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This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGS analysis | Other | Residual anonymized samples stored at -80°C at the Tropica Biobank of the DITM and for which diagnostic analysis for germ infection has previously been carried out at the DITM by blood culture and MDR surveillance in routine diagnostic rectal swab will be used. DNA extraction will be carried out on these residual samples (with subsequent quality and quantification analysis of the nucleic acid) for subsequent NGS analyses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGS Analysis | Diagnostic Test | An analytical pipeline with NGS technology developed in the GENRES study will be used for the identification of infecting microorganisms and the drug resistance they carry. For this purpose, a sequencing method will be identified and adopted that can obtain gene sequences of approximately 75 bp in length and on the Illumina MiSeq platform. Furthermore, IT software and bioinformatics analyzes with specific quality control parameters (pre- and post-alignment of reads) will be identified and adopted in order to develop an IVD system that includes a complete package of sequencing kits and software. |
| Measure | Description | Time Frame |
|---|---|---|
| Microorganism presence (positive/negative) | Microorganism presence identified by NGS technology. | Baseline |
| Microorganism identification | Microorganism identification obtained using NGS technology. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible) | Results (resistant/susceptible) obtained using NGS technology in the identification of gene mutations that convey resistance to antibiotics. | Baseline |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Sacro Cuore Don Calabria hospital | Recruiting | Negrar | Verona | 37024 | Italy |
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