Laboratory Test Catalog
Synovasure® Alpha Defensin, PJI
This test can be ordered as a stand-alone test option.
Description
The Synovasure® Alpha Defensin lab developed test (LDT) for PJI consists of assays for synovial fluid alpha defensin ELISA and C-reactive Protein (CRP) to aid in the diagnosis of periprosthetic joint infection (PJI).
This test is not intended to be used to determine timing for reimplantation in 2-stage procedures
Panel Test Components
| Test |
|---|
| Alpha Defensin, synovial fluid |
| C-reactive Protein (CRP), synovial fluid |
Panels Included In
| Panel |
|---|
| Synovasure Comprehensive PJI Panel (Go to Panel) |
Available in New York State?
Yes. This test is available to patients within New York state.
Specimen Source(s)
Periprosthetic joint prior to implant removal (i.e. Hip or Knee).
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
Required Volume
1.0 mL
Volume by Tube Type*
No Additive Tube: 1.0mL
*Tubes are provided within specimen transportation kits
Specimen Stability
4 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 (i.e. more than 5 days)
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
$155.00 (effective as of 01/01/2023)
CPT Codes
| Test | CPT Code |
|---|---|
| Alpha Defensin | 83516 |
| C-reactive Protein (CRP) | 86140 |
Ordering SKU
This test utilizes the Infection Specimen Transportation Kit (00-8888-130-01). The test is selected using the requisition form provided within the 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].