Lodestar UTI product sheet

Product catalog summary

Overview: The document provides details about the Lodestar DX, a molecular diagnostic tool designed for rapid and affordable point-of-care testing for urinary tract infections (UTIs). It highlights the device's capabilities, specifications, and clinical performance.

Specifications:

Sensitivity and Specificity: The device offers 98% sensitivity and 91% specificity for E. coli, with an overall sensitivity of 88% and specificity of 87%.
Technology: Utilizes isothermal LAMP technology for molecular accuracy comparable to microbiological culture analysis.
Size and Weight: Compact dimensions of 140 mm (w) x 200 mm (d) x 90 mm (h) and a weight of 720 g.
Power and Connectivity: Operates on 240-12V power and connects to LIMS via Bluetooth or USB.
Warranty: Comes with a 12-month warranty from the date of installation.

Procedures:

Sample Testing: Tests for six common UTI pathogens from a single urine sample, requiring only 10 μL of urine.
Process: Add urine to the diluent tube, mix into assay tubes, and place the test panel in Lodestar DX for results in 35 minutes.
Indicators: Green light for negative results and red light for positive results.

Clinical Performance:

Pathogen Detection: The test panel can detect multiple pathogens in a mixed growth sample, including E. coli, Enterococcus/S. aureus, Staph. saprophyticus, Proteus mirabilis, Pseudomonas aeruginosa, and Klebsiella pneumoniae.
Performance Metrics: High sensitivity and specificity rates for various pathogens, with some achieving 100% sensitivity and specificity.

Recommendations:

Ease of Use: Designed for minimal preparation and no maintenance or calibration required.
Portability: Small and lightweight, suitable for use in busy labs, clinics, or offices.
Informed Decisions: Enables informed prescribing decisions based on rapid and accurate test results.

Catalog excerpts

BRILLIANT MOLECULAR DIAGNOSTICS Lodestar DXMolecular UTI testing at the point-of-care • 98% sensitivity and 91% specificity for E.coli • 88% overall sensitivity and 87% specificity • No extraction step required • Test for six pathogens simultaneously • Small and portable - fits into the busiest lab, clinic or office • Test the patient sample at any time on the day of collection

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BRILLIANT MOLECULAR DIAGNOSTICS Lodestar DX • Isothermal LAMP technology provides molecular accuracy comparable to microbiological culture analysis • Simple sampling steps with minimal preparation • Green light indicates a negative result; red light indicates a positive result • Connect to LIMS via Bluetooth or by USB • No analyser maintenance or calibration is required • 12 month warranty from date of installation • Test for the six most common pathogens that cause UTI from one sample • Detects multiple pathogens in a mixed growth sample • Test strip includes positive and negative controls •...

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