What is point-of-care testing?
In the early days of medicine, few medical tests existed that were done at the patient’s bedside. By the 1950s, automated technologies meant centralized clinical laboratories could run large numbers of tests at low cost. It became common to send samples away to laboratories and then wait days to weeks for results.
As the need for faster test results has grown and certain testing devices have become portable and easy to use, medical testing has evolved once again. Today, results from clinical laboratories remain a crucial component of your health care, but they are now complemented by tests performed outside of the laboratory, wherever you are.
Point-of-care testing spans so many areas of medicine that it is best defined by where it’s done – anywhere outside the centralized laboratory – rather than by the kinds of tests that are performed. It may be referred to by many different names, such as near-patient testing, remote testing, satellite testing, and rapid diagnostics. In general, point-of-care testing encompasses any tests that are performed at or near a patient and at the site where care or treatment is provided. Results are typically available relatively quickly so that they can be acted upon without delay.
Point-of-care tests can happen in a wide variety of locations: in your home, at a health care practitioner’s office, in the emergency department, in an infectious disease containment unit, in ambulances, at an accident scene, in the military, in the radiology department, on a cruise ship, or even on the space shuttle. And a wide variety of people can perform point-of-care tests, including laboratory professionals, emergency first responders, radiologists, doctors, nurses, physician assistants, or other health care practitioners. They may even be done by yourself, sometimes called “self-tests” or “home tests.”
Devices for point-of-care tests come in an array of forms. They may use basic dipsticks as with urinalysis, handheld devices like glucose meters, or sophisticated molecular analyzers to detect infectious diseases. A health care practitioner may use a handheld device to perform a test at a patient’s bedside. Alternatively, that health care practitioner may collect a blood sample from the patient and walk the sample down the hallway to a satellite lab, where the sample is processed and tested on instrumentation. Both examples are considered point-of-care testing.
And the same type of point-of-care device may be used by a health care practitioner and a “lay person” such as yourself. For example, glucose meters are used by health care practitioners in hospitals to monitor patients in intensive care units. Glucose meters can also be used by diabetics at home to monitor levels and to adjust their insulin if necessary. Though the regulation and oversight of the use of these devices may differ when health care practitioners use them as opposed to the general public, they are more or less comparable devices.
The most common point-of-care tests are blood glucose monitoring and home pregnancy tests. Other common tests are for hemoglobin, fecal occult blood, rapid strep, as well as prothrombin time/international normalized ratio (PT/INR) for people on the anticoagulant warfarin. As medical care evolves to become more consumer-focused, point-of-care testing will continue to be an important way to perform medical testing. However, for you to receive the highest quality care by using these tests, it’s important that point-of-care tests are part of a testing continuum that includes centralized clinical laboratories and a team of health care practitioners.
About Point-of-Care Testing
Why is Point-of-Care Testing Growing?
As health care becomes more consumer-focused, the need for convenient diagnosis, monitoring, and screening tests is expanding worldwide. In some cases, technology has caught up; testing devices that are smaller, more portable, and easier to operate have been developed.
The market for point-of-care testing is estimated to grow 9.3% between 2013 and 2018. There are a number of reasons for this trend. Point-of-care tests provide results in real time, rather than in hours or days, so they can help you and your providers make faster, and hopefully better, decisions about your medical care. With results in hand during your consultation, you can receive immediate follow-up testing or treatments without returning for another office visit.
For example, if you are given a point-of-care test and diagnosed with influenza right away, your health care practitioner can explain why you don’t need antibiotics and instead treat you with an antiviral medication if it’s appropriate.
Point-of-care testing is useful as medical care shifts to a focus on prevention, early detection, and managing chronic conditions. In the emergency room, early detection can help determine if people with flu-like symptoms have influenza or if they have a higher-risk infection like Middle Eastern Respiratory Syndrome (MERS). In the health care practitioner’s office, the rapid strep test allows for earlier treatment of strep throat and reduces the risk of complications from not treating it. At home, glucose meters allow people with diabetes to tailor their insulin therapy. It makes up the largest segment of the point-of-care testing market.
There is also a growing need for rapid screening for infectious diseases like HIV, dengue fever, malaria, and influenza. Infectious disease tests are useful in community clinics and remote or resource-limited areas where there may not be access to a central lab or where infrastructure is limited for transporting samples. Infectious disease tests at the point of care can also lead to prompter treatment, which can prevent infections from spreading.
When used as part of a larger health care strategy, point-of-care testing can make diagnosis and treatment a smoother and more efficient process. Point-of-care tests are most beneficial when they are viewed as one step in a testing continuum that may begin at the point-of-care, but eventually leads to coordinated testing with a central laboratory.
