Products & Targets

Products

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PN-101 AsperGenius® 2.0 Species Multiplex real-time PCR kit (50 rxn)  

Species multiplex

• Aspergillus fumigatus    
• Aspergillus flavus
• Aspergillus species
• Internal Control (IC)
• Aspergillus terreus (only on Rotor-Gene Q and CFX96)

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PN-201 AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit (50 rxn)

Resistance TR multiplex

• Aspergillus fumigatus TR34
• Aspergillus fumigatus TR46
• Aspergillus fumigatus cyp51A (WT)
• Internal Control (IC)

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Features and benefits

• Aids in the diagnosis of Invasive Aspergillosis (IA)
• Differentiation of A. fumigatus, A. flavus (PN-101 only), A. terreus (in PN-101 only in Rotor-Gene Q and CFX96) and A. species
• Identification of most prevalent azole-resistant markers in A. fumigatus: TR34 and TR46
• Fast sample-to-result
• Companion diagnostic strategy with galactomannan (high sensitivity and specificity)
• Validated on organ transplant/hematology/Intensive Care Patient cohorts
• Allows for timely, targeted antifungal treatment resulting in improved clinical outcome

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Real-time PCR instruments

• LightCycler 480 II (Roche)
• Rotor-Gene Q (Qiagen)
• CFX96 (Biorad)
• Quantstudio 5 (Thermo Fisher Scientific)
• Mic qPCR (Bio Molecular Systems)
• ABI7500 (Thermo Fisher Scientific)*

*Only AsperGenius® Species multiplex kit (PN-002)

Diagnostic specimens

• Bronchoalveolar lavage (BAL) samples
• Serum samples
• Plasma samples
• Biopsy, CSF samples (not validated)

DNA extraction

• NucliSENS EasyMAG (bioMérieux)
• QIAamp MinElute Virus Spin kit (Qiagen) (not validated)

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Quality

• Validated on on clinical samples
• Internal Control (IC) included
• Positive Controls (PCs) included
• Validated on EQA programmes of QCMD
• CE-IVD marked

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Background

Invasive pulmonary aspergillosis (IPA) is the most frequent invasive mold infection in immunocompromised patients and is mainly caused by Aspergillus fumigatus (A. fumigatus).
Aspergillus species are responsible for over 200,000 cases of IPA annually, and global estimates suggest that over 1.2 million patients have chronic pulmonary aspergillosis (CPA) and 4.8 million suffer from allergic bronchopulmonary aspergillosis (ABPA). The survival rates of immunocompromised patients with invasive aspergillosis have improved dramatically due to many factors, one of which is the availability of azole antifungal drugs. A number of these azoles have activity against aspergillus infections, including itraconazole, voriconazole, posaconazole and most recently isavuconazole. Voriconazole is normally the recommended first line therapy for IPA. However, azole resistance in A. fumigatus has been reported increasingly over the past decade with prevalence rates varying between 1.0% and 20.0%

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References

Chong et al., BAL validation, JCM 2015 Mar;53(3):868-74

White et al., Serum validation, JCM, 2015 Jul;53(7):2115-21

Chong et al., Multicenter study, JAC 2016 Dec;71(12):3528-3535

Chong et al., Sibling species, Diagn Microbiol Infect Dis. 2017 Mar;87(3):247-252

White et al., Plasma validation, JCM, 2017 Aug;55(8):2356-2366

Montesinos et al., Methods azole-resistance, JCM, 2017 Aug;55(8):2391-2399

Schauwvlieghe et al., Co-infection wt-mut, JAC, 2017 Nov 1;72(11):3047-3050

Guegan et al., Cystic fybrosis, Front Microbiol. 2018 Mar 27;9:531

Tsitsopoulou et al., Environmental resistance, Front Microbiol. 2018 Jun 26;9:1395

Abdolrasouli et al., Resistance, JAC, 2018 Nov 52(5):637-642

Pelzer et al., Allogeneic HSCT, Med Mycol, 2019, May 21