Point of care testing in primary care in Europe

Christopher P. Price, Peter B. Luppa and Rogier Hopstaken

Healthcare systems around the world are rapidly changing, with an overall aim to improve healthcare delivery and reduce costs. Specific  discussions focus on healthcare access, quality, diagnosis and treatment, and subsequently increasing clinical outcomes. Indeed, there is a move to delivery of a more integrated approach to health and social care, and a shift in healthcare management away from a focus on activity to an emphasis on outcomes.¹ There is a strong drive to prevent patients being hospitalised unnecessarily and a general trend towards consolidating networks of hospitals and improving primary care.^2,3 However, these changes bring about challenges and pressures regarding adoption of new practices, such as utilising POC testing and potential lack of incentives for general practitioners (GPs) in providing this service. This pressure stems from increasing demands and expectations from patients, an aging population, an increase in long-term complex conditions, understaffing and the transition from secondary to primary care.⁴

A more integrated approach to healthcare has a special focus on delivering care closer to home, which may improve patient satisfaction and encourage more patient self-care.⁵ Primary care physicians in particular have expressed a desire for POC testing for use in the patient pathway, in order to aid diagnosis and manage long-term conditions more efficiently.⁶ POC testing can transform patient care, enabling early and on-site detection of biomarkers, leading  to reduced turnaround times by giving the clinician access to rapid and actionable test results.⁷ The portability of POC devices allows for testing to be performed in multiple venues of care such as in primary care clinics, emergency departments, out-patient rooms, care homes, patient’s homes and pharmacies.⁸ Using capillary blood samples negates the need for venepuncture and on-site requirements for phlebotomists, and is more convenient for the patients.⁹ In addition to enabling faster diagnosis and more efficient therapy management, using POC tests in primary care can also help to reduce the amount of referrals to secondary care and can help the patient and physician decide upon the best-suited approach of management.^8,9

Concerns have been expressed about access to healthcare in rural areas. The use of POC testing in rural communities of  Australia  and  Norway  have demonstrated how access, and healthcare outcomes, can be improved.^9,10,11 Overall, POC testing in a primary care or community setting can provide both clinical and economic benefits.

There is a wealth of evidence demonstrating that POC testing shows benefits in clinical pathways typical  of  primary care presentation   when used alongside clinical decision tools and with approved clinical guidelines. For patients on oral vitamin K antagonist  therapy, regular  monitoring of the international normalised ratio (INR) is necessary. One of the advantages of POC INR testing systems is the ability to perform the test at home or in the primary care clinical environment. Self-testing and self-management strategies in particular have been shown to provide better anticoagulation control, and improve the quality of life for patients and their families.^12,13,14 Furthermore, device training programmes can aid patients on oral anticoagulation treatment, to optimise their INR self-measurements.¹⁵ Frequent INR testing is seen to improve time in therapeutic range and can be delivered in primary care.^16,17

POC testing in diabetes improves glycaemic control in patients.⁹ HbA1c POC testing can improve patients’ quality of life and clinical outcomes, and contribute to cost and time savings for both patients and healthcare professionals (HCPs).¹⁸ A recent German primary care study demonstrated a reduction in required visits to the GP by 80% and a reduction in venous blood draws by 75%, compared to before implementation of the POC test system.¹⁹ Improvements were also seen in clinic workflow and patient satisfaction.

One of the main presentations in primary care is acute cough. POC C-reactive protein (CRP) testing can be used to differentiate bacterial pneumonia requiring an antibiotic from a non-serious lower respiratory tract infection in primary care, and has been shown to reduce antibiotic use in general practice across Europe.^20-24

In addition, POC tests for upper respiratory tract infections due to streptococcus A have a fast turnaround time compared with laboratory culture of throat swabs, providing immediate results and preventing unnecessary use of antibiotics.^25,26

POC D-Dimer testing, used with clinical decision tools such as the Wells score, helps to rule out patients who present with symptoms of venous thromboembolism, such as deep vein thrombosis or pulmonary embolism. Patients with low D-Dimer levels and no other concerning symptoms may be managed without the need to refer the patient for conventional lab-based testing or secondary care ultrasonography referral.²⁷ One study showed that age-adjusted cut-off values for D-dimer tests improve overall testing in patients over 50 years.²⁸

In cardiology, POC brain natriuretic peptide (BNP) testing has been shown to improve the diagnosis of heart failure (HF).²⁹

Similar results have been shown for primary care, where it aids in the management of difficult-to-diagnose causes of dyspnoea and congestive HF.³⁰