When used properly, point-of-care testing can lead to more efficient, effective medical treatments and improved quality of medical care.
At home, point-of-care tests allow for more frequent and more consistent testing and can empower you to take control of your medical care. Ideally, the end result is higher quality care. For example, clinical trials have shown that individuals monitoring blood thinners (anticoagulants) like warfarin at home had fewer major complications from the treatment.
Point-of-care testing is also crucial in emergency situations and in the operating room. If someone is having a stroke, a first responder or other healthcare practitioner needs to measure prothrombin time/international normalized ratio (PT/INR) to test blood coagulation before he or she can give stroke medications. Point-of-care tests are also used to measure coagulation during open-heart surgery and organ transplants.
Point-of-care tests can also help alleviate emergency room overcrowding by reducing the time it takes to treat people and thus shortening their stays. They are also useful in disaster situations like Hurricane Katrina or any scenario that prevents access to power, water, and laboratory infrastructure.
When used in a healthcare practitioner’s office, point-of-care testing can reduce follow-up visits or calls. In one study, delivering the routine tests hemoglobin A1c, hemoglobin, and lipids at the point-of-care decreased tests ordered for each patient by 21%, reduced follow-up calls by 89%, and reduced patient follow-up visits by 61%.
One concern with conventional laboratory testing is that people may not return for treatment if they have to go home and wait for results. This has been the case for HIV viral load and tuberculosis testing. In one study at a clinic in Ghana, point-of-care testing helped remedy this problem. When people seeking care at a tuberculosis clinic were offered HIV tests on the spot, they were more likely to also return for HIV care.
Point-of-care testing can also provide test results in locations where clinical laboratories don’t exist or are too far away, like in the developing world, rural regions, or on cruise ships or even the space shuttle.
While many point-of-care tests are designed to be relatively simple and low risk to use, they are not error-proof. Individuals using point-of-care tests, even healthcare practitioners, must carefully follow test directions and be familiar with the test system. Some point of care tests, such as those used to adjust doses of medications, have the potential to lead to serious health consequences if not performed properly. Many large hospitals have point-of-care coordination teams to ensure that testing procedures are properly followed.
It’s important that the convenience of point-of-care testing does not tempt users to apply them beyond their intended purpose or misinterpret results. For example, glucose meters and point-of-care hemoglobin A1c tests are designed only for monitoring diabetes and should not be used for diagnosis or screening.
You and your health care practitioner also need to be cautious when comparing test results from different sources. Just as test results may not be consistent from laboratory to laboratory, they may vary between point-of-care testing techniques, or between laboratory results and point-of-care results.
One major challenge is managing the data generated by point-of-care tests. When tests are performed at the point-of-care, it is important that the results are incorporated into your health record.
If you are performing point-of-care tests at home, it’s best to seek professional guidance. For example, if you are monitoring a medicine like warfarin for anticoagulation, a testing mistake could lead to a blood clot or internal bleeding. That’s why it’s recommended that you learn to perform the test with professional supervision and have the result verified by a clinician before performing it at home and periodically to ensure consistent technique.
Getting a follow-up diagnosis from a healthcare practitioner is also important if you use home screening tests. For example, the U.S. Food and Drug Administration (FDA) approved HIV testing for home use in 2012. While home tests are less sensitive and home users can make more mistakes than professionals, the FDA thought the benefit of increased HIV testing outweighed the risks.
Home tests and some point-of-care HIV tests used in clinics, for example, detect only HIV antibody and not the HIV antigen, so they may miss some early infections with HIV. All HIV screening tests that are positive should be followed by a second, different antibody test for diagnosis, and should not stand alone to make a diagnosis. Though HIV home tests and point-of-care tests can offer speed, convenience and privacy, it is important for individuals using these tests to seek follow-up care and diagnosis.
While speed is often one of the advantages of point-of-care tests, the results may not be as specific or sensitive as centralized laboratory test results. For example, there are several types of rapid influenza diagnostic tests (RIDTs) available to help differentiate influenza (flu) from other infections with similar symptoms that must be treated differently. Depending on the method, RIDTs may be done in less than 15 minutes in a health care practitioner’s office or may be sent to a laboratory, with the results available the same day.
But not all RIDTs have the same ability to detect influenza. Some tests can only detect influenza A while others can detect both influenza A and influenza B but not distinguish between the two. Still others can detect and distinguish between influenza A and B but may not detect the latest strain of influenza circulating that year due to antigenic changes in the virus. Moreover, point-of-care flu tests are not designed to identify the subtype of influenza the patient has, i.e. H3N2 or the pandemic H1N1 strain.
