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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 as an aid in the 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. The Synovasure Alpha Defensin Control Kit is used in the Synovasure Alpha Defensin Lateral Flow Test Kit as assayed quality control samples to monitor performance and reliability of the Synovasure Alpha Defensin Lateral Flow Test Kit.

The Synovasure Alpha Defensin Lateral Flow Test Kit (Synovasure LFT) is an immunoassay for the detection of alpha defensin levels in the synovial fluid of patients with a potential PJI. Antibodies specific to alpha defensin bind host alpha defensin in the synovial fluid, become immobilized on the lateral flow test strip, and are detected as a colored line due to the use of a colloidal gold reporter. Synovasure Alpha Defensin Lateral Flow Test Kit contains two sub components: - 1. Synovasure Alpha Defensin Lateral Flow Test Device - 2. Synovasure Lateral Flow Sample Prep Assembly The Synovasure Lateral Flow Sample Prep Assembly further contains - 1. One Synovasure Dilution Buffer Bottle - 2. One Sample Cup - 3. Two Microsafe Tubes The Synovasure Alpha Defensin Lateral Flow Test Device is a cassette that includes a reagent strip. Each cassette contains a reagent strip with all the critical components for the assay. The Synovasure Alpha Defensin Lateral Flow Test Kit is accompanied by the Synovasure Alpha Defensin Control Kit. The Synovasure Alpha Defensin Control Kit further contains - 1. Synovasure Alpha Defensin Positive Control - 2. Synovasure Alpha Defensin Negative Control - 3. Synovasure Control Reconstitution Bottle The positive control contains 0.25 mL of 16 µg/mL alpha defensin in synthetic synovial fluid and the negative control contains 0.25 mL of synthetic synovial fluid. Additional materials required but not provided include 1. Timer