1. SAMPLE COLLECTION & PRESERVATION

Saliva RNA Collection and Preservation Devices Dx

  • CE-IVD marked in accordance with EU Directive 98/79/EC
  • Ideal for use in in vitro diagnostic workflows
  • Render samples non-infectious for safe shipping and handling
  • Preserved RNA is suitable for a variety of downstream molecular applications, including PCR and qPCR
  • Preserved RNA is stable for up to 2 months at room temperature
  • Inactivates viruses including SARS-CoV-2 upon mixing - Explore the Application Note
  • Non-invasive, user-friendly sample collection
  • Compatible with most commerical isolation methods

Preserve High Quality RNA for over 2 Months and DNA for over 4 Months at Ambient Temperature

fig-1_0

Figure 1. Stability of RNA and DNA stored in Norgen's Total Nucleic Acid Preservative. GAPDH (for DNA) and β-actin (for RNA) were monitored over an 18 week period for DNA and 60 days for RNA from swab samples stored at ambient temperature in Norgen’s Total Nucleic Acid Preservation Tubes. RNA was isolated from 250 µL of preserved swab samples on day 0, day 4, day 6, day 10, day 16, day 30 and day 60 using Norgen’s Total RNA Isolation Kit (Cat.# 17200). DNA was isolated from 250 µL of preserved swab samples on day 0 and 18 weeks using Norgen’s Saliva DNA Isolation Kit (Cat# Dx45400). Next, 4 µL of elution was used in a 20 µL real-time PCR reaction using CFX96 Touch™ Real-Time PCR Detection System (Bio-Rad). RNA can be stored in Norgen’s Total Nucleic Acid Preservative for up to 60 days and DNA can be stored for up to 18 weeks at room temperature with no change in quality and quantity of RNA and DNA.

Total Nucleic Acid Preservation Tubes Dx

68800-web
  • Authorized for diagnostic use by Health Canada
  • CE-IVD marked in accordance with EU Directive 98/79/EC
  • Ideal for use in in vitro diagnostic workflows
  • No need to immediately process samples
  • Total DNA, including viral DNA, preserved at room temperature over 4 months
  • Total RNA, including viral RNA, preserved at room temperature over 2 months
  • Inactivate microorganisms including bacteria, fungi, yeast and viruses
  • Inactivates viruses including SARS-CoV-2 upon mixing - Explore the Application Note
  • Ship swab samples at room temperature safely
  • Compatible with most DNA and Viral RNA isolation methods


Proceed to Viral RNA isolation

2. VIRAL RNA ISOLATION

Saliva/Swab RNA Purification Kits Dx

17200-web
  • CE-IVD marked in accordance with EU Directive 98/79/EC
  • Fits into in vitro diagnostic workflows
  • Isolate high quality total RNA, including viral RNA, from fresh and preserved saliva and swab samples
  • Fast and easy processing using rapid spin-column format
  • Isolate total RNA, from large rRNA down to microRNA (miRNA)
  • No phenol or chloroform extractions
  • Very sensitive & linear down to a few cells/viral copies without the need for carrier RNA
  • High throughput 96-well plate format for rapid purifications is also available
  • Buffer chemistry inactivates viruses including SARS-CoV-2
  • Purified RNA is suitable for a variety of downstream applications, including Small RNA Sequencing. Find out more information on Norgen's NGS services
  • Learn 5 Reasons to Choose Silicon Carbide (SiC) Based RNA Extraction Technology

Isolate High Quality Total RNA, including Viral RNA, from Fresh & Preserved Saliva and Swab Samples

fig-1_0

Figure 1. SARS-CoV-2 E-gene and RdRP Amplification from Preserved Swabs and Saliva RNA isolated by Norgen’s Saliva/Swab RNA Purification Kit (Cat. #69100). Duplicate Nasopharyngeal swabs, Oropharyngeal Swabs and Saliva samples were collected from different donors. Nasopharyngeal and Oropharyngeal swab samples were collected into Norgen’s Total Nucleic Acid Preservative Tubes (Cat. 69200). Saliva samples were collected into Norgen’s Saliva RNA Collection and Preservation Devices (Cat. RU53800). All collected samples were spiked with 3 different concentrations from Norgen’s E/RdRP/RP Positive Control (included in Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes – TM67200) and processed for RNA isolation using Norgen’s Saliva/Swab RNA Purification Kit (Cat. #69100), using an input of 0.25 mL from each preserved samples. The sensitivity of the isolation method was assessed amplifying the spiked SARS-CoV-2 spiked targets using Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes (TM67200). Figure 1 shows the linear recovery of the different spike-in amounts indicating the high sensitivity of the isolation procedure as well as the high quality of the RNA purified using Norgen’s Saliva/Swab RNA Purification Kit (Cat. #69100).