Point-of-care tests may also deliver a more limited range of results compared to full laboratory workups. So, following up with a laboratory test will likely be necessary after an initial test at the point of care.
In general, point-of-care tests should be viewed as a valuable tool for medical testing, but not the only tool. Since you benefit most when point-of-care tests and central laboratory tests are coordinated, it’s important that point-of-care tests are not used in isolation.
For some conditions, like diabetes, point-of-care testing has already drastically altered how care is delivered and managed. With the market for point-of-care testing only expected to expand, it will continue to change the way healthcare is delivered, making care more patient-driven and focused, providing more data to support evidence-based medicine.
New point-of-care tests that may emerge in the future include new technologies intended to manage critically ill patients in the emergency room, in the hospital, or undergoing surgery, such as complete blood count or tests for drug overdoses. And new tests may be developed for earlier cancer detection, such as cervical cancer. Point-of-care tests will also continue to be important for managing chronic conditions.
Infectious disease testing is the fastest growing area of point-of-care testing. These tests are intended to diagnose infections quickly, to allow timely treatment, limit their spread, and slow or prevent outbreaks. These may include point-of-care tests for Lyme disease, avian influenza (bird flu), chikungunya virus, and drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA).
In the developing world and remote rural regions, the use of point-of-care tests is motivated by the need for better options to make diagnosis and treatment of diseases like malaria, HIV, and tuberculosis more accessible and affordable. In the developed world, respiratory and sexually transmitted infections are areas where new point-of-care tests could help.
For the last two decades, efforts have been underway to develop new technologies to bring more tests to the point-of-care and to make the tests more sensitive and specific. Molecular techniques such as polymerase chain reaction (PCR) will likely be used to deliver new infectious disease tests at the point-of-care. Another big focus area has been lab-on-a-chip systems. These miniature devices are designed to rapidly automate every step of a laboratory test using very small sample sizes, without the need for manual handling of the sample.
Point-of-care testing is never likely to replace clinical laboratory testing. However, as technology evolves to meet the demand for more streamlined, higher quality healthcare, point-of-care testing will continue to be a growing part of your healthcare experience.
There are many point-of-care tests available in a variety of settings. Here are some that you may encounter:
|Test Name||Why It’s Done||Where it’s performed||Who Performs it|
|Blood glucose||Diabetes screening and monitoring||A health care professional||You, a health care professional|
|Activated clotting time||Heparin drug monitoring||Operating room||A health care professional|
|Oxygen saturation||Assessment of oxygen delivery||Operating room, clinic, hospital||A health care professional|
|Blood gases and electrolytes||Assessment of gas exchange, electrolyte disorders, acid-base disorder||Operating room, intensive care unit, emergency department||A health care professional|
|Hemoglobin/Hematocrit||Screening for anemia||Clinic, hospital||A health care professional|
|Rapid HIV||Screening for HIV||At home, clinic, hospital||You, a health care professional|
|Thyroid stimulating hormone (TSH)||Screening for hypothyroidism||At home, clinic, hospital||You, a health care professional|
|hCG||Pregnancy testing||At home, radiology, emergency department, clinic||You, a health care professional|
|Creatinine||Risk assessment for developing contrast-induced nephropathy (CIN)||
|A health care professional|
|Lipid profile||Screening and diagnosis of high cholesterol, cardiovascular risk assessment, long-term monitoring of patients already on treatment||Clinic, hospital||A health care professional|
|Fecal occult blood||Colorectal cancer screening||At home, clinic||You, a health care professional|
|Dipstick urinalysis||Used to screen and monitor the kidneys and urinary tract and diagnose urinary tract infections||At home, clinic, hospital||You, a health care professional|
|Rapid strep||Diagnose strep throat||Clinic, hospital||A health care professional|
|Prothrombin time/International normalized ratio (PT/INR)||Monitoring warfarin (anticoagulant) therapy||At home, clinic, hospital||You, a health care professional|
St. John, A. and Price, C. P. (2014 August) Existing and Emerging Technologies for Point-of-Care Testing. Clinical Biochemistry Review. Available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4204237/. Accessed 11/10/2015.
Henry’s Clinical Diagnosis and Management by Laboratory Methods. 22nd ed. McPherson R, Pincus M, eds. Philadelphia, PA: Saunders Elsevier: 2011.
Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Burtis CA, Ashwood ER, Bruns DE, eds. 5th edition, St. Louis: Elsevier Saunders; 2012.
