In June 2019, OrthoBuzz reported on the FDA approval of a rapid, lateral-flow alpha defensin test that helps detect periprosthetic joint infections (PJIs) from synovial fluid. In the January 20, 2021 issue of The Journal of Bone & Joint Surgery, Deirmengian et al. report findings from the Level II diagnostic-accuracy study that led to this FDA approval.
The authors compared diagnostic sensitivity and specificity of the lateral-flow alpha defensin test with the “gold-standard” PJI diagnostic criteria endorsed by the Musculoskeletal Infection Society (MSIS) in 2013. They made the comparison with 2 groups: a prospective patient cohort of 305 patients with a failed hip or knee arthroplasty (57 of whom were determined by MSIS criteria to have a PJI) and among a “control” cohort of 462 synovial fluid samples (65 of which met MSIS criteria for PJI).
After excluding 17 patients from the prospective cohort who had grossly bloody aspirates, the authors found a sensitivity of 94.3% and a specificity of 94.5% for the lateral-flow test in that group. Among the control cohort, the lateral-flow test’s sensitivity was 98.5% and its specificity was 98.2%. Furthermore, after combining data from the 2 cohorts, Deirmengian et al. found no performance difference between the lateral-flow test (which yields results in 10 to 15 minutes) and the lab-based alpha defensin ELISA test (which typically yields results in 24 hours). Finally, in a nonstatistical descriptive comparison between the 2 alpha defensin tests and 4 other individual lab tests used in the MISI criteria to diagnose PJI (such as synovial fluid white blood cell count and erythrocyte sedimentation rate), the authors concluded that “alpha defensin tests led to the highest raw number of correct diagnoses (accuracy).”
The 2018 International Consensus Meeting on Orthopaedic Infections included alpha defensin as a minor criterion. That decision, along with these findings and the FDA approval of the lateral-flow test, should lead to increased adoption of the rapid test—and to more data being published on its clinical utility.