Saliva RNA Collection and Preservation Devices Dx

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

Previous

Next

Click for expanded view

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.