Panel Description

The Synovasure® Comprehensive PJI Test Panel with SynTuition^TM is intended as an aid in diagnosing periprosthetic joint infection (PJI) through a combination of proprietary and standard of care (SoC) synovial fluid tests for adult patients experiencing joint pain and/or inflammation following a total joint arthroplasty. 

The SynTuition™ Score is generated utilizing a validated, machine-learning algorithm comprised from the test results included in the Synovasure® Comprehensive PJI Panel. The SynTuition™ Score is presented via a colorimetric scale and numerical score from >1% to <99% to aid in the test result interpretation and diagnosis of PJI.

Tests Included

• Synovasure® Alpha Defensin
• Synovasure® Microbial Identification
• Synovial Fluid C-reactive Protein (CRP)
• White Blood Cell (WBC) Count with Differential 
• Specimen Integrity

 Note: Culture (Aerobic and Anaerobic) is tested alongside the Synovasure® Comprehensive PJI Panel but is not included in the SynTuition™ Score.

Crystal Analysis is available as an optional add-on test.

Available in New York State?

A modified Comprehensive PJI Panel is available in New York State without Synovasure® Microbial Identification and SynTuition^TM.

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

$840.00

+$30.00 for Crystal Analysis optional add-on test

CPT Code

81599 (Unlisted multianalyte assay with algorithmic analysis)

Note: Panel currently under review with Center for Medicare Services (CMS) for a new Proprietary Laboratory Analysis (PLA) code

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].