The prospects, prominence, possibilities of point-of-care testing

Aug. 26, 2021
Outcomes can span the promise, the questionable and the curiously intriguing

One thing clinicians and patients alike consistently have demanded or sought during the COVID-19 pandemic – access to testing for the virus, along with convenience and speed of obtaining the results.

Unfortunately, the desire for convenience and speed sometimes can affect the accuracy, integrity and security of results. While the healthcare industry may be closer to seeing the emergence of “tricorder” technology used in the cinematic “Star Trek” franchise than ever before, it also recognizes that such science fiction technology is not ready for prime-time or even real-time applications … yet.

Still, the desire for convenience and speed motivates the research and development for such advancements as technological development pushes boundaries about which healthcare administrators and clinicians – as well as patients – only can dream of and conceive right now. Although today we reside in the “right now,” appreciative of the capabilities and contributions that current point-of-care testing products provide caregivers and patients alike look forward to what’s in store, but with caveats and within reason.

The promise

From measuring a variety of vital signs as well as COVID-19 and influenza among others, point-of-care testing (POCT) provides a wealth of key benefits for clinicians and patients.

Dennis Begos, M.D., Medical Director, Medical and Scientific Affairs, Nova Biomedical, points to what he calls the obvious – speed of results.

“With near real-time results, clinical and in the case of COVID testing, social and political decision-making, can also be expedited,” he told Healthcare Purchasing News.

Begos refers to blood glucose testing as an example of why speed matters. “Many critically ill patients are on tight glucose control parameters in the ICU,” he indicated. “Insulin drips are common, and blood glucose can change rapidly under these conditions. Sending blood to the central laboratory can often take over an hour to be resulted, causing delay in treatment and potential patient harm. In addition, the treatment is based on what the patient’s glucose was an hour ago, which may have rapidly changed in the ensuing hour. Lastly, a nurse caring for a patient sends down the specimen but by the time it comes back he or she will likely be doing something else and thus further delays ensue.”

POCT glucose testing capabilities, however, alleviate much of this.

“With POCT glucose testing, results are known within seconds, and the appropriate clinical management can happen immediately,” Begos noted. “In addition to glucose, we can now measure ionized magnesium (iMg), ionized calcium (iCa), hemoglobin and hematocrit, lactate and many other parameters that have similar time-sensitive clinical implications.”

POCT also provides consistency of results as another advantage, according to Begos.

“Many tests sent to the central laboratory will change over time, such as lactate and glucose,” he said. “This leads to an inherent bias, especially when trending results, as is often done for both of those analytes. If one specimen sat for 45 minutes, and another was run immediately, or if one was on ice and one wasn’t, the preanalytical factors can be significant. Whereas with POCT the test is generally run immediately and preanalytical differences between tests are minimized.”

Begos emphasizes that while speed may be one important advantage, it’s “always secondary” to an accurate result.

“Fortunately, most POCT devices are now as accurate as the central laboratory analyzers, and the results can be trusted and acted upon,” he added. “In fact, in one recent study, a handheld POCT device was more accurate than a hospital central laboratory in eGFR testing.”

Jon Gingrich, CEO, Echosens, concentrates on the nuances of patient centricity and active participation in their healthcare processes as important differentiators.

“POCT tools can enhance the patient experience and outcomes through patient-centric care and help providers achieve the Triple Aim [of] convenient, affordable and accessible care,” Gingrich noted. “FibroScan, for example, is a liver stiffness assessment tool that can also measure how much fat is stored within the liver, at the point of care, that provides rapid results for timely, earlier interventions that help keep patients on track with lifestyle changes. These useful tests allow more clinicians to access the technology and treat more patients typically earlier in the management pathway, which reduces total overall healthcare costs.”

Recognizing that patient experience and satisfaction can affect reimbursement, Gingrich emphasizes clear fiscal benefits.

“POCT tools can also help health systems and hospitals positively impact STAR ratings and give them a stronger competitive position,” he said. “In general, POCT is about better serving the patients, advancing care compliance and expanding provider capabilities around disease management and chronic care management.”

Dena Marrinucci, Ph.D., Co-Founder and Chief Operating Officer, Truvian, POCT benefits center on three primary attributes: Accuracy, convenience and affordability.

“The COVID-19 pandemic placed a bright spotlight on challenges that have existed for many years in diagnostics, exposing the need for accurate and rapid testing that is accessible and affordable to all,” she said. “The new generation of point-of-care testing delivers on three key dimensions: accuracy, convenience and affordability.”

Marrinucci remains solidly behind accuracy, convenience and affordability as effective justifications for POCT.

“Accuracy is a non-negotiable as quality cannot be compromised for any reason,” she insisted. “POCT that demonstrates comparable sensitivity and specificity levels with centralized lab machines will ensure consumers can focus on the treatment plan recommended by providers, instead of worrying about whether or not their results were reliable.

“Convenience provides benefits for consumers and providers alike,” Marrinucci continued. “Rapid sample-to-results empowers consumers to get answers to their health questions before they leave the clinic or doctor’s office. For providers, the streamlined workflows and ease of use afforded by POCT expands the ability to meet consumers where they are in the context of their lives, fulfilling the promise of decentralized testing.

