Neil Spooner

There is increased interest in the provision of healthcare in a manner that is more convenient to the patient. The COVID-19 pandemic has further shifted this trend, driven by the need for social distancing precautions to avoid unnecessary personal contact and potential exposure to the virus. Virtual doctors’ visits and remote COVID-19 testing have now become commonplace.

 This shift towards patient-centricity in healthcare has accelerated telemedicine and at-home testing, bypassing the inconvenience of travel and time away from family, work, and school.

 These approaches use technology to build systems around the patient. We are in a unique moment, with an opportunity to rethink how healthcare is provided, to improve health outcomes by increasing accessibility and decreasing patient burden. Can we build upon what we have learned during the pandemic and develop patient-centric approaches across healthcare?

An important component for the provision of patient-centric healthcare is the ability to collect blood samples remotely in a manner that delivers samples of a quality comparable to that of current standard phlebotomy collection, enabling routine clinical testing, monitoring disease progression and testing drug concentrations.

 This blood sampling could be performed at the patient’s home, at a nearby pharmacy, or at a local clinic, rather than a centralized facility. There is a growing body of evidence to suggest that home-based phlebotomy will become increasingly common and is preferred by many patients over more traditional approaches involving centralized clinical facilities.

 The ability to collect a sample of blood without needing a phlebotomist can decrease patient burden and improve patient compliance, especially with scheduled sample collections.

Significant technological advancements in analytical science have enabled the use of very small blood sample volumes for quantitative testing. However, standard venipuncture approaches are still being practiced to collect several milliliters of venous blood, of which less than 10% is typically used for testing. These advancements are making the current logistical and procedural hurdles for patients more a function of habit and inertia, rather than medical necessity. Reducing the volume of blood collected is critical, particularly amongst vulnerable populations like oncology and pediatric patients.

 The possibility of reducing blood collection volumes in adults was proposed by Smoller in 1989, by employing pediatric-sized tubes.10 Since then, technological advancements have made the collection of reduced blood volumes a reality. Coupling convenient, routine blood sampling approaches with advanced highly sensitive analytical testing can provide high quality decisional data in a patient-centric manner.

The collection of a small volume of blood from a heel prick has been used for over 60 years for metabolic and genetic testing in newborns. More recently, this technology has advanced significantly, with commercially available devices that collect high quality blood samples from finger pricks or the upper arm for all age groups.

 Importantly, these sampling devices do not require a phlebotomist to be present. Instead, the sample can be self-collected, or with the assistance of a care giver and are designed to collect small volumes of blood of the same quality as professionally collected venous blood.

 Some of these techniques require a finger-prick using a lancet, followed by blood collection, while others are self-contained devices with a built-in incision and blood collection. Examples of commercially available devices include the Neoteryx Mitra,

 These devices are capable of collecting from as little as 20 microliters (approximately half a drop) to several hundred microliters of blood and have been widely used to determine clinical parameters,

 and more recently, COVID antibody levels.

 Some of these devices enable the collection of a fixed volume of blood, collected as dried blood, which can then be shipped and handled at room temperatures—avoiding the need for freezers and dry-ice for storing and shipping samples—enabling its adoption even in remote areas with limited infrastructure. Devices are also available for the collection of a small volume of wet blood from the upper arm which can then be separated as plasma or serum, similar to a standard venipuncture blood draw, thus providing the same liquid matrix for analysis (examples include Tasso SST and SeventhSense TAP II).

Patient-centric blood sampling techniques have been gaining popularity for use in pharmaceutical drug development; however, to date they have not been broadly accessible to the general public.

 This can be partially attributed to the “clinic-centric” healthcare model, where reimbursement is dependent on in-person visits and sample collection. Thus, the status quo remains and anyone who needs a blood test is required to go to the doctor’s office or clinic. However, recent experiences have demonstrated that these techniques can be widely implemented and that commercially available blood sampling devices are a perfect complement to the exponentially expanding space of telemedicine.

 It is apparent that improving patient convenience and the sampling experience, as well as enabling more frequent testing, can improve and expand monitoring of our “bodies” to know if everything is okay or react to issues early. Such information can empower the physician and patient to seek earlier intervention and evolve beyond reactive treatment, toward proactive disease prevention.

The cost of some of the technologies involved in this new paradigm may be higher than traditional blood collection approaches. However, studies have demonstrated that the overall cost to society will be lower, by improving health outcomes and allowing broader access and patient convenience.

 The availability and adoption of patient-centric approaches can provide access and treatment options to patients not geographically co-located with clinical sites and improving access in rural or lesser developed communities, globally, potentially improving general health of the population.

