Complete COVID-19 Workflow

Get the highest quality in your results at any step

1 Sample Collection & Preservation

Saliva RNA Collection & Preservation Device

  • Non-invasive collection procedure — just spit, twist, test
  • Viral inactivation for safe transport & handling
  • Tested on SARS-CoV-2 virus
  • Inactivates virus within 5 minutes of mixing
  • CE-IVD marked version available
  • Authorized for sale by Health Canada
  • Suitable for self-collection of saliva samples supervised by a trained individual in the collection procedure by watching the training video and reading over the collection instructions.
Product Description

Norgen’s Saliva RNA Collection and Preservation Devices Dx are designed for 1) safe and non-invasive saliva collection and 2) preservation of RNA in saliva samples at ambient temperature. Each of the 50 Saliva RNA Collection and Preservation Devices Dx consists of 3 components: (1) Saliva Collection Funnel and Collection Tube, (2) Collection Tube Cap, and (3) Norgen’s Saliva RNA Preservative contained within a sealed squeezable ampoule. Saliva samples are collected by spitting inside the Collection Funnel which has been assembled with the Collection Tube. After collecting the required volume of saliva the Collection Funnel is removed and the contents of the Preservative Ampoule are then added and mixed with the collected saliva. The Saliva Collection Tube is subsequently sent to the laboratory for RNA isolation and analysis. RNA can be isolated from the preserved saliva samples using Norgen’s Saliva/Swab RNA Purification Kits Dx (Cat# Dx69100/Dx69300). Each of Norgen’s Collection Tubes is labeled with a unique serial number that can be used for secure and anonymous tracking of the sample. The saliva RNA in preserved samples is stable for up to 2 months at room temperature. This kit is ideal for collecting and preserving RNA samples for in vitro diagnostic use for medical purposes.

Norgen’s Saliva RNA Collection and Preservation Devices Dx do not provide a diagnostic result. It is the sole responsibility of the user to use and validate these devices in conjunction with a downstream in vitro diagnostic assay.

SALIVA RNA PRESERVATIVE
Norgen’s Saliva RNA Preservative is an aqueous storage buffer designed for rapid cellular lysis and subsequent preservation of RNA from fresh saliva specimens. The buffer eliminates the need to immediately process or freeze samples and allows the samples to be shipped to centralized testing facilities at ambient temperature. The components of the buffer allow samples to be stored for up to 2 months at room temperature. The Saliva RNA Preservative also inactivates all bacteria, yeast and viruses present in the saliva sample.

NUCLEIC ACID ISOLATION FROM PRESERVATIVE
Saliva RNA can be isolated from the preserved saliva samples using Norgen’s Total RNA Purification Kit Dx (Cat# Dx17200). To minimize irregularities in diagnostic results, suitable controls for downstream applications should be used.

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Dx53800 Saliva RNA Collection and Preservation Devices Dx
RU53800 Saliva RNA Collection and Preservation Devices

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Total Nucleic Acid Preservation Tubes

  • 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
  • CE-IVD marked version available
  • Authorized for sale by Health Canada
Product Description

Norgen’s Total Nucleic Acid Preservation Tubes Dx are designed for ambient preservation and transport of total nucleic acids (DNA and RNA) from samples collected using a swab. The Total Nucleic Acid Preservation Tubes contain Norgen’s Total Nucleic Acid Preservative in a liquid format. The user simply collects the specimen using a sterile nylon flocked swab (not provided), and then transfers the swab into the Total Nucleic Acid Preservative. The Preservative prevents the growth of Gram-negative and Gram-positive bacteria and fungi, and also inactivates viruses allowing the resulting non-infectious samples to be handled and shipped safely. In addition, the Total Nucleic Acid Preservative eliminates the need to immediately process or freeze samples and allows the samples to be shipped to centralized testing facilities at ambient temperatures. The components of the preservative allow DNA samples to be stored at room temperature for over 4 months and RNA samples to be stored at room temperature for over 2 months. This kit is ideal for collecting and preserving nasal and oral swab samples for in vitro diagnostic use for medical purposes. Norgen’s Total Nucleic Acid Preservation Tubes Dx are intended for use by professional users such as technicians, physicians and biologists experienced and trained in molecular biological techniques. Norgen’s Total Nucleic Acid Preservation Tubes Dx do not provide a diagnostic result. It is the sole responsibility of the user to use and validate these devices in conjunction with a downstream in vitro diagnostic assay.

