Performance of a new rapid immunoassay test kit for point-of-care diagnosis of significant bacteriuria

Ann E. Stapleton, Marsha E. Cox, Robert K. Di Nello, Mark Geisberg, April Abbott, Pacita L. Roberts, Thomas Hooton

Research output: Contribution to journalArticle

5 Citations (Scopus)

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<sup>3</sup> CFU/ml. The sensitivities for Gram-negative bacteriuria at ≥10<sup>4</sup> CFU/ml and> 10<sup>5</sup> 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.

Original languageEnglish (US)
Pages (from-to)2805-2809
Number of pages5
JournalJournal of Clinical Microbiology
Volume53
Issue number9
DOIs
StatePublished - Sep 1 2015

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Point-of-Care Systems
Bacteriuria
Immunoassay
Urinary Tract Infections
Staphylococcus saprophyticus
Emergency Medical Services
Lakes
Microbiology
Silver
Inpatients
Primary Health Care
Outpatients
Age Groups
Urine
Escherichia coli
Sensitivity and Specificity
Research

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Performance of a new rapid immunoassay test kit for point-of-care diagnosis of significant bacteriuria. / Stapleton, Ann E.; Cox, Marsha E.; Di Nello, Robert K.; Geisberg, Mark; Abbott, April; Roberts, Pacita L.; Hooton, Thomas.

In: Journal of Clinical Microbiology, Vol. 53, No. 9, 01.09.2015, p. 2805-2809.

Research output: Contribution to journalArticle

Stapleton, Ann E. ; Cox, Marsha E. ; Di Nello, Robert K. ; Geisberg, Mark ; Abbott, April ; Roberts, Pacita L. ; Hooton, Thomas. / Performance of a new rapid immunoassay test kit for point-of-care diagnosis of significant bacteriuria. In: Journal of Clinical Microbiology. 2015 ; Vol. 53, No. 9. pp. 2805-2809.
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