Lodestar DX (rapid point-of-care UTI analyser)

For healthcare professionals practising in the UK

Lodestar DX is a rapid point-of-care (POCT) molecular analyser that identifies six common uropathogens from a urine sample in 35 minutes.

Lodestar DX point-of-care UTI analyser with a test strip being loaded
Lodestar DX point-of-care UTI analyser display

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Lodestar DX (rapid point-of-care UTI analyser), UKCA-marked IVD

Lodestar DX test strip and diluent tubes

The analyser

The Lodestar DX analyser (LDS-UK-1, supplied with power pack) is a compact bench-top POCT analyser for urinary tract infection. It uses loop-mediated isothermal amplification (LAMP) to detect the DNA of common uropathogens directly from a urine sample, with no separate extraction step. One single-use test strip is run per 35-minute cycle and the result is read from the analyser display. The analyser needs bench space, a power supply and refrigerated storage for test kits; the footprint is about the size of an A5 sheet of paper.

The test kits

Lodestar DX UTI Test Kit, HUTI-10: ten single-use test strips with diluent tubes. Each strip tests one urine sample for six common uropathogens: Escherichia coli, Enterococcus species, Staphylococcus saprophyticus, Proteus mirabilis, Pseudomonas aeruginosa and Klebsiella pneumoniae. Positive and negative controls are built into every strip. Test kits are supplied and stored cold chain.

Lodestar DX QC material, QC-HUTI-10: kit of ten, for routine quality control and on each new lot.

Lodestar DX tube rack, RACK-01: reusable rack for sample preparation.

Installation, operator training and ongoing support are provided by Syner-Med. Every operator is trained before first use.

Important information

Lodestar DX is UKCA-marked. For in vitro diagnostic use only, by trained healthcare professionals. Results must be used in conjunction with the full clinical profile of the patient. Lodestar DX does not replace urine culture and does not test antibiotic susceptibility. Manufactured by Llusern Scientific Ltd. Lodestar is a registered trademark of Llusern Scientific Ltd. Distributed in the UK by Syner-Med (Pharmaceutical Products) Ltd.

Reporting of adverse incidents

Adverse incidents involving Lodestar DX should be reported to Syner-Med (Pharmaceutical Products) Ltd at PV@syner-med.com or on +44 (0)20 8655 6380 (Option 1), and via the MHRA Yellow Card scheme at www.mhra.gov.uk/yellowcard.