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

Figure 1 / 4

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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

Introduction

Usages:
Pancreatic digest of casein obtained with a process to maintain a high level of vitamins and growth factors, it is particularly recommended for a rapid growth and detection of microorganisms present in low concentrations.

Technical specification:
Total nitrogen(TN)—————————≥11.5%
Amino nitrogen(AN) ————————≥3.0%
Sulphuri ash———————————–≤15.0%
Loss on drying——————————–≤6.0%
Chlorides—————————————≤2.0%
PH(5% solution)——————————7.0±0.5
Solubility in 5% water ———————–complete
Nitrites——————————————negative


Storage: Keep container tightly closed, store in a cool, dry place, away from bright light.

Specifications: 500g/bottle; 10kg/bag

500g/bottle;10KG/bag

Overview

• Detection kits for Listeria monocytogenes
• CE-IVD marked version available for in vitro diagnostic use
• Available in TaqMan format for analysis.

Listeria monocytogenes have emerged as significant foodborne pathogens that pose a serious public health problem. As the causative agent of Listeriosis, L. monocytogenes has the highest rate of fatality rate among all foodborne pathogens. L. monocytogenes is a facultatively intracellular, Gram-positive bacterium that could survive high and low temperatures, low pH. It is a rare causative agent of mastitis in cow. However, due to its ability to resist various food processing technologies as well as to grow at low temperature, L. monocytogenes is know to be associated with both raw and pasteurized milk, as well as dairy products such as cheese. As little as 1000 organisms may cause the disease with pregnant, new-born, and immunocompromised individuals the most susceptible.

Listeria monocytogenes TaqMan 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

Listeria monocytogenes TaqMan 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 PCR Master Mix (#28007) or customer supplied master mix

Details

Supporting Data

Figure 1 / 3

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Storage Conditions and Product Stability
All kit components can be stored for 2 years after the date of production without showing any reduction in performance.

All kit components should be stored at -20°C upon arrival.

Component	Cat. TM30450 (100 preps)	Cat. TM30410 (100 preps)
MDx TaqMan 2X PCR Master Mix	2 x 700 μL	–
Listeria monocytogenes Primer & Probe Mix	280 μL	280 μL
Listeria monocytogenes Positive Control	150 μL	150 μL
Nuclease-Free Water (Negative Control)	1.25 mL	1.25 mL
Product Insert	1	1

Heat Sealing Time:		0.5~2s			Heat Sealing Tube Outer Diameter:		2~6mm
Indicator Light Colors:		Red/Blue			RF Frequency:		40.68MHz
Grounding Protection:		Class l			Spacing Adjustment		65,70,75,80,85,90,95,100mm
Power Consumption:		250W during operation,10Win standby			Power Supply:		100V~120V/220V~240V AC
Weight:		4.5kg			Dimensions:		336×65×173mm
Operating Temperature:		0~40℃			Storage Temperature:		-20~70℃

A device that uses the principle of high-frequency oscillation to generate heat through the friction of molecules in PVC hoses, thereby melting the PVC hose and achieving the sealing effect. This device is also referred to as a pipe sealing machine in some places.

Overview

• Detection kits for Cryptosporidium
• CE-IVD marked version available for in vitro diagnostic use
• Available in TaqMan format for analysis

Cryptosporidium is a parasite found in water that causes an infection in mammals termed cryptosporidiosis. It is one of the most common water-borne diseases and is found world-wide. It affects the intestines of mammals and typically causes an acute short-term infection. The most common symptom is self-limiting diarrhea in healthy individuals, however in immunocompromised individuals the symptoms are particularly severe and often fatal. There is no specific treatment for cryptosporidiosis other than fluid rehydration and management of any pain. Therefore early detection of Cryptosporidium in water is the foremost action to prevent the infection.

Cryptosporidium 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

Cryptosporidium 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

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. TM39150 (100 preps)	Cat. TM39110 (100 preps)
MDx TaqMan 2X PCR Master Mix	2 x 700 μL	–
Cryptosporidium Primer & Probe Mix	280 μL	280 μL
Cryptosporidium Positive Control	150 μL	150 μL
Nuclease-Free Water (Negative Control)	1.25 mL	1.25 mL
Product Insert	1	1