In addition to this, home monitoring of BNP linked to primary assessment and monitoring has been shown to be a feasible testing approach in managing discharged HF patients.³¹

Sexual health services have used community-based POC testing for human immunodeficiency virus. The direct availability of results has been especially useful in situations where it is difficult to give people their results at a later stage: for example, if they are unwilling to leave their contact details or to come forward to a sexual health clinic for privacy reasons.^32,33

As well as the pathways identified above, many other POC tests are used routinely in primary care, including tests for glucose, urinalysis, human chorionic gonadotrophin and creatinine.^1,34

Although GPs in England and the rest of the UK have expressed a desire for more access to POC testing  in practices, they are still aware that system-level changes must be made in order to aid the wider adoption of POC testing.^4,35 The NHS sustainability and transformation plans offer a broad opportunity to transform care delivery closer to home, and propose that care should be organised around GP clusters while also encouraging patients to take more responsibly, resulting in a reduction in hospitalisations.³⁵ Widespread implementation of POC testing  could  deliver  significant  benefits  within this NHS strategy. A higher level of POC testing services is reported in Scotland compared with other parts of the UK, which may be due in part to the more remote location of a significant proportion of the population.¹

In Germany there is a diagnosis-related group (DRG) hospital care reimbursement system for medical devices, adopted following the high degree of accurateness of the Australian DRG system. Testing  is conducted in general practice and also in the more specialist physician office sector. POC testing with troponin, D-Dimer and BNP in ambulatory care and in primary care surgeries has proved  to  be  very successful in Germany.^36,37,38 Additionally, the implementation of HbA1c POC testing in German medical practices has shown improved practice workflow and increased satisfaction among physicians, staff members and patients.¹⁹ POC testing is widely used in Switzerland where many POC tests are found in the list of ‘Rapid Analyses’, consisting of drugs that are effective, efficacious, appropriate and cost-effective, of the Swiss Federal Office of Public Health, which are carried out in primary care and are reimbursed by the patients’ insurance companies.

The implementation of CRP POC testing in physicians’ offices in the Netherlands has been shown to improve the quality of care of patients with lower respiratory tract infections and the decision to prescribe antibiotics for patients with acute cough.³⁹  A  joint initiative of HCPs  and  clinical chemistry and microbiology laboratory professionals was responsible for the successful implementation of  CRP quality-assured POC testing in the Netherlands, and there is now a high demand for  it  among  GPs.⁶ One of the major factors contributing to the broad and sustainable uptake of CRP POC tests in primary care has been the introduction of national guidelines for GPs, which ensured that GPs are able to perform POC tests rationally.^40,41 Other success factors include free training at dedicated websites, advocacy for rational use, good consultation skills, connections with insurance companies regarding reimbursements, face-to-face contact with thousands of GPs in the Netherlands and collaboration with laboratories to deliver a high- quality service to GPs.³⁹

In Norway, POC testing is well developed and there  is a large range of routinely offered tests. Out-of-hours services utilise the rapid results which can be delivered across a range of illnesses and, critically, to remote settings.¹

Some barriers that have been identified with POC testing within primary care are the impact on clinical decision making, patient experience and cost-related issues. Findings from the literature have identified the major barrier at present to be the absence of funding and reimbursement models for most European countries. The quality of POC results as well as the clinical governance are concerns for managing diagnostic results in primary care. It is therefore important  that a clinical governance framework is put in place and the ideal features of a POC test device are specified.

There are a number of features POC test devices should possess in order for them to be more widely adopted. These include having laboratory-level accuracy and a broad test menu to avoid requiring many small systems. Additionally, they require the ability to utilise small sample sizes (preferably capillary blood where it is used), produce fast results near to the patient in many settings, be used and stored at room temperature, and should be very simple to use. Cost-effectiveness, digital transfer of results to the patient health record, and central management of quality procedures are desirable features for successful adoption, with patient care and satisfaction being the most important considerations.

POC testing has the potential to revolutionise patient services in primary care, improving overall quality of care and limiting health costs. Small, portable POC devices that allow for easier use and portability would be especially beneficial, allowing use not only in primary care clinics, but also in care homes, patient homes and by paramedics.⁴² Using a capillary blood sample rather than venous blood is more patient- friendly and requires no phlebotomist. Being able to receive the result quickly, in a few minutes, would improve clinical decision making. Technology has now improved such that it is possible to bring two-way smart connectivity to primary care POC testing. This has the ability to send the result from different venues of care to the patient’s electronic health record, which should comply with strict European data security legislation can be immediately transferred. Remote connectivity via quality management systems mean that a central hospital laboratory POC coordinator could oversee instruments in the community and ensure quality and governance policies are implemented. This would be a solution to overcoming some barriers such as insufficient training of POC device users and insufficient quality assurance.^9,43 Finally, there is a lack of available POC devices that have extensive multiple test capability in order to have one system for many parameters. Using multiple separate instruments has issues due to requiring different training and quality management protocols, and increased storage and inventory monitoring. This would ultimately improve patients’ and HCPs’ experiences.⁴⁴

a Christopher P. Price, BSc, PhD, DSc (Hon), FRCPath. Queen  Mary,  University  of  London,  London,  United Kingdom.

