title: Performance of a New Rapid Immunoassay Test Kit for Point-of-Care Diagnosis of Significant Bacteriuria.
abstract: Urinary tract infections (UTIs) are frequently encountered in clinical practice and most commonly caused by Escherichia coli and other Gram-negative uropathogens. We tested RapidBac, a rapid immunoassay for bacteriuria developed by Silver Lake Research Corporation (SLRC), compared with standard bacterial culture using 966 clean-catch urine specimens submitted to a clinical microbiology laboratory in an urban academic medical center. RapidBac was performed in accordance with instructions, providing a positive or negative result in 20 min. RapidBac identified as positive 245/285 (sensitivity 86%) samples with significant bacteriuria, defined as the presence of a Gram-negative uropathogen or Staphylococcus saprophyticus at ≥10(3) CFU/ml. The sensitivities for Gram-negative bacteriuria at ≥10(4) CFU/ml and ≥10(5) CFU/ml were 96% and 99%, respectively. The specificity of the test, detecting the absence of significant bacteriuria, was 94%. The sensitivity and specificity of RapidBac were similar on samples from inpatient and outpatient settings, from male and female patients, and across age groups from 18 to 89 years old, although specificity was higher in men (100%) compared with that in women (92%). The RapidBac test for bacteriuria may be effective as an aid in the point-of-care diagnosis of UTIs especially in emergency and primary care settings.
authors.affiliation: Department of Medicine, University of Washington, Seattle, Washington, USA stapl@uw.edu.
authors.forename: Ann E
authors.identifier: http://orcid.org/0000-0003-0130-8659
authors.initials: AE
authors.lastname: Stapleton
authors.affiliation: Department of Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: Marsha E
authors.initials: ME
authors.lastname: Cox
authors.affiliation: Silver Lake Research Corporation, Monrovia, California, USA.
authors.forename: Robert K
authors.initials: RK
authors.lastname: DiNello
authors.affiliation: Silver Lake Research Corporation, Monrovia, California, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Geisberg
authors.affiliation: Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: April
authors.initials: A
authors.lastname: Abbott
authors.affiliation: Department of Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: Pacita L
authors.initials: PL
authors.lastname: Roberts
authors.affiliation: University of Miami, Miller School of Medicine, Miami, Florida, USA.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Hooton
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001437:Bacteriuria / Q000175:diagnosis*; D003955:Diagnostic Tests, Routine / Q000379:methods*; D004926:Escherichia coli / Q000302:isolation & purification; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D057790:Staphylococcus saprophyticus / Q000302:isolation & purification; D013997:Time Factors; D055815:Young Adult