Point Of Care in Medicine: State of Art & Future Developments

Written By: Anirban Kundu

 

Introduction

From the stethoscope to robotic surgery, the field of medical innovations has transformed to make disease diagnosis and prognosis fast, error-free, and widely accessible. A significant milestone in this endeavor involves the creation of point-of-care devices. The term “point of care” (hereby referred to as POC) was coined by Dr. Gerald J Kost, a University of California Davis doctor quantifying Calcium levels in blood samples using a biosensor1. Since then, POC devices have been used for a variety of diseases – from tuberculosis to infectious diseases such as HIV and syphilis, from diabetes to pregnancy. It is also remarkable that POC devices have been fabricated on a range of support material – from paper to microfluidic devices2-5.

What is Point Of Care (POC) detection?

In simple terms, POC refers to an examination/investigation of a disease that ensures instant availability of results determining whether the user is infected or not. The POC device/detection kit usually has an assembly of biochemical and immunological components that exhibit chemical reactivity with the disease-causing agent (antigen, receptor, specific surface proteins etc.) leading to a easy-to-interpret result that includes a colorimetric change, change in observed light intensity, fluorescence, etc. A POC device aims to accelerate the steps usually performed in a laboratory setting to give quick, instantaneous, and reliable disease diagnosis results.

Furthermore, a POC device should be easy to use and troubleshoot, accompanied with a clear set of instructions involving 1) type of sample required (e.g., clinical samples such as saliva, blood, urine; environmental samples, etc.), 2) quantity of sample, 3) any specific instructions involving operation of the POC (e.g., pressing a specific button, inserting the sample tube into a specific location, smartphone-based results interpretation etc.), 4) steps on how to observe and read the result generated by the POC diagnosis. Moreover, in most cases a POC device aims to provide results in a quick timeframe to enable the user (patient) to take the necessary next steps without delay, thereby leading to more informed healthcare.

 

Exhibit 1 (The Pregnancy home-test). POC pipeline for pregnancy testing using commonly available POC pregnancy kits, one of the most widely used POC devices today. Step #2 occurs via a process called Lateral Flow Chromatographic Immunoassay leading to either a positive or negative result as determined by one or both bands highlighted (in yellow, Step #3)

 

Exhibit 2 (Blood glucose monitoring). POC pipeline for blood glucose monitoring using the commonly available glucose strips and quantification meters (Image Credit on top: Accu-Chek). As opposed to the Pregnancy POC kit, biochemical reactions occur in the strip itself (Step #1A-B) leading to reaction end-products. These generate signals in the blood glucose testing device, leading to an instantaneous assessment of blood glucose levels (Step #3).

The User’s perspective for Point Of Care use:

A summary of reports and peer-review studies on POC diagnosis and detection led to distilling the following as important for easy POC application and use.6-8

Exhibit 3: Operational, Quality, and Performance indicators for POC detection

1CLSI stands for Clinical and Laboratory Standards Institute

2CAP stands for The College of American Pathologists

3National Pathology Accreditation Advisory Council

The POC Market: Trends in Technology

Exhibit 4: Technology Trends are evolving rapidly to design POC devices that are efficient in terms of detection sensitivity, diversity of user samples, data availability and interpretation. A classification of 1st, 2nd, and Next-Gen POC technologies follows9 :

Note: ADR refers to Antibiotic Drug Resistance

The POC Market: Growth & Scope of Expansion

A McKinsey study10 suggests a major shift in medical services from the clinic to the home to occur by 2025. Furthermore, the study provides a detailed insight into the extent by which capabilities are matured or still in development stage for various stages of medical services (primary, long term, acute, emergency etc.) – See Exhibit 4.

Exhibit 5: Market growth for medical services in clinics and how these services can shift to the home by 2025 (Source: McKinsey & Company)

 

The McKinsey thought article estimated up to $265 billion of care to shift from clinics (traditional setting) to in-house domestic care. Services such as primary care and patient consultations are expected to scale at home as point solutions. Furthermore, 15 – 40% of elaborate services from dialysis to infusions are expected to be increasingly delivered at home. Finally, acute conditions such as respiratory illnesses (asthma, pneumonia), cardiac failure, pulmonary diseases (COPD) etc. can be expected to be treated reliably in home settings. Clearly, there is ample opportunity to develop POC technologies for pre-disease assessments and informed next steps.

Moreover, integrating these POCs with developments such as telehealth and more connected health-information networks is expected to make disease diagnosis efficient, reliable, and fast at the domestic level. Well-connected and technologically sounds health ecosystems have the potential to deliver personalized and integrated diagnosis and assessment to users, enhancing productivity, and encouraging drive towards frugal solutions11. Technological developments (Exhibit 4) will help in this effort by providing more informed diagnosis platforms while enabling easier user experience. This would also assist in treatment of emerging diseases due to ADR strains, SARS-CoV-2, virus outbreaks etc.

 

Bibliography

  1. Liu, X., Zhu, X., Kost, G. J., Liu, J., Huang, J., & Liu, X. (2019). The creation of point-of-careology. Point of Care, 18(3), 77-84.
  2. Dheda, K., Ruhwald, M., Theron, G., Peter, J., & Yam, W. C. (2013). Point‐of‐care diagnosis of tuberculosis: Past, present and future. Respirology, 18(2), 217-232.
  3. Laksanasopin, T., Guo, T. W., Nayak, S., Sridhara, A. A., Xie, S., Olowookere, O. O., & Sia, S. K. (2015). A smartphone dongle for diagnosis of infectious diseases at the point of care. Science translational medicine, 7(273), 273re1-273re1.
  4. Murray, L. P., & Mace, C. R. (2020). Usability as a guiding principle for the design of paper-based, point-of-care devices–A review. Analytica Chimica Acta, 1140, 236-249.
  5. Yetisen, A. K., Akram, M. S., & Lowe, C. R. (2013). based microfluidic point-of-care diagnostic devices. Lab on a Chip, 13(12), 2210-2251.
  6. St John, A., & Price, C. P. (2014). Existing and emerging technologies for point-of-care testing. The Clinical Biochemist Reviews, 35(3), 155.
  7. Pai, N. P., Vadnais, C., Denkinger, C., Engel, N., & Pai, M. (2012). Point-of-care testing for infectious diseases: diversity, complexity, and barriers in low-and middle-income countries.
  8. Point-of-care testing. Ottawa: CADTH; 2017 Oct. (Environmental scan; no. 65)
  9. Jani, I. V., & Peter, T. F. (2013). How point-of-care testing could drive innovation in global health. New England Journal of Medicine, 368(24), 2319-2324.
  10. McKinsey & Co: From facility to home: How healthcare could shift by 2025 (Published February 1, 2022)
  11. McKinsey & Co: The next wave of healthcare innovation: The evolution of ecosystems (Published June 30, 2020)

 

Anirban Kundu is an Environmental Engineering PhD candidate and Sustainability ChangeMaker at McGill University. He's worked with superb teams at reputed universities & institutions across India, Canada, France; Fortune 500 companies; Governments; non-profit organizations. Demonstrated leadership excellence in Fine Arts and cultural activities, leading to being General Secretary of Students' Dramatics team, co-producing 4 theatre productions and annual cultural programs in India.

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