Clinical Trial: Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection in Synovial Fluid

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational




Official Title:

Brief Summary:

  • To demonstrate the tests' performance when compared to the detection of PJI using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI.1 This criteria-based definition of PJI places emphasis on culture techniques that identify pathogens, but also provides for minor criteria that can be used to diagnose PJI;
  • To calculate the tests' clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV).