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NucleoMag Dx Pathogen, CE-IVD-zertifizierte Isolierung viraler RNA/DNA

Auf magnetischen Beads basiertes Kit für die Isolierung viraler RNA aus humanem Speichel und Nasen-Rachen-Abstrichen (validiert für SARS-CoV-2), sowie für die Isolierung viraler RNA und viraler DNA aus humanen Stuhlproben (validiert für Norovirus). Konform mit IVDR 2017/746.

Anwendung Isolierung von viralen Nukleinsäuren
Automatische Nutzung Ja
CE-zertifiziert Ja, CE-IVD-gekennzeichnet für die diagnostische Verwendung in der EU und anderen Ländern
Elutionsvolumen 50–100 µL
Format Magnetic beads
Fragmentgröße 300 bp–ca. 50 kbp
Gefahrstoffe Ja
Gewicht Brutto (ink. Verpackung) 1897 g
Haltbarkeit (ab Produktion) 19 Monat(e)
Handhabung Magnetische Trennung
Kompatibilität der Automatisierung Kompatibel mit den meisten offenen Roboterplattformen. Bitte besuchen Sie www.mn-net.com/automation oder wenden Sie sich an unseren technischen Support für weitere Informationen.
Lagertemperatur 18–25 °C
Präparationszeit 40-120 min/96 Präps, je nach verwendeten Geräten/Automaten
Probenmaterial Human Nasen-Rachen-Abstrichen, Humane Stuhlproben, Humaner Speichel
Probenmenge ≤ 200 µL Tupferwaschlösung/Speichel/Stuhlsuspension
Technologie Magnetische Bead-Technologie
Theoretische Bindungskapazität 0.4 µg/µL beads
Typische Downstream-Anwendung NGS, RT−PCR
Typische Rückgewinnung Abhängig von Probenmenge und Qualität
Verfügbarkeit Für US-Kunden bestellen Sie bitte das äquivalente NucleoMag Pathogen, REF 744210.4 (nur für Forschungszwecke)
Verpackungsabmessung 220 x 220 x 234 mm
Warenzeichen NucleoMag
Ziel Viral RNA und DNA

NucleoMag Dx Pathogen*

* Not for sale in the US. Please inquire.

  • CE-IVD-certified – compliant with European IVD Regulation 2017/746
  • Suitable for viral RNA isolation from human respiratory swabs and saliva
  • Suitable for viral RNA and viral DNA from human stool samples
  • Magnetic bead based purification - manual or automated (open access platforms)
  • Excellent diagnostic sensitivity

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. Furthermore, the kit is intended for viral RNA and viral DNA from human raw stool samples. The purification of viral nucleic acid is based on the reversible binding of nucleic acids to the NucleoMag magnetic beads. The NucleoMag Dx Pathogen can be automated on common open access automation platforms.

The kit is available as IVD product compliant with European IVD Regulation, as research-use only product (REF 744210.1/.4/.100), and as prefilled plates for convenient automated use (REF 744211). These kits include ready to use buffers, Proteinase K and Carrier RNA.

The NucleoMag Dx Pathogen kit shows market-leading performance enabling reliable detection of RNA and DNA viruses from clinical samples.

Application data

Excellent diagnostic sensitivity – competitor comparison

Consistent performance with different sample types

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.).

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.

Efficient isolation of viral nucleic acids

Sensitivity screening for pathogen detection from human stool samples

Human stool samples were spiked with dsRNA- (BTV – bluetongue virus), ssRNA- (CDV – canine distemper virus) and dsDNA (POX - vaccinia virus) representing exemplary virus genomes. Viral nucleic acids were extracted with the NucleoMag Dx Pathogen kit (MN) and with supplier T kit following each manufacturers protocols (n = 4). Subsequently, viral nucleic acids were analyzed via specific qRT-PCR (AgPath-ID™* One-Step RT-PCR kit) or qPCR (QuantiTect®* Multiplex PCR kit).
A six-fold dilution series was created from human stool samples. Viral RNA/ DNA was extracted using the NucleoMag Dx Pathogen kit and eluates were analyzed using the RIDA®* GENE Viral Stool Panel I (R-Biopharm). Viral nucleic acids were detected over 6 order magnitude with an excellent linearity.

References

Publication

Sample type – Nucleic acid

Tran, X.D., Hoang, V.T., Dao, T.L. et al.

High Prevalence of Non-typeable Haemophilus influenzae and Haemophilus haemolyticus Among Vaccinated Children with Community-Acquired Pneumonia in Vietnam.

J Epidemiol Glob Health 14, 498–501 (2024).

https://doi.org/10.1007/s44197-024-00195-8

  • Nasopharyngeal samples
  • DNA and RNA extraction
  • Automated on Thermo Scientific KingFisherTM* Flex

Beaufils, Q., Bénéjat, L., Ducournau, A. et al.

Performance evaluation of the Biosynex AMPLIQUICK Fecal Bacteriology PCR kit.

BMC Microbiol 25, 400 (2025).

https://doi.org/10.1186/s12866-025-04118-w

  • Stool samples – 200µL Fecal SwabTM* liquid
  • Bacterial DNA extraction
  • Automated on MagnetaPure

Charfi, R., Guyonnet, C., Untrau, M. et al.

Performances of two rapid LAMP-based techniques for the intrapartum detection of Group B Streptococcus vaginal colonization.

Ann Clin Microbiol Antimicrob 23, 37 (2024).

https://doi.org/10.1186/s12941-024-00695-2

  • Cell culture from vaginal swab sample
  • Nucleic acid extraction

Tran, X.D., Hoang, VT., Goumballa, N. et al.

Viral and bacterial microorganisms in Vietnamese children with severe and non-severe pneumonia.

Sci Rep 14, 120 (2024).

https://doi.org/10.1038/s41598-023-50657-5

  • Nasopharyngeal samples + Sigma-Transwab®* medium
  • Viral DNA & viral RNA extraction
  • Automated on Thermo Scientific KingFisherTM* Flex

Tran, X.D., Hoang, V.T., Dang, T.T.D. et al.

Aetiology of Acute Undifferentiated Fever Among Children Under the Age of Five in Vietnam: A Prospective Study.

J Epidemiol Glob Health 13, 163–172 (2023).

https://doi.org/10.1007/s44197-023-00121-4

  • Blood samples
  • Viral DNA & viral RNA extraction
  • Automated on Thermo Scientific KingFisherTM* Flex

Script support for automation

Basic scripts or protocols for the implementation of the NucleoMag Dx Pathogen kit on different open access 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.

Click here to read about the MACHEREY-NAGEL script support for NucleoMag Dx Pathogen.

* KingFisher™ and AgPath ID™ are registered trademarks of Thermo Fisher Scientific, USA. qScriptTM is a registered trademark of Quantabio, Inc., USA QuantiTect® is a registered trademark of QIAGEN, Netherlands RIDA® is a registered trademark of R-Biopharm AG, Germany Fecal SwabTM is a registered trademark of Copan ITALIA SPA, Italy Sigma-Transwab® is a registered trademark of Medical Wire & Equipment Co Ltd., United Kingdom
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