Assessment of point-of-care testing devices for infectious disease surveillance, prevention and control – a mapping exercise - ISS-G20 Laboratorium Repository

The ability to rapidly diagnose infectious diseases is critical, not only for the appropriate and timely treatment of infected patients, but also for infectious disease surveillance, the detection of outbreaks and controlling the rapid spread of infectious diseases nationally and internationally. Point-of-care testing (POCT) for infectious diseases represents a set of technologies that can lead to the rapid detection of such diseases which can influence the way patients are treated.

This document provides the final report of a mapping exercise undertaken as part of a wider study that was commissioned by ECDC and undertaken by RAND Europe between November 2019 and April 2020. The objective of the wider project was to assess the availability, use and impact of POCT devices in European Union/European Economic Area (EU/EEA) Member States and the United Kingdom (UK) for communicable diseases under EU surveillance. Please note that the data collection was undertaken in 2019, from EU/EEA Member States, thus the UK was still a Member State of the EU at this time. This explains the inclusion of UK data in this report. The project included two parts, a scoping review and a mapping exercise. The mapping exercise, to assess the current status of the use of POCT in EU/EEA Member States and the UK, including the impact of POCT on clinical practice and on key public health functions, is the focus of this report.

The methods for this mapping exercise included the appointment of expert advisers and an initial scoping, including one expert scoping interview, a survey sent to 186 recipients, including to at least two experts per European country, a prioritisation process to identify a select number of infectious diseases for focused analysis, and follow-up research comprising interviews and desk-based research.

A total of 54 responses were received from 26 different EU/EEA Member States and the UK. The disease or health issue for which most countries reported that POCT is in use was influenza, which was reported by 19 countries (73% of countries responding to the survey). This was closely followed by HIV/AIDS, reported by 17 countries (65%), and legionnaires’ disease and malaria, both reported by 13 countries (50%). At least five countries (19% of countries responding to the survey) reported that POCT is in routine clinical use for the following diseases or health issues: syphilis, chlamydia infections, hepatitis B, hepatitis C, nosocomial infections, antimicrobial resistance, tuberculosis, invasive pneumococcal disease, dengue, invasive meningococcal disease, gonorrhoea and cryptosporidiosis. The disease or health condition for which most countries reported that guidelines or similar documentation are available is HIV/AIDs, with 11 countries (65% of countries in which POCT for HIV/AIDS was reported to be in routine clinical use). The disease or health issue for which POCT is most often quality assessed is also HIV/AIDS. Evidence on the tests that have been replaced by POCT (e.g. for screening, triaging or diagnosing) was limited. Chlamydia infections, HIV/AIDS and legionnaires’ disease were the diseases for which most countries reported that POCT has replaced other tests. The country in which POCT has had the most significant clinical impact, in terms of replacement, is Spain, where respondents reported that POCT had replaced existing tests across 14 diseases and health issues. Cross-analysis was conducted, exploring whether POCT has replaced other tests with whether POCT alone is sufficient for diagnosis. This analysis is based on a small number of respondents and was not asked in relation to each specific infectious disease or associated health issues, however, it does indicate that in almost all cases where POCT has replaced an existing test, that further tests would be needed to confirm a diagnosis. The public health key function which most countries (seven countries) reported POCT-derived results being used for was disease surveillance. No countries reported that POCT-derived results are used for antibiotic resistance monitoring.

Limitations of this study primarily relate to the number of responses received to the survey (n=54/186). A major consideration here was the fact that the survey implementation period coincided with the escalation of the COVID-19 pandemic, which severely affected the availability of in-country staff to participate in the survey. Similarly, there are limitations in that we received no responses from five European countries, however, for three of these, information was gathered through follow-up interviews. There are challenges of limited knowledge of any given respondent and lack of possibility for comparison across responses where only one response was received. Finally, there are also limitations relating to the way in which respondents interpreted the questions asked by the survey. We also recognise the importance and relevance of COVID-19 to this study on point of care testing, but we could not include this disease in the mapping report as the study was already underway before the pandemic occurred.

The ongoing COVID-19 pandemic has highlighted the essential role of large-scale POCT for the surveillance, prevention and control of infectious diseases. Alongside centralised laboratory-based testing, the development of rapid and reliable diagnostic tests, usable at the point of care, has quickly been recognised as a necessity in order to adequately meet public health needs. This study has provided evidence on the availability of POCT devices and the arrangements surrounding their use and their impact on clinical practice. The mapping exercise has also provided evidence on the impact of POCT in relation to clinical disease management and public health key functions. However, given the limitations outlined above, it is unlikely to be a complete picture of POCT use across EU/EEA Member States and the UK.

Entire content available on: https://www.ecdc.europa.eu/en/publications-data/assessment-point-care-testing-devices-infectious-disease-surveillance-prevention