b Peter B. Luppa, MD. Institute of Clinical Chemistry and Pathobiochemistry, University Hospital Rechts  der  Isar,  Munich,  Germany.

c Rogier Hopstaken, MD, PhD. Star-shl Diagnostic Centres, Etten-Leur, Netherlands.

1. Price CP, van den Bruel A. Challenges in primary care delivery and the opportunities for point of care testing. A UK Perspective. Point of Care 2017;16:112
2. Thompson MI, Lasserson D, McCann L, et al. Suitability of emergency department attenders to be assessed in primary care: Survey of general practitioner agreement in a random sample of triage records analysed in a service evaluation project. BMJ Open 2013;3:e003612
3. Nolte E, Pitchforth E, Miani C, et al. The changing hospital landscape: An exploration of international experiences. Rand Health Q 2014;4:1
4. Baird B, Charles A, Honeyman M, et al. Understanding pressures in general practice, www.kingsfund.org.uk (2016)
5. Turner PJ, Van den Bruel A, Jones CH, et al. Point-of-care testing in UK primary care: A survey to establish clinical needs. Fam Pract 2016;33:388–394
6. Howick J, Cals JW, Jones C, et al. Current and future use of point-of-care tests in primary care: An international survey in Australia, Belgium, The Netherlands, the UK and the USA. BMJ Open 2014;4:e005611
7. Wang P, Kricka LJ. Current and emerging trends in point-of- care technology and strategies for clinical validation and implementation. Clin Chem 2018;64:1–14
8. Kehre JP and James DE. The role of pharmacists and pharmacy education on point-of-care testing. Am J Pharm Educ 2016;80:129
9. Larsson A, Greig-Pylypczuk R, Huisman A. The state of point-of-care testing: A European perspective.Ups J Med Sci 2015;120:1–10
10. Baird AG, Wright N. Poor access to care: Rural health deprivation? Br J Gen Pract 2006;56:567–568
11. Spaeth BA, Kaambwa B, Shephard MD, et al. Economic evaluation of point-of-care testing in the remote primary health care setting of Australia’s Northern Territory. Clinicoecon Outcomes Res 2018;10:269–277
12. Barcellona B, Fenu L, Maronglu F. Point of care testing INR: An overview. Clin Chem Lab Med 2017;55:800
13. Heneghan C, Ward A, Pererra R. Self monitoring of oral anticoagulation: Systematic review and meta-analysis of individual patient data. Lancet 2012;379:322–324
14. Pozzi M, Mitchell J, Henaine AM, et al. International normalized ratio self-testing and self-management: Improving patient outcomes. Vasc Health Risk Manag 2016;12:387–392
15. Sawicki PT. A structured teaching and self-management program for patients receiving oral anticoagulation: A randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation. JAMA 1999;281:145–150
16. Morgan CL, McEwan P, Tukiendorf A, et al. Warfarin treatment in patients with atrial fibrillation: Observing outcomes associated with varying levels of INR control. Thromb Res 2009;124:37–41
17. St John A. The evidence to support point-of-care testing.Clin Biochem Rev 2010;31:111–119
18. Schnell O, Crocker JB, Weng J. Impact of HbA1c testing at point of care on diabetes management. J Diabetes Sci Technol 2017;11:611–617
19. Patzer KH, Ardiomand P, Gohring K. Implementation of HbA1c point of care testing in 3 German medical practices: Impact on workflow and physician, staff, and patient satisfaction.J Diabetes Sci Technol 2018;12:687
20. Hopstaken RM, Muris JW, Knottnerus JA, et al. Contributions of symptoms, signs, erythrocyte sedimentation rate, and C-reactive protein to a diagnosis of pneumonia in acute lower respiratory tract infection. Br J Gen Pract 2003;53:358–364
21. van Vugt SF, Broekhuizen BD, Lammens C, et al. Use of serum C reactive protein and procalcitonin concentrations in addition to symptoms and signs to predict pneumonia in patients presenting to primary care with acute cough: diagnostic study. BMJ 2013;346:f2450
22. Aabenhus R, Jensen JU, Jorgensen KJ, et al. Biomarkers as point-of-care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care. Cochrane Database Syst Rev 2014;CD010130
