A Single Source for Joint Infection Diagnosis
Joint infection can occur in a patient with a joint prosthesis (Periprosthetic Joint Infection, or PJI) or a patient without a prosthesis (Native Septic Arthritis, or NSA). Diagnosing joint infection can be challenging and making a comprehensive laboratory workup important to provide a complete view of the potential organism that may be the source of the potential infection.
At CD Laboratories, we offer comprehensive synovial fluid testing solutions to aid in the diagnosis of joint infection – Synovasure® Comprehensive PJI Panel and Synovasure Comprehensive NSA Panel – through a combination of proprietary and standard of care (SoC) tests and fulfills the 2018 International Consensus Meeting (ICM) PJI diagnosis criteria. Learn more about the criteria, click here.
Joint infection can occur in a patient with a joint prosthesis (Periprosthetic Joint Infection, or PJI) or a patient without a prosthesis (Native Septic Arthritis, or NSA). Diagnosing joint infection can be challenging and making a comprehensive laboratory workup important to provide a complete view of the potential organism that may be the source of the potential infection.
At CD Laboratories, we offer comprehensive synovial fluid testing solutions to aid in the diagnosis of joint infection – Synovasure® Comprehensive PJI Panel with SynTuitionTM and Synovasure Comprehensive NSA Panel – through a combination of proprietary and standard of care (SoC) tests and fulfills the 2018 International Consensus Meeting (ICM) PJI diagnosis criteria. Learn more about the criteria, click here.
Synovasure Comprehensive Infection Panels
The Synovasure Comprehensive PJI Panel offers proprietary and standard of care (SoC) tests to aid in the diagnosis of Periprosthetic Joint Infection (PJI). The panel includes:
- Synovasure Alpha Defensin
- Synovasure Microbial Identification*
- Synovial Fluid C-reactive Protein (CRP)
- Culture
- White Blood Cell (WBC) with differential
Optional Add-on: Crystal Analysis
For additional information on tests, click here
*Note: Synovasure Microbial Identification is not available in New York
The Synovasure Comprehensive NSA Panel offers proprietary and standard of care (SoC) tests to aid in the diagnosis of Native Septic Arthritis (NSA). The panel includes:
- Synovasure Alpha Defensin for NSA (alpha defensin and lactate)
- Synovasure Microbial Identification
- Culture
- White Blood Cell (WBC) with differential
- Crystal Analysis
For additional information on tests, click here
Note: Synovasure Comprehensive NSA Panel is not available in New York
The Synovasure Comprehensive PJI Panel with SynTuition offers proprietary and standard of care (SoC) tests that are combined into a proprietary, validated machine learning algorithm providing a probability score to aid in the diagnosis of Periprosthetic Joint Infection (PJI). The panel includes:
- Synovasure Alpha Defensin
- Synovasure Microbial Identification*
- Synovial Fluid C-reactive Protein (CRP)
- White Blood Cell (WBC) with differential
Optional Add-on: Crystal Analysis
Culture is performed alongside the Synovasure Comprehensive PJI Panel with SynTuition, but is not included within the score.
For additional information on tests, click here
*Note: SynTuition and the Synovasure Microbial Identification is not available in New York.
Note: SynTuition is available as a laboratory developed test (LDT)
The Synovasure Comprehensive NSA Panel offers proprietary and standard of care (SoC) tests to aid in the diagnosis of Native Septic Arthritis (NSA). The panel includes:
- Synovasure Alpha Defensin for NSA (alpha defensin and lactate)
- Synovasure Microbial Identification
- Culture
- White Blood Cell (WBC) with differential
- Crystal Analysis
For additional information on tests, click here
Note: Synovasure Comprehensive NSA Panel is not available in New York
Note: All specimens are tested for specimen integrity as part of the Synovasure Comprehensive Infection Panels
What is SynTuitionTM?
SynTuitionTM is the first-of-its-kind machine learning algorithm-based score that combines multiple biomarker analyte test results to aid in the diagnosis of PJI through a streamlined interpretation.
Accurate1
- High sensitivity and specificity (vs. 2018 ICM PJI definition)
- Minimizes inconclusive diagnosis rate to 0.6%
Timely
- Results within 24 hours of receipt at CD Laboratories
Simple
- Easy-to-understand graphical representation of score and individual test results provided on results report
Synovasure Alpha Defensin ELISA
Alpha defensin is an antimicrobial peptide released in response to a pathogen in synovial fluid which is used as a biomarker to aid in the diagnosis of joint infection.
The Synovasure Alpha Defensin ELISA Test is a laboratory-based test, only available from CD Laboratories, to detect elevated alpha defensin levels in synovial fluid.
Clinically Validated Performance
- High sensitivity and specificity based on 2013 MSIS criteria for PJI1
- Performance unaffected by:
- Prior antibiotic administration2,3
- Comorbidities related to inflammation2,4
- Type and/or virulence of organism2,5
Synovasure Microbial Identification
Only available from CD Laboratories, the Synovasure Microbial Identification (ID) Test offers a novel method for early detection of microbial antigen of microorganism species that cause more than 70% of PJI7 in 24 hours including:
- Staphylococcus species
- Enterococcus species
- Candida species
- C. acnes
Performance Backed by Data
- Demonstrated >94% overall panel sensitivity for the detection of microorganism species in infected synovial fluid samples6,7
- Demonstrated >98% overall panel specificity in non-infected synovial fluid samples6,7
- A 2023 clinical study showed the panel’s ability to detect a microorganism in >49% of culture-negative PJI samples7
*Synovasure Microbial Identification is not available in New York State
Species | Sensitivity6 | Specificity6 |
|---|---|---|
Staphylococcus species | 94% | 99% |
Enterococcus species | 97% | 99% |
Candida species | 90% | 99% |
Due to difficulty culturing C. acnes, sensitivity and specificity data is not available.
Staphylococcus species
- M40003 – Synovasure Alpha Defensin ELISA Instructions for Use (IFU), 2023.
- Deirmengian C., et al. Combined Measurement of Synovial Fluid a-Defensin and C-Reactive Protein Levels: Highly Accurate for Diagnosing Periprosthetic Joint Infection. Journal of Bone and Joint Surgery. 96(17):1439-45, 2014.
- Shahi A., et al. The Alpha-Defensin Test for Periprosthetic Joint Infection is Not Affected by Prior Antibiotic Administration. Clinical Orthopedics and Related Research. 474(7):1610-5, 2016.
- Miyamae Y., et al. Diagnostic Accuracy of the Alpha-Defensin Test for Periprosthetic Joint Infection in Patients with Inflammatory Diseases. Journal of Arthroplasty. 34(8):1767-1771, 2019.
- Deirmengian C., et al. The C-reactive Protein May Not Detect Infections Caused by Less-Virulent Organisms. Journal of Arthroplasty. 31(9 Suppl):152-155, 2016.
- M40022 – Synovasure Microbial Identification Instructions for Use (IFU), 2022.
- Toler K, et al. Nationwide Results of Microorganism Antigen Testing as a Component of Preoperative Synovial Fluid Analysis. The Journal of Bone and Joint Surgery, 105(6):448-454, 2023.