Features of ideal POC tests and systems:
- Operation in the proximity of the patient
- Localization and portability outside a central or satellite laboratory
- The ability to perform multiple testing in a single assay run
- No sample preparation needed, using whole blood as examination material
- Small sample size
- Minimal maintenance
- No medical or technical qualification required for the operation of devices
- Rapid availability of results
Impact of POC tests and systems on hospitals and patient outcomes:
The benefits of POCT are numerous and holistic. They start from contributing to speed-to-therapy, reducing burdens on hospitals, to eventually improving patient outcomes.
- Efficiency: Determination of need for testing is made at the bedside with the testing being implemented within a short time frame.
- Diminished space requirements for operation and storage
- Speed of diagnosis and treatment: In addition to rapid implementation of treatment, the process is more efficient for the physician, as there is not a need to refamiliarize with the case after test results are returned from a central laboratory.
- Expanded testing potentials: The convenience of testing in a wide variety of departments and sites within the health care facility locations with limited personnel for example.
- Sample stability and ease of handling
- Reduced potential for sample deterioration, since most POCT is initiated and performed rapidly once the sample is obtained. Potential changes may occur to samples sent to the central laboratory due to analyte instability or temperature variation.
- Sample volume influences patient convenience with less blood loss for patients requiring frequent testing, as well as neonatal and pediatric benefit with a reduction in specimen volume.
- Improved patient outcomes: The immediate availability and accuracy of test results can be linked to patient management. It can facilitate movement of individual patients through the system faster or can allow the handling of more patients in less time, empowering physicians to tailor the appropriate treatments for patients, and to also fulfill the goal of precision medicine to target the right treatments to the right patients at the right time.
Time equal lives:
In a study comparing TATs between POCT and laboratory testing when a tube transport system was implemented for the rapid transport of samples. Even under circumstances that were thought to minimize sample transport time, POCT results were available an average of 46 minutes earlier than from the central laboratory (3).
In Germany, in order for clinics to obtain certification as a chest pain unit, the clinic must be able to perform blood analysis within 15 minutes. According to German Society of Cardiology (DGK) guidelines, “the time from blood collection to result documentation may not be exceeded 45-60 minutes. If this is not possible, a point-of-care test unit on-site to determine cardiac markers is mandatory.” (2). Would that not be practical or even realistic especially in the case of hospitals outsourcing their laboratory diagnostics to external service providers?
Cost-efficiency and Cost-effectiveness:
Most hospitals aim at not only achieving outcomes by utilizing available resources, but they aim furtherly at using less resources to achieve expected or even better outcomes. POCT fulfills both criteria as it is considered both cost-efficient and cost-effective, ultimately leading to the optimization of the hospital beds occupancy.
- Cost-effectiveness of POCT depends not only on direct costs for measuring a parameter but also on the consequences of quick results.
- Usually, easy to perform POCT has no impact on the number of working hours at the hospital. Therefore, it does not affect a labor cost, but rather a change in productivity.
- Economic considerations are also relevant. Screening with laboratory tests could reduce the use of expensive imaging procedures, this might lead to overall savings in the health system.
- POCT can also reduce up to 25% of the total cost during the patient hospital stay (3).
Laboratory in the small hospital
Annual sales for POCT diagnostics in Europe amounted to approximately 3.5 billion euros in 2016, with a German share of approximately 1.1 billion Euros (5,6). There is a growing demand for test results that are available even more rapid. These results should be decentrally provided, complementary to existing laboratories, by healthcare providers, mainly nurses, at bedside and be available directly to the physician reducing TAT.
In Germany, there are many small-sized hospitals (fewer than 500 or even 200 beds (Fig. 1)) (4). For a long time, personnel costs were the main reason why these facilities outsourced laboratory diagnostics to external service providers. On the top of that, hospitals are also challenged by the shortage of qualified personnel which makes the 24/7 operation of laboratories or even daytime staffing impossible. POCT can be considered as an easy-to-operate cost-saving alternative with less TAT to external laboratories.
“Currently, POCT is complementary to the medical laboratory, but in the long term would be a alternative to conventional laboratory diagnostics will emerge with increasing miniaturization of technologies and faster measurement methods.” (4) This is a quote from a review of POCT in 2009, when POCT was heavier, slower and more complicated back then. Nowadays, POCT devices weigh less than three kilograms, provide a variety of assays from cardiac biomarkers, thyroid-stimulating hormone up to novel biomarkers for acute kidney injury, and provide results in less than half an hour. POCT is already established as a complementary method to conventional laboratories and also as an alternative in many cases.
(1) Kankaanpää, M., Raitakari, M., Muukkonen, L. et al. Use of point-of-care testing and early assessment model reduces length of stay for ambulatory patients in an emergency department. Scand J Trauma Resusc Emerg Med 24, 125 (2016). https://doi.org/10.1186/s13049-016-0319-z
(2) Mueller-Bardorff M, Rauscher T, et al. Clinical Chemistry. 1999;45:1002-08
(3) Rooney KD, Schilling UM. Point-of-care testing in the overcrowded emergency department--can it make a difference? Crit Care. 2014 Dec 8;18(6):692. doi: 10.1186/s13054-014-0692-9. PMID: 25672600; PMCID: PMC4331380.
(4) Dtsch Arztebl Int 2010; 107(33): 561–7
(5) Patientennahe Sofortdiagnostik in Theorie und Praxis. MTA Dialog 2016; 17 (3): 68–9.
(6) Lenzen-Schulte, M: Point-of-Care-Diagnostik: Das Labor in der Kitteltasche. Dtsch Arztebl 2016; 113 (29–30): 1396.
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