EUnetHTA project plan for clinical utility of D-dimer and troponin tests has been published

In mid-August 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA22 “Clinical utility of Point-of-care Tests (POCT) D-Dimer and Troponin.”

This project is being executed by The Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) and the Romanian School of Public Health, Management and Professional Development (NSPHMPDB). The dedicated reviewers are Swiss Network for HTA (SNHTA) and Association of Austrian Social Insurance Institutions (HVB).

The rationale of this assessment is to collaboratively produce structured (rapid) core HTA information on other technologies. In addition, the aim is to apply those collaboratively produced assessments in the national or regional context.

This rapid assessment addresses the research question whether using the POCT D-dimer and troponin in symptomatic populations presenting at ambulatory [general (primary) or specialist medicine at outpatient or community care settings)] or emergency care settings more effective and/or safer than current diagnostic practice. This topic was chosen based on a request from the representatives of the federal states in Austria who commissioned EUnetHTA to do an HTA on two POCTs, D-dimer and cardiac troponin (or cTn), in symptomatic patients [such as those reporting chest pain, breathlessness or swelling of the leg for the former and symptoms of acute coronary syndrome (ACS) such as chest pain or breathlessness that are potentially indicative of acute myocardial infarction for the latter] presenting at outpatient or general practice settings. The relevance of the topic lies in the fact that POCT enables testing during a consultation, potentially enabling triage to operate more effectively, through for instance, preventing unnecessary further tests or hospital admissions.

The HTA core model® for Rapid Relative Effectiveness (REA) will be used, focusing on the effectiveness (EFF), safety (SAF) and organizational (ORG) modules. Manufacturers will be asked to submit non-confidential evidence, focusing on the technical characteristics and current use of the technology. The evidence provided will be used in addition to the literature identified by the literature search.

The point of care cardiac troponin products planned to be assessed include i-STAT CtnI CARTRIDGE (Abbott Diagnostics), CARDIAC POC Troponin T (Roche), Stratus® CS Analyzer (Siemens), Minicare Troponin-I (cTnI) assay and Minicare I-20 (Philips), LABGEOIB10 analyzer and LABGEOIB TnI (Samsung), ADEXUSDx® Troponin I Test (NowDiagnostics), RAMP® Cardiac Troponin I test (Response Biomedical), Troponin I Test (Eurolyser), mLabs Troponin I (Micropoint), PATHFASTTM (LSI Medience Corporation; former Mitsubishi), Quidel Cardio3 (cTnI), Cardio2, Triage Troponin I (Quidel), AQT90 FLEX cTnI and AQT90 FLEX cTnT (Radiometer), troponin I test (PBM), i-CHROMA Diagnostics (Sycomed).

The final version of this rapid assessment is expected to be published on 29th November 2019.

The full details in English can be found here.

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