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New frontiers in point-of-care testing

POCT devices with wireless or cellular capabilities can link test results with the patient’s electronic medical record.

Point-of-care testing (POCT) is diagnostic testing performed close to the site of patient care. POCT uses small, portable devices to obtain rapid test results while the clinician is still examining the patient. The analysis uses small amounts of unprocessed blood and urine samples, does not require continuous power or purified water and can be performed by non-laboratory clinical staff with minimal training. POCT is simple and results are sufficiently reliable to meet medical needs for triage, diagnosis and management of patients in the field, outside of a laboratory. This allows for POCT to be performed on hospital wards and outpatient clinics without having to collect and transport specimens to a laboratory. The portability and rapid return of test results has found application of POCT in schools, charity or free clinics, athletic events, concerts, helicopter and air transport, ambulances, cruise ships, and remote settings such as military field hospitals, disaster relief, and expeditions. POCT has even been conducted on a space shuttle and Mount Everest.

Early healthcare featured a doctor who made house-calls to a sick child or injured farmer. A family would call the doctor who brought his black bag and medicines to diagnose and manage the patient in their home. With increasing numbers of patients in need of healthcare, it became more efficient for patients to visit the physician in an office or hospital for the management of illness. In this modern healthcare model, the patient must wait for an appointment and laboratory tests are ordered when the physician examines the patient. Blood is collected and the specimen is processed, transported to a laboratory for analysis, and test results are communicated back to the physician. Then, the patient waits to hear back from their physician for the test results and follow-up. This process delays laboratory results, impedes access to healthcare, and depersonalises the healthcare experience.

Recent regulatory changes in the United States allow patients the right to access personal health information under the Health Insurance Portability and Accountability Act (HIPAA). Together with changes to the interpretation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), patients or their representative can now access completed test reports. Prior to these changes, laboratory test results could only be released to the ordering physician. Kathleen Sebelius, the former United States Secretary of Health and Human Services, stated that “information like lab results empowers patients to track their health progress, make decisions with healthcare professionals and adhere to treatment plans”. In response, many hospitals and health systems have opened patient portals over the Internet. These portals provide patients easy access to personal health information and laboratory results.

Role of the patient

POCT promotes the personal role of the patient in their healthcare. For example, women concerned about pregnancy can purchase a test over-the counter at their pharmacy or grocery store without a prescription. The test can be conducted without a doctor’s appointment and privately without results being recorded in their medical record. Several products are now available for over-the-counter purchase such as tests for glucose, lipids, fertility, drugs of abuse and human immunodeficiency virus (HIV) infection. A challenge with over-the-counter POCT and home self-testing is the interpretation of results. In one study, 638 laywomen using 11 different pregnancy tests, falsely interpreted 230/478 (48 per cent) negative urine results as positive due to the difficulty of understanding explanatory leaflets and reading results. Review of 16 pregnancy tests found test instructions were written at the 7 – 10th grade reading level and the question and answer sections were written at the 11 – 14th grade level, while 7th grade literacy was the target. In addition, the typeset, graphics and paper size were too small for user friendliness. Of note, digitally read results offer more clarity over non-digital pregnancy tests that are manually interpreted.

Direct-to-consumer (DTC) testing facilities offer laboratory testing directly to the patient without a physician order. The menu varies by location depending on regional laws, but most facilities collect blood on-site, send the sample to a CLIA-certified laboratory for analysis, and either mail results to the patient or post results online. A full menu of tests such as paternity testing, health and wellness, drug and steroid testing as well as sexually transmitted disease tests are available without physician interaction. The advantage of direct-to-consumer testing is professional performance of the test. This allows access of patients to laboratory quality testing for disease prevention and management. However, the patient must still interpret the test result. This can be complicated. For example, fertility testing with follicle stimulating hormone (FSH) and luteinizing hormone (LH). These hormones are affected by stress, irregular eating, alcohol use as well as endocrine function. Results from either home POCT or direct-to-consumer FSH and LH may require follow-up tests such as progesterone and oestrogen to diagnose menopause. In this case, test results are best interpreted in conjunction with past medical history and physical examination by a clinician rather than by a consumer without medical training.

When patients need non-acute healthcare (not warranting an emergency department visit), but can’t get an appointment at their own clinic, a pharmacy clinic may be an option. A clinician, generally a nurse practitioner, examines the patient, orders the appropriate test and even conducts a range of POCT in the clinic. Results can then be interpreted by the clinician on-site in conjunction with the patient’s physical symptoms and medical history. This option offers patients a way to receive the care they need all from one place. When a child wakes up with a sore throat, the parent can take them to a pharmacy clinic, have the child examined, get rapid strep POCT and leave with prescribed antibiotics all in the same visit. The pharmacy clinic streamlines care and minimises the amount of time the parent must take off from work, the child missing school and limits the illness and duration of symptoms by receiving prompt treatment.

Personalised experience

There is now a wave of healthcare on the rise, doctors making house calls! This may not be new, as our predecessors relied on doctor house-calls for care in the past, but there is a current resurgence. This time, the doctors come equipped with POCT devices to provide on-site testing as well as a short supply of drugs to treat common conditions. These on-call services can be accessed through mobile phone applications or through a hotel concierge, if traveling. A nurse practitioner will call back within the hour and come directly to the patient’s home, office or hotel to provide non-emergent focused assessment and triage the patient. A doctor house call provides a more personalised healthcare experience than current clinic or hospital visits. For patients who are frail and/or have limited mobility, house calls provide safe access to healthcare. Additionally, healthcare providers equipped with POCT devices can travel to remote areas to provide healthcare services to patients without the means for transportation to a clinic or hospital.

POCT devices with wireless or cellular capabilities can link test results with the patient’s electronic medical record. This ensures dissemination of results across their healthcare team. The future of POCT may take the form of smartphone attachment/readers to provide automated test interpretation and data transmission. Devices with glucose readers can analyse the test and phone results to the physician. Digital pregnancy tests are available that can call a patient’s phone with the test interpretation. Even microscope lenses have been attached to phones to provide inexpensive POCT devices for developing counties. Watches, wearable devices and smart contacts and patches are in development that can connect to other digital health applications.

The growth of social media provides even more personalised healthcare with the growing opportunity to access digital health resources. Social media can be used to promote disease state discussions, disseminate peer published literature and exchange professional education. Patients with the same disease can connect and share experiences through blogs, Facebook, Twitter, Instagram, and other social media sites.

Patients can seek laboratory test information from sites such as LabTestsOnline.org, a website by the American Association for Clinical Chemistry (AACC), which provides information on laboratory tests and is currently available in 14 countries and in 12 languages. As the availability of POCT and direct-to-consumer testing expands, trusted resources on laboratory testing will be in high demand.

POCT is at the cusp of a digital revolution merging laboratory diagnostics with information technologies. As POCT grows, the technology will expand to new locations finding greater applications for improving healthcare. This is an exciting time for POCT innovations that are yet to come.

References available on request.

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