The InviScreen® UTI Pathogen Panel is a molecular near-sample testing assay designed to detect clinically relevant microorganisms associated with urinary tract infections (UTI) in urine specimens.
The assay includes a rapid sample extraction procedure, followed by Loop-mediated Isothermal Amplification (LAMP) of 10 clinically relevant targets on the InviDx® instrument. After amplification, results are automatically interpreted using the InviDx® Hub.
The InviScreen® UTI Pathogen Panel detects the following UTI-associated microorganisms:
The assay workflow is designed for near-sample and decentralised molecular testing environments. All assay-specific components required to perform the test are included in the kit, supporting a standardized and streamlined workflow with the InviDx® system. Positive and negative controls are included to monitor assay validity and help identify potential run failures.
For Research Use Only (RUO). Intended for use by trained personnel.
For downstream antimicrobial resistance detection, the separately available InviScreen® AMR Gene Panel is recommended.
The InviScreen® UTI Pathogen Panel features a simplified urine-to-DNA workflow designed for decentralized molecular testing.
After urine collection, the sample is added to prefilled lysis tubes and briefly incubated at room temperature. The lysed sample is then extracted and purified using a dedicated DNA Extraction Pipette and finally transferred into a resuspension buffer tube, ready for downstream target detection.
All required materials, including single-volume pipettes and pipette tips, are included in the kit, supporting fast and accessible sample preparation at the point of care.
Figure 1: General Workflow of the InviScreen®UTI Pathogen Panel.
The extracted DNA is diluted and loaded directly into the ready-to-use 12-well reaction strips. Each well contains lyophilized LAMP reaction mixes for the 10 different targets as well as a positive and a negative control.
The prepared reaction strip is inserted into the InviDx® instrument. Targets are detected by Loop-mediated Isothermal Amplification (LAMP) in only 30 minutes.
Results are automatically analysed, interpreted and presented by the InviDx® Hub.
| Specifications | |
|---|---|
| Contents |
|
| Specimen type | Urine |
| Sample Preparation | Integrated rapid sample extraction workflow with minimal hand-on-steps. No additional equipment or materials required. |
| Panel targets | E. coli, K. pneumoniae, P. mirabilis, S. saprophyticus, P. aeruginosa, E. cloacae, S. agalactiae, A. baumannii, Enterococcus spp., S. aureus |
| Internal controls | Included |
| Turnaround time | From sample collection to result in less than 60 min |
| No. of tests | 8 |
| Technology | Loop-mediated Isothermal Amplification (LAMP) |
| Instrument compatibility | InviDx® Instrument |
| Certification | RUO |
08 SEP 2026
| Product Name | Package Size | Catalogue No. |
|---|---|---|
| InviScreen® UTI Pathogen Panel | 8 samples | 3010010199 |
The InviScreen® UTI Pathogen Panel detects pathogen-specific nucleic acid sequences associated with urinary tract infections. The assay can test for 10 predefined pathogen targets in parallel from a single patient sample.
The panel is intended to support rapid molecular detection. Results should be interpreted together with the patient’s clinical presentation and other relevant laboratory information.
The InviScreen® UTI Pathogen Panel is designed to provide rapid results, with a complete workflow from sample preparation to result available in less than 60 minutes.
The assay uses colorimetric loop-mediated isothermal amplification (LAMP) to detect pathogen-specific nucleic acid sequences.
Unlike conventional PCR, LAMP amplification takes place at a constant temperature. The InviDx® instrument controls the amplification conditions and detects the resulting colorimetric signal through automated image acquisition.
The InviScreen® UTI Pathogen Panel is designed for testing urine samples.
Sample collection, transport, storage, and preparation must be performed according to the current Instructions for Use supplied with the test kit.
The panel requires the InviDx® instrument and the associated InviDx® Hub web page.
The InviDx® instrument performs the isothermal amplification, reaction monitoring, and image acquisition. The InviDx® Hub processes the run data and provides automated, assay-specific result interpretation and reporting.
The workflow includes:
The guided workflow is designed to reduce hands-on steps and simplify molecular testing in laboratory, near-sample, and decentralized settings.
Yes. The assay includes a dedicated sample extraction workflow designed for minimal hands-on operation. The required extraction materials and single-use fixed-volume pipettes are supplied with the kit.
The workflow is designed to require the InviDx® instrument and the materials supplied with the test kit only. External pipettes are not required because single-use fixed-volume pipettes are included in the kit workflow.
For the InviScreen® UTI Pathogen Panel, one patient sample is tested per run.
Each sample uses one 12-well reaction strip. The wells are allocated to the pathogen targets and the required positive and negative controls.
The InviScreen® UTI Pathogen Panel uses a 12-well reaction strip supplied with the kit.
The strip configuration is as follows:
One complete 12-well reaction strip is used to test one patient sample while including the controls needed to verify run validity.
The kit can detect 10 UTI-associated pathogen targets in parallel, including E. coli, K. pneumoniae, P. mirabilis, S. saprophyticus, P. aeruginosa, E. cloacae, S. agalactiae, A. baumannii, Enterococcus spp., S. aureus.
In total 8 tests can be performed with one kit. Each test corresponds to one patient sample and uses one 12-well reaction strip.
The InviDx® Hub is the web-based application used to configure and monitor runs, process reaction data, interpret results, maintain run records, and export reports.
Data captured by the InviDx® instrument are transferred to the InviDx® Hub for automated, assay-specific analysis and standardized qualitative reporting.
No. The panel is specifically designed and validated for use with the InviDx® instrument and InviDx® Hub.
Use with other instruments, unapproved reagents, or non-validated workflows may produce unreliable or incorrect results.
No. The InviScreen® UTI Pathogen Panel is designed to detect pathogen-specific nucleic acid sequences and does not detect antimicrobial-resistance genes.
For antimicrobial-resistance gene detection, use the separately available InviScreen® AMR Gene Panel.
The InviScreen® UTI Pathogen Panel and InviDx® System are designed to support near-sample, and decentralized testing environments.
The compact instrument, specialized reaction strips, integrated controls, and guided software workflow support flexible deployment outside a centralized molecular laboratory.
No. The InviDx® System is currently designated for Research Use Only (RUO) applications only. It can be used for research workflows across human health, and other settings. It is not intended or approved for use in human clinical diagnostics.
.jpeg)
Search