savings on travel and time. In addition, if the sample is self collected, then there is a reduced requirement for the involvement of healthcare providers. Furthermore, if appropriate sample stability is demonstrated, then cost savings on sample shipment (if required) can be realised.
Q: What are the benefits for healthcare providers?
A: The use of PCS technologies adds flexibility to sample collection. It allows remote sample collection with added data points, while using less resources from the clinic. It offers a patient-friendly way of remote safety- and drug-monitoring.
Q: What are the benefits for consumers who want to monitor their wellness?
A: The use of PCS technologies enables consumers to take control of their own wellbeing through varieties of consumer-led health screening products. It facilitates a consumer-friendly way to gather quality wellness data, allowing individuals to make their own decisions on wellness and lifestyle.
Q: What are the benefits for clinical trials?
A: PCS technologies enable a patient-centric decentralized clinical trial model, allowing remote sample collection. It is considered that this will improve enrolment and retention rates. Furthermore, it enables sample collection at time of disease flare-ups or drug administration, gathering more relevant data. PCS technologies have also demonstrated the ability to become connected to the internet and to transmit valuable information to data repositories. Ultimately this enables the collection of more pertinent clinical data, while saving on the study budget.
Q: What are the benefits for governing and monitoring bodies?
A: PCS technologies can improve public engagement with healthcare and medication adherence. It also provides an innovative solution in sports medicine and anti-doping communities.
Q: How do the results from PCS technologies compare with the standard collection and analyte testing?
A: The result comparison is analyte and sampling device dependent. Measurements are validated to show good concordance between results from PCS technologies and those from standard sample collection. PCS technologies have also demonstrated major benefits in usability compared to standard sample collection methods, which can lead to improved compliance and satisfaction.
Q: Do PCS technologies give me a result at the time of collection?
A: No. The sample needs to be sent to a laboratory for analysis and where it is appropriate, results will be routed to you via the normal channels.
Q: Are these PCS technologies regulated and validated?
A: Because these devices are involved in the generation of a test result, most of the PCS technologies have completed, or are undergoing regulatory review/approval. Many of the technologies are categorized as medical devices and have been granted 510(k) and/or CE mark (or other similar standards depending on country and/or region) where the quality and safety profile has been reviewed.
Q: Who are the members of the PCSIG?
A: This group currently includes patient representatives, healthcare providers, regulators, pharmaceutical companies, technology providers, contract research organisations, academics, clinical laboratories and consultants. The group is open to anyone that is interested in helping the progression of these PCS approaches to being used routinely.
Q: What is out of scope for PCSIG?
A: We do not engage in any activities in marketing or promoting any particular PCS method or analysis technology. We also do not share any company proprietary intellectual property.
Q: How can I take part in PCSIG?
A: If you are actively involved in the development, implementation or utilization of patient centric sampling technologies, or are involved in the downstream analysis of samples or data generated from such technologies, or simply want to help, then please reach out to contact@pcsig.org and find out how you can contribute to the group.
Q: How can PCS technologies help in pandemic situations?
A: Rapid and reliable diagnostic testing is critical in pandemic situations such as during SARS, MERS, COVID-19 outbreaks. PCS technologies offer blood sampling that can be self-administered by individuals while in quarantine, reducing unnecessary exposure of healthcare workers and uninfected populations. More importantly, PCS has the ability to extend central lab testing data quality to both laypersons and professionals.