Question 1

What does Lodestar DX do?

Accepted Answer

Lodestar DX is a UKCA-marked molecular analyser for laboratory and near-patient settings. It detects the DNA of six common uropathogens directly from a urine sample and returns a pathogen result in 35 minutes.

Question 2

What does the panel cover?

Accepted Answer

DNA of six common uropathogens: Escherichia coli, Enterococcus species, Staphylococcus saprophyticus, Proteus mirabilis, Pseudomonas aeruginosa and Klebsiella pneumoniae. It does not detect organisms outside the panel, including Group B Streptococcus. Cross-reactivity is documented in the Instructions for Use.

Question 3

How does the technology work?

Accepted Answer

The test uses loop-mediated isothermal amplification (LAMP). Each test strip carries six target reactions plus a positive and a negative control; both controls are read on every run.

Question 4

How accurate is it?

Accepted Answer

Against laboratory urine culture across 657 samples, overall sensitivity was 86% and specificity 84%. Full population-level figures and citations are on the Clinical Evidence page.

Question 5

Who can run the test, and where?

Accepted Answer

Trained healthcare professionals, in laboratory or near-patient settings. Training is required before first use and is provided by Syner-Med.

Question 6

How long does it take?

Accepted Answer

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.

Question 7

How are results recorded?

Accepted Answer

Results are read from the display — red indicates the target was detected at clinically relevant levels — and are not stored on the analyser. Record the result in the patient record; EPR integration is possible via EKF Link, subject to local IT.

Question 8

What about quality control?

Accepted Answer

QC material (QC-HUTI-10) is available; monthly QC is recommended, or on starting a new lot. All test strips include positive and negative controls, read on every run.

Question 9

What happens if a control fails?

Accepted Answer

Discard the result and repeat the test with a fresh strip, following the Troubleshooting Guide. If quality control also fails, stop using the affected kits and contact Syner-Med.

Question 10

How are the kits stored?

Accepted Answer

Test kits are supplied and stored cold chain; refrigerate on arrival. Refer to the Instructions for Use for shelf life and handling.

Question 11

How soon must a sample be tested?

Accepted Answer

Urine samples should be processed within 24 hours of collection, stored as directed in the Instructions for Use.

Question 12

Does the analyser need servicing or calibration?

Accepted Answer

No routine servicing or calibration is required after installation. Wipe down the analyser and testing area at the end of each session with an appropriate disinfectant wipe.

Question 13

Does Lodestar DX tell me which antibiotic to use?

Accepted Answer

No. Lodestar DX identifies the pathogen; it does not test antibiotic susceptibility. The identified organism is read against your local antibiogram and current guidance, at the clinician's discretion.

Question 14

Does it replace urine culture?

Accepted Answer

No. It is used alongside laboratory urine culture, which remains the reference standard and the route to susceptibility testing. Samples continue to the laboratory as normal.

Question 15

What does a negative result mean?

Accepted Answer

A negative result does not rule out the possibility of a UTI. Results are used in conjunction with the full clinical profile of the patient.

Question 16

Can it be used in pregnancy?

Accepted Answer

Lodestar DX is not currently indicated for use in pregnancy, and the panel does not include Group B Streptococcus.

Question 17

Can it be used before urological procedures?

Accepted Answer

In pre-operative urology screening, sensitivity was 78%, specificity 92% and negative predictive value 92% (n=189). See the Clinical Evidence page for the source.

Question 18

What is the regulatory status?

Accepted Answer

Lodestar DX is UKCA-marked for in vitro diagnostic use. It is manufactured by Llusern Scientific Ltd, ISO 13485:2016 certified (BSI MD 812652), and distributed in the UK by Syner-Med (Pharmaceutical Products) Ltd.

Question 19

How do I get the Instructions for Use?

Accepted Answer

The Instructions for Use (HUTI-10, Version 4, March 2026) are available on request from Syner-Med. They are not published as a public download.

Question 20

How do I report an adverse incident?

Accepted Answer

Adverse incidents should be reported to Syner-Med at PV@syner-med.com and via the MHRA Yellow Card scheme.

Question 21

How do I arrange an evaluation or place an order?

Accepted Answer

Contact Syner-Med. The team supports evaluation requests, installation, training and ordering across the UK.

Frequently asked questions

The test

Using it in practice

Storage and handling

Clinical use

Regulatory and support

Change the way you manage UTIs.