Micro-Dx™ CE IVD

Micro-Dx™ CE IVD is a rapid test for the culture-independent identification of pathogens

Micro-Dx™ CE IVD for the first time runs a test system that is based on the fully automated MolYsis™ technology to remove human DNA from clinical specimens and extraction of enriched pathogen DNA. This together with the extremely active broad-range PCR or Real-Time PCR followed by sequencing analysis enables the sensitive detection and identification of pathogens. All buffers, reagents and consumables are DNA-free which eliminates false-positive results due to endogenous contamination.
Walk-away automation of pathogen DNA extraction

Micro-Dx™ CE IVD is the premiere of a walk-away automation in sample preparation for the precise, direct diagnosis of pathogens. Micro-Dx™ CE IVD follows the MolYsis™ technology of the removal of human DNA, which is a known factor negatively influencing PCR analysis. The whole automation process of ‘Sample in – Eluate-out’ greatly reduces tedious, time-consuming extraction. Handling is reduced to the loading of the SelectNA™plus instrument with 1ml samples and consumables. The instrument can run 1 to 12 samples simultaneously.

Typical specimens:

• Body fluids – EDTA/citrate blood, CSF, synovial fluid, ascites fluid and others
• Tissue biopsies – heart valve, bone, brain, liver and others
• Other specimens – BAL, Smears, swabs, wound biopsies

Broad-range molecular analysis

Micro-Dx™ CE IVD can diagnose typical, rare and slow-growing pathogens. The Micro-Dx™ CE IVD diagnosis is growth-independent and thus particularly useful for the identification of non-growing pathogens in patients who are on antibiotic therapy. Clinical studies indicate that Micro-Dx™ CE IVD finds pathogens in many cases where cultures stay negative. The diagnosis is directed to diseases including:

• Sepsis
• Meningitis
• Wound infections
• Joint infections
• Endocarditis and others

Guaranteed DNA-free reagents and consumables are supplied necessary for the broad range 16S and 18S rRNA gene PCR or Real-Time PCR analysis together with primers for Sanger-sequencing based identification of pathogens in positive cases. Micro-Dx™ CE IVD serves a variety of specified PCR and Real-Time PCR run protocols.

Sequence identification of pathogens is performed using the free online tool, SepsiTest-Blast (www.sepsitest-blast.net) with >7,000 sequence-edited entries of cultured bacterial, Candida, Cryptococcus and Aspergillus species.

For more detailed information, including a list of publications, a quotation or presentation in your laboratory, please feel free to contact the Molzym support-team.