Excellent Performance of FDA-Authorized Test for Periprosthetic Joint Infection
For Immediate Release
November 9, 2019
Dallas, November 9, 2019 – The study, “Prospective, Multicenter, Adjudicator-Blinded Clinical Trial of the Alpha-Defensin Lateral Flow Test for Periprosthetic Infection,” was presented by Carl A. Deirmengian, MD at the 2019 AAHKS Annual Meeting. The study evaluated the alpha-defensin (AD) lateral-flow test for periprosthetic joint infection (PJI) for Food and Drug Administration (FDA) submission and also compared it to the AD laboratory-based test.
Dr. Deirmengian and co-authors, Carlos A. Higuera, MD, Janet D. Conway, MD, John Madigan, MD, Sujith Kallur, MS, Robin Ratel, MD and Keith Kardos, PhD, followed FDA requirements in designing the trial. Methods included a cohort of patients anticipating revision hip or knee arthroplasty and laboratory-derived fresh synovial fluid sample cohort of subjects meeting Musculoskeletal Infection Society (MSIS) criteria. A blinded panel of three expert adult reconstruction surgeons independently adjudicated each subject.
The AD lateral flow test for PJI demonstrated a sensitivity of 94.3% and specificity of 94.8% in the combined cohorts. In the prospective cohort alone, the AD lateral flow test had a sensitivity of 89.7% and specificity of 94.8%. The sensitivity and specificity of the AD lateral flow test in combined cohorts did not demonstrate a statistically significant difference from the AD laboratory-based test.
Authors note that with “excellent performance,” the AD lateral-flow test is now the first FDA-authorized diagnostic test to aid in detecting PJI.
Synovasure® Alpha Defensin Lateral Flow Test Intended Use
The Synovasure® Alpha Defensin Lateral Flow Test Kit is a qualitative, visually read immunochromatographic assay for the detection of human host response proteins, Alpha Defensins 1-3, in the synovial fluid of adults with a total joint replacement who are being evaluated for revision surgery. The Synovasure Alpha Defensin Lateral Flow Test Kit results are intended to be used in conjunction with other clinical and diagnostic findings to aid in diagnosis of periprosthetic joint infection (PJI). The Synovasure Alpha Defensin Lateral Flow Test Kit is not intended to identify the etiology or severity of a PJI.
About the American Association of Hip and Knee Surgeons (AAHKS)
Established in 1991, the mission of AAHKS is to advance hip and knee patient care through education, advocacy and research. AAHKS has a membership of over 4,000 surgeons and other hip and knee health care professionals.
Denise Smith Rodd