title: Validation of FLEXICULT SSI-Urinary Kit for use in the primary health care setting.
abstract: The efficacy of the FLEXICULT SSI-Urinary Kit for point-of-care diagnosis and susceptibility testing of urinary tract pathogens was evaluated. The kit, which was exclusively developed for urine culture in the primary health care setting, is designed as an ordinary Petri dish divided into 6 compartments: I large one for quantitative analysis and 5 smaller ones for susceptibility testing. The agar in each small compartment contains 1 of 5 antimicrobials (trimethoprim, sulfamethoxazole, ampicillin, nitrofurantoin and mecillinam) at a concentration adjusted to the breakpoint, and growth in these compartments indicates resistance. The kit was tested in-house with 116 urinary tract pathogens and by 19 general practitioners in a field trial with 121 diagnostic urine specimens. The kit was flooded with the urine specimens for a couple of seconds, incubated overnight and read the following day. Quantitative readings were evaluated by comparing with standardized inoculi and the susceptibility tests were compared with the MIC value of the strain for each of the 5 antimicrobials. In the field trial, the quantitation had an overall error rate of 4% and correctly determined susceptibility in 93% of the tested bacteria. Although identification of the isolates is not a feature of this kit, it is suitable for point-of-care diagnosis and for susceptibility testing of uncomplicated urinary tract infections in the primary health care setting.
authors.affiliation: Department of Microbiological Research and Development, Statens Serum Institut, Copenhagen, Denmark. mbl@ssi.dk
authors.forename: Marianne
authors.initials: M
authors.lastname: Blom
authors.forename: Thomas Lund
authors.initials: TL
authors.lastname: Sørensen
authors.forename: Frank
authors.initials: F
authors.lastname: Espersen
authors.forename: Niels
authors.initials: N
authors.lastname: Frimodt-Møller
mesh_terms: D004867:Equipment Design; D006801:Humans; D008826:Microbial Sensitivity Tests / Q000295:instrumentation*; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D014552:Urinary Tract Infections / Q000175:diagnosis*
chemical_list: D011933:Reagent Kits, Diagnostic