Overview

• Detection kits for H5N1
• Available in TaqMan format for analysis

Influenza virus infection of birds, humans and other animals is a major public health problem worldwide. Influenza viruses are classified as either type A, B or C based on differences in their nucleoproteins and matrix proteins. The type A viruses are the most virulent human pathogens among the three influenza types and cause the most severe disease and epidemics. The different types can be further classified into subtypes based on antigenic differences in two surface glycoproteins; hemagglutinin and neuroamidase. All known subtypes of influenza A can be found in birds (H1-H16, N1-N9), while a limited number of the subtypes have been found in humans (H1-H3, N1 and N2). However, over the past few years, various subtypes of Influenza A viruses, including H5N1, have been reported to infect humans (WHO, 2006). In addition, the coexistence of human influenza viruses and avian influenza viruses may provide an opportunity for genetic material to be exchanged between these viruses. This could potentially create a new virulent influenza strain that is easily transmissible and lethal to humans (Food Safety Research Information Office, 2006). Thus, there is the need for sensitive diagnostic tests to allow for the rapid and early detection of these H5 influenza virus infections, to help reduce the risk of epidemics or pandemics in both animals and humans.

H5N1 TaqMan RT-PCR Kit, 100 reactions

• Ready to use format, including Master Mix for the target and PCR control to monitor for PCR inhibition and validate the quality
• Specific Primer and Probe mix for the pathogen/virus/viroid of interest
• Primer and Probe mix
• Positive and negative control to confirm the integrity of the kit reagents

H5N1 TaqMan RT-PCR Probe/Primer Set and Controls, 100 reactions

• Specific Primer/Probe mix and Positive Control for the pathogen/virus/viroid of interest
• Nuclease-free water
• Can be used together with Norgen’s RT-PCR Master Mix (#28113) or customer supplied master mix

For research use only and NOT intended for in vitro diagnostics.

Details

Supporting Data

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Storage Conditions and Product Stability
All kit components can be stored for 1 year after the date of production without showing any reduction in performance.

All kit components should be stored at -20°C upon arrival. Repeated thawing and freezing (> 2 x) of the Master Mix and Positive Control should be avoided, as this may affect the performance of the assay. If the reagents are to be used only intermittently, they should be frozen in aliquots.

Component	Cat. TM35450 (100 preps)	Cat. TM35410 (100 preps)
MDx TaqMan 2X PCR Master Mix	2 x 700 μL	–
H5N1 Primer & Probe Mix	280 μL	280 μL
H5N1 Positive Control	150 μL	150 μL
Nuclease-Free Water (Negative Control)	1.25 mL	1.25 mL
Product Insert	1	1

Overview

• CE-IVDR marked in accordance with the European Commission Regulation (EU) No. 2017/746.
• 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
• 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.

Norgen’s Saliva RNA Collection and Preservation Devices Dx are designed for 1) safe and non-invasive supervised self-collection of saliva specimens and 2) preservation of RNA in saliva specimens 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 collection is performed through supervised self-collection. 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. This kit can be used to collect and preserve viral RNA, including SARs-CoV-2 RNA for detection of COVID-19.

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 Saliva/Swab RNA Purification Kits Dx (Cat# Dx69100, Dx69300). To minimize irregularities in diagnostic results, suitable controls for downstream applications should be used.

Details

Supporting Data

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Kit Specifications
Volume of Saliva Collected	2 mL
Volume of Saliva-Preservative Mix	4 mL
Preservation Temperature	Room Temperature
Preservation time	Up to 2 months at room temperature

Shelf Life and Handling

• The Collection Device should be kept tightly sealed and stored at room temperature for up to 2 years without any reduction in kit performance (The collection due date is written on the device label).
• Once collected, saliva RNA is stable for up to 2 months when kept tightly sealed and stored at room temperature.
• The Collection Tube, the Collection Funnel and the Device Container of each individual Saliva RNA Collection and Preservation Device are recyclable.

Kit Components	Cat. RU53800 (50 Devices)
Individual Saliva RNA Collection and Preservation Devices	50
Donor Procedure Flowchart	1
Product Insert	1
Individual Saliva RNA Collection and Preservation Device Dx Contents
Saliva Collection Funnel and Collection Tube	1
Collection Tube Cap	1
Preservative Ampoule	1
Donor Instructions	1

Overview

• Fast and easy processing using a rapid spin-column format
• Isolate high quality genomic DNA from fresh or preserved saliva samples
• Compatible with preserved saliva samples collected using Norgen’s Saliva DNA Collection and Preservation Devices (Cat. RU49000)

This kit provides a fast and simple spin column procedure for isolating genomic DNA from saliva samples collected and preserved using Norgen’s Saliva DNA Collection and Preservation Devices (Cat. RU49000), as well as fresh saliva samples.

Saliva DNA purified using Norgen’s kit is of the highest quality, and is compatible with a number of downstream research applications including PCR, Southern Blot analysis, sequencing and microarray analysis.

Background

Saliva represents an excellent non-invasive alternative to blood collection. Human genomic DNA extracted from buccal epithelial cells and white blood cells found in saliva can be used in various applications in diagnostics. Saliva DNA can be used for the detection of biomarkers to diagnose a disease, follow the diseases progress or monitor the effects of a particular treatment. Saliva DNA can also be used to diagnose particular types of infections. Isolation of DNA from saliva has become an attractive alternative to isolation from blood or tissue due to the fact that sample collection is non-invasive, the samples can be collected by individuals with little training, and no special equipment is required. Norgen’s Saliva DNA Isolation Kit provides a fast and simple procedure for isolating genomic DNA from both preserved saliva samples and fresh saliva samples.

Details

Supporting Data

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Kit Specifications
Maximum Saliva Input	0.5 mL preserved saliva 0.25 mL fresh saliva
Average Yield from 0.25 mL of Saliva*	3 – 7 μg
Average Purity (OD260/280)	1.7 – 2.1
Time to Complete 10 Purifications	30 minutes

* Average yield will depending on the donor

Storage Conditions and Product Stability
All solutions should be kept tightly sealed and stored at room temperature. This kit is stable for 1 year after the date of shipment. The kit contains a ready-to-use Proteinase K, which is dissolved in a specially prepared storage buffer. The buffered Proteinase K is stable for up to 1 year after the date of shipment when stored at room temperature.

Component	Cat. RU45400 (50 preps)
Lysis Buffer F	30 mL
Proteinase K in Storage Buffer	1.2 mL
Binding Buffer B	12 mL
Wash Solution A	18 mL
Elution Buffer B	15 mL
Spin Columns	50
Collection Tubes	50
Elution Tubes (1.7 mL)	50
Product Insert	1