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A new point-of-care test for the rapid detection of urinary tract infections
Alyexandra Arienzo1, Valentina Cellitti2, Valeria Ferrante2
1Science Department, Università degli Studi Roma Tre, Rome, Italy.
Insights
The Micro Biological Survey (MBS) point-of-care test (POCT) accurately detects high bacterial count urinary tract infections (UTIs) within 5 hours. This rapid diagnostic tool shows high sensitivity and specificity, aiding timely UTI management.
Area of Science:
- Urology
- Infectious Diseases
- Clinical Diagnostics
Background:
- Urinary tract infections (UTIs) are highly prevalent across all age groups.
- Rapid and precise diagnosis is crucial for effective UTI treatment.
- Current clinical practice has limited adoption of developed point-of-care tests (POCTs) for UTIs.
Purpose of the Study:
- To evaluate the performance and limitations of the Micro Biological Survey (MBS) POCT for UTI detection.
- To compare MBS POCT results against standard culture-based diagnostic methods.
Main Methods:
- Two open-label, monocentric, non-interventional clinical trials were conducted.
- 349 patients from hospital emergency and outpatient departments participated.
- MBS POCT urine analysis results were compared with hospital laboratory culture-based tests.
Main Results:
- The MBS POCT demonstrated high accuracy (97%) for detecting UTIs with bacterial counts ≥10^5 CFU/ml.
- The test achieved 92% sensitivity, 100% specificity, 99% positive predictive value (PPV), and 96% negative predictive value (NPV).
- Results were obtained within a 5-hour analytical time threshold.
Conclusions:
- The MBS POCT is a fast and reliable tool for diagnosing high bacterial count UTIs.
- Its high accuracy, sensitivity, and specificity support its potential implementation in clinical practice.
- The test facilitates timely management of urinary tract infections.
Abstract:
Urinary tract infections (UTIs) are among the most common infections in all age groups. Fast and accurate diagnosis is essential to ensure a timely and effective therapy. Alongside with reference culture-based methods, several point-of-care tests (POCTs) for early detection of UTIs have been developed, but they have not been significantly implemented in current clinical practice. The Micro Biological Survey (MBS) POCT is a simple test developed by MBS Diagnostics Ltd. (London, UK) for the detection and management of UTIs. The present study has been undertaken to investigate the potentials and limits of the MBS POCT. A total of 349 patients were enrolled in two open-label, monocentric, non-interventional clinical trials in collaboration with an Emergency Medicine department and the outpatient clinic of two hospitals in Rome. Results of urine analysis using the MBS POCT were compared with those of the routine culture-based tests for UTI diagnosis performed by the hospital laboratory. The MBS POCT provided fast results revealing high bacterial count UTIs (≥ 105 CFU/ml) with 97% accuracy, 92% sensitivity, 100% specificity, 99% PPV, and 96% NPV within a 5-h analytical time threshold.
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