Director, Infectious Disease Antech Diagnostics, MARS Science & Diagnostics Kalamazoo, MI, United States
Abstract:
Background: Routine veterinary serologic screening for Borrelia antibodies in dogs is recommended in Lyme endemic regions.
Objective: To determine: 1. The performance of trūRapid FOUR® lateral flow immunoassay (trūRapid FOUR®), Antech Diagnostics, Mars Petcare Science & Diagnostics, for detection of C6 antibodies in dogs as compared to an indirect fluorescent antibody (IFA) test, and 2. Agreement between trūRapid FOUR® and a point-of-care (POC) test (SNAP® 4Dx® Plus, IDEXX). Animals: Anonymized remnant serum samples submitted to a veterinary reference laboratory for wellness testing from individual client-owned dogs in the United States.
Methods: Operators processed samples (n =270) using all three tests: 1. trūRapid FOUR®, 2. POC, and 3. IFA, following manufacturers’ instructions and blinded to previous results. All samples underwent analysis with trūRapid FOUR® and IFA, while a subset of 128 samples, selected based on sample volume, were also tested with POC. Sensitivity and specificity were calculated for trūRapid FOUR® using IFA as the standard. Kappa was calculated for trūRapid FOUR® and IFA, and trūRapid FOUR® and the POC test.
Results: trūRapid FOUR® demonstrated a sensitivity of 99.0% (95% CI: 94.8–100%) and specificity of 98.2% (95% CI: 94.8–99.6%) compared to IFA, with a high level of agreement (Kappa) between: 1. trūRapid FOUR® and IFA 0.97 (95% CI: 0.94-0.99) and 2. trūRapid FOUR® and POC 0.97 (95% CI: 0.94-0.99). Clinical Importance: The trūRapid FOUR® is a highly accurate tool for identifying canine antibodies to the C6 peptide of Borrelia burgdorferi, supporting its use in veterinary tick-borne pathogen surveillance.
