Overview

• CE-IVDR marked in accordance with the European Commission Regulation (EU) No. 2017/746.
• 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 SARS-CoV-2 virus – Explore the Application Note
• Ship swab samples at room temperature safely
• Compatible with most DNA and RNA isolation methods

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. This kit can be used to preserve viral RNA, including SARs-CoV-2 RNA for detection of COVID-19.

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.

Details

Supporting Data

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Kit Specifications
Stability of DNA at Room Temperature	4 months
Stability of RNA at Room Temperature	2 months

Shelf Life and HandlingThe tubes should be kept tightly sealed and stored at room temperature for up to 1 year without any reduction in performance (The collection due date is written on the device label and the kit box label).Once collected, RNA is stable for up to 2 months and DNA is stable for up to 4 months when the tubes are kept tightly sealed and stored at room temperature.

Kit Components	Cat. Dx69200
Total Nucleic Acid Preservation Tubes Dx	50
Product Insert	1

Description

RAA uses a novel RNA substrate tagged with a fluorescent reporter molecule (fluor) on one end and a quencher on the other. In the absence of RNases, the physical proximity of the quencher dampens fluorescence from the fluor to extremely low levels. When RNases are present, however, the RNA substrate is cleaved, and the fluor and quencher are spatially separated in solution. This causes the fluor to emit a bright green signal when excited by light of the appropriate wavelength. Fluorescence can be readily detected with a fluorometer. Since the fluorescence of the RAA Substrate increases over time when RNase activity is present, results monitored with a fluorometer can be evaluated kinetically. The sequence of the RAA Substrate has been carefully optimized to detect several RNases, including RNase A, RNase T1, RNase I, micrococcal nuclease, S1 nuclease, mung bean nuclease, and Benzonase.

RNase activity in a convenient and sensitive fluorimetric assay that delivers results in real time. Great for Quality Testing for RNase contamination of materials and supplies.

Introduction

The Kit is specially designed for simultaneous purification of genomic DNA and total RNA from formalin-fixed, paraffin-embedded (FFPE) tissue sections. Purified DNA/RNA is suitable for use in applications such as real-time PCR and Pyrosequencing.

Details

Specifications

Features	Specifications
Main FunctionsC	Co-isolation total RNA and DNA from FFPE tissue
Applications	RT-PCR, cDNA synthesis, PCR and second-generation sequencing, etc.
Purification method	Polydisperse magnetic beads
Purification technology	Magnetic beads technology
Process method	Manual or automatic
Adaptive instrument	Nucleic acid extractor and pipetting workstation
Sample type	FFPE slice, FFPE puncture sample, embedded tissue
Sample amount	No more than six 10µm sections of 150 mm2 surface area or three 20µm sections of 150 mm2 surface area.

Principle

FFPE samples are incubated in an optimized lysis buffer, which results in the release of RNA and precipitation of DNA. After centrifugation, the RNA-containing supernatant and DNA-containing pellet are then processed separately to purify RNA and DNA. After adding magnetic particles and binding solution, DNA/RNA will be adsorbed on the surface of magnetic particles, and impurities such as proteins will be removed without adsorption. The adsorbed particles were washed with washing solution to remove proteins and impurities, washed with ethanol to remove salts, and finally DNA/RNA was eluted by RNase Free Water.

Advantages

• Post digestion sorting – higher DNA and RNA yields
• Economy – the price is much lower than imported reagents

Kit Contents

Contents	IVD3026
Purification Times	200 Preps
MagBind Particles	9.0 ml
Proteinase K	180 mg
Protease Dissolve Buffer	10 ml
Buffer DPS	150 ml
Buffer FRL	40 ml
Buffer ATL	40 ml
Buffer AL	80 ml
Buffer BXW1*	110 ml
RNase Free Water	30 ml

Storage and Stability

Proteinase K and MagBind Particles should be stored at 2-8°C upon arrival. However, short-term storage (up to 24 weeks) at room temperature (15-25°C) does not affect their performance. The remaining kit components can be stored at room temperature (15-25°C) and are stable for at least 18 months under these conditions.

The Kit is specially designed for simultaneous purification of genomic DNA and total RNA from formalin-fixed, paraffin-embedded (FFPE) tissue sections. Purified DNA/RNA is suitable for use in applications such as real-time PCR and Pyrosequencing.