- CE-IVD marked in accordance with EU Directive 98/79/EC
- Fits into in vitro diagnostic workflows
- Isolate high quality total RNA, including viral RNA, from fresh and preserved saliva and swab samples
- Fast and easy processing using rapid spin-column format
- Isolate total RNA, from large rRNA down to microRNA (miRNA)
- No phenol or chloroform extractions
- Very sensitive & linear down to a few cells/viral copies without the need for carrier RNA
- Buffer chemistry inactivates viruses including SARS-CoV-2 - Explore the Application Note
- Purified RNA is suitable for a variety of downstream applications, including Small RNA Sequencing. Find out more information on Norgen"s NGS services
Saliva / Swab RNA Purification Kit Dx
Norgen’s Saliva/Swab RNA Purification Kit Dx provides a rapid method for the purification of totalRNA from non-preserved saliva and nasal/throat swabs, and from preserved saliva collected onNorgen’s Saliva RNA Collection and Preservation Devices Dx (Cat. 53800) or preserved swabscollected in Norgen’s Total Nucleic Acid Preservative Tubes Dx (Cat. Dx69200). Purification isbased on using Norgen’s proprietary resin separation matrix. RNA is preferentially purified fromother cellular components such as proteins, without the use of phenol or chloroform. Thechemistry employed in the kit allows the purification of total RNA, including viral and bacterialRNA, irrespective of size or GC content. The purified RNA is ideal for in vitro diagnostic use formedical purposes.
This kit is optimized to be used with any downstream application employing enzymaticamplification or other enzymatic modifications of RNA followed by signal detection oramplification. Any diagnostic results generated using the RNA isolated with Norgen’s Saliva /Swab RNA Purification Kit Dx in conjunction with an in vitro diagnostic assay should beinterpreted with regard to other clinical or laboratory findings.
To minimize irregularities in diagnostic results, suitable controls for downstream applicationsshould be used.
Norgen’s Saliva / Swab RNA Purification Kit Dx is intended for use by professional users such astechnicians, physicians and biologists experienced and trained in molecular biological techniques.
Norgen’s Saliva / Swab RNA Purification Kit Dx does not provide a diagnostic result. It is the soleresponsibility of the user to use and validate the kit in conjunction with a downstream in vitrodiagnostic assay.
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About Norgen
The Company
Norgen Biotek was founded in 1998 by Dr. Yousef Haj-Ahmad. The company is located in a 24,000 square foot state-of-the-art facility in Thorold, Ontario, Canada a few blocks from Brock University. Norgen is an ISO 9001, ISO 13485 and Illumina Propel certified fully-integrated Canadian biotechnology company focusing on developing products for sample collection, sample preparation and sample detection, as well as providing comprehensive research services to the scientific community. Norgen’s ISO 9001 and ISO 13485 certifications indicate our commitment to manufacturing and selling high quality products, as well as our commitment to continually improving our company, our products and our quality management system. Our Illumina Propel certification emphasizes our proficiency with Illumina Next-Generation Sequencing (NGS) to support genetic and genomic research and provide high quality services to our customers.
Norgen's Technology
Norgen holds more than thirty issued and pending patents. Norgen has developed a unique platform technology based on a proprietary resin/matrix with many applications including the purification, concentration and clean-up of DNA, RNA, microRNA, proteins and exosomes from various specimen types. The efficient purification of these macromolecules is often the first step in diagnostics and in hundreds of molecular biological applications fueling discovery for genomics and proteomics. The novelty of this technology has been recognized by the National Research Council by awarding Norgen the prestigious "Innovation Leader Award for 2003".
Manufacturing Capability, Contract Manufacturing and OEM
Norgen develops and manufactures all of our products, including isolation and purification kits, sample collection and preservation devices, molecular diagnostic kits and NGS kits. We not only manufacture all the reagents and solutions for these kits, we also manufacture the spin columns associated with these kits. Norgen has a fully equipped manufacturing facility, including an ISO class 5 certified cleanroom used for high capacity liquid filling. Norgen also has tremendous expertise in OEM and contract manufacturing of kits and reagents for the molecular biology and diagnostics markets. This includes customized manufacturing of full purification/isolation kits, sample collection and preservation devices, as well as molecular biology reagents including buffers and RNA/DNA standