Evaluation of the Lodestar DX: a comparison with traditional culture for the detection of bacteriuria in the workup of urinary tract infection.

BACKGROUND

The Lodestar DX is a point-of-care test (POCT) using loop-mediated isothermal amplification (LAMP) to detect common uropathogens. Novel POCTs may provide an adjunct in the diagnostic work up of urinary tract infection (UTI).

OBJECTIVES

To evaluate the performance of the Lodestar DX in the identification of bacteriuria.

METHODS

We compared the Lodestar DX against urine culture results from August to November 2024 at the Eastern Pathology Alliance in non-pregnant adults.

RESULTS

379 urine samples were tested on the Lodestar DX. 344 (90%) of these passed both internal controls. Summary Lodestar DX performance was sensitivity 85.6% (95% CI 69.2%-94.6%), specificity 92.0% (95% CI 88.1%-94.9%), positive predictive value 64.1% (95% CI 48.7%-77.2%), negative predictive value 97.0% (95% CI 94.0%-98.6%) and overall accuracy 91.2% (95% CI 87.5%-94.0%).In cultures positive for their respective organisms, the sensitivity was 87.9% ( = 66, 95% CI 77.5%-94.6%) for , 80% ( = 20, 95% CI 56.3%-94.3%) for , 27.3% ( = 11, 95% CI 6.0%-61%) for , 92.3% ( = 13, 95% CI 64.0%-99.8%) for , 93.8% ( = 16, 95% CI 69.8%-99.8%) for , 84.2% ( = 19, 95% CI 60.4%-96.6%) for and 100% sensitivity ( = 2, 95% CI 15.8%-100%) for .

CONCLUSIONS

In summary, the Lodestar DX had good performance for the detection of uropathogens apart from . Further comparison with other POCTs would be beneficial.