Santrach, P. J. Mayo Clinic. Current and Future Applications of Point-of-care Testing, Available online at http://wwwn.cdc.gov/cliac/pdf/addenda/cliac0207/addendumf.pdf. Accessed 10/12/2015.
(2013 March 29, Updated) Point-of-care Diagnostic Testing. National Institutes of Health. Available online at http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=112. Accessed 10/12/2015.
(2010) Lab Medicine. Point-of-Care Testing Guideline. Published by CLSI. Available online at http://labmed.ascpjournals.org/content/41/8/499.full. Accessed 10/12/2015.
Gubbin, P.O., et al. (2014) Point-of-Care Testing for Diseases: Opportunities, Barriers, and Considerations in Community Pharmacy. Journal of the American Pharmacists Association. Available online at http://www.medscape.com/viewarticle/827464_5. Accessed 10/12/2015.
(2012 September) Burns, E. TechTarget. Clinicians discuss pros and cons of point-of-care testing devices. Available online at http://searchhealthit.techtarget.com/feature/Clinicians-discuss-pros-and-cons-of-point-of-care-testing-devices. Accessed 10/12/2015.
Ritzi-Lehnert, M. (2012) Development of chip-compatible sample preparation for diagnosis of infectious diseases. Expert Review of Molecular Diagnostics. Available online at http://www.medscape.com/viewarticle/759549_5. Accessed 11/10/2015.
Ansell, J. (2014 November 7) Home Monitoring for Warfarin Therapy. National Blood Clot Alliance. Available online at http://www.stoptheclot.org:home-monitoring-for-warfarin-therapy.htm. Accessed 11/10/2015.
Rooney, K.D. and Schilling, U.M. (2014) Point-of-care testing in the overcrowded emergency department – can it make a difference? Critical Care. Available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4331380/. Accessed 11/10/2015.
Crocker, J.B. et al. (2014) Implementation of point-of-care testing in an ambulatory practice of an academic medical center. American Journal of Clinical Pathology. Available online at http://www.ncbi.nlm.nih.gov/pubmed/25319979. Accessed 11/10/2015.
Kost, G.J., et al. (2006) Katrina, the tsunami, and point-of-care testing. American Journal of Clinical Pathology. Available online at http://ajcp.ascpjournals.org/content/126/4/513.long. Accessed 11/10/2015.
Appiah, L. T. et al. (2009) Efficacy and Acceptability of Rapid, Point-of-Care HIV Testing in Two Clinical Settings in Ghana. AIDS Patient Care and STDs. Available online at http://online.liebertpub.com/doi/abs/10.1089/apc.2008.0224. Accessed 11/10/2015.
Howick, J., et al. (2014) Current and future use of point-of-care tests in primary care: an international survey in Australia, Belgium, The Netherlands, the UK and the USA. BMJ Open. Available online at http://bmjopen.bmj.com/content/4/8/e005611.full. Accessed 11/10/2015.
(2014 September) Point-Of-Care Diagnostic Market worth $27.5 Billion by 2018. Markets and Markets. Available online at http://www.marketsandmarkets.com/PressReleases/point-of-care-diagnostic.asp. Accessed 11/10/2015.
(Reviewed, 16 March 2015). Clinical Laboratory Improvement Amendments (CLIA). Centers for Disease Control and Prevention. Available online at https://wwwn.cdc.gov/clia/Resources/WaivedTests/. Accessed 11/23/2015.
(Modified 10 August 2015). Clinical Laboratory Improvement Act. Centers for Medicare and Medicaid Services. Available online at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/. Accessed 11/23/2015.
(September 28, 2015) Silas Grossman, The “Tricorder” of Patient Care, Part 1: From glucometers to genetics and the future of testing. Advance for Administrators of the Laboratory. Available online at http://laboratory-manager.advanceweb.com/Features/Articles/The-Tricorder-of-Patient-Care-Part-1.aspx. Accessed 11/30/2015.
(October 26, 2015) Grossman, Silas. The “Tricorder” of Patient Care, Part 2: From glucometers to genetics and the future of testing. Advance for Administrators of the Laboratory. Available online at http://laboratory-manager.advanceweb.com/Features/Articles/The-Tricorder-of-Patient-Care-Part-2-2.aspx. Accessed 11/30/2015.
(April 2014) Paxton, Anne. How POC testing is pushing the envelope. CAP Today. Available at http://www.captodayonline.com/how-poc-testing-is-pushing-the-envelope/. Accessed 11/30/2015.