AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit

Primary DI

08719326750996

Basic UDI-DI Code

B-08719326750996

Reference

PN-201

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PathoNostics B.V.

The AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit (PN-201) is a non-automated, qualitative real-time multiplex PCR test for detection and differentiation of Aspergillus fumigatus cyp51A wildtype, Tandem repeat 34 mutant and Tandem repeat 46 mutant DNA, which is obtained after nucleic acid extraction with a NucliSENS® easyMAG® instrument (BioMérieux) or QIAamp Minelute virus spin kit (QIAGEN) from bronchoalveolar lavage (BAL) samples. The test aids in the diagnosis of pan-azole resistant invasive pulmonary aspergillosis (IPA) in ‘at risk’ patients (humans), such as patients with hematological malignancies, solid organ transplant (SOT) and allogeneic transplant recipients, patients with chronical lung diseases (eg. CF, COPD) and as a co-infection with other infections, when used in combination with other clinical and laboratory findings. The AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit is for use with LightCycler® 480 II (Roche), Rotor-Gene® Q (QIAGEN), QuantStudio™ 5 (Thermo Fisher Scientific), Mic qPCR instrument (BMS) and CFX96™ (Bio-Rad).

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).