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

Introduction

This product is suitable for rapid extraction of DNA from tissue, cells, blood, saliva, swabs, blood spots, semen and other clinical samples. DNA can be used directly for PCR, quantitative PCR, Southern Blot, test of virus DNA and so on.

Details

Specifications

Features	Specifications
Main Functions	Isolation total DNA from blood, buffy coat, tissue and other samples
Applications	Second generation sequencing, PCR, real time PCR, etc.
Purification method	Polydisperse magnetic beads
Purification technology	Magnetic beads technology
Process method	Manual or automatic
Sample type	Anticoagulant blood, concentrated blood, buffy coat, lymphocytes and cultured cells
Sample amount	Whole blood :< 200μl; Saliva / swab:< 400μl; Tissue :< 20mg
Yield	0.1 – 50μg
Elution volume
Time per run

Principle

This product is based on the purification method of high binding magnetic particles. The sample is lysed and digested under the action of lysate and protease. DNA is released into the lysate. After adding magnetic particles and binding solution, DNA 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 was eluted by Elution Buffer.

Advantages

• High purity – OD 260 / 280 : 1.7- 1.9, OD 260 / 230 : 1.5 – 2.0
• Economy – less than 50% of the price of Qiagen and other imported products
• High yield – most optimal process, ensuring the recovery up to 90%
• Strong processing ability – samples including animal blood, cultured cells, animal tissues, etc.

Kit Contents

Contents	IVD3102
Purification Times	200
MagPure Particles	5 ml
Proteinase K	100 mg
Protease Dissolve Buffer	10 ml
Rnase A	40 mg
Buffer ATL	60 ml
Buffer AL	60 ml
Buffer BD*	20 ml
Buffer BW1*	110 ml
Elution Buffer	30 ml

Cat.No	Reagent	IVD3102-F-96
Proteinase K		50 mg
Protease Dissolve Buffer		6 ml
RNase A		20 mg
Buffer ATL		30 ml
Buffer AL		30 ml
96-Tip		1
Sample plate (DW Plate)	450µl Buffer BD(Ethanol Added)	1
Wash 1 Plate (DW Plate)	600µl Buffer BW1(Ethanol Added)	1
Wash 2 Plate (DW Plate)	600µl Buffer BW1(Ethanol Added)	1
Wash 3 Plate (DW Plate)	750µl Buffer GW2, 20µl MagPure Particle	1
Elution plate (DW Plate)	80µl Elution Buffer	1

Cat.No	Reagent	IVD3102-TL-06
Proteinase K		50 mg
RNase A		20 mg
Protease Dissolve Buffer		6 ml
Buffer ATL		40 ml
Buffer AL		40 ml
AS-Tip		12
2.0ml V-bottom plate	Row 1/7：450µl Buffer BDRow 2/8：450µl Buffer BW1Row 3/9：450µl Buffer BW1Row 4/10：20μl Magpure Particle450μl Wash Buffer GW2 Row 5/11：450μl Wash Buffer GW2 Row 6/12：80µl Elution Buffer	6

Storage and Stability

Proteinase K, RNase A, MagPure 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.

Experiment Data

This product is suitable for rapid extraction of DNA from tissue, cells, blood, saliva, swabs, blood spots, semen and other clinical samples. DNA can be used directly for PCR, quantitative PCR, Southern Blot, test of virus DNA and so on.

Description

Specifications

Clone	IHC008
Source	Mouse Monoclonal
Positive Control	Ovarian Carcinoma (Non-Mucinous Carcinoma), Thyroid Carcinoma, Renal Cell Carcinoma
Dilution Range	1:200

PAX-8 is a member of the paired box (PAX) family of transcription factors, which are key regulators in early development. This protein plays a role in development of thyroid follicular cells and the expression of thyroid-specific genes, with mutations in the PAX-8 gene linked to thyroid follicular carcinomas, atypical thyroid adenomas, and thyroid dysgenesis. The PAX-8 protein is expressed in simple ovarian inclusion cysts and non-ciliated mucosal cells of the fallopian tubes, but is absent from normal ovarian surface epithelial cells. PAX-8 is also not expressed in normal lung or lung carcinomas. Reports have associated PAX-8 expression with renal carcinoma, nephroblastoma, and seminoma, and have indicated PAX-8 as a useful marker for renal epithelial tumors, ovarian cancer, and for differential diagnoses in lung and neck tumors. Anti-PAX-8 can be useful in determining the primary site of invasive micropapillary carcinomas of ovary from bladder, lung, and breast, when used in adjunct with a panel of organ-specific markers such as uroplakin, mammaglobin, and TTF-1.