What are the differences between SepsiTest™-UMD and Micro-Dx™?
Both are culture-independent
diagnostic kits for the detection and identification of bacteria and fungi from
clinical samples by 16S and 18S rRNA amplification and subsequent Sanger
sequencing.
The difference between both kits is that the host DNA depletion and
microbial DNA isolation are performed manually with the SepsiTest™-UMD and
fully automated with the Micro-Dx™ kit. For the automated DNA extraction, the
SelectNA™plus instrument is required.
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What is included in the kits SepsiTest™-UMD and Micro-Dx™?
SepsiTest(tm)-UMD Micro-Dx(tm) Manual and short manual Yes Yes Reagents for sample pre-treatment e.g. tissue biopsies Yes Yes Reagents for host DNA depletion and microbial DNA isolation Buffers and enzymes Prefilled buffer cartridges and enzyme vials ...
Can FFPE samples be analyzed with SepsiTest™-UMD or Micro-Dx™?
FFPE samples Yes, FFPE samples can be processed by simply following the tissue protocol of the kit. There are no additional steps like a deparaffinization required.
Will SepsiTest™-UMD and Micro-Dx™ transit to IVDR?
CE IVD Yes, both kits will be transferred to IVDR, at the latest in May 2026. Please find Molzym’s statement on the transition to IVDR here.
What IT infrastructure is required for SepsiTest™-UMD and Micro-Dx™?
IT infrastructure The required IT infrastructure is quite small: a software to view (and if required edit) sequences, e.g., Chromas internet access for the BLAST search space on the server is quite small, sequencing files are between 200 and 300 kb ...
Can molds be isolated and detected with SepsiTest™-UMD or Micro-Dx™?
Mold? Yes, some genera belonging to molds have been successfully isolated and detected (18S PCR), for example, Aspergillus, Fusarium, and Cladosporium. See List of Microorganisms/Fungi