Fungal Infection Diagnostics

Fungal Infection Diagnostics

Fungal infections is one of our main areas, where we offer a wide portfolio with ‘gold’ standard’ products. We offer PCR, Antigen and Antibody assays.

PathoNostics offers a range of diagnostic real-time PCR kits for the detection of fungal infections. The mission is to rapidly detect the disease-causing fungus and simultaneously identify antifungal resistance, allowing clinicians to initiate a dedicated and timely therapy and save on costs and lives.

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

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)

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)

Features and benefits

  • Aids in the diagnosis of dermatophytosis (superficial fungal infections)
  • Detects > 95% of the clinically most relevant dermatophytes
  • Dermatophyte species identification, enabling: Targeted Treatment
    Detection of mutations in the squalene epoxidase (SQLE) gene (D. Resistance)
  • Differentiation between wildtype and resistant SQLE strains (D. Resistance)
  • Detection in nail, skin and hair samples
  • Sample-to-result in less than 3 hours
  • Higher sensitivity: up to 20% more positive results compared to culture
  • Identification of source of infection
  • Assistance in Outbreak management
  • Including Pan-dermatophyte mix

PN-301 DermaGenius® 2.0 Nail Multiplex real-time PCR kit (50 rxn)

Targets

  • Candida albicans
  • Trichophyton rubrum
  • Trichophyton interdigitale
  • Internal Control (IC)‍

PN-401/402 DermaGenius® 2.0/3.0 Complete Multiplex real-time PCR kit (50 rxn)

Targets

  • Scopulariopsis brevicaulis*
  • Candida paraosilosis*
  • Nannizia gypsea*
  • Candida albicans
  • Trichophyton mentagrophytes
  • Trichophyton interdigitale
  • Trichophyton rubrum / soudanense
  • Trichophyton tonsurans
  • Trichophyton violaceum
  • Microsporum canis
  • Microsporum audouinii
  • Epidermophyton floccosum
  • Trichophyton benhamiae
  • Trichophyton verrucosum
  • Pan-dermatophyte*
  • Internal Control (IC)

*Addtional targets offered in DermaGenius® 3.0 Complete Multiplex real-time PCR kit


PN-303 DermaGenius® Resistance Multiplex real-time PCR kit (25 rxn)

Targets

  • Trichophyton rubrum/soudanense
  • Trichophyton interdigitale/mentagrophytes
  • Trichophyton mentagrophytes (ITS type IV)
  • ‍Trichophyton tonsurans
  • Trichophyton violaceum
  • Trichophyton quinckeanum/schoenleinii
  • SQLE: Leu393Phe, Phe397Leu, Leu393Ser, Phe397Ile, Phe397Val
    Internal Control (IC)

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)

PN-600 PneumoGenius® Multiplex real-time PCR 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 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)

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

Targets

  • Pan-Mucormycetes
    • Rhizopus spp.
    • Mucor spp.
    • Lichtheimia spp.
    • Cunninghamella spp.
    • Rhizomucor spp.
  • Internal Control (IC)

Teco®Fast Aspergillus Galactomannan Ag Lateral Flow Assay (TE 1069)
Separate calculation of serum and BAL samples using a common cut-off index of 0.5
Sensitivity: 90.43% (serum); 92.4% (BAL)
Specificity: 97.66% (serum); 95.5% (BAL)

Teco®Fast Aspergillus IgG Antibody Lateral Flow Assay (TE 1070)
Semiquantitative assay in serum with a cut-off value of 135 AU/mL
Sensitivity: 88.9%; specificity: 91.3%

Teco®Fast Candida Mannan Ag Lateral Flow Assay (TE 1081)
Quantitative assay in serum with a cut-off value of 60 pg/mL
Sensitivity: 88.1%; specificity: 96.9%

Teco®Fast Candida IgG Antibody Lateral Flow Assay (TE 1083)
Semiquantitative assay in serum with a cut-off value of 135 AU/mL
Sensitivity: 86.2%; specificity: 95.3%

Teco®Fast Cryptococcus neoformans Ag Lateral Flow Assay (TE 1085)
Quantitative assay in serum and CSF with a cut-off value of 0.5 ng/mL
Sensitivity: 97% (serum); 100% (CSF)

TECO® Fungus (1-3)-β-D-Glucan

Assay

(1-3)-β-D-glucan is an integral part of the cell wall of most fungi and is not found in bacteria, viruses, or human cells. For this reason, the detection of (1-3)-β-D-glucan in human serum is a diagnostic indicator of invasive fungal diseases.

TECO® Aspergillus

Galactomannan Assay

Detection of Aspergillus galactomannan antigen for the diagnosis of Invasive Aspergillosis (IA)

The mortality rate of Invasive Aspergillosis is between 60 and 100% without timely treatment, thus reliable determination of galactomannan antigen may be essential.

  • Sandwich ELISA as diagnostic gold standard
  • Validated for serum and BAL samples
  • Significantly simplified sample preparation
  • Only 150 μL sample volume required
  • Automation possible from sample to final result

Dynamiker MycoMDx Candida PCR Assay

Click here to see intended use, specification, procedure, suitable platform and clinical performance.