Evaluation
Syner-Med supports clinical evaluation requests across the UK. Arrange a demonstration or an evaluation with the team.
For your service
Support
Installation, training, quality control and documentation for services using, or evaluating, the Lodestar UTI testing system.
Getting started
From evaluation to go-live.
Installation and training
Installation, operator training and ongoing support are provided by Syner-Med. Training is required before first use.
Before first use
Near-patient testing sits under local laboratory or POCT governance. We ask that the service names the responsible lead and agrees the standard operating procedure — including how results are recorded and how a result with more than one target is handled — before installation.
Running the test
Day to day.
Controls
Every test strip carries a positive and a negative control. Both controls are read on every run.
Quality control
QC material QC-HUTI-10 is available for the six-target panel. Monthly QC is recommended, or on starting a new lot.
Storage and handling
Test kits are supplied and stored cold chain; refrigerate on arrival. Urine samples should be processed within 24 hours of collection. Wipe down the analyser and testing area at the end of each session with an appropriate disinfectant wipe; no routine servicing or calibration is required after installation.
The sample continues to the laboratory
Lodestar DX is used alongside laboratory urine culture, not in place of it. The same sample continues to the laboratory as normal; culture remains the reference standard and the route to susceptibility testing.
What you need
On the bench.
- Lodestar DX analyser with its power adaptor
- HUTI-10 test kit (10 tests per box)
- 5 µL fixed-volume pipette, tips and an eight-well tube rack
- QC-HUTI-10 quality control kit
- The urine sample
Hands-on time per sample is about two minutes; the run itself is 35 minutes and must be allowed to finish before the strip is removed.
Troubleshooting
First checks.
Before troubleshooting, check the strip was prepared correctly: even volumes in every tube, uniform colour, no large bubbles. The full Troubleshooting Guide is available on request from Syner-Med.
Negative control positive
Discard the result. Run QC (QC-HUTI-10). If QC passes, repeat with a fresh strip stored at the correct temperature, taking care not to add sample to tube 8. If QC fails, stop using the affected kits and contact Syner-Med.
Positive control negative
Discard the result. Check the kit is in date and repeat with a fresh strip. Heavily sedimented urine can inhibit the reaction: allow the sample to settle and repeat using clear urine from the top.
‘Error’ light lit
If the lid was briefly opened during the run, the result can be read as normal. If the lid was not opened, disregard the result.
Test will not start
Allow 10 to 15 minutes from switch-on for the analyser to reach temperature; the ‘Busy’ light must be off.
Unusually many positives for the same target
Never open used tubes. Dispose of used strips as directed, clean the analyser and testing area as described in the IFU, and run QC. If QC fails, stop using the affected kits and contact Syner-Med.
For anything else, or if a problem persists, contact Syner-Med support.
Results and connectivity
Recording the result.
Recording
Results are read from the display — red indicates the target was detected at clinically relevant levels, green indicates it was not — and are not stored on the analyser. Record the result in the patient record.
EPR integration
Lodestar DX can integrate with common EPR systems via EKF Link, subject to local IT configuration. Ask Syner-Med for the connectivity overview.
Documentation
Available on request.
Instructions for Use
The Lodestar DX UTI Test Kit (HUTI-10) Instructions for Use, Version 4, March 2026. Available on request from Syner-Med.
Troubleshooting Guide
The Lodestar UTI Test Troubleshooting Guide (V2, March 2026), covering control failures, error states and contamination checks.
Connectivity overview
EKF Link integration overview for local IT teams.
Regulatory documentation
UKCA declaration of conformity and ISO 13485:2016 certificate (BSI MD 812652) for procurement and governance files.
Downloads and links
Materials and published sources.
Lodestar DX — an overview for clinicians
The six-page introduction to the Lodestar UTI testing system: the clinical problem, where culture works and where it leaves patients without an answer, the published UK evaluations, and using Lodestar DX in your service.
6 pages
Download PDF →1.5 MB
Job code LS006 · Date of preparation September 2026
A note for microbiology and infection services
Two pages for the people asked to govern the test: what each test answers, how the two run on the same sample, quality control, recording, and the questions we would rather raise ourselves.
2 pages
Download PDF →187 KB
Job code LS008 · Date of preparation September 2026
Product specification sheet
One page: sample, time to result, targets, limit of detection, storage, connectivity, quality control, operators and setting, regulatory status.
1 page
Available after certification
Published evidence and external references
- Diggle J, et al. Lodestar DX, an evaluation: LAMP for the diagnosis of urinary tract infection in symptomatic adult females. JAC-Antimicrobial Resistance 2024;6(5):dlae148 (open access) →
- Drazich-Taylor S, Moore J, McCann B. Evaluation of the Lodestar DX: a comparison with traditional culture for the detection of bacteriuria. JAC-Antimicrobial Resistance 2025;dlaf128 (open access) →
- NICE. Point-of-care tests for urinary tract infections to improve antimicrobial prescribing: early value assessment (HTE7, May 2023) →
- MHRA Yellow Card scheme — report an adverse incident →
Adverse incidents
How to report.
Adverse incidents relating to Lodestar DX should be reported to Syner-Med at PV@syner-med.com and via the MHRA Yellow Card scheme. Refer to the Instructions for Use for full safety and operational guidance.
Contact support
Talk to the support team.
For installation, training, quality control, connectivity and procurement enquiries, contact Syner-Med. We respond within two working days.
Syner-Med (Pharmaceutical Products) Ltd, Castle Court, 41 London Road, Reigate, Surrey, RH2 9RJ, United Kingdom