NucleoMag Dx Pathogen, CE-IVD certified kit for isolation of viral RNA

 

CE-IVD certified viral RNA isolation 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 NucleoMag® Dx Pathogen kit can be automated on common automation platforms. 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.

 

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.).

Consistant 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.

 

Application	Isolation of viral RNA
Target	Viral RNA
CE certified	Yes, CE-IVD labelled for diagnostic use in the EU and other countries
Availability	For U.S. customers please order the equivalent research use only NucleoMag Pathogen, REF 744210.4
Technology	Magnetic bead technology
Brand	NucleoMag
Format	Magnetic beads
Package unit	384 Prep(s)
Handling	Magnetic separation
Automated use	Yes
Sample material	Respiratory swabs, saliva (human)
Sample amount	≤ 200 µL swab wash solution/saliva
Fragment size	300 bp–approx. 50 kbp
Typical recovery	Depending on sample amount and quality
Theoretical binding capacity	0.4 µg/µL beads
Elution volume	50–100 µL
Preparation time	40-120 min/96 preps, depending on instruments/automation used
Typical downstream application	NGS, RT−PCR
Storage temperature	18–25 °C
Shelf life	19 Months
Hazardous material	Yes

 

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* It is the sole responsibility of the user to validate the performance in combination with a particular downstream assay and / or automation device.

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