WebAug 16, 2016 · Synovasure® PJI ELISA Test results are intended to be used in conjunction with other clinical and diagnostic findings to aid in a patient's diagnosis of infection. Synovasure® PJI Lateral Flow Test is a qualitative in vitro diagnostic device intended as an adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid ... WebRelationships between Synovasure results and categorical variables were calculated using the Fisher’s exact test and t-test for continuous variables in testing for significance. A p-value of 0.05 or less was considered significant. Results. Synovasure was performed on 69 patients and 78 joints. Of the 78 joints, eight were performed on native ...
510(k) Premarket Notification - Food and Drug Administration
WebBackground and purpose - The Synovasure lateral flow test was developed as a rapid test for the detection or exclusion of periprosthetic joint infection (PJI). 3 studies have reported promising results on its diagnostic value in total joint revision surgery. Web• Results usually available within 24 hours • Simple, easy-to-read reports designed specifically for orthopedics • No out-of-pocket costs; covered by most insurance … fulton county family law information center
Qualitative α-defensin test (Synovasure) for the diagnosis of ... - PubMed
WebAug 1, 2024 · The combined failure to detect an elevated WBC count, because of either false-negative or invalid results, was 47.1% and 41.4% for the Roche and Siemens test strips, respectively. The combined failure to detect an elevated WBC count because of false-negative or invalid results for the Synovasure NE immunoassays was 8.0% and 9.2%, … WebJan 3, 2024 · The overall accuracy of the Synovasure test was 96.9% (95% CI, 93.4% to 98.9%), 189 of 195 cases. Conclusions: Our results suggest that the Synovasure periprosthetic joint infection test has a very high accuracy in diagnosing periprosthetic infections after total hip arthroplasty or total knee arthroplasty. WebAlpha Defensin, Lateral Flow Assay, Synovial Fluid Useful For Detection of alpha defensins 1-3, human host response proteins, in synovial fluid of adults with a total joint … fulton county family law division