Abstract
BACKGROUND/OBJECTIVES: Urinary tract infections (UTIs) pose an increasing risk of antimicrobial resistance, and novel diagnostic tests have been developed to address the limitations of standard urine culture in these cases. It is important that these novel tests be validated for agreement and error rates against the standard antibiotic susceptibility testing (AST) methods. METHODS: Polymicrobial (≥two non-fastidious microorganisms) consecutive clinical urine specimens submitted for UTI diagnostic testing were included in this analysis. Specimens were tested with Pooled Antibiotic Susceptibility Testing (P-AST) and with broth microdilution/disk diffusion (BMD/DD) in parallel. Performance characteristics, such as essential agreement (EA%), very major errors (VMEs), and major errors (MEs), were assessed using Clinical and Laboratory Standards Institute (CLSI) standards. Specimens with P-AST-resistant and BMD/DD consensus-sensitive results were assessed for heteroresistance. Real-world clinical sample data were used to assess associations between increasing organism counts and average "sensitive" antibiotic count per sample. RESULTS: The essential agreement between P-AST and standard isolate AST was ≥90%, VMEs were <2.0%, and MEs were <3.0%, meeting the CLSI guidelines for AST verification and validation studies. When heteroresistance was accounted for, overall VMEs and MEs were both <1.5%. The presence of additional non-fastidious organisms dropped the number of average "sensitive" antibiotics from 9.8 with one organism to 2.5 with five or more organisms. The presence of fastidious organisms did not have any meaningful impact. CONCLUSIONS: P-AST, a component of the Guidance(®) UTI assay (Pathnostics, Irvine, CA, USA), performed within CLSI standards for AST in polymicrobial UTI diagnostic urine specimens.