Performance of the cobas u 701 Analyzer in Urinary Tract Infection Screening

Negative urine cultures to rule out urinary tract infections (UTI) generate a considerable laboratory workload; thus, a rapid screening test is desirable. We evaluated the performance of a new automated microscopy analyzer, cobas u 701 (Roche Diagnostics International, Rotkreuz, Switzerland) for the screening of UTI, and developed a rule-out strategy to reduce the number of samples requiring culture. We also assessed squamous epithelial cell (SEC) count as a predictor of culture contamination.

In total, 1,604 urine samples from outpatients were analyzed with cobas u 701 and culture. Bacterial (BAC) and white blood cell (WBC) counts were used for sample interpretation. To determine a useful cut-off point to predict negative cultures, we selected the highest sensitivity and specificity values obtained from ROC curves. Diagnostic accuracy by age and gender was evaluated.

Urine culture showed growth of ≥10⁴ colony forming units (CFU)/mL in 256 samples (16.0%). The highest sensitivity (91.8%) and specificity (68.4%) were obtained for cut-off points of 119 BAC/μL and 22 WBC/μL. The combination of BAC and WBC improved the performance of the rule-out strategy with a low rate of false-negative results (1.5%) and a high negative predictive value (NPV, 97.3%). Fifty-seven percent of the samples would not have required culture. SEC count was a poor predictor of culture contamination.

cobas u 701 can substantially reduce the number of urine samples requiring culture, with a low false-negative rate and a high NPV.