The Lodestar DX system
A bench-top molecular analyser and single-use test strip. One test, six pathogens, 35 minutes.
How it works
LAMP in a closed tube at constant temperature.
The test strip holds six pathogen assays plus positive and negative controls. Both controls are read on every run.
From sample to answer
Five steps to a result.
Collect a urine sample. Samples should be processed within 24 hours of collection.
Transfer 10 µL of urine into the supplied diluent tube and mix thoroughly.
Transfer 5 µL of the mixture into each of tubes 1 to 7 on the test strip. Tube 8 is the negative control and takes no sample.
Seal the tubes, mix, load the strip into the analyser and start the run. The run takes 35 minutes.
Read the display. Red indicates the target was detected at clinically relevant levels, green indicates it was not. Record the result: results are not stored on the analyser.
Six-pathogen panel
Six of the most common uropathogens, identified in one run.
The Lodestar human UTI test panel detects DNA of six uropathogens that account for the majority of community and hospital UTI presentations. See clinical performance data.
Escherichia coli · Enterococcus species · Staphylococcus saprophyticus · Proteus mirabilis · Pseudomonas aeruginosa · Klebsiella pneumoniae
The panel does not include Group B Streptococcus. Cross-reactivity is documented in the IFU: the E. coli assay may also detect Shigella species, the Enterococcus assay may detect some strains of Staphylococcus aureus or S. saprophyticus, and the K. pneumoniae assay may detect some strains of K. variicola or K. oxytoca.
Specifications
Built for clinical use.
- Sample volume
- 10 µL urine
- Time to result
- 35 minutes
- Throughput
- One test strip, one patient, per 35-minute cycle
- Technology
- Loop-mediated isothermal amplification (LAMP)
- Targets
- Six uropathogens plus positive and negative controls
- Limit of detection
- Between 10⁴ and 10⁵ cfu/mL across all six assays
- Test strip storage
- Supplied and stored cold chain; refer to the Instructions for Use
- Connectivity
- Can integrate with common EPR systems via EKF Link, subject to local IT configuration
- Quality control
- QC material available (QC-HUTI-10); monthly QC recommended, or on starting a new lot
- Operators and setting
- Trained healthcare professionals, in laboratory or near-patient settings
- Regulatory
- UKCA-marked. ISO 13485:2016 (BSI certificate MD 812652). GMDN 64635.
Specifications correct at time of publication. Refer to the Instructions for Use for full technical detail.
Support
Installation, training and ongoing support.
Installation, operator training and ongoing support are provided by Syner-Med. Training is required before first use.
Change the way you manage UTIs.
Talk to Syner-Med about implementing the Lodestar UTI testing system in your clinic or lab.