DIAGNOS TICS
Location
Grade 1A 1B 2A 2B 3
Hospital 3 3 X X X
Laboratory 3 X X X X
Other healthcare facility X X
3 X X
Key: ED, emergency department; ICU, intensive care unit; GP, general practice. Table 1. How different point-of-care testing situations may be graded, according to location and person completing the testing.1
based recommendations for POCT within clinical guidelines/algorithms and progress the test into clinical practice. Evidence for the use of POCTs in the
rapid detection of infection is commonly in the form of small-scale, short-term, pilot or feasibility studies.23
Very often these studies
stop when funding runs out and while results may be presented at a meeting or conference, they may not be published as peer-reviewed manuscripts. This ‘bottom-up’ approach has limitations and is unlikely to lead to much advancement. A ‘top-down’ approach whereby central organisations drive adoption of POCT at a national level may yield more widespread results.23 Across UK healthcare, a complex,
interacting group of stakeholders, such as regulators, industry, commissioners, policy makers, laboratory services, POCT teams, clinicians, and patients, all have an interest in POC testing, and their motivations and priorities need to be considered.23 A disparity exists between information
that is reported from an academic and industry perspective compared with information that is considered pertinent by clinicians, or policy and decision makers.23 Characteristics most often reported in diagnostic accuracy studies are those relating to test performance (such as sensitivity, specificity, negative and positive predictive values) and turnaround time. Clinical utility (defined as the “extent
to which a correct (treatment) decision, as based on the POC test result, has added value in clinical outcomes”) and data associated with risks (defined as “the impact of a [wrong] treatment/advice based on a [wrong] test result”), workload, reimbursement, and relevant legislation are rarely reported but are the test characteristics of most value to the clinician and other decision makers.24 Given the diversity of POCT available for
rapid detection of infection and the range of healthcare provision in the UK, it is important to choose the most appropriate POCT for your setting/population.2 Success may be measured in different ways depending on desired outcomes of implementation. While clinical practices are standardised
to a certain degree, each clinical setting is as unique as the patients it serves, therefore, a POC workstream that is successful in one location may not work for another. To illustrate this point, two studies that evaluated the same POCT (FilmArray BioFire with the respiratory panel) in different clinical practices are presented. The first study, a randomised control trial
comprising 720 patients, used the FilmArray BioFire, a molecular syndromic POCT, to aid diagnosis of acute respiratory tract infection in the acute medical unit and emergency department of Southampton General Hospital during two successive respiratory seasons (pre-COVID-19). Outcomes assessed were the proportion of patients who received antibiotics while hospitalised (up to 30 days), duration of antibiotics, proportion of patients receiving single doses or brief courses of antibiotics, length of stay (LOS), antiviral use, isolation facility use, and safety. Using the molecular POCT, there was strong evidence (p <0.0001) for improved turnaround time of result (FilmArray: 2.3 hours [mean 1.4]; laboratory-based: 37.1 hours [mean 21.5]), and an increase in the rate of influenza detection and appropriate antiviral use. However, routine use of molecular POCT for respiratory viruses did not reduce the proportion of patients treated with antibiotics.13 The same respiratory molecular POCT was
evaluated in a much smaller, feasibility study in primary care comprising four GP practices over 6 weeks (n=93 samples tested). Clinical diagnosis was changed for 19 patients and eight patients were contacted regarding a change to their treatment plan according to the POCT results; however, the turnaround time to result (65 minutes) did not suit a routine GP consultation. Lack of targets for common bacterial causes of respiratory tract infection was also seen as a shortcoming of the molecular POCT.25
Barriers to adoption Despite the number and variety of POCTs available for rapid detection of infection, implementation has been slow.24
Operator
Healthcare Professional 3 3 3 3 X
Example
Satellite Laboratory ED, ICU
GP surgery Care home
Self-testing at home
Financial,
cultural, organisational, and logistical factors are often cited as barriers to implementation rather than failure of a POCT to deliver a result in a particular setting.23,26,27 Costs associated with introducing
POC testing and lack of funding are frequently identified as barriers to implementation.23,27,28
and it has been
acknowledged that UK healthcare needs to develop ways to ensure funding is transferred to appropriate areas in order for POCT to be implemented successfully.29 The cost per POCT is usually presented
as more per test compared with centralised laboratory testing; however, this simplistic approach does not take into account the complexity of healthcare provision and possible longevity of POCT outcome. Nor does the low cost of centralised laboratory testing take into account the pre- and post- analytical steps and costs associated with the delay in results compared with POC real-time results.28 The availability of high-quality health
economic data for the use of POC testing in an acute setting is lacking.30
However, Fig.4 Urine dipstick (Roche Combur-Test) 34 l
WWW.CLINICALSERVICESJOURNAL.COM
the introduction of POC testing should not always be expected to be cost saving. An increase in costs associated with rapid detection of infection may be justified when better prognosis, longer life expectancy, a reduced need for hospitalisation, and reduced risk of serious life-threatening complications are all possible outcomes. The economic impact for adopting POC testing needs to assess both the immediate
DECEMBER 2021
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