Myconostica has released the results of a study evaluating the analytical and preliminary clinical performance of MycAssay Aspergillus kit for the diagnosis of Invasive Aspergillosis (IA) using serum samples.
The trial tested 31 high risk haematology subjects, of which 10 patients were classified as having proven/probable IA and 21 as at risk of IA with a total of 170 samples.
The sensitivity of the assay was >70% and the specificity >90%.
This was a retrospective study with stored samples and some degradation of the DNA was likely to have occurred so it is proposed that a prospective study would improve the assay sensitivity.
The study found that when MycAssay Aspergillus is combined with a suitable DNA extraction system, a result can be obtained within 3 hours therefore providing a rapid, sensitive and specific alternative to the conventional techniques used to identify Aspergillus infections.
Myconostica chief business officer John Thornback said the potential to detect Aspergillus in blood using PCR has been a topic of great interest to clinicians since it opens up the possibility of new screening strategies for the early detection of IA.
"The study found that, for the first time a commercial kit is available providing a methodology that is standardised with reagents that are quality controlled and can facilitate the use of PCR serum testing for IA," Thornback said.