Abstract: PNFLBA-02
Sources of Funding: None _x000D_ _x000D_

Introduction

The aim of our study was to conduct a Head to Head Comparative Phase II trial of standard urine culture and sensitivity versus DNA next generation sequencing testing for diagnosis and treatment efficacy in patients with urinary tract infections (UTI) based on short-term outcomes.

Methods

Between January 2016 and December 2016, 56 patients were entered into this study with symptoms of an UTI, 44 patients completed the study. All subjects completed a standardized UTI symptom score questionnaire on day 0-7 and day 14. Twenty-two volunteers were entered as controls in this study without symptoms of a urinary tract infection. The Level 1 Panel as a quantitative real-time Polymerase chain reaction (PCR) test for bacteria and fungi and the Level 2 test which detects virtually all microbial organisms and fungal pathogens were used versus routine culture and sensitivity test.

Results

The symptom scores were statistically significantly better for those patients whose diagnosis and treatment was based on DNA results versus traditional culture studies. For instance, all 44 patients showed positive results in DNA sequencing tests, while only 13/44 patients had positive urine culture tests. The difference in average improvement of 8.5 is highly significant (p<0.0001) (Fig.1). Especially in the cohort of patients with DNA positive test and culture negative the treatment outcomes were improved with respect to symptom scores when they started treatment on day 8. That ultimately led to faster recovery times and decreased the cost of treatment. Advantages of the DNA test also include an increased sensitivity for the diagnosis of anaerobic flora. _x000D_ _x000D_

Conclusions

In this study DNA testing demonstrated a more accurate diagnosis of UTI than standard urine culture tests. In addition, DNA next generation testing led to better treatment outcomes in patients treated with antibiotics for primary anaerobic, aerobic or a combination of bacteria. Therefore, DNA testing allowed for the improved diagnosis and treatment based on symptoms of a UTI especially when urine cultures are negative._x000D_ _x000D_ Figure 1. Box-plot of Symptom Severity Reduction at Day 14 in Treatment Arms (group 1- based on culture and sensitivity, group 3 and 4- based on DNA results)

Funding

None _x000D_ _x000D_