Norgen IVD

COVID-19 Diagnostic Workflow

Collection & Preservation
Viral RNA Isolation
PCR Based Detection
PCR Components

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1. SAMPLE COLLECTION & PRESERVATION

Total Nucleic Acid Preservation Tubes Dx 

68800-web
  • 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
  • Ship swab samples at room temperature safely
  • Compatible with most DNA and Viral RNA 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.

Cat. # Description Size
Cat. Dx69200 Total Nucleic Acid Preservation Tubes Dx  (For Diagnostic Use) 50 units View product page 

Option 2: Saliva RNA Collection and Preservation Devices Dx 

Saliva RNA Preservation Device

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
  • Purified RNA is suitable for a variety of downstream applications, including Small RNA Sequencing. Find out more information on Norgen’s NGS services

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

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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).

Cat. # Description Size
Dx69100 Saliva / Swab RNA Purification Kit Dx  50 Preps View product page 
Cat. Dx69300 Saliva/Swab RNA Purification 96-Well Kit Dx  2 x 96-well plates View product page 

Option 2: Total Purification Kits Dx  

Saliva RNA Preservation Device

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 Pending

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.

Cat. # Description Size
Cat. TM67200 COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) 500 rxns View product page 

Option 2: 2019-nCoV TaqMan RT-PCR Kit

COVID-19 Detection Kit
Cat. # Description Size
TM67100, TM67120 2019-nCoV TaqMan RT-PCR Kit 50 rxns, 500 rxns View product page 

+ 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 

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2019-nCoV RT-PCR Positive Control

PositiveControl(Cat.PC67102)-TheoreticalCopyNumber

2019-nCoV_N1F 2019-nCoV_N2F RNAse P-F
2×108 + + +
2×107 + + +
2×106 + + +
2×105 + + +
2×104 + + +
2×103 + + +
2×102 + + +
2×101 + + +
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).