Description

The Synovasure® Microbial Identification (MID) Test is a qualitative in vitro diagnostic test intended for the early detection of microbial antigen in synovial fluid of patients experiencing joint pain and/or inflammation. The Synovasure® MID Test detects antigen from:

• Staphylococcus species
• Candida species
• Enterococcus species
• P. acnes 

The test results are intended to be used as an additional test to microbial culture and to detect the presence of an organism in culture negative specimens

Included In

• Synovasure® Comprehensive PJI Panel with SynTuition^TM
• Synovasure® Comprehensive NSA Panel
• Synovasure RISC® Panel

Available in New York State?

No. This test is not available in New York State.

• Identifies >70% of organism species that cause PJI¹
• A 2023 clinical study showed the panel’s ability to detect a microorganism in >49% of culture-negative PJI samples²

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

Requested Volume

1.0 mL

Volume by Tube Type*

No Additive Tube: 1.0mL

*Tubes are provided within specimen transportation kits

Specimen Stability

7 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

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.7

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

Synovasure® Microbial Identification Testing only – $155.00

Refer to panels for overall test panel price:

• Synovasure® Comprehensive PJI Panel with SynTuitionTM
• Synovasure® Comprehensive NSA Panel
• Synovasure RISC® Panel

CPT Code

87449 (Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]), qualitative or semiquantitative; multiple-step method, not otherwise specified)

Note: This code is applied x3 for multiple tests that make up the overall test.

Ordering SKU

This test is available utilizing either the Infection Specimen Transportation Kit (00-8888-130-01) or Arthritis Specimen Transportation Kit (00-8888-160-01). 

For complete Arthritis testing, utilize the Arthritis Specimen Transportation Kit. 

For Infection testing, utilize the Infection Specimen Transportation 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].