In WP4.2, the user requirements specifications were translated into procurement demands. We matched the clinical perspectives with the currently available innovative diagnostics based on the algorithms defined in WP4.1.
Hospital-acquired lower respiratory tract infections, such as Ventilator-Associated Pneumonia (VAP) served as an example of how the demand side from a clinical perspective can be matched with the currently available innovative diagnostics, as discussed in our previous WP4.1 report.
We first analyzed online available VAP guidelines and compared the diagnostic parameters and treatment options for VAP. We also reviewed the VAP clinical scoring systems. Secondly, we defined clinical decision trees for VAP based on these guidelines. The UAntwerp developed a questionnaire to identify the product specifications for the selection of a rapid diagnostic test for the two VAP algorithms (antibiotic stewardship and detection of colonization). With the support of the European Respiratory Society (ERS), we invited seven VAP experts to fill out this questionnaire. Next, the different outcomes were identified that could be linked to these technical specifications. This resulted in a clear picture on the proposed clinical pathway for the diagnosis of VAP, the technical specification for the diagnostic test and the first draft of the URS. Finally, UAntwerp constructed a database with variables for landscaping diagnostic tests for detection of microbial and host biomarkers for diagnosis of respiratory tract infections. This landscaping is a joint initiative with another EU funded Marie Curie project (New Diagnostics for Infectious Diseases). Information collected includes: intended use, setting, performance, patient type, method, target, analysis, detection, detected pathogens, detected antimicrobial resistance (AMR), storage conditions, shelf life, kit components, volume/amount required, test preparation, sample processing, controls, calibration, maintenance, hands on time, results readout, time to result, instrumentation, instrument specifications, connectivity, waste disposal, samples per run, patient population, sensitivity, specificity, PPV, NPV, reproducibility, limit of detection, cross- reactivity, interference, training, required, on-site training, cost of kit (€), instrument availability in Europe, cost of instrument (€)/leasing possibility, calibration, maintenance/support, stage of development, market region, regulatory approval, and CLIA complexity.