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.
This study aims to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI and will be executed as a retrospective review of existing data. The Synovasure R\&D database consists of PJI Panel test results digitally transferred from the instruments to a laboratory information system (LIS), (CGM LabDAQ, CompuGroup Medical, Phoenix, AZ), which has high data-integrity architecture built on an industry standard ACID (atomicity, consistency, isolation, durability) compliant relational database management system (RDBMS), Microsoft SQL Server. These PJI Panel data come from SF samples submitted to CDL from various clinics and hospitals for clinical diagnostic testing between 2013 and 2022 (CD Laboratories, Towson, MD). The data are deidentified in accordance with an existing IRB approval (WCG-IRB #20150222). The deidentified data includes the institution, ordering physician information, anatomical location of the aspiration, number of days from aspiration to receipt of the sample at the lab, age, gender, and results of comprehensive infection testing including: specimen integrity (red blood cells (RBC) and absorbance at 280 nm (A280)), AD, HNE, CRP, WBC, %PMN, MID Panel, and SF-Cx. The Synovasure R\&D database will be submitted to an exclusion/inclusion screening process to target samples for inclusion in this research activity. Subsequently, samples collected between 2017 and 2022 will be randomly selected for inclusion in this study. Classification of positive and negative samples will be according to the criteria for diagnosis of PJI using Synovasure Comprehensive PJI Synovial Fluid Panel as defined in Table 1. Only samples classified as Infected (positive) and Not Infected (negative) will be qualified for further enrichment. Case report forms will be completed with data obtained through in-person or remote review of hospital and/or physician office records to enrich the PJI Panel database with the elements included in the 2011 MSIS, 2013 ICM, 2018 New Definition of PJI, 2018 ICM, and 2021 EBJIS definitions of PJI.
Study Type
OBSERVATIONAL
Enrollment
810
The Synovasure Comprehensive PJI Test Panel (PJI Panel) is a laboratory-developed test (LDT) panel (CD Laboratories, CLIA Registration No.: 21D0216863) intended to aid the diagnosis of PJI.
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, United States
Positive/Negative Percent Agreement between PJI RISC Panel and Clinical Guidelines
The primary endpoint of this study is the rate of agreement (positive and negative) for the diagnosis of PJI between the PJI Panel and the previous and current clinical guidelines.
Time frame: 1 year
Positive/Negative Predictive Value of PJI RISC Panel
The secondary endpoint is defined by the estimate of positive predictive value (PPV) and negative predictive value (NPV) of the PJI Panel compared to the previous and current clinical guidelines.
Time frame: 1 year
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