Description

The Synovasure® Relative Inflammatory Status Classification (RISC) Panel is a comprehensive, synovial fluid test panel comprised of laboratory-developed tests (LDTs) intended to provide indications for diagnosing different types of arthritis that may correspond to higher risk levels for postoperative complications in patients experiencing knee pain and/or inflammation prior to primary knee arthroplasty.

The panel is intended to determine whether there are abnormal levels of markers present in knee synovial fluid and provide physicians with an objective result for the presence of biomarkers that may be indicative of a certain type of arthritis

The target arthritis conditions include:

• Osteoarthritis (OA)
• Rheumatoid Arthritis (RA)
• Crystal Arthritis (gout)
• Native Septic Arthritis (NSA)

Panel Test Components

Available in New York State?

No. The Synovasure RISC® Panel is not available for patients located within New York State.

Specimen Source(s)

Native Knee. 

Note: Performance on specimens from other anatomic locations is not defined.

Specimen Type

Synovial Fluid

Required Volume

7.0 mL

Volume by Tube Type*

No Additive Tube 1: 3.0mL

No Additive Tube 2: 3.0mL

EDTA 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

$186.00 (effective as of 01/01/2023)

+$212.00 if specimen is reflexed for added infection testing ($398.00 total)

CPT Codes

Product (Kit) SKU

00-8888-160-01

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].