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PATHONOSTICS

The products of PathoNostics are designed to detect clinically relevant fungal infections. All real-time PCR kits are validated according to IVD guidelines and annually verified using quality assessment programs.

AsperGenius®

AsperGenius®  - Detection & Resistance

Detection and identification of Aspergillus fumigatus, Aspergillus terreus, Aspergillus species and azole-resistance markers TR34 and TR46

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

  • Species multiplex

  • Aspergillus fumigatus    

  • Aspergillus flavus

  • Aspergillus species

  • Internal Control (IC)\\

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Aspergillus terreus (only on Rotor-Gene Q and CFX96)

  • ‍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

  • Validated on organ transplant/hematology/Intensive Care Patient cohorts

  • Allows for timely, targeted antifungal treatment resulting in improved clinical outcome

DermaGenius® 2.0

DermaGenius® 2.0

Detection and identification of dermatophyte infections in nail, hair and skin samples

PRODUCTS & TARGETS

Products
PN-301  DermaGenius® 2.0 Nail multiplex kit (50 rxn)  
Targets

  • Candida albicans

  • Trichophyton rubrum

  • Trichophyton interdigitale

  • Internal Control (IC)


‍PN-401 DermaGenius® 2.0 Complete multiplex kit (50 rxn)

Targets

  • Candida albicans

  • Trichophyton mentagrophytes

  • Trichophyton interdigitale

  • Trichophyton rubrum / soudanense

  • Trichophyton tonsurans

  • Trichophyton violaceum

  • Microsporum canis

  • Microsporum audouinii

  • Epidermophyton floccosum

  • Trichophyton benhamiae

  • Trichophyton verrucosum

  • Internal Control (IC)


Features & Benefits

  • Aids in the diagnosis of dermatophytosis (superficial fungal infections)

  • Detects > 95% of the clinically most relevant dermatophytes

  • Detection in nail, skin and hair samples

  • Sample-to-result in less than 3 hours

  • Simple and fast DNA extraction kit included (20 min)

  • Higher sensitivity: up to 20% more positive results compared to culture

  • Dermatophyte species identification, enabling:

  • Targeted treatment

  • Identification of source of infection

  • Outbreak management


Real-time PCR instruments

  • LightCycler 480 II (Roche)

  • Rotor-Gene Q (Qiagen)

  • CFX96 (Biorad)

  • QuantStudio 5 (Thermo Fisher Scientific)

  • Mic qPCR (BMS)

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Diagnostic specimens

  • Nail, hair and skin samples

  • Paraffin embedded samples (FFPE)


Quality

  • Validated on clinical samples

  • Internal Control (IC) included

  • Positive Controls (PCs) included

  • Validated on nail, hair and skin samples

  • Validated on EQA programmes of QCMD

  • CE-IVD marked

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Background
Dermatophytes represent the most numerous and widespread group of all mycoses and have the capacity to invade keratinized tissue of humans and animals to facilitate infections that are generally restricted to the corneocytes of the skin, hair and nails.
Dermatophytes are classified in three genera: Epidermophyton, Microsporum and Trichophyton. Diagnosis of these infections is currently based on microscopy or histology associated with culture on specific agar media. However, direct microscopy lacks specificity and culturing has a long turn-around-time of 2-4 weeks and is prone to contamination. These limitations can be prevented by the use of molecular diagnostics.

PneumoGenius®

PneumoGenius®

Detection and quantification of Pneumocystis jirovecii and DHPS mutations

PRODUCTS & TARGETS

Products
PN-600  PneumoGenius® kit (25 rxn) 

Targets

  • Pneumocystis jirovecii

  • DHPS mutations (codon 55 and 57)

  • Internal Control (IC)‍

  • Quantification standards:

  • Standard 1: 10000 copies/μl

  • Standard 2: 1000 copies/μl

  • Standard 3: 100 copies/μl

  • Standard 4: 10 copies/μl

 
Features and benefits

  • Aids in the diagnosis of Pneumocystosis

  • Direct detection in BAL samples

  • Quantification standards included

  • Sample-to-result in less than 3 hours

  • Sulfa drug resistance markers included (DHPS mutations)

  • High sensitivity due to detection of conserved multi copy genes (mtLSU)

  • Clinically validated on BAL samples (published data)


Real-time PCR instruments

  • LightCycler 480 II (Roche)

  • Rotor-Gene Q (Qiagen)

  • CFX96 (Biorad)

  • Quantstudio 5 (Thermo Fisher Scientific)

