Fungiplex® Aspergillus Azole-R

Fungiplex® Aspergillus Azole-R IVD PCR

The Fungiplex^® Aspergillus Azole-R PCR IVD Kit is a real-time PCR test which identifies the most common mutations of the Cyp51 gene associated with resistance to the azole class of antifungal drugs.

Azole Resistance

Azole antifungal drugs are the primary option for the prophylaxis and treatment of invasive aspergillosis. Resistance to azoles in Aspergillus fumigatus is emerging as a global health problem, through both the use of azoles in the environment and the prolonged use in the management of patients with invasive aspergillosis.

Delayed diagnosis, and limited treatment options for azole-resistant invasive aspergillosis results in poor patient outcomes, with mortality reported as high as 88%¹. Early detection of resistance is crucial to ensure patients receive effective treatment quickly.

¹Van der Linden et al. Emerg Infect Dis, 2015; 21 (6): 1041-44.

Molecular testing for azole resistance

Resistance in Aspergillus fumigatus is caused by known mutations of the Cyp51 gene that threaten the role of the azole class of antifungals. The most common of these mutations, and their associated amino acid substitutions, are:

Tandem Repeat 34 (TR34) and the associated amino acid substitution L98H
Tandem Repeat 46 (TR46) and the associated amino acid substitutions T289A and Y121F.

Bruker’s Fungiplex^® Aspergillus Azole-R PCR IVD Kit assay is a real-time PCR designed to detect the presence of these TR 34 and TR46 mutations in the Cyp51 gene of A. fumigatus.

The Fungiplex^® Aspergillus Azole-R PCR IVD Kit can be used as a companion test with Fungiplex Aspergillus and has been designed to run on the same conditions.

Validated on DNA extracted from serum and plasma
Validated on DNA extracted from bronchoalveolar lavage (BAL) fluid.

The Fungiplex^® Aspergillus Azole-R PCR IVD Kit can be used alongside Fungiplex Aspergillus for an early indication of azole resistance in high risk patients, or in patient samples testing positive for Aspergillus with the Fungiplex Aspergillus PCR. The kits are sold separately to allow flexibility of testing and efficient use of the Fungiplex Aspergillus assays.

Rapid results

The Fungiplex^® Aspergillus Azole-R PCR IVD Kit provides results in under 2 hours from extracted DNA, allowing rapid identification of patients with invasive A. fumigatus carrying a mutation for azole resistance. This supports clinical decision-making to ensure appropriate antifungal drug therapy is administered: