Vol. 23 • Issue 9 • Page 24
Point-Of-Care Testing
The world of laboratory medicine has changed considerably in the last decade. Specifically, the need for hospitals to improve capacity utilization and efficiency as more patients seek care has propelled clinical laboratories into a bold new journey in point-of-care testing (POCT). As new efforts bring advanced testing to point-of-care (POC) locations, there must also be new criteria for evaluating POC tests. To effectively meet the goal of POCT-which is to offer high-quality testing at primary care locations to streamline patient management-POC diagnostics need to meet quality standards across a broader range of categories. Beyond providing accurate and fast results, the quality of these tests must be equally determined by evaluating their scalability, ease-of-use, cost ðstructure, and effectiveness in improving healthcare system efficiency.
POCT Success Factors
Of course, the ability of diagnostics to yield fast and accurate results critical to allowing prompt and effective treatment decisions is ðimportant, but other factors hold equal weight in the success of a given POC test. As advanced diagnostic tests continue to move out of laboratory settings, it becomes increasingly important for tests to be easy to use and compliant with Clinical Laboratory Improvement Amendments (CLIA) regulations. CLIA waived tests are deemed by CLIA to have low complexity and low risks for erroneous results, are typically easy to perform, and require minimal special training.1 Consequently, these tests will likely be the most successful in POC locations where they will be administered by a range of healthcare providers instead of by trained lab technicians. Also significant is the cost of diagnostic tests, as laboratory testing can often run at higher prices than those performed in clinics.1,2
For POC diagnostics, matters of cost and reimbursement significantly impact a location’s decision to incorporate that device into standard protocol. If a high quality test has extensive implementation costs that aren’t compensated by savings in patient care, the test will not be implemented; point-of-care locations will not expand their diagnostic capabilities; and economies of scale will not be realized. Without meeting functional and cost standards, there could be a highly useful test that is unable to be implemented at point-of-care, and thus falls short of the goal of POCT, which is to improve ðsystematic efficiencies in patient care.
Several commonly used diagnostic tools fall into this category and are not ideal for POCT. For example, reverse transcriptase polymerase chain reaction tests (RT-PCR) may be the gold standard for detecting viruses in laboratories, but do not successfully transfer to POC locations.3 These tests require extensive time and money for implementation; have a turnaround time of anywhere from one to six hours,3 and require sophisticated laboratory infrastructure and protocols. Thus, they are certainly high-quality tests, but may not be the best option for large scale implementation in POC.
The Need to Prioritize
Because of the increasing number of factors that influence the value of POC diagnostics, there is a corresponding need to prioritize development efforts of new POC tests so that these cross-dimensional standards can be met. High-priority disease and infection areas include:
• those where current tests are of low quality and/or testing protocols creates systematic inefficacies;
• those for which antibiotic stewardship and antimicrobial resistance is of concern; and
• those for which timing is of critical importance to patient outcome.
Sepsis, MRSA, pneumonia, and influenza all meet these criteria and have received considerable attention.2 The performance of current tests and antibiotic stewardship in influenza, in particular, have been highlighted as major concerns.5 Influenza is also a prime example of where the healthcare system could benefit from faster and broader care, as peak flu season leads to large hospital queues and a heavy burden in emergency departments.2
Advancements
As a result of this need, there have been a number of recent influenza diagnostic advancements that clearly illustrate the expanding definition of quality in POCT. A new class of POC diagnostics – digital immunoassay rapids (DIA) – has balanced quality in sensitivity, usability, and cost. As the name indicates, these tests offer an instrument-based, digital read out test that can be measured objectively, and use an ðimmunoassay crafted of particles and antibodies to ensure precise detection. The digital read system offers an accurate, fast and clear result, unlike several visual read rapid tests for conditions (e.g., influenza) that may not be as accurate and rely on visual interpretation of colored lines to indicate a positive or negative result. Thus, the sensitivity of digital immunoassay rapids has been shown to surpass other tests.3 Additionally, DIAs offer favorable ease-of-use and cost-effective characteristics. They typically take just over 10 minutes to use, and some are CLIA waived3 – meaning they are regulated and simple enough for healthcare providers to use at POC locations without additional certification requirements. Additionally, from a cost perspective, these tests remain relatively inexpensive compared to other tests and can detect a variety of infections, increasing returns and efficiency gains for locations that administer them. Hospitals and other clinical settings that adopt technologies such as these will be able to manage beds in a timelier manner, as quick, on-site test results will ensure they will be able to make informed placement decisions without risking contamination. The clear, highly accurate test results also minimize additional unnecessary testing. Finally, when performed close to patient care, DIAs will also be able to initiate treatment more quickly and have an easy-to-use technology at their disposal to accurately detect and diagnose a range of conditions. These types of diagnostics are bringing increased quality to POCT, which will positively impact the healthcare system.
Ultimately, the growing momentum in POCT development is meant to bring quality care to more locations, streamline patient care, and improve patient outcomes. To ensure we achieve just that – quality care – value must be placed on sensitivity, usability, efficiency and cost standards.
Dr. Cooper is director of Medical Affairs, BD Diagnostics.
References
1. Wagner EA, Yasin B, Yuan S. Point-of-Care Testing: Twenty Years’ Experience. Dept. of Path. Lab Medicine, UCLA; 2008 Sept; 39(9). Available at: http://labmed.ascpjournals.org/content/39/9/560.full.pdf. Accessed May 8, 2014.
2. Paxton A. How POC testing is pushing the envelope. CAP TODAY; 2014 Apr. Available at: http://www.captodayonline.com/how-poc-testing-is-pushing-the-envelope/. Accessed May 7 2014.
3. Ortega-Sanchez IR, et al. Indirect, out-of-pocket and medical costs from influenza-related illness in young children. Vaccine, 2012; 4175-4181.
4. Humer C. Insurers tally flu’s costs as U.S. epidemic continues. Reuters Health News. 2013 Jan. Available at http://pennstatehershey.adam.com/content.aspx?productId=16&pid=16&gid=59990. Accessed Dec. 18, 2013.
5. CDRH Microbiology Devices Advisory Committee Meeting. Executive Summary: Proposed Reclassification of the Rapid Influenza Detection Tests. 2013 June. Available at: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesupel/UCM356185.pdf. Accessed Sept. 28, 2013.