  • Mic qPCR (Bio Molecular Systems)


Diagnostic specimens

  • BAL samples


DNA extraction

  • NucliSENS EasyMAG (bioMérieux)

  • QIAamp® Blood minikit (Qiagen)

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Quality

  • Validated on clinical samples (BAL)

  • Internal Control (IC) included

  • Positive Controls (PCs) included

  • Validated on EQA programmes of QCMD

  • CE-IVD marked

‍
Background

Pneumocystis pneumonia, a (major) opportunistic infection in immunocompromised patients, is caused by the fungus Pneumocystis jirovecii (P. jirovecii). The incidence of Pneumocystis pneumonia, which increased dramatically with the advent of the HIV/AIDS pandemic, has decreased in the industrialized world owing to the widespread use of sulfa drug prophylaxis and the introduction of highly active antiretroviral therapy (HAART). However, P. jirovecii remains an important cause of morbidity and mortality in HIV/AIDS patients, as well as in non-HIV immunocompromised patients, in whom its diagnosis is difficult.
Current diagnosis of P. jirovecii is mostly done by direct microscopic examination of bronchoalveolar lavage (BAL) samples. The fungus is visualized using standard staining techniques or immunofluorescence staining.  The drawback of these methods is that diagnosis is difficult and requires specific skills, particularly when the fungal burden is low, which is mainly observed in non-HIV infected patients. Nowadays, (real-time) PCR is increasingly used for the diagnosis of Pneumocystis pneumonia as this technique has an increased sensitivity compared to direct microscopic examination.

MucorGenius®

MucorGenius®

Detection of clinically relevent Mucorales species

PRODUCTS & TARGETS

Products
PN-700 MucorGenius® real-time PCR (25 rxn) 

Targets

  • Pan-Mucormycetes
    -Rhizopus spp.
    -Mucor spp.
    -Lichtheimia spp.
    -Cunninghamella spp.
    -Rhizomucor spp.

  • Internal Control (IC)

 
Features and benefits

  • Aids in the diagnosis of mucormycosis

  • The only commercial real-time PCR kit available

  • Direct detection in BAL samples

  • Sample-to-result in less than 3 hours

  • Detection of clinically relevant species:undefined Rhizopus spp., Mucor spp., Rhizomucor spp., Lichtheimia spp. and Cunninghamella spp.

  • High diagnostic value resulting in adapted patient management and in therapeutic decisions

  • Can be used in parallel with the AsperGenius® PCR kit (same protocol)


Real-time PCR instruments

  • LightCycler 480 II (Roche)

  • Rotor-Gene Q (Qiagen)

  • CFX96 (Biorad)

  • Mic qPCR (BMS)

  • QuantStudio 5 (Thermo Fisher Scientific)


Diagnostic specimens

  • Bronchoalveolar lavage (BAL) samples

  • Biopsy samples, paraffin embedded

  • Serum samples


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Quality

  • Validated on clinical samples

  • Internal Control (IC) included

  • Positive Controls (PCs) included

  • Validated on FPCRI panel (Fungal PCR Initiative)

  • CE-IVD marked

‍
Background

Mucormycosis is a rare invasive fungal infection with exceedingly high mortality and few therapeutic options. The disease is caused by Mucorales, which is a large group of species within the order of zygomycetes.
Mucorales are widespread in the environment and generally affect severely compromised individuals. Persons at risk include patients with organ transplants, hematologic malignancies, diabetes mellitus or renal failure. Mucorales can also infect people with normal immunity who underwent subcutaneous traumatic inoculation.
Invasive mucormycosis can result in rhino-orbitalcerebral, pulmonary, gastrointestinal, cutaneous, widely disseminated, and miscellaneous infection. The hallmark of disease is tissue necrosis resulting from angioinvasion and subsequent thrombosis; black, necrotic eschars are common in affected tissues. In many cases, the disease progresses rapidly and may result in death unless underlying risk factors are corrected and appropriate antifungal therapy and surgical excision are initiated. The most prevalent etiological agents of mucormycosis in humans are Rhizopus oryzae, Mucor racemosus, Rhizomucor pusillis, Lichtheimia corymbifera and Cunninghamella bertholletiae. Rhizopus oryzae is the single most frequently identified pathogen causing mucormycosis and is responsible for up to 70% of all cases.
The incidence of mucormycosis is unknown and probably underestimated because diagnosis is difficult, and most cases in which a diagnosis is proven histologically or microbiologically are underreported.

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