Lodestar DX Clinical Evidence
Validated against laboratory urine culture in independent UK microbiology services.
Evidence base as of September 2026.
Overall performance
Clinical validation across the six-target panel.
The Lodestar DX molecular analyser was evaluated against laboratory urine culture in independent UK studies. Performance is summarised below.
| Population | Sensitivity % | Specificity % | PPV % | NPV % | Accuracy % |
|---|---|---|---|---|---|
| Adults (18 years and over), n=468 | 87 | 72 | 85 | 75 | 82 |
| Paediatrics (0 to 17 years), n=189 | 77 | 97 | 90 | 93 | 92 |
| Overall (adults and paediatrics), n=657 | 86 | 84 | 86 | 84 | 85 |
| Pre-operative urology screening, n=189 | 78 | 92 | 78 | 92 | 88 |
Llusern Scientific HUTI-10 IFU v4, March 2026, Section 14. Overall sensitivity 85.8% (95% CI 82–89%), specificity 83.7% (95% CI 79–88%), n=657 (455 female and 202 male urine samples). Reference standard: laboratory urine culture.
Public Health Wales, Cardiff
Independent evaluation in symptomatic adult women.
199 samples from symptomatic adult women were tested within four hours and before any culture result. Sensitivity was 88.1% (95% CI 77.8–94.7%), specificity 83.9% (95% CI 72.3–92.0%) and accuracy 86.1% (n=129 evaluable). PPV was 85.5% (95% CI 76.9–91.3%) and NPV 86.7% (95% CI 77.1–92.6%). The E. coli assay showed 97.8% sensitivity and 90.4% specificity. Testing was performed independently by Public Health Wales.
Norfolk and Norwich Microbiology Services
Non-pregnant adult cohort, August–November 2024.
379 samples from non-pregnant adults were collected between August and November 2024. Sensitivity was 85.6% (95% CI 69.2–94.6%), specificity 92.0% (95% CI 88.1–94.9%), negative predictive value 97.0% (95% CI 94.0–98.6%) and accuracy 91.2%. PPV was 64.1%. S. aureus sensitivity was 27.3% (n=11); S. aureus is not a named target of the panel.
Drazich-Taylor et al., JAC-Antimicrobial Resistance, 2025.
Pre-operative urine screening
Pathogen results before urological procedures.
In pre-operative urology screening, sensitivity was 78%, specificity 92% and negative predictive value 92% (n=189).
Llusern Scientific. Clinical Performance of the Lodestar UTI Testing System for Preoperative Urology Screening, data on file.
Samples that culture could not resolve
Molecular identification where culture was inconclusive.
In the Cardiff evaluation, 70 samples were reported by culture as mixed growth with no clinical result. Lodestar DX returned a positive identification for one or more target pathogens in 19 of them. The clinical significance of those identifications was not established in the study.
Diggle J, et al. JAC-Antimicrob Resist 2024;6(5):dlae148, Table 4 and Discussion.
Urine culture and Lodestar DX
Urine culture: where it works — and where it leaves patients without an answer
Culture is the reference standard, and Lodestar DX does not replace it. Both halves below are true at once — and the second half concentrates in recurrent and chronic patients.
Reference standard
Every UTI diagnostic is validated against it
Route to susceptibility
Testing is performed on the cultured isolate
No fixed panel
Grows whatever is present
Quantified, viable growth
cfu/mL — significance and test of cure
Surveillance substrate
Antibiograms are built from its isolates
Where it leaves patients without an answer
Design limits of any growth-based method — not failures of laboratory technique.
The limit
The evidence
So what — for the patient
Time to answer
Laboratory urine culture takes 48 to 72 hours from sample to reported result.
The first treatment decision is made without a pathogen result
Mixed growth reported without a clinical result
In the Cardiff evaluation, 70 samples were reported by culture as mixed growth with no clinical result; Lodestar DX returned a positive identification for one or more target pathogens in 19 of them.
No organism named, and no susceptibility to act on
Growth depends on viable organisms
Culture requires organisms that grow under standard laboratory conditions.
A symptomatic patient can be reported as no significant growth
Prior antibiotics suppress growth
Samples taken after treatment has started can fail to grow the causative organism.
Empirical treatment continues without confirmation
Quantitative thresholds
Reporting thresholds are set to distinguish significant bacteriuria from contamination.
Low-count but symptomatic infection can fall below the reporting line
Repeat negatives in recurrent and chronic presentations
Patients with recurrent or persistent symptoms accumulate repeated negative or inconclusive culture reports.
Symptoms continue while the record shows no infection
One sample, two tests
One urine sample supports both tests. Lodestar DX returns a pathogen result in 35 minutes, in the clinic, to inform the prescribing decision. The same sample continues to the laboratory, where culture confirms the organism, quantifies viable growth and provides antibiotic susceptibility.
The two are sequential, not alternative. Neither answers the other's question.
Lodestar DX does not replace urine culture, does not test antibiotic susceptibility and does not detect organisms outside the six-target panel. Culture remains the reference standard and the route to susceptibility testing. Results are used in conjunction with the full clinical profile of the patient.
Sources: Diggle J, et al. JAC-Antimicrob Resist 2024;6(5):dlae148. Drazich-Taylor S, et al. JAC-Antimicrob Resist 2025. Llusern Scientific HUTI-10 IFU v4, March 2026. Lodestar DX is UKCA-marked. For in vitro diagnostic use only.
Limitations of use
Lodestar DX is UKCA-marked. For in vitro diagnostic use only. Use in conjunction with the full clinical profile of the patient. A positive result does not guarantee that an infection is present; a negative result does not rule out the possibility of a UTI. Lodestar DX does not test antibiotic susceptibility, does not detect organisms outside the six-target panel, and does not replace urine culture. It is not currently indicated for use in pregnancy.
Change the way you manage UTIs.
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