Application Note: Evaluation of MiQLab Bacterial and AMR Test for Rapid Detection of Bacterial Pathogens Causing Canine UTI’s

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Bacterial and AMR Test Abstract

The objective of this study was to evaluate the analytical and clinical performance of the MiQLab™ Bacterial and AMR Test for
rapid detection of common bacterial pathogens causing urinary tract infections (UTI) in dogs. For the analytical part of the study,
limit of detection (LoD) and linearity of the test were determined for some of the pathogens most frequently isolated from
canine UTI. For the clinical study, 51 canine urine (26 positive and 25 negative) samples with available culture data were
processed on the MiQLab System using the MiQLab Bacterial and AMR Test.

The LoD of the MiQLab Bacterial and AMR test for Escherichia coli was determined to be 10,000 CFU/mL. The linearity study
demonstrated very high correlation of the MiQLab Ct outputs with quantitative culture results in CFU/mL (R2
values of 0.96 and 0.94 for E. coli and Proteus mirabilis, respectively). Similarly, the clinical study results demonstrated very high sensitivity and specificity of the MiQLab test with positive, negative, and overall percent agreements of 100%, 98.8% and 98.9%, respectively with culture results.

These results indicate that the MiQLab Bacterial and AMR Test compares favorably with traditional culture results, and
when used in a clinic-like setting, and the test would provide veterinarians a valuable diagnostic tool to enable timely
evidence-based treatment decisions.

Introduction on Bacterial UTI’s in Companion Animals

Bacterial UTI are a common clinical condition and a major reason for antimicrobial use in cats and dogs. Approximately 14% of all dogs are believed to have at least one instance of UTI in their lifetime.1 The great majority of UTI in cats and dogs are caused by a few pathogens such as Escherichia coli, Staphylococcus spp., Proteus spp., Enterobacter spp., Enterococcus spp., Klebsiella spp., and Streptococcus spp.2

Bacterial AMR Test

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Bacterial AMR Test App Note