Myconostica has announced the publication of an evaluation of the clinical performance of its Mycassay Aspergillus kit for the diagnosis of Invasive Aspergillosis (IA) using serum samples.
The trial tested 31 high-risk haematology subjects.
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 per cent and the specificity >90 per cent.
This was a retrospective study with stored samples and the authors note that some degradation of the DNA was likely to have occurred so it is proposed that a prospective study would improve the assay sensitivity.
Infection caused by Aspergillus is the leading cause of infectious death in immuno-compromised patients with an estimated 10 million people at risk globally each year.
Studies have shown that diagnosis of Aspergillus infection followed by antifungal treatment within the first 10 days of infection reduces mortality from 90 to 40 per cent, thus highlighting the necessity of rapid diagnostic testing.
Traditional methods used to identify Aspergillus infections are well-documented as being inaccurate, insensitive and slow, with a result taking up to 10 days.
Indeed Aspergillus does not usually culture from blood samples.
When Mycassay Aspergillus is combined with a suitable DNA extraction system, a result can be obtained within three hours therefore providing a rapid, sensitive and specific alternative to the conventional techniques used to identify Aspergillus infections.
Commenting on these results, Dr John Thornback, Chief Business Officer of Myconostica, 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 authors note 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'.
