These diagnostic tests play critical role in chronic disease management, early interventions, and emergency situations.
Point-of-care testing (POCT) has been around since ancient times, with records showing that doctors used uroscopy, or the practice of examining urine for substances or visual cues, as far back as the Greek empire.1
But as society evolved, so did the POCT technology.
POCT has become a billion-dollar business.2 Demand for accessible testing has exploded in recent years, partly because of the COVID-19 pandemic. The US market for diabetic glucose monitoring alone has increased from $3.5 billion to approximately $7 billion, and this trend can be applied to nearly every other POCT available and marketed commercially.2
POCT includes any test performed by a qualified staff member near the patient with results available at the same clinical visit to support clinical decisions.3
Overall, the health care system spends about $2 trillion per year on the approximately 330 million Americans.4,5 Although the United States spends more per capita than most other countries, it consistently ranks among the worst performers.
Primary care in medicine is poorly funded and supported, and the demands of a growing population create an opportunity for pharmacists to fill the primary care gap.
POCT allows pharmacies to combat population health issues, expand patient care services, and simultaneously increase revenue. Depending on the state, pharmacists may need additional training or collaborative practice agreements to provide POCT.6
POCT’s essential purposes are behavior modification, disease identification and monitoring, and reducing barriers to use.6
Type of POCT
Traditionally, primary care providers’ (PCPs) offices have used POCT to diagnose acute conditions (BOX).7 These tests help improve patient outcomes in acute conditions, and now POCT has started to transition into chronic disease diagnosis and management too. PCPs most often use POCT for diabetes, usually determining glycated hemoglobin A1C levels from blood fingerstick samples.7
Common POCT include rapid flu and COVID-19 antigen tests. Less common tests include drug testing kits and those for iron or vitamin levels. A unique POCT is used to guide antimalaria treatment in low resource settings.3 Overall, the areas that benefit from POCT are acute conditions, general health, and infectious disease.
Why POCT Makes Sense
Numerous health care barriers create poor patient outcomes,including lack of an accessible PCP, health insurance, or transportation.8 The health care system is struggling to meet patients’ needs while dealing with provider shortages and other pressing public health concerns. In underserved areas, POCT decreases patient burden, is accessible, and saves time.8
Nearly 90% of the US population lives within 5 miles of a community pharmacy, making pharmacies accessible.9 The Public Readiness and Emergency Preparedness Act authorized community pharmacies to offer COVID-19 POCT in addition to administering vaccines and prescribing therapies to eligible patients.8 Before that, pharmacists were crucial in immunizing for the 2019 measles outbreak, and prior to that, the influenza A virus.10
In addition, patients report that they are comfortable with pharmacists. They visit pharmacies twice as often as they see their prescribers because pharmacists communicate well to increase health literacy and patient understanding.8,9 POCT offered by pharmacists shortens time to treatment, and pharmacists can also recommend symptomatic treatment relief for certain conditions.11
Challenges of POCT
Incorporating POCT has hurdles. Pharmacies and retail settings that want to offer POCT need to file for a Clinical Laboratory Improvement Amendments waiver, and policies and procedures are needed to train staff members, especially if pharmacists are working in conjunction with providers.11 In addition, other health care providers may be resistant, often because of a lack of awareness or trust of the pharmacy’s service.12
Depending on the type of POCT used, result validity may be a concern.
Sensitivity and specificity may be an issue because overall POCT is less reliable than lab testing.12 However, US standards require an 85% accuracy and reliability rate for POCT to be marketed,12 so it is far better than not being tested at all.
Another major challenge is the lack of provider status for pharmacists—who may not get compensated directly for offering POCT services.4 Lastly, documenting pharmacist-driven POCT into electronic medical records and the overall public health system may create an operations issue.
POCT and rapid tests are critical in chronic disease management, early intervention, and emergency situations.12 A rapid test result can increase timely decisions about treatment, reduce risks associated with infectious diseases, and lead to overall decreased hospitlizations.11 Expanding pharmacists’ scope of practice can help ease the burden on PCPs, especially considering the national shortage projected to affect the United States in the next decade.4
1. Campbell S. Point of care testing: (a little) past and (more) future. CDC. Accessed December 1, 2022. https://www.cdc.gov/cliac/docs/april-2022/7_the-laboratory-perspective.pdf
2. Stewart C. Size of the U.S. point of care diagnostics and testing market from 2015-2022, by product. Statista. July 14, 2017. Accessed December 1, 2022. https://www-statista-com.ezproxy.lib.uconn.edu/statistics/726084/us-point-of-care-diagnostics-and-testing-market-size/
3. Albasri A, Van den Bruel A, Hayward G, McManus RJ, Sheppard JP, Verbakel JYJ. Impact of point-of-care tests in community pharmacies: a systematic review and meta-analysis. BMJ Open. 2020;10(5):e034298. doi:10.1136/bmjopen-2019-034298
4. Salgado TM, Rosenthal MM, Coe AB, Kaefer TN, Dixon DL, Farris KB. Prima-ry healthcare policy and vision for community pharmacy and pharmacists in the United States. Pharm Pract (Granada). 2020;18(3):2160. doi:10.18549/pharmpract.2020.3.2160
5. Phillips RL. Primary care in the United States: problems and possibilities. BMJ. 2005;331(7529):1400-1402. doi:10.1136/bmj.331.7529.1400
6. Point-of-care testing (POCT). National Community Pharmacists Association. Accessed December 1, 2022. https://ncpa.org/point-care-testing-poct
7. Sohn AJ, Hickner JM, Alem F. Use of point-of-care tests (POCTs) by US primary care physicians. J Am Board Fam Med. 2016;29(3):371-376. doi:10.3122/jabfm.2016.03.150249
8. Sahr M, Blower N, Johnston R. Patient perceptions of acute infectious disease point-of-care tests and treatment within community pharmacy settings. J Am Pharm Assoc (2003). 2022;62(6):1786-1791. doi:10.1016/j.japh.2022.05.027
9. Berenbrok LA, Tang S, Gabriel N, et al. Access to community pharmacies: a nationwide geographic information systems cross-sectional analysis. J Am Pharm Assoc (2003). 2022;62(6):1816-1822.e2. doi:10.1016/j.japh.2022.07.003
10. Hess K, Bach A, Won K, Seed SM. Community pharmacists roles during the COVID-19 pandemic. J Pharm Pract. 2022;35(3):469-476. doi:10.1177/0897190020980626
11. How retail clinics & pharmacies benefit from point-of-care (POC) testing. McKesson. May 9, 2022. Accessed December 2, 2022. https://mms.mckesson.com/resources/managing-my-lab/how-retail-clinics-pharma-cies-benefit-from-point-of-care-poc-testing
12. Future of point of care & rapid testing. Ipsos. February 2022. Accessed December 3, 2022. https://www.ipsos.com/sites/default/files/ct/publication/documents/2022-03/Ipsos_Future%20of%20POC%20and%20Rapid%20Testing_March%202022.pdfBOX
About the Author
Jessica Bylyku is a PharmD candidate at the University of Connecticut School of Pharmacy in Storrs.