23. Tonkin-Crine SK, Tan PS, van Hecke O, et al. Clinician-targeted interventions to influence antibiotic prescribing behaviour for acute respiratory infections in primary care: An overview of systematic reviews. Cochrane Database Syst Rev 2017;9:CD012252
24. Cooke J, Butler C, Hopstaken R, et al. Narrative review of primary care point-of-care testing (POCT) and antibacterial use in respiratory tract infection (RTI). BMJ Open Respir Res 2015;2:e000086
25. NICE. Point-of-care diagnostic testing in primary care for strep A infection in sore throat. Public Health England 2018;MIB 145
26. Cohen JF, Bertille N, Cohen R, et al. Rapid antigen detection test for group A streptococcus in children with pharyngitis. Cochrane Database Syst Rev 2016;7: CD010502
27. Geersing GJ, Toll DB, Janssen KJ, et al. Diagnostic accuracy and user-friendliness of 5 point-of-care D-dimer tests for the exclusion of deep vein thrombosis. Clin Chem 2010;56:1758–1766
28. Schouten HJ, Geersing GJ, Koek HL, et al. Diagnostic accuracy of conventional or age adjusted D-dimer cut-off values in older patients with suspected venous thromboembolism: Systematic review and meta-analysis.BMJ 2013;346:f2492
29. Morbach C, Buck T, Rost C, et al. Point-of-care B-type natriuretic peptide and portable echocardiography for assessment of patients with suspected heart failure in primary care: Rationale and design of the three-part Handheld-BNP program and results of the training study. Clin Res Cardiol 2018;107:95–107
30. Nayer J, Aggarwal P, Galwankar S. Utility of point-of-care testing of natriuretic peptides (brain natriuretic peptide and n-terminal pro-brain natriuretic peptide) in the emergency department. Int J Crit Illn Inj Sci 2014;4:209–215
31. McDonald K, Troughton R, Dahlstrom U, et al. Daily home BNP monitoring in heart failure for prediction of impending clinical deterioration: Results from the HOME HF study. Eur J Heart Fail 2018;20:474–480
32. Leber W, Anderson J, Griffiths C. HIV testing in Europe: How can primary care contribute? Sex Transm Infect 2015;91:464–465
33. NICE. HIV testing: Increasing uptake among people who may have undiagnosed HIV. Public Health England 2016
34. Gbinigie O, Price CP, Heneghan C, et al. Creatinine point-of- care testing for detection and monitoring of chronic kidney disease: Primary care diagnostic technology update. Br J Gen Pract 2015;65:608–609
35. Alderwick H, Ham C. Sustainability and transformation plans for the NHS in England: What do they say and what happens next? BMJ 2017;356:j1541 doi: 10.1136/bmj.j1541
36. Wilke P, Masuch A, Fahron O, et al. Diagnostic performance of point-of-care and central laboratory cardiac troponin assays in an emergency department. PLoS One 2017;12:e0188706
37. Prochaska JH, Frank B, Nagler M, et al. Age-related diagnostic value of D-dimer testing and the role of inflammation in patients with suspected deep vein thrombosis. Sci Rep 2017;7:4591
38. Olausson J, Peterson C, Bergstrom M, et al. Evaluation of the Meritas® BNP test for point-of-care testing. Clin Lab 2015;61:727–730
39. Cals JW, Butler CC, Hopstaken RM, et al. Effect of point of care testing for C reactive protein and training in communication skills on antibiotic use in lower respiratory tract infections: Cluster randomised trial. BMJ 2009;338:b1374
40. Hopstaken RM, van Balen JA, Kusters R. [Point-of-care-testing in general practice]. Ned Tijdschr Geneeskd 2015;159:A9475
41. De Vries CGJCA, Doggen CJM, Geertshuis M, et al. Point-of- care testing in primary care in the Netherlands: Management of patient safety related aspects. Rijksinstituut voor Volksgezondheid en Milieu 2013;1–55
42. St John A, Price CP. Existing and emerging technologies for point-of-care testing. Clin Biochem Rev 2014;35:155–167
43. Wagar EA, Yasin B, Yuan S. Point-of-care testing: Twenty years’ experience. Labmedicine 2008;39:560–563
44. Junker R, Schlebusch H, Luppa PB. Point-of-care testing in hospitals and primary care. Dtsch Arztebl Int 2010;107:561–567