RenDx Fungiplex Assay

RenDx Fungiplex Assay gains CE mark

  • Detect 12 Candida and Aspergillus species
  • Achieve single organsim detection
  • Results within hours
  • No culture required
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Overview

RenDx RUO Kitbox

Invasive fungal diseases (IFDs) are emerging as an increasingly important cause of life-threatening infections and represent a significant cause of morbidity and mortality in patients who receive immunosuppressive therapies, such as those prescribed for solid organ transplants (SOT) and hematopoietic stem cell transplants (HCT), and in patients suffering immune compromising conditions such as AIDS. 

The Renishaw Diagnostics RenDx Fungiplex Assay is a multiplex PCR in vitro test for the qualitative detection of Candida and Aspergillus DNA extracted from EDTA whole blood, EDTA plasma or serum. The assay is designed for use with the RenDx Multiplex Assay System, an automation and detection platform that allows processing of up to 45 samples from post extraction to result in around 7 hours. The assay identifies 12 Candida and Aspergillus species using a unique detection technology known as surface enhanced resonance Raman scattering (SERRS). The high sensitivity provided by this method offers the potential for early diagnosis while quality controlled manufacture ensures that the user can have full confidence in assay quality and reproducibility. 

 

  • 12 Candida and Aspergillus species detected
  • Single organism detection
  • 45 samples in 7 hours
  • No culture required                   
  • Semi-automated workflow
  • Intuitive reporting
  • Full sample traceability
  • ISO:13485 manufacture
RDL CE Mark

Targets

Candida         Aspergillus       
Candida spp.*Aspergillus spp.*
          C. albicans          A. fumigatus
          C. parapsilosis          A. flavus
          C. tropicalis          A. niger
          C. guilliermondiiA. terreus*   
          C. lusitaniae 
          C. dubliniensis 
C. krusei*       
C. glabrata*      

* reported

Assay performance

Analytical sensitivity and specificity

Based on testing of 2415 plasmid and simulated samples at relevant clinical concentrations.

Number of samples

2415

Total number of true positives

371

Total number of true negatives

2015

Total number of false positives

21

Total number of false negatives

8

Analytical sensitivity

97.9 %

Analytical specificity

99.0 %

 

 Publications

Journal of Clin. Microbiol., 52 (10), 3536 (2014)

Next steps

Contact us online if you require more information or you have a pricing query, or alternatively you may like to speak directly to Renishaw Diagnostics.