NucleoMag Dx Pathogen*
*Not for sale in the US. Please inquire.
- CE-IVD-certified for viral RNA isolation for use with human respiratory swabs and saliva
- Magnetic bead based purification with established automation workflows** on various open access platforms
- excellent diagnostic sensitivtiy
The NucleoMag Dx Pathogen kit is intended for the isolation of viral RNA from human respiratory samples, including nasal and oral swabs as well as saliva. The kit includes ready to use buffers, Proteinase K and Carrier RNA. The purification of viral RNA is based on the reversible binding of nucleic acids to the NucleoMag magnetic beads.
The kit has been validated for SARS-CoV-2 specific diagnostic workflows and shows a market leading performance enabling reliable detection of RNA viruses from clinical samples. The kit can be combined with sample collection devices and downstream assays of your choice**. Components and protocol of the NucleoMag Dx Pathogen kit are identical to the kit for research purposes. However, the intended use is limited to viral RNA from swabs and saliva.
** It is the sole responsibility of the user to validate the performance in combination with a particular downstream assay and / or automation device.
Application data
Excellent diagnostic sensitivity - competitor comparison
Viral RNA from 19 SARS-CoV-2 positive samples (duplicates) was extracted with the NucleoMag Dx Pathogen on a KingFisher™ Flex and a competitor kit (Q). Viral RNA was quantified with a SARS-CoV-2 specific qRT-PCR assay (qScript XLT One Step RT qPCR ToughMix + nCoV IP4 assay; Institute Pasteur, Paris). The NucleoMag Dx Pathogen kit performed equally well (3/19) or better (14/19) than the competitor kit. For two samples extracted with Q the CT could not be determined (n.d.).
Consistent performance with different sample types
A dilution series of inactivated SARS-CoV-2 viruses was created in three different sample types (nasal swabs, oral swabs, saliva). RNA was extracted using the NucleoMag Dx Pathogen on a KingFisher™ Flex system. Viral RNA was quantified via specific qRT-PCR (AgPath ID™ One Step RT PCR mix + nCoV IP4 assay, Institute Pasteur, Paris). Viral RNA was detected consistently and reliably over a a range of five log10 dilutions.
Script support for automation
Basic scripts or protocols for the implementation of the NucleoMag Dx Pathogen kit on different automation
platforms can be provided by MACHEREY-NAGEL.
If the NucleoMag Dx Pathogen kit is used in in-vitro diagnostic workflows, the use of the kit must be validated by the user in conjunction with the automation platform and consumables used and the subsequent in-vitro diagnostic assay (e.g., qRT-PCR). It is recommended to use appropriate controls (e.g. internal controls, extraction controls, positive / negative controls).
Individual protocol steps may vary depending on available consumables, hardware, platform and instrument setup.