Assessment of Point of Care Testing devices for infectious disease surveillance, prevention and control
Dec 2, 2021
Published in: European Centre for Disease Prevention and Control (2022). doi: 10.2900/853921
Posted on RAND.org on April 29, 2022
This article was published outside of RAND. The full text of the article can be found at the link above.
The ability to rapidly diagnose infectious diseases is critical, not only for 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 for suspected infectious diseases.
This document provides the final report of a scoping review undertaken as part of a wider study on the 'Assessment of point of care testing devices for infectious disease surveillance, prevention and control' 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 point-of-care testing devices (POCT) in the EU/EEA Member States and the 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 objective of the scoping review was to obtain an overview of available POCT devices in Europe and their use for the 56 specific communicable diseases currently under EU surveillance and related health issues.
The final scoping review protocol was developed following the PRISMA-ScR checklist. A broad literature search protocol was developed with corresponding broad inclusion criteria (e.g. any POCT device; any EU/EEA Member State and the UK; any of the infectious diseases of interest). The scoping review focused on academic literature and was limited to between 2014 and 2019. Four databases of peer-reviewed scientific literature were searched to ensure we identified as much of the relevant literature as possible: (1) PubMed, (2) Embase.com (Elsevier), (3) Cochrane Library (Wiley) and (4) Scopus. We ran the database/repository searches between the 15th-22nd November 2019 which returned 11,728 results. Whether a study met the inclusion criteria was based on screening the title and abstract.
Of the results, 1,315 articles were taken forward and 350 articles fully extracted and analysed. Literature reviews formed the largest group of articles, accounting for 115 of the 350 articles. Evaluation studies were the second largest category of reviewed articles, forming 102 of the 350 articles and observational studies made up 37 of the articles. A large number of studies had patients or the general population as their population (148 studies). The majority of the evaluation studies, comparative studies, observational studies and RCTs recruited patients or the general population for the study. The most common study setting was a laboratory (i.e. non-clinical, with the study/evaluation carried out in a laboratory), with 51 studies conducted in this setting. Twenty-four took place in an emergency department and 47 in other secondary care settings. The country with the most conducted studies was the UK (58 studies), closely followed by France (55 studies).
The reviewed literature covered 44 of the diseases/pathogens of interest. The most frequent disease of focus was HIV, covered in 108 studies, followed by influenza (89 studies) and tuberculosis (37 studies). The diseases with the largest number of available POCT devices were influenza (65 devices for all types of influenza) HIV (23 devices) and hepatitis C (11 devices). Out of those POCT devices in which turnaround time was specified, most provided results between 10 and 29 minutes (145 tests). A smaller number provided results in 30-59 minutes (53 tests) and 60-90 minutes (63 tests). Only 33 devices provided results in less than 10 minutes. In most cases, the POCT devices were used only for detection/diagnosis of an infectious disease (252 devices). Very few were used to detect antimicrobial resistance (AMR) or for other (non-detection/diagnosis) reasons. Of the articles that discussed the clinical and patient impact of POCT (69 articles), most described a positive impact, such as allowing for more appropriate use of antimicrobials, reducing the time to diagnosis or treatment, or reducing likelihood of hospital admissions, length of hospital stay and/or waiting times.
Scoping reviews do not aim to critically appraise the literature, nor to provide a synthesised answer to the type of research question typically answered by a systematic review. Although we maintained a broad scope in most areas (e.g. any POCT device, any of the infectious diseases of interest), we only included literature published in English in 2014–2019 and studies conducted in EU/EEA Member States and the UK. This may have led to the exclusion of articles discussing POCT devices in their early development in regions outside the EU/EEA Member States and the UK which may be relevant to an EU/EEA context.
For many years, POCT has been applied to detect and diagnose a range of infectious diseases in a short amount of time and with limited resources and infrastructure, effort and skill required. The ongoing COVID-19 pandemic has highlighted the importance of developing and deploying, on a large scale, POCT devices to detect infectious diseases both for medical care as well as for public health risk management. This is important both to identify when an individual is currently infected and when an individual has been previously infected and recovered. Therefore, an update of this scoping review to include COVID-19 POCT devices would be of value, to document studies performed on their potential usefulness and public health effectiveness in Europe.