The responsibility for our collective health belongs to us all. The successful adoption and implementation of these blood sampling capabilities will require stakeholders to work together across organizational boundaries to deliver improved care. The benefits of implementing home blood sampling are clear; however, there are challenges for widespread adoption including training to ensure proper collection and processes for expedited return of the sample for analysis. Advances in mobile technologies for training, data capture (time/date stamp) and sample tracking, along with expanding home delivery and collection processes are expected to potentially alleviate this. We believe the learnings from the COVID pandemic will further drive innovation, including the ability to conveniently sample blood at home. This is a call for action for healthcare systems to make “patient-centric” blood sampling a reality to improve human health.

is a Researh Advisor for Lilly Research Laboratories, Eli Lilly and Company

is a Principal Scientist for Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck & Co, Inc.

is the Director of Spooner Bioanalytical Solutions Ltd.

Keesara, S.; Jonas, A.; Schulman, K., Covid-19 and Health Care's Digital Revolution. 

James, C. A.; Barfield, M. D.; Maass, K. F.; Patel, S. R.; Anderson, M. D., Will patient-centric sampling become the norm for clinical trials after COVID-19? 

Anderson, M., How the COVID-19 pandemic is changing clinical trial conduct and driving innovation in bioanalysis. 

PCSIG Patient Centric Sampling Interest Group. 

Mbughuni, M. M.; Stevens, M. A.; Langman, L. J.; Kudva, Y. C.; Sanchez, W.; Dean, P. G.; Jannetto, P. J., Volumetric Microsampling of Capillary Blood Spot vs Whole Blood Sampling for Therapeutic Drug Monitoring of Tacrolimus and Cyclosporin A: Accuracy and Patient Satisfaction. 

WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy

Wickremsinhe, E. S., M.; Talkington, B.; West. L, DIY Blood Sampling for Pediatric Clinical Trials – The Patients Perspective. 

Sztefko, K.; Mamica, K.; Bugajska, J.; Maziarz, B.; Tomasik, P., [Blood volume for biochemistry determinations--laboratory needs and everyday practice]. 

Valentine, S. L.; Bateman, S. T., Identifying factors to minimize phlebotomy-induced blood loss in the pediatric intensive care unit. 

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

Smoller, B. R.; Kruskall, M. S.; Horowitz, G. L., Reducing adult phlebotomy blood loss with the use of pediatric-sized blood collection tubes. 

Delahaye, L.; Veenhof, H.; Koch, B. C. P.; Alffenaar, J. C.; Linden, R.; Stove, C., Alternative Sampling Devices to Collect Dried Blood Microsamples: State-of-the-Art. 

Spooner, N.; Anderson, K. D.; Siple, J.; Wickremsinhe, E. R.; Xu, Y.; Lee, M., Microsampling: considerations for its use in pharmaceutical drug discovery and development. 

https://www.trajanscimed.com/pages/hemapen

https://hemaxis.com/products/hemaxis-db10/

https://www.drawbridgehealth.com/onedraw/

Crawford, M. L.; Collier, B. B.; Bradley, M. N.; Holland, P. L.; Shuford, C. M.; Grant, R. P., Empiricism in Microsampling: Utilizing a Novel Lateral Flow Device and Intrinsic Normalization to Provide Accurate and Precise Clinical Analysis from a Finger Stick. 

Roadcap, B.; Hussain, A.; Dreyer, D.; Carter, K.; Dube, N.; Xu, Y.; Anderson, M.; Berthier, E.; Vazvaei, F.; Bateman, K.; Woolf, E., Clinical application of volumetric absorptive microsampling to the gefapixant development program. 

Delahaye, L.; Stove, C., Alternative Sampling Strategies in Therapeutic Drug Monitoring: Microsampling Growing Toward Maturity. 

NIAID SARS-COV2 Pandemic Serosurvey and Blood Sampling. 

https://clinicaltrials.gov/ct2/show/NCT04334954

Klumpp-Thomas, C.; Kalish, H.; Drew, M.; Hunsberger, S.; Snead, K.; Fay, M. P.; Mehalko, J.; Shunmugavel, A.; Wall, V.; Frank, P.; Denson, J. P.; Hong, M.; Gulten, G.; Messing, S.; Hicks, J.; Michael, S.; Gillette, W.; Hall, M. D.; Memoli, M. J.; Esposito, D.; Sadtler, K., Standardization of ELISA protocols for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling. 

Spooner, N.; Anderson, M.; Wickremsinhe, E. R., Patient-centric sampling special focus issue. 

Martial, L. C.; Aarnoutse, R. E.; Schreuder, M. F.; Henriet, S. S.; Bruggemann, R. J.; Joore, M. A., Cost Evaluation of Dried Blood Spot Home Sampling as Compared to Conventional Sampling for Therapeutic Drug Monitoring in Children. 

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