Multiplex real‑time PCR assays for the detection and identification of Aspergillus species (PN-101) and azole resistance markers (PN-201) directly from clinical respiratory or blood samples.
Detailed Description
Invasive pulmonary aspergillosis (IPA) is a serious infection in immunocompromised individuals, caused mainly by Aspergillus fumigatus. Worldwide, more than 200,000 annual cases of IPA are recorded, and millions of people suffer from other forms of aspergillosis. Treatment is usually performed with azole antifungals, such as voriconazole, although resistance of A. fumigatus to these drugs has increased in the last decade, with prevalence rates of 1% to 20%.
AsperGenius® 2.0 is an advanced diagnostic solution composed of two multiplex real‑time PCR kits, designed to support the rapid and accurate diagnosis of invasive aspergillosis (IA), as well as the detection of resistance to azole‑based antifungal treatments.
• AsperGenius® 2.0 Species (PN-101): allows simultaneous identification of Aspergillus fumigatus, Aspergillus flavus, other Aspergillus species, and includes optional detection of A. terreus in a fifth channel. It analyzes the 28s region of ribosomal DNA, guaranteeing high specificity and sensitivity.
• AsperGenius® 2.0 Resistance TR (PN-201): allows detection of the main genetic markers of azole resistance in A. fumigatus (TR34 and TR46), in addition to the wild‑type (WT) cyp51A gene.
Both kits share an identical PCR protocol, facilitating simultaneous or sequential implementation in clinical laboratories. Results are obtained in approximately 1 hour after DNA extraction, favoring agile diagnosis that can positively impact the choice and speed of antifungal treatment.
The system is validated for use with bronchoalveolar lavage (BAL), serum, and plasma samples, without the need for prior culture. This allows direct detection of the pathogen and its resistance mechanisms, which is key for timely therapeutic intervention in immunocompromised patients or those with suspected IA.
The kits include internal and positive controls for each assay to ensure result reliability.
Key Features
Direct detection of Aspergillus spp. in BAL, serum or plasma without the need for culture
Specific differentiation of A. fumigatus, A. flavus and A. terreus
Detection of azole resistance (TR34 and TR46 in A. fumigatus)
Multiplex assays with unified protocol for both tests
Approximate PCR time: 1 hour
Validated on clinical samples and External Quality Control programs (QCMD)
Include internal and positive controls
Certified for in vitro diagnostic use (CE-IVD)
Enable rapid and targeted optimization of antifungal treatment
Presentation Details
AsperGenius® 2.0 Species (PN-101)
Content: 50 reactions
Targets: Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus (only on Rotor-Gene Q and CFX96), other Aspergillus species, and internal control
AsperGenius® 2.0 Resistance TR (PN-201)
Content: 50 reactions
Targets: TR34, TR46, wild‑type (WT) cyp51A of A. fumigatus, and internal control
Additional Information
Compatible instruments: LightCycler® 480 II, Rotor-Gene® Q, CFX96, QuantStudio™ 5, Mic qPCR cycler
Compatible samples: bronchoalveolar lavage (BAL), serum, plasma
Recommended DNA extraction: NucliSENS® easyMAG® (bioMérieux), QIAamp MinElute Virus Spin kit (QIAGEN)
Certification: CE-IVD
Manufacturer: PathoNostics B.V. (Netherlands)
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