Clinical Evaluation of Micro-Dx™ CE IVD – Eubacterial and Panfungal PCR Diagnosis Using Automated DNA Extraction

Micro-Dx™ is the new kit for the in-vitro diagnosis of microbial pathogens without the need for cultivation. The kit is used with the SelectNA™plus instrument which automatically processes a variety of routine specimens ending up with human DNA depleted, pure DNA from eubacterial and fungal pathogens. Assaying is performed by broad-range 16S and 18S rRNA genes PCR or Real-Time PCR analysis which provides a positive-negative result after 3.5 to 4 hours. Identification of species by Sanger sequencing analysis is completed within another 3 to 4 hours. Here, the results of multi-sites evaluations by routine laboratories are presented which either used results from other molecular tests or culture as reference systems.