“Affordability is top-of-mind for healthcare consumers as deductibles and out-of-pocket expenses steadily increase year after year,” she observed. “POCT plays an important role in increasing access to essential healthcare services, reducing the financial burden that can often deter patients from getting the care they need.” 

The questionable

As with any device or technology, the benefits also may be balanced with limitations or works in progress that POCT experts readily acknowledge as part of development and progress.

Nova Biomedical’s Begos asserts that “accuracy is paramount – it trumps speed and convenience,” but some issues can complicate matters, particularly within glucose testing.

“Many POCT glucose monitoring devices have interferences from exogenous substances (i.e., medications) or endogenous factors (i.e., anemia, acidosis), that make them error-prone in critically ill patients,” Begos said. “Not every device suffers from these limitations, and there is one POCT blood glucose monitoring system that has been approved by the FDA and Health Canada for use in critically ill patients.”

Echosens’ Gingrich cautions about the economics of POCT in context of laboratory capabilities and advises clinicians and administrators to take a holistic approach based on facility needs.

“Providers should understand the importance of acquiring expensive testing and diagnostic capabilities before investing,” he said. “For instance, assessment and analysis of test findings may require additional expertise — adding to the cost. With this in mind, understanding how the particular POCT will fit into the patient pathway, what information the POCT can and cannot deliver and what decisions the healthcare provider can and cannot effectively make will optimize its benefit.

“Other considerations include knowing up front if the technology is portable and how much space it requires, as well as who will be qualified to operate the equipment and interpret results,” Gingrich continued. “FibroScan is designed to be performed by a medical assistant in the physician’s office for the physician to interpret within minutes. Also, it’s covered by Medicare, Medicaid and most insurance plans, which is important to patients.”

Focus on the patient profile, according to Gingrich.

“Purchasing decision makers should also consider the overall cost of patient care, which may be lower when POCT is employed because it allows patients to be treated or processed more quickly through the healthcare system, as well as more efficiently rule-out those patients who do not need more expensive and advanced testing,” he said. “This is a significant benefit to POCTs. Other limitations may include appropriate documentation, which could be challenging due to testing and personnel location, administrative oversight of personnel and storage of records. Also, some POCT equipment may not be interfaceable or may require storage.”

Truvian’s Marrinucci remains sacrosanct: “It’s important to evaluate options comprehensively for the intended use case, as some POCT devices may be less accurate, specific and/or sensitive than the testing performed in a clinical laboratory setting,” she urged.

The curiously intriguing

Aside from the benefits and limitations of POCT, all three POCT experts marvel at the ongoing developments and prospective capabilities that POCT promises to offer in the future.

Begos homes in on outside the hospital setting.

“One of the areas where POCT will be paradigm-changing is outside of the hospital,” he predicted. “POCT creatinine and eGFR is already being used in remote areas and in low- and middle-income countries where access to health care is limited. In these environments, acute kidney injury (AKI) and chronic kidney disease (CKD) often go undiagnosed, or at best are delayed, and with no access to dialysis, are often death sentences. Screening programs using POCT are being implemented and some preliminary results have shown favorable outcomes.

Begos also taps into remote care, which has been driven in part by the pandemic, as well as military applications.

“Another area outside the hospital where POCT can impact patient care is by testing patients where it is more convenient for them, thereby increasing compliance,” he noted. “There are programs starting up in pharmacies, for example, where kidney function can be tested and dose adjustments of medications can be made on the spot. Also, compliance with diabetic treatment can be addressed by measuring HbA1c and on-the-spot counseling can be given which may improve patient compliance with caregiver counseling.

“Prehospital testing of lactate in trauma or potentially septic patients can allow for faster care and transport to an appropriate facility,” Begos continued. “For example, a patient with suspected sepsis and an elevated lactate may be better served at a tertiary care facility, which may be further away but initial transport to this facility may save a secondary transfer, which are never good for the patient. Along similar lines, POCT by the military can significantly aid in decision-making for soldiers injured on the battlefield, in terms of triage, transport and use of blood products in the field.”

Gingrich finds that POCT capability expansion not only will be a boon for clinicians and patients but also will become attractive to payers.

“A key trend in the adoption of POCT is being driven by specific disease management demands in various healthcare settings,” he indicated. “FibroScan has been adopted at a rapid pace by providers due to the growing liver disease and obesity epidemic in the United States and around the world.

“While frontline care professionals welcome the convenience of POCT tools and having rapid test results, payers still hesitate unless you can demonstrate both need and cost efficiency,” he continued. “Echosens, makers of FibroScan, recognized this early-on and worked diligently over the past decade to establish extensive coverage for our technology. Beyond this, POCT shows promise in the areas of microbiology, epidemic outbreaks, endocrine testing to guide surgical therapy, sepsis markers, stroke markers and DNA testing.”

Marrinucci expresses excitement about Truvian developing a fully automated blood testing system. “By integrating three crucial testing modalities – chemistry, immunoassay and hematology – in a single device, we can deliver comprehensive health panel results in one run,” she said. “In removing the barrier of sending out common blood tests and taking the guesswork out of diagnosis, we are setting the new standard for routine blood testing.”