Total RNA Purification Kits Dx

Saliva RNA Preservation Device
  • Authorized for diagnostic use by Health Canada
  • CE-IVD marked in accordance with EU Directive 98/79/EC
  • Ideal for use in in vitro diagnostic workflows
  • Extract high quality & purity total RNA including miRNA
  • No phenol step required
  • Bind & elute all RNA irrespective of size or GC content, without bias
  • Efficiently extract small RNA irrespective of GC content
  • Very sensitive & linear down to a few cells without the need for carrier RNA
  • Convenient & fast spin column format
  • Isolate from a wide variety of specimens
  • Purified RNA is suitable for a variety of downstream applications
  • Buffer chemistry inactivates viruses including SARS-CoV-2 - Explore the Application Note

Product Insight

Accelerated Emergency Use Authorization (EUA) Summary Curative
SARS-COV-2 Assay

(KorvaLabs Inc. Clinical Laboratory)


Background: Curative, Inc. developed an RT-PCR test for SARS-CoV-2 that makes use of Norgen’s Total RNA Purification 96-well Kit, #24350/#24380. They employ the use of this kit both manually or automated on the Tecan Resolvex A20. They have recently received received Emergency Use Authorization from the FDA for in vitro diagnostic use of this kit at KorvaLabs LLC.

"...RNA Extraction for all specimen types is performed using Total RNA Purification 96-Well Kit (Norgen Biotek Corporation) manually or using Tecan Resolvex A200. The input sample volume is 300µl, the elution volume is 60µl." (p.2)


View Full Document



Proceed to PCR Based Detection

3. PCR BASED DETECTION

COVID-19 TaqMan RT-PCR Kit (E/RdRP genes)

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  • SARS-CoV-2 detection based on the Charité/Berlin protocol (E/RdRP genes) recommended by WHO.
  • Primer & Probe Mixes contain all E gene/RP and RdRP gene assays in individual tubes
  • All assays are premixed to the working concentrations recommended by the Charité/Berlin protocol.
  • Positive Control contains the three SARS-related target genes: E gene, RdRP gene as well as the human RP (internal control)
  • Convenient ready-to-use 2X One-Step RT-PCR Master Mix
  • Manufactured under ISO 13485:2016 for research use only
  • CE-IVD marked version available

Detect SARS-CoV-2 specific RNA with real time RT-PCR According to the Charite/Berlin Protocol

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Figure 1. Duplex TaqMan RT-PCR analytical sensitivity for each of the SARS-CoV-2 targets based on the Charité/Berlin protocol. The analytical sensitivity was determined by analyzing six serial dilutions (200,000 copies to 2 copies) of Norgen's positive control from the COVID-19 TaqMan RT-PCR Kit (E/RdRP gene)(Cat. TM67200). Five µL of template was used in a 20 µL of the one-step RT-PCR reaction and the arrow indicates a copy number of 10.

2019-nCoV TaqMan RT-PCR Kit

COVID-19 Detection Kit
  • COVID-19 detection based on the assays and protocols developed by the CDC
  • Primer & Probe Mixes contain all 3 CDC developed assays in individual tubes
  • All assays are premixed to the working concentrations recommended by the CDC
  • Positive Control contains 2 nCoV nucleocapsid target gene RNA (N1,N2) and RNase P (internal control) which are compatible with the CDC primer/probe set
  • Convenient ready-to-use 2X One-Step RT-PCR Master Mix
  • Manufactured under ISO 13485:2016 for research use only
  • CE-IVD marked version available


PCR Components


+ PCR COMPONENTS

2019-nCoV Primer & Probe Mixes

  • COVID-19 detection based on the assays and protocols
    developed by the CDC
  • Primer & Probe Mixes contain all 3 CDC developed assays in individual tubes
  • All assays are premixed to the working concentrations
    recommended by the CDC
  • Positive Control contains 2 nCoV nucleocapsid target gene RNA (N1,N2) and RNase P (internal control) which are compatible with the CDC primer/probe set
  • Convenient ready-to-use 2X One-Step RT-PCR Master Mix
  • Manufactured under ISO 13485:2016 for research use only

Ordering Information

Cat. TM67101 50 Rxns
Cat. TM67130 500 Rxns
View product page

2019-nCoV RT-PCR Positive Control

PositiveControl(Cat.PC67102)-TheoreticalCopyNumber

2019-nCoV_N1F 2019-nCoV_N2F RNAse P-F
2x108 + + +
2x107 + + +
2x106 + + +
2x105 + + +
2x104 + + +
2x103 + + +
2x102 + + +
2x101 + + +
NTC N/D N/D N/D
  • Positive control for SARS-CoV-2, which causes COVID-19 (2019-nCoV)
  • Contains 2 nCoV nucleocapsid target gene RNA (N1, N2) and RNase P.
  • Compatible with CDC primer/probe set

Ordering Information

Cat.PC67102 50 µL
Cat.PC67120 500 µL
View product page

2X One-Step RT-PCR Master Mix

  • Convenient ready-to-use solution
  • High sensitivity and yield
  • Robust amplification

Ordering Information

Cat. 28113 100 Rxns
Cat. 28114 200 Rxns
Cat. 28115 500 Rxns
View product page
28113
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Figure 1. Performance of Norgens 2X One-Step RT-PCR Master Mix (28113) to detect SARS-CoV-2 using Norgens 2019-nCoV Primer & Probe Mixes (TM67101) and Norgens 2019-nCoV RT-PCR Positive Control (PC67102). The one-step RT-PCR reaction was prepared according to the CDC protocol and the sensitivity of detection of the three targets; 2019-nCoV_ N1 (Circle), 2019-nCoV_ N2 (Triangle) and RNase P (Cross), was compared with Competitor Ns product (Red).

Always ready to do our part.


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Always Ready To Do Our Part. The complete COVID-19 workflow for testing from Norgen Biotek. Made in Canada. Diagnostic steps also availble. #AlwaysReady