RenDx Fungiplex Assay

RenDx Fungiplex Assay

  • Detect 12 Candida and Aspergillus species
  • Achieve single organsim detection
  • Results within hours
  • No culture required
Page contentDownloads  Contact us

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

 

The RenDx Fungiplex Assay and RenDx Multiplex Assay System are currently undergoing performance evaluations prior to CE marking.

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

Data generated using Research Use Only (RUO) version of RenDx Fungiplex Assay and RenDx Multiplex Assay System.

 200 input copies per PCR (n = 40)20 input copies per PCR (n = 40)

 Target

 % detected 

% detected 

C. albicans

100

95.0

C. glabrata

100

92.5

C. krusei 

100

80.0

C. guilliermondii

100

90.0

C. parapsilosis 

97.5

95.0

C. lusitaniae 

100

90.0

C. tropicalis 

100

92.5

C. dubliniensis 

100

97.5

A. fumigatus 

100

95.0

A. terreus 

100

97.5

A. niger 

100

82.5

A. flavus 

100

97.5

Overall

99.8

92.1

 

 Clinical performance

Data generated using Research Use Only (RUO) version of RenDx Fungiplex Assay and RenDx Multiplex Assay System.

 

Proven/Probable IFD

vs NEF* (n = 109)

Proven/Probable IA

vs NEF* and IC (n = 109)

              IC vs NEF* and

Proven/Probable IA (n = 109)

Sensitivity:

no. detected/total no. (%)                

24/29 (82.8) 

12/14 (85.7) 

12/15 (80.0) 

Specificity:

no. detected/total no. (%)    

70/80 (87.5) 

83/95 (87.4) 

84/94 (89.4) 

Likelihood ratio positive 

6.62 

6.86 

6.4 

Likelihood ratio negative 

0.2

0.16 

0.23 

Diagnostic odds ratio 

33.6

42 

28 

 * NEF = No evidence of fungal disease

 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.