Fungal Infection Diagnostics

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)‍

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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.