Myconostica

 

 


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MycAssay® Aspergillus is a CE- marked, Real-Time PCR assay for the detection of Aspergillus DNA in lower respiratory tract and from September 2010 also in serum samples.

The kit is designed to be used by qualified laboratory professionals; the results provided by MycAssay® Aspergillus aid physicians to make a diagnosis in immunocompromised patients suspected of having an infection caused by Aspergillus spp.

When MycAssay® Aspergillus is used in conjunction with Myconostica's® fungal DNA extraction system, MycXtra®, a result can be obtained within 3 hours of sample receipt. MycAssay® Aspergillus provides rapid and accurate results to physicians, enabling appropriate drug treatments to be administered thereby improving patient outcomes.

Aspergillus spp.

  • Are filamentous fungi or moulds that are ubiquitous in the atmosphere.
  • Pose no threat to healthy individuals, but to those who are immunocompromised e.g. transplant recipients, leukaemics, patients on ICU, may cause severe respiratory and systemic infections.

Traditional methods used in the diagnosis of invasive aspergillosis have limitations associated with poor sensitivity and specificity. MycAssay® Aspergillus offers increased sensitivity, specificity and speed of diagnosis, all of which are key factors in improving patient survival rates.

 


Features of MycAssay® Aspergillus
      

  • Validated for use on the following platforms: Cepheid SmartCycler®, AB7500 (1.4), LightCycler® 2.0 and Stratagene Mx3000 series
  • Highly sensitive: MycAssay® Aspergillus has a Limit of Detection of < 50 target copies
  • Clinical cut-off
  • Provides highly reproducible data
  • Set-up is very simple, taking approximately 10-15 minutes
  • Run-time is less than 2 hours
  • Internal amplification control in every reaction to highlight false negative results
  • Consists of closed tube reactions and single use reagents to reduce the risk of contamination

Experimental data

Clinical lower respiratory tract samples were extracted using MycXtra® and subsequently tested using MycAssay® Aspergillus. The results obtained with MycAssay® Aspergillus were compared to the culture and clinical diagnoses available for the samples.

Comparing MycAssay® Aspergillus results with Aspergillus culture positive data provides a sensitivity and specificity of 94% and 77% respectively, with positive and negative predictive values of 91% and 83%.

When compared to the clinical diagnoses MycAssay® Aspergillus provides a sensitivity and specificity of 94% and 91% respectively, with positive and negative predictive values of 97% and 83%.

These data compare favourably with traditional methods for diagnosing infections caused by Aspergillus spp. indicating that the use of MycAssay® Aspergillus can enable the accurate diagnosis of invasive aspergillosis.