Description

The Cartilage Oligomeric Matrix Protein (COMP) ELISA is a quantitative laboratory-developed test (LDT) intended to detect the presence of the COMP biomarker, a cartilage breakdown biomarker, in the synovial fluid of patients experiencing knee pain or inflammation with suspected arthritis. Results are combined with results from Interleukin-8 (IL-8)Cartilage Oligomeric Matrix Protein (COMP) in a COMP/IL-8 ratio provide clarification in diagnosing OA

Panels Included In

Available in New York State?

No. This test is not available for patients within New York state. In addition, the Synovasure Comprehensive NSA Panel and Synovasure RISC Panels are not available within the state. A modified version of the Synovasure Comprehensive PJI Panel CAN be ordered for patients in the state, but this panel does not include the Synovasure Microbial Identification test.

Specimen Source(s)

Native 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

Reasons for Specimen Rejection

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

This test is not available as a stand-alone test option. For pricing for the test panel, please refer to the Synovasure RISC® Panel test page.

CPT Codes

Ordering SKU

This test utilizes the Arthritis Specimen Transportation Kit (00-8888-160-01). The test is selected using the requisition form provided within the kit as part of the Synovasure RISC Panel.

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].