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Dx69200 Total Nucleic Acid Preservation Tubes Dx
69200 Total Nucleic Acid Preservation Tubes

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2 Viral RNA Isolation

Total RNA Purification Kits

  • Extract high quality & purity total RNA including miRNA
  • No phenol step required
  • Bind & elute all RNA irrespective of size or GC content, without bias
  • 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
  • Purification is based on spin column chromatography that uses Norgen’s proprietary Silicon-Carbide resin separation matrix
  • Authorized for sale by Health Canada
  • CE-IVD marked version available
Product Description

Norgen’s Total RNA Purification Kit Dx provides a rapid method for the isolation and purification of total RNA from tissue samples, blood, plasma, serum, saliva, bacteria, yeast, fungi and viruses for subsequent in vitro diagnostic use.

This kit is designed to be used with any downstream application employing enzymatic amplification or other enzymatic modifications of RNA followed by signal detection or amplification. Extract high quality and purity RNA with excellent RIN values and A260/A280 suitable for downstream applications including qRT-PCR, RT-PCR, microarrays, NGS and more. Any diagnostic results generated using the RNA isolated with Norgen’s Total RNA Purification Kit Dx in conjunction with an in vitro diagnostic assay should be interpreted with regard to other clinical or laboratory findings.

To minimize irregularities in diagnostic results, suitable controls for downstream applications should be used.

Norgen’s Total RNA Purification Kit Dx is intended for use by professional users such as technicians, physicians and biologists experienced and trained in molecular biological techniques.

Norgen’s Total RNA Purification Kit Dx does not provide a diagnostic result. It is the sole responsibility of the user to use and validate the kit in conjunction with a downstream in vitro diagnostic assay.

NOTE: This product is not available for sale in the United States.

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Cat. No Product Add to Cart
Dx17200 Total RNA Purification Kit Dx
17200
37500
17250
17270
Total RNA Purification Kit
Dx24300
Dx24350
Dx24380
Total RNA Purification 96-Well Kit Dx
24300
24350
24370
24380
Total RNA Purification 96-Well Kit

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Saliva/Swab RNA Purification Kits

  • 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
  • Buffer chemistry inactivates viruses including SARS-CoV-2
  • High throughput 96-well plate format for rapid purifications is also available
  • Purification is based on spin column chromatography that uses Norgen’s proprietary Silicon-Carbide resin separation matrix
  • Authorized for sale by Health Canada
  • CE-IVD marked version available
Product Description

Norgen’s Saliva/Swab RNA Purification Kit Dx provides a rapid method for the purification of total RNA from non-preserved saliva and nasal/throat swabs, and from preserved saliva collected on Norgen’s Saliva RNA Collection and Preservation Devices Dx (Cat. 53800) or preserved swabs collected in Norgen’s Total Nucleic Acid Preservative Tubes Dx (Cat. Dx69200). Purification is based on using Norgen’s proprietary resin separation matrix. RNA is preferentially purified from other cellular components such as proteins, without the use of phenol or chloroform. The chemistry employed in the kit allows the purification of total RNA, including viral and bacterial RNA, irrespective of size or GC content. The purified RNA is ideal for in vitro diagnostic use for medical purposes.

This kit is optimized to be used with any downstream application employing enzymatic amplification or other enzymatic modifications of RNA followed by signal detection or amplification. Any diagnostic results generated using the RNA isolated with Norgen’s Saliva / Swab RNA Purification Kit Dx in conjunction with an in vitro diagnostic assay should be interpreted with regard to other clinical or laboratory findings.

To minimize irregularities in diagnostic results, suitable controls for downstream applications should be used.

Norgen’s Saliva / Swab RNA Purification Kit Dx is intended for use by professional users such as technicians, physicians and biologists experienced and trained in molecular biological techniques.

Norgen’s Saliva / Swab RNA Purification Kit Dx does not provide a diagnostic result. It is the sole responsibility of the user to use and validate the kit in conjunction with a downstream in vitro diagnostic assay.

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Cat. No Product Add to Cart
Dx69100 Saliva / Swab RNA Purification Kit Dx
69100 Saliva / Swab RNA Purification Kit
Dx69300 Saliva/Swab RNA Purification 96-Well Kit Dx
69300 Saliva/Swab RNA Purification 96-Well Kit

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3 RT-PCR Detection

COVID-19 TaqMan RT-PCR Kit (N/ORF1ab genes)

  • Multiplex RT-PCR system detects two SARS-CoV-2 specific genes (N gene and ORF1ab) in a single one step RT-PCR reaction
  • Primer & Probe Mixes contain all N gene, ORF1ab and human RP assays
  • Positive Control contains the three SARS-related target genes: N gene, ORF1ab gene as well as the human RP (internal control).
  • Convenient ready-to-use  2X One-Step RT-PCR Master Mix
  • CE-IVD marked version availble
Product Description

Norgen’s COVID-19 TaqMan RT-PCR Kit (N/ORF1ab genes) Dx includes 2X One-Step RT-PCR Master Mix, a primer/probe mix, a positive control and a negative control (nuclease-free water). The primer/probe mix contains three SARS-CoV-2 detection targets; N (Nucleoprotein), ORF1ab (Open reading frame1ab) and the human RNase P transcript (RP - HEX/VIC) as an internal control target to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The provided N/ORF1ab/RP Positive Control contains an in vitro RNA transcript for the two SARS-related target genes: N gene, ORF1ab gene as well as the human RP gene (internal control).

