Molecular Diagnostics

ViennaLab Diagnostics specialises in easy-to use IVD assays for the detection of genetic variants associated with:

• Genetic disorders
• Genetic predispositions
• Pharmacogenetics
• Cancer
• Human microbiome

ViennaLab kits are designed to enable precise diagnosis. They are CE/IVD labelled and meet the requirements of ISO13485 quality standards.

• RealFast™ Assays – single and low multiplex markers
  Based on real-time PCR these assays detect single nucleotide polymorphisms (SNPs) and copy number variations quickly and easily.

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• StripAssays® – up to 38 genetic variants analysed simultaneously
  Based on reverse hybridisation technology with up to 38 immobilised probes for wild-type and mutated alleles on a single test strip.

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• Next Generation Sequencing (NGS) – comprehensive investigation of numerous genes
  Two-step PCR-based enrichment technique for bacterial classification based on the 16S rRNA sequence. Species level classification of bacterial composition with the ViennaLab Microbiome Analysis Webtool.

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The AID Line Probe Assays are based on the reverse hybridisation of DNA and produce reliable and reproducible results. The tests are suitable for automated systems and the results are evaluated and documented with AID scanner and software.

Kits are available for:

• MRSA

Differentiation of Staphylococcus aureus and coagulase negative staphylococci
Detection of mecA and mecC
Detection of the most frequent resistance genes of staphylococci

• ESBL

Detection of the most important mutations in TEM and SHV
Detection of CTX-M and KPC (Klebsiella pneumoniae carbapenamase)
Validated for use with bacterial cultures and clinical samples

• TB Resistance

Detection of Mycobacteria and Mycobacterium tuberculosis complex
Detection of Isoniazid and Rifampicin resistance genes
Detection of Kanamycin, Amikacin and Capreomycin resistance genes
Detection of Fluoroquinolone and Ethambutol resistance genes
Validated for use with bacterial cultures and clinical samples

• Carbapenamases

Detection of 13 different carbapenamase resistance genes
Validated for use with bronchoelar lavage, sputum, wound swabs, bacterial cultures
16S pan bacterial control included