Description

The Synovasure® Alpha Defensin ELISA test is a laboratory-developed test (LDT) to aid in diagnosing infection in patients experiencing joint pain and/or inflammation. The test assesses for presence of alpha defensins, a protein excreted by neutrophils as part of the body’s innate immune response to a microorganism.

For native joint testing, the Synovasure® Alpha Defensin ELISA test is combined with lactate results to provide a final test result.  

Panels Included In

• Synovasure® Comprehensive PJI Panel with SynTuitionTM
• Synovasure® Comprehensive NSA Panel
• Synovasure RISC® Panel

Available in New York State?

Yes. Refer to panel information for panel comprehensive panel availability.

Clinical Performance¹

• 94.9% Sensitivity
• 97.4% Specificity

Additional Performance Considerations

Performance has been demonstrated to be unaffected by:

• Prior Antibiotic Administration^2,3
• Comorbidities related to inflammation^2,4
• Type/Virulence of Organism^2,5

Note: Performance is for the diagnosis of PJI. Performance in a native joint is not defined.

Specimen Source(s)

Periprosthetic or native joint 

Note: Performance on specimens from other anatomic locations is not defined. Non-intraarticular joint fluid will be tested if Zimmer Biomet is participating in a clinical study.

Specimen Type

Synovial Fluid

Requested Volume

1.0 mL

Volume by Tube Type*

No Additive Tube: 1.0mL

*Tubes are provided within specimen transportation kits

Specimen Stability

7 days post-aspiration.

Storage

Ambient/Room Temperature prior to shipment. If being held overnight or over a weekend, store in refrigeration.

Shipping Materials

All materials needed to package and ship are included within transportation kit. Make sure to retain tracking number from provided FedEx label for tracking purposes

Shipping Guidelines

Monday to Friday

Ship specimen the same day as aspiration

Saturday to Sunday

Place in refrigeration and ship specimen on Monday

Specimens are rejected for any of the below reasons:

1.  Specimen is outside stability range

2.  Specimen is not representative of synovial fluid (i.e. blood, urine, etc.)

3.  Specimen is aspirated from a location other than the intra-articular joint space

*Note: Non-synovial fluid or intra-articular joint specimens will be tested if associated with a Zimmer Biomet-approved clinical study.

When submitting a specimen to CD Laboratories for this panel:

• • Do not use lavage, contrast or other foreign liquids to aspirate fluid

• • Ensure specimen is not overly hemolyzed

• • A completed requisition form is required with each specimen

• • A barcode label from the specimen transportation kit is required on the top of completed requisition

• • For Physician Accounts Only: Patient signature and insurance information are required

Pricing

Synovasure® Alpha Defensin for PJI only – $125.00

Refer to panels for overall test panel price:

• Synovasure® Comprehensive PJI Panel with SynTuitionTM
• Synovasure® Comprehensive NSA Panel
• Synovasure RISC® Panel

CPT Code

83516 (Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method)

Ordering SKU

This test is available utilizing either the Infection Specimen Transportation Kit (00-8888-130-01) or Arthritis Specimen Transportation Kit (00-8888-160-01). 

For complete Arthritis testing, utilize the Arthritis Specimen Transportation Kit. 

For Infection testing, utilize the Infection Specimen Transportation Kit.

How to Order Kit

Contact your local Zimmer Biomet sales representative

For result or test questions, contact CD Laboratories Customer Service at 888-981-8378 or [email protected].