Positive results are indicative of SARS-CoV-2 RNA detection, however clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with other viruses and therefore the agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Any negative results must be combined with clinical observations, patient history, and epidemiological information

Norgen’s COVID-19 TaqMan RT-PCR Kit (N/ORF1ab genes) Dx is intended for use by professional users including clinical laboratory personnel experienced and trained in molecular biology techniques including real-time PCR and in vitro diagnostic procedures.

Norgen’s COVID-19 TaqMan RT-PCR Kit (N/ORF1ab genes) Dx was developed and validated to be used with the BioRad CFX96 TouchTM Real-Time PCR Detection System.

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Cat. No Product Add to Cart
DxTM67300 COVID-19 TaqMan RT-PCR Kit (N/ORF1ab genes) Dx
TM67300 COVID-19 TaqMan RT-PCR Kit (N/ORF1ab genes)

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

  • 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 pre-mixed 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
  • Authorized for sale by Health Canada
  • CE-IVD marked version available
Product Description

Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx includes 2XOne-Step RT-PCR Master Mix and 2 primer/probe mixes, a positive control and a negative control (nuclease-free water). The first primer/probe mix is used for first line screening and contains the E gene/RP that targets the SARS-CoV-2, SARS-CoV and bat-SARS-related CoVs Envelope gene(E gene -FAM) in addition to the human RNase P transcript (RP-HEX/VIC) as an internal control target to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The second Primer/Probe Mix is only required as a confirmatory/discriminatory step with samples showing positive amplification of the E gene. This second Primer/Probe Mix is for the RdRP gene and detects two RNA-dependent RNA Polymerase (RdRP) targets where the first RdRP target is SARS-CoV-2 specific (FAM) while the second RdRP target is to detect SARS-CoV-2, SARS-CoV and bat-SARS-related CoVs (HEX). The provided E gene/RdRP/RP Positive Control contains an in vitro RNA transcript for the three SARS-related target genes: E gene, RdRP gene as well as the human RP gene (internal control).

Positive results are indicative of SARS-CoV-2 RNA detection, however clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with other viruses and therefore the agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Any negative results must be combined with clinical observations, patient history, and epidemiological information.

Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx is intended for use by professional users including clinical laboratory personnel experienced and trained in molecular biology techniques including real-time PCR and in vitro diagnostic procedures.

Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx was developed and validated to be used with the BioRad CFX96 Touch™ Real-Time PCR Detection System.

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Ordering Information

Cat. No Product Add to Cart
DxTM67200 COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx
TM67200
TM67240
COVID-19 TaqMan RT-PCR Kit (E/RdRP genes)

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2019-nCoV TaqMan RT-PCR 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
  • Authorized for sale by Health Canada
  • CE-IVD marked version available
Product Description

Norgen’s 2019-nCoV TaqMan RT-PCR Kit Dx provides SARS-CoV-2 detection based on the assays and protocols developed by the CDC. The kit utilizes RT-PCR for the amplification of specific target sequences and target specific probes for the detection of the amplified cDNA. The Primer & Probe Mixes contain all 3 CDC developed assays in individual tubes where probes are labelled with the fluorophore FAM. All assays are premixed to the working concentrations recommended by the CDC. The Positive Control contains two nCoV nucleocapsid target gene RNA (N1 and N2) and RNase P (internal control). The kit contains a positive control to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The 2019-nCoV TaqMan RT-PCR Kit Dx comprises Master Mix for the target and PCR control detection, 3 target Primer & Probe Mixes, as well as a positive control and a negative control (nuclease-free water) to confirm the integrity of the kit reagents.

Positive results are indicative of SARS-CoV-2 RNA detection, however clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with other viruses and therefore the agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Any negative results must be combined with clinical observations, patient history, and epidemiological information.

Norgen’s 2019-nCoV TaqMan RT-PCR Kit Dx is intended for use by professional users including clinical laboratory personnel experienced and trained in molecular biology techniques including real-time PCR and in vitro diagnostic procedures. Norgen’s 2019-nCoV TaqMan RT-PCR Kit Dx was developed and validated to be used with the BioRad CFX96 Touch™ Real-Time PCR Detection System.

