Synovasure® Comprehensive Infection Laboratory Test Panels

A Leader in Synovial Fluid Laboratory Testing

A Single Source for Joint Infection Diagnosis*

A timely, accurate diagnosis of joint infection is critical to developing a patient treatment plan. Through our facility CD Laboratories, we offer a comprehensive panel of tests to aid in the diagnosis of joint infection with a single joint aspiration. A leader in synovial fluid testing, CD Laboratories has tested over 180,000 synovial fluid specimens since 2013.

The Synovasure Comprehensive Infection Laboratory Test Panels combine standard of care (SoC) tests with proprietary tests only available through Zimmer Biomet to aid in the diagnosis of Periprosthetic Joint Infection (PJI) and Native Septic Arthritis (NSA) including:

Synovasure Diagnostic ZB.com 1000x1000px Graphics-Circle Diagram

A Streamlined Process

Submitting a specimen to CD Laboratories uses a simple, streamlined process following aspiration to result reporting.

Synovasure Diagnostic ZB.com 1000x1000px Graphics-Streamlined Process

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 Diagnosis1

  • 95% Sensitivity
  • 97% Specificity

 

Performance Unaffected by:

  • Prior Antibiotic Administration2,3
  • Comorbidities related to inflammation2,4
  • Type/Virulence of organism2,5

The Synovasure Microbial Identification test utilizes a novel bead-based method, only offered through CD Laboratories, a subsidiary of Zimmer Biomet, for 24-hour detection of microbial antigens in synovial fluid.

Validated for Common Species

Designed to identify organisms responsible for more than 70% of PJI6 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 techniques

Organism genus

Sensitivity6

Specificity6

Staphylococcus species

94%

99%

Enterococcus species

97%

99%

Candida species

90%

99%

Due to difficulty in culturing C.acnes, performance data is unavailable.

  • Identifies more than 54% of culture-negative PJI specimens7

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 strip8

Performance Backed by Data9

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

 

Sensitivity

Specificity

vs. LE Test Strip

96%

89%

vs. PMN count

100%

92%

Approximately 8% of synovial fluid specimens are affected by quality including dilution and blood contamination.10 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.11 All WBC counts >3,000 cells/mm3 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 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.

Additional Information

  1. Synovasure Alpha Defensin ELISA Test Instructions for Use (IFU), 2018.
  2. 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.
  3. 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.
  4. 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
  5. Deirmengian C., et al. The C-reactive Protein May Not Detect Infections Cause by Less-Virulent Organisms. Journal of Arthroplasty. 31(9 Suppl):152-5, 2016.
  6. M40022B – Synovasure Microbial Identification Instructions for Use (IFU), 2019.
  7. Deirmengian C., et al. Diagnostic Performance of the Synovasure MID Test [abstract]. In: Proceedings of the MSIS Annual Meeting; 2019 Aug 2-3; New York, NY
  8. Deirmengian C., et al. The Leukocyte Esterase Test Strip is a Poor Rule-Out Test for Periprosthetic Joint Infection. Journal of Arthroplasty. 33(8):2571-2574, 2018.
  9. M40016B – Synovasure Neutrophil Elastase ELISA Instructions for Use (IFU), 2017.
  10. Deirmengian C., et al. Synovial Fluid Aspirates Diluted with Saline or Blood Reduce the Sensitivity of Traditional and Contemporary Synovial Fluid Biomarkers. Clinical Orthopaedics and Related Research. DOI 10.1097/CORR.0000000000001188, 2020.
  11. Deirmengian C., et al. False-Positive Automated Synovial Fluid White Blood Cell Counting is a Concern for Both Hip and Knee Arthroplasty Aspirations. Journal of Arthroplasty. 35(6S):S304-S307, 2020.

* Final patient diagnosis responsibility lies with the medical professional
** The Synovasure Alpha Defensin ELISA test is validated to aid in the diagnosis of PJI. Performance in aiding in the diagnosis of NSA has not been determined

 

Legal Manufacturer:

CD Diagnostics
650 Naamans Road
Suite 100
Claymont, DE 19703 USA

 


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