TEMPOtest - An Integrated Tool-Kit for the Clinical Evaluation of Microbial Detection and Antibiotic Susceptibility Point-of-Care Testing Technologies

EC contribution: : € 3.064.573
Duration: : 36 months
Starting date: : 18/01/2010
Funding scheme: : Focused Research Project
Keywords: : Point-of-Care testing, antimicrobial resistance, survey, quality control, comparison software
Contract/Grant agreement number: : FP7-241742
Project web-site: : http://tempotest-qc.eu/index.php

Summary:

The TEMPOtest project will help fill the current gap between microbiological point-of-care testing (POCT) technologies and the actual clinical need/uptake of testing protocols and kits that have been based upon these technologies. Presently, POCT methodologies are being adopted at a faster rate in other health-care related fields, for example clinical chemistry, than in microbiology. TEMPOtest will be used to identify specific problems, opinions and issues related to the implementation of microbiological POCT within the European Union, and provide suggestions on how to increase microbiological POCT uptake within the EU member states. Further, to increase confidence in microbiological POCT technologies, a standard archive of bacterial isolates and accompanying software will be developed to encourage harmonisation and standardization for the development and quality control of microbiological POCT technologies within the POCT-developing industries, as well as within POCT end-user laboratories.

Problem:

Point-of-care testing procedures are gaining momentum in many fields of health-care e.g. for the measurement of blood glucose levels, or blood gas and electrolyte testing. However, a gap currently exists between the realization of point-of-care testing technologies and actual clinical need within the field of microbiology. For example, if microbiological point-of-care tests are to be developed for home use, would the general public feel confident enough to actually use microbiological point-of-care test kits at home, or alternatively, would they prefer face-to-face contact with their own general practitioner? A further problem involves building confidence in microbiological POCT technologies to facilitate the replacement of currently accepted standard methodologies with new microbiological POCT technologies. This confidence-hurdle will be overcome by developing internationally recognized and harmonized quality control standards, and by collecting (anonymous) comparative data that will allow direct comparisons between new POCT and older microbiological testing technologies to be performed.

Aim:

The TEMPOtest project addresses the need to design integrated tools for closing the gap between microbiological point-of-care technologies and actual clinical need. In this respect, TEMPOtest has 3 main objectives:

To provide a better understanding of the social, ethical and economic hurdles to microbiological point-of-care testing within Europe, to be achieved by gathering data from both commercial and public sources within the EU member states and by comparing and contrasting the concerns and issues raised. Suggestions as to how these problems may be solved will also be provided.
To set up a standard bacterial archive that will i) allow manufacturers of microbiology POCT technologies to set up standardized small- to medium-scale pre-evaluation studies, and ii) allow clinical hospitals to validate and quality control there own use of microbiological POCT kits, including comparison against their current standard testing methodologies. The archive will comprise several hundred bacterial isolates representing the most frequent bacterial species associated with current (and future) priority diseases, including antibiotic resistant and sensitive phenotypes of clinically relevant bacterial species, collected from all over the world, and including category 3 pathogens. It is expected that the bacterial archive will be an expanding resource in order to meet the future needs of the global health-care sector.
To provide a standard software package that will accompany the bacterial archive developed in 2) above, which will allow clinical hospitals (intra- and inter-laboratory testing) , manufacturers of microbiological point-of-care tests, as well as other interested parties, to determine the sensitivity, specificity, reproducibility etc parameters of their own microbiological point-of-care tests. Moreover, users of the software will be able to compare their own test parameter values with the complete (anonymous) data set obtained from other users of the bacterial archive.

Expected results: :

The TEMPOtest project will allow an informed, European-wide, assessment to be made of the clinical needs and hurdles to the implementation of microbiological POCT, identifying the strategies necessary to increase confidence and uptake of POCT methodologies within clinical hospitals and amongst the general public of the EU member states. International harmonization of POCT development and quality control testing will be promoted by the provision of an archive of clinically relevant and bacterial isolates and accompanying comparison software. This will increase confidence in the use and capabilities of microbiological POCT methodologies within both commercial and clinical environments.

Potential applications:

Collating information on the clinical needs and public perception of microbiological POCT testing will allow both general and state-specific recommendations to be made regarding the steps necessary to close the gap between current POCT technologies and their uptake in the microbiological health-care field. Further, the adoption of a standard, and internationally recognised, quality control archive and accompanying comparison software, by manufacturers and end-users, will allow convenient and accurate comparisons to be made with respect to the value of implementing and promoting individual microbiological POCT methodologies within both the clinical setting and at home.

Coordinator:

John P. Hays
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam
The Netherlands
j.hays@erasmusmc.nl

European Commission