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Cat. No Product Add to Cart
DxTM67100
DxTM67120
2019-nCoV TaqMan RT-PCR Kit Dx
TM67100
TM67120
2019-nCoV TaqMan RT-PCR Kit

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COVID-19/Influenza (A & B) TaqMan RT-PCR Kit

  • Multiplex RT-PCR system detects SARS-CoV-2 specific gene (N gene), Influenza A (M gene) and Influenza B (HA gene) in a single one step RT-PCR reaction
  • Primer & Probe Mixes contain all N gene, M gene, HA gene and human RP assays
  • Positive Control contains the SARS-related target genes: N gene, Influenza A target gene (M gene), Influenza B target gene (HA gene) as well as the human RP (internal control)
  • Convenient ready-to-use 2X One-Step RT-PCR Master Mix included in kit
  • Manufactured under ISO 13485:2016 for research use only
  • CE-IVD marked version pending
Product Description

Norgen’s COVID-19/Influenza (A & B) TaqMan RT-PCR Kit includes 2X One-Step RT-PCR Master Mix, a primer/probe mix, a positive control and a negative control (nuclease-free water). The primer/probe mix contains SARS-CoV-2 detection target; N (Nucleoprotein), Influenza A detection target; M gene and Influenza B detection target; HA (Hemaglutinin) and the human RNase P transcript as an internal control target to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The provided N/Inf A & B/RP Positive Control contains an in vitro RNA transcript for the two SARS-related target genes: N gene, ORF1ab gene as well as the human RP gene (internal control).

Norgen’s COVID-19/Influenza (A & B) TaqMan RT-PCR Kit was developed and validated to be used with the following PCR instruments:
• Qiagen Rotor-Gene Q, BioRad CFX96 Touch™ Real-Time PCR Detection System, ABI 7500, ABI Quantstudio 5 and 7.

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TM67400 COVID-19/Influenza (A & B) TaqMan RT-PCR Kit

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Documentation

Protocol & Supplementary Materials

Resources

Saliva as a Viable Alternative Sample Type for SARS-CoV-2 Detection

Abstract: SARS-CoV-2 virus, the main causative agent for COVID-19, is a serious and potentially deadly virus. Nasopharyngeal/Oropharyngeal swabbing followed by viral RNA extraction and RT-qPCR is currently the gold standard workflow for the detection of SARS-CoV-2 infection. Besides being an invasive method for sample collection, the current sample collection strategy requires highly trained personnel at specimen acquisition sites who are at risk of becoming infected. During the past few months there has also been a worldwide shortage of swabs, adding another challenge on the path to widespread population screening. Norgen Biotek has optimized a completed workflow using saliva as a viable alternative and non-invasive sample type for the detection of SARS-CoV-2 infection. Norgen’s Saliva RNA Collection & Preservation Device, which is the first step in the workflow, doesn’t require any trained personnel during sample collection and most importantly, it renders the sample non-infectious for safe shipping and handling, minimizing the risk to our frontline workers. Given the complexity of saliva samples, Norgen’s Saliva/Swab RNA Purification kits have been carefully optimized to yield viral RNA from saliva with the highest quantity and quality allowing for the detection of as low as 10 viral copies/µL using any of Norgen’s COVID-19 RT-PCR detection. Norgen’s optimized and validated Saliva-based workflow offers a non-invasive, safe and reliable COVID-19 detection method that has been proven to have equivalent sensitivity and specificity to the current gold standard workflow.

Related Videos

Saliva Samples: A Viable Alternative to Nasopharyngeal Swabs

Top 5 Reasons to Choose Silicon Carbide RNA Extraction Technology

Tutorial: Saliva RNA Extraction with Silicon Carbide

Improve your Total RNA Extraction Results with Norgen Biotek's Patented Technology

Tutorial: Detection of COVID-19 with TaqMan RT-PCR Kit (E/RdRP genes)

How to Reduce False Negative COVID-19 Test Results in Your Lab

Related Blogs

By: Ben Abraham, MSc

In this blog, you’re going to learn what makes saliva a viable alternative to nasal and oral swabs for the detection of SARS-CoV-2.

By: Jason Perez, MSc

In this blog, you are going to learn about different viable sample types for the detection of SARS-CoV-2 in infected individuals.

By: The Norgen Team

Explore the world of RNA extraction! Here are 5 reasons why Norgen’s Saliva/Swab RNA Purification Kit (Cat. 69100), utilizing Silicon-Carbide (SiC) based technology, is superior to traditional silica-based RNA extraction methods.

By: The Norgen Team

Is it possible that your COVID-19 workflow is not as accurate as you may think? At the start of the COVID-19 pandemic, researchers and laboratories scrambled to develop SARS-CoV-2 test kits in mass quantity...

By: June 17, 2021

In the past, diagnoses were limited to what could be observed by an attending physician with their own senses. As one might expect, this resulted in wildly varying levels of patient care and unconventional tests and treatments, many of which unfortunately involved livestock. Fortunately, the modern era has seen vast advancements in the area of molecular biology, and by extension, medical diagnosis...

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Complete COVID-19 workflow. Easy, safe collection, isolate high quality viral RNA. Detect all variants of coronavirus