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All specimens are evaluated for white blood cell (WBC) count with differential via automated cell count (all counts >3,000 cells confirmed with manual count). If final reported WBC count is >3,000 cells/μL or neutrophil is >70%, specimens are reflexed to Synovasure Alpha Defensin for NSA (alpha defensin and lactate), Synovasure Microbial Identification and Fluid Culture.��

Synovasure Alpha Defensin for NSA

Laboratory-developed test (LDT) for alpha defensin biomarker and lactate. The alpha defensin biomarker demonstrates high level of accuracy in identifying infection¹* and is unaffected by:

• Prior Antibiotic Administration^2,3
• History of Inflammatory Conditions^2,4
• Type/Virulence of Organism^2,5

**Validation and performance of alpha defensin is based on cases of PJI and has not been defined for NSA due to no comparative “Gold Standard” criterion.

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Synovasure Microbial Identification

Novel, antigen bead-based test for early identification of potential infection causing organisms including:

• Staphylococcus species
• Enterococcus species
• Candida species
• C. acnes

Synovasure Microbial Identification is also capable of identifying more than 54% of culture-negative PJI specimens⁶.

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Fluid Culture

Aerobic and anaerobic culture performed to aid in the diagnosis and treatment of infection.

All fluid cultures are held for seven (7) days.

The first laboratory test to aid in the diagnosis of OA, Synovasure OA testing includes assessment of Cartilage Oligomeric Matrix Protein (COMP) and Interleukin-8 (IL-8) concentration levels in synovial fluid.

• Utilization of COMP/IL-8 ratio to differentiate primary versus secondary OA patients
• Increased IL-8 shows higher likelihood of inflammatory condition compared to OA
• Highly Accurate⁷
  • 87.0% Sensitivity
  • 88.9% Specificity

Rheumatoid Arthritis diagnostic testing includes synovial fluid assessment of inflammatory biomarkers concentrations commonly tested via blood – Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Rheumatoid Factor (RF).

• Testing closer to the knee pain source – synovial fluid vs. blood
• Sufficiently capable to discriminate RA and Non-RA patients⁷
• Effective “Rule-In” Test⁷
  • Demonstrated 100% specificity

High powered microscopy to assess synovial fluid for the presence of Monosodium Urate (MSU) and Calcium Pyrophosphate Dihydrate (CPPD) crystals commonly found in Crystalline arthritis (gout and pseudogout).