Laboratory Test Catalog
Synovasure® Comprehensive PJI Panel
Panel Description
The Synovasure® Comprehensive Periprosthetic Joint Infection (PJI) Panel is a comprehensive, synovial fluid test panel to aid in the diagnosis of Periprosthetic Joint Infection (PJI) through the use of multiple biomarkers. Testing using this panel provides sufficient results to fulfill diagnostic criteria from major societies including Musculoskeletal Infection Society (MSIS), International Consensus Meeting (ICM) and European Bone and Joint Infection Society (EBJIS).
Panel Test Components
| Test |
|---|
| Synovasure® Alpha Defensin for PJI (Alpha Defensin and C-reactive Protein (CRP)) |
| Synovasure® Microbial Identification (MID) |
| Synovasure® Neutrophil Elastase (HNE) |
| Synovial Fluid Culture |
| White Blood Cell (WBC) Count with Differential |
| Optional Add-on: Crystal Analysis |
Available in New York State?
Yes. A modified version of this panel is available for patients located within New York State. This modified panel includes all tests listed above EXCEPT Synovasure® Microbial Identification.
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
6.5 mL (+0.5mL if adding Crystal Analysis test)
Volume by Tube Type*
No Additive Tube 1: 3.0mL
No Additive Tube 2: 3.0mL
EDTA Tube: 0.5mL (+0.5mL if adding Crystal Analysis test)
*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
$259.00 (effective as of 01/01/2023)
+$30.00 if adding Crystal Analysis test
CPT Codes
| Test | CPT Code |
|---|---|
| Synovasure® Alpha Defensin for PJI (Alpha Defensin and CRP) | Alpha Defensin: 83516 CRP: 86140 |
| Synovasure® Microbial Identification (MID) | 87449 (x3) |
| Synovasure® Neutrophil Elastase (HNE) | 83516 |
| Synovial Fluid Culture | Aerobic: 87070 Anaerobic : 87075 |
| White Blood Cell (WBC) Count with Differential | 89051 |
| Optional Add-on: Crystal Analysis | 89060 |
Product (Kit) SKU
00-8888-130-01
How to Order
Contact your local Zimmer Biomet sales representative to order.
For result or test questions, contact CD Laboratories Customer Service at 888-981-8378 or [email protected].