Urinary tract infection test kit InviScreen® UTI Pathogen Panel

for research laboratoryfor molecular biologyfor research

Product overview
The InviScreen® UTI Pathogen Panel is a near‑sample molecular assay for detection of clinically relevant microorganisms associated with urinary tract infections (UTI) in urine specimens. The kit integrates a rapid extraction workflow and Loop‑mediated Isothermal Amplification (LAMP) for 10 targets on the InviDx® instrument. Results are automatically interpreted via the InviDx® Hub. Positive and negative controls are provided. For Research Use Only (RUO). Intended for use by trained personnel.

Highlights

• Near‑sample qualitative detection of 10 clinically relevant UTI pathogens directly from urine
• Complete kit workflow with prefilled lysis tubes and fixed‑volume pipettes to minimise hands‑on steps
• Fast time‑to‑result: from sample collection to result in under 60 minutes
• Lyophilized LAMP reagents in ready‑to‑use 12‑well strips; no additional reagents required
• Automated, assay‑specific interpretation using the InviDx® Hub

Technology & workflow
The panel uses a simplified urine‑to‑DNA process designed for decentralized molecular testing. Urine is added to prefilled lysis tubes and incubated briefly at room temperature. Lysate is processed with the supplied DNA Extraction Pipette and transferred into resuspension buffer. Extracted DNA is diluted and loaded into 12‑well reaction strips containing lyophilized LAMP mixes. The strip is run on the InviDx® instrument; LAMP amplification and colorimetric detection complete in ~45 minutes, with automated analysis via the InviDx® Hub.

Detected microorganisms / Panel targets

• Escherichia coli
• Klebsiella pneumoniae
• Proteus mirabilis
• Staphylococcus saprophyticus
• Pseudomonas aeruginosa
• Enterobacter cloacae
• Streptococcus agalactiae
• Acinetobacter baumannii
• Enterococcus spp.
• Staphylococcus aureus

Controls and compatibility

• Positive and negative controls included to monitor assay validity
• Designed for use with the InviDx® Instrument and InviDx® Hub for automated, assay‑specific interpretation

Intended use and limitations
The kit is intended for near‑sample and decentralized molecular testing environments and is designated Research Use Only (RUO). Use by trained personnel only. The panel detects pathogen‑specific nucleic acid sequences and does not detect antimicrobial resistance genes; a separate AMR gene panel is recommended for resistance profiling.

Supplementary material
Product page includes embedded videos and workflow illustrations to support training and correct operation of the InviDx® system.

Technical specifications

• Contents: Complete sample extraction kit with prefilled lysis tubes, DNA extraction pipettes, fixed‑volume pipettes and 8 × 12‑well reaction strips with lyophilized mixes
• Specimen type: Urine
• Sample preparation: Integrated rapid extraction workflow; minimal hands‑on steps; no additional equipment 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: < 60 minutes from collection to result (LAMP ~45 minutes)
• No. of tests per kit: 8 tests (one patient sample per 12‑well strip)
• Technology: Loop‑mediated Isothermal Amplification (LAMP), colorimetric detection
• Instrument compatibility: InviDx® Instrument and InviDx® Hub
• Designation: Research Use Only (RUO)