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

Inclusion Criteria: * • Subject has a total knee and/or hip joint arthroplasty. * The subject will be evaluated for revision surgery. o Operative samples are required for full MSIS classification. * Subject is ≥22 years of age. * Subject has had no recent injections or surgeries of the joint (within past 6 weeks). * Subject has or will have all of the medical tests required to allow MSIS classification. * Subject signs informed consent form. Exclusion Criteria: * • Subject does not have a total knee and/or hip joint arthroplasty. * Healthy subjects without medical need for aspiration. * Subject did not have a revision surgery. * Subjects with a diagnostic synovial fluid specimen collection within the past 14 days. * Subjects \<22 years of age. * Subject has had an injection, lavage, or surgery of the joint within the past 6 weeks. * Subject does not have all of the medical tests required for MSIS classification. * Subject does not sign informed consent form.