Evaluation of the BacterioScan 216Dx for Standalone Preculture Screen of Preserved Urine Specimens in a Clinical Setting

Abstract Background The BacterioScan 216Dx laser microbial growth monitoring system was evaluated as an option for preurine culture screening of preserved urine specimens at an acute care medical center. Methods The BacterioScan 216Dx system performance characteristics and the economic impact (cost effectiveness) for the laboratory were assessed. Urinalysis performance compared to urine culture was assessed if urinalysis was ordered as part of the patient care set. Results When compared to urine culture, the BacterioScan had an overall performance with corresponding 95% confidence intervals of 76% (68-83) sensitivity, 84% (80-87) specificity, 55% (48-63) positive predictive value, and 93% (90-95) negative predictive value for 610 randomly selected preserved urine specimens. Urinalysis compared to urine culture overall performance was 59% (48-69) sensitivity, 87% (83-90) specificity, 53% (43-63) positive predictive value, 89% (86-92) negative predictive value for 414 urine specimens. Conclusions While the system did improve the turnaround time to a negative report, adoption of the BacterioScan system would increase the reagent budget for laboratory urine culture by 2.34 times the current cost, potentially making BacterioScan prohibitive in a budget restricted environment. Additionally, performance when compared to traditional urine culture was less than acceptable for a diagnostic laboratory to use as a stand-alone urinary tract infection screen.