Synovasure^®
Comprehensive
Infection Laboratory
Test Panels

The first and only laboratory test designed and developed to aid in the diagnosis of PJI, the Synovasure Alpha Defensin ELISA Test assesses levels of alpha defensin, an antimicrobial peptide released by neutrophils in response to a pathogen, in synovial fluid.

Highly Accurate for PJI Diagnosis²

• 94.9% Sensitivity
• 97.4% Specificity

Performance Unaffected by:

• Prior Antibiotic Administration^3,4
• Comorbidities related to inflammation^3,5
• Type/Virulence of organism^3,6

The Synovasure Microbial Identification test utilizes a novel bead-based method for 24-hour detection of microbial antigens in synovial fluid.

Validated for Common Species

Designed to identify organisms responsible for more than 70% of PJI⁷ including: 

• Staphylococcus species
  
• Enterococcus species
• Candida species
• Cutibacterium acnes (formerly P. acnes)

Performance backed by Data

• High sensitivity and specificity compared to synovial fluid culture techniques⁷ 
• Identifies more than 54% of culture-negative PJI specimens⁸

*Not Available in New York State

Designed as a proxy to the leukocyte esterase (LE) test strip, the Synovasure Neutrophil Elastase ELISA test measures the elastase enzyme released by neutrophils and is validated for use with synovial fluid.

Designed Specifically for Synovial Fluid

The Synovasure Neutrophil Elastase ELISA test may be used in place of the leukocyte esterase (LE) test strip and is not prone to the high rate of invalid results due to blood observed with LE strip.⁹

Performance Backed by Data¹⁰

Compared to the LE test strip and PMN%, the Synovasure Neutrophil Elastase ELISA demonstrates high sensitivity and specificity.

Approximately 8% of synovial fluid specimens are affected by quality including dilution and blood contamination.¹¹ As part of the panel, every specimen is tested for integrity prior to result reporting.

Specimen integrity test assesses:

• Absorbance at 280 nm (A280) – Identifies if specimen has been diluted via lavage or use of contrast agents
• Red Blood Cell Count – Verifies that specimen is characteristic of synovial fluid, not blood

In addition to proprietary tests, the Synovasure Comprehensive PJI Test Panel also includes standard of care (SoC) tests:

Synovial Fluid Culture

Aerobic and anaerobic culture to determine identity and susceptibility of organisms. Cultures are held for seven (7) days on all samples and 14 days for shoulder specimens.

White Blood Cell (WBC) Count w/ Differential

Automated, high-performance cell count that provides overall number of white blood cells and percentage breakdown of white blood cell type in synovial fluid.

A recent study shows that automated WBC count can be affected by the presence of a total joint arthroplasty, leading to higher rates of false-positive results.¹² All WBC counts >3,000 cells/ul are confirmed by a manual count.

Crystal Analysis

Polarized microscopy to detect monosodium urate (MSU) and calcium pyrophosphate dihydrate (CPPD) crystals to aid in identifying the presence of gout and CPPD disease (pseudogout).

The Synovasure Comprehensive NSA Panel offers similar tests to the Synovasure Comprehensive PJI panel that are fine-tuned for the nuances associated with a native joint through the inclusion of lactate (vs CRP) testing as part of Synovasure Alpha Defensin ELISA and crystal analysis testing.