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The recently FDA-cleared alpha-defensin lateral flow test is a highly accurate ten-minute test for diagnosing periprosthetic joint infection (PJI), a serious and costly complication of total joint replacement, reports a study in The Journal of Bone & Joint Surgery. The magazine is published in the Lippincott portfolio in collaboration with Wolters Kluwer.
The study shows “solid diagnostic performance” of the alpha-defensin lateral flow test, according to the report by Carl Deirmengian, MD, of the Rothman Orthopedic Institute, Wynnewood, Pa., And colleagues. The data led to the US Food and Drug Administration clearing the new test – the first rapid test specifically designed and validated to help diagnose PJI. The alpha-defensin test is also the first diagnostic test specifically designed for use in orthopedics.
The lateral flow test allows for quicker and easier diagnosis of PJI
Periprosthetic joint infection is a devastating complication of failed total hip or knee replacement and can be difficult for orthopedic surgeons to diagnose. Accounting for 25% of total knee replacement failures and 16% of total hip replacement failures, PJI has a major impact on patients’ lives and healthcare costs.
Alpha defensins are peptides produced by the immune system specifically in response to an infection. The new test measures alpha-defensin levels in synovial fluid samples from the joint. The new alpha-defensin lateral flow test is a simple test kit that provides results in 10-20 minutes. An alpha-defensin enzyme-linked immunosorbent assay (ELISA) is also available. With ELISA, the sample must be sent to a laboratory, providing results within 24-48 hours.
Dr. Deirmengian and colleagues designed a formal study to evaluate the performance of the alpha-defensin lateral flow test in diagnosing PJI. The study included synovial fluid samples from 305 patients with knee (203 patients) or hip (102 patients) arthroplasty. Of these, 57 patients had PJI, based on the expert review.
The alpha-defensin lateral flow test was very accurate in distinguishing between patients with and without PJI. The sensitivity and specificity of the alpha-defensin lateral flow assay were 94.3% and 94.5%, respectively, excluding rare poor-quality synovial fluid samples composed of consistent blood (greater than 1 M RBC / μL). Including poor quality samples, the test had a sensitivity of 89.5% and a specificity of 94.8%.
Another important finding was that the diagnostic performance of the rapid lateral flow test matched the accuracy of the laboratory test for alpha-defensin. Both tests demonstrated diagnostic performance that closely matched the standard approach to diagnosing PJI, based on a combination of clinical findings and laboratory tests (Musculoskeletal Infection Society criteria).
Our study enriches the literature by extending the evaluation of alpha defensin to a formal diagnostic study, thus confirming the robust diagnostic performance demonstrated by previous studies using other methods. “
Dr. Carl Deirmengian, MD, The Rothman Orthopedic Institute, Wynnewood, Pa. And co-authors
They emphasize the need for further studies to compare different approaches to diagnosis in patients with suspected PJI.
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