Alpha-defensin was recently introduced as a new biomarker having a very high accuracy to rule out periprosthetic joint infection (PJI). A new rapid lateral flow version of the Alpha-defensin test was developed and introduced to detect high levels of Alpha-defensin in synovial fluid quickly and with ease. We conducted a single-centre prospective clinical study to compare the results of the Alpha-defensin rapid test* against the conventional diagnostics according to MSIS criteria. A total of 223 consecutive patients with painful total hip or knee arthroplasty were enrolled into the study. In all patients, blood C-reactive protein was measured and joint aspirations were performed. From the synovial fluid a leukocyte cell count with granulocyte percentage, microbiology cultures and Leukocyte Esterase tests were carried out according to the recommendation of MSIS for diagnosing PJI. At the same time, the Lateral Flow Test* was performed from the aspirate. 191 subjects with 195 joint aspirations (96 hips, 99 knees) were included in final clinical and statistical evaluation. We had 119 joints with an aseptic revision and 76 joints with PJI.Aim
Method
A key of success in the treatment of prosthetic joint infection (PJI) is the proper diagnosis. There is a lack of diagnostic tools able to diagnose a PJI with high accuracy. Alpha-defensin has been proposed as possible solution but the available literature is still limited. This prospective study was carried out in order to determine (1) what is the sensitivity, the specificity, the positive and the negative predictive value of the Alpha-defensin immunoassay test in diagnosing PJI; (2) which clinical features may be responsible for false positive and false negative results? Preoperative aspiration was performed in patients presenting with a painful hip/knee arthroplasty. Metallosis, other inflammatory comorbidities and previous/concomitant antibiotic therapy were not considered as exclusion criteria. Patients with inadequate amount of synovial fluid for culture were excluded. At time of revision synovial fluid samples were taken in the OR in order to perform Alpha-defensin assay. During surgical debridement tissue samples for cultures were obtained. Prospectively, 156 patients (65 knees and 91 hips) were included. A diagnosis of PJI was confirmed in 29 patients.Aim
Method