In this study, the Sponsor wants to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Samples included in the Synovasure R\&D database from patients tested for PJI through the PJI Panel at CDL.
Exclusion Criteria:
* From Synovasure Database
* Samples not submitted to CDL for PJI testing
* Samples submitted to CDL from Institutions not participating in this study
* Samples designated as being from anatomical locations other than "left hip", "left knee", "right hip", "right knee
* Samples without SF-Cx results
* Samples without SF-CRP results
* Samples without AD results
* Samples without WBC results
* Samples without %PMN results
* Samples with RBCs ≥ 1 million
* Samples not meeting A280 specification for integrity: Remove A280 \< 0.342 and A280 \> 1.19
* Samples received more than four (4) days after aspiration
* Patient age \< 18 From Institutional Medical Record
* Patient who did not undergo surgical interventions after PJI Panel Testing
* Synovasure testing performed less than 6 weeks after index surgery
* Evidence of sinus tract communicating with the joint
* Samples aspirated from patients using a spacer at the time of aspiration
What they're measuring
1
Positive/Negative Percent Agreement between PJI RISC Panel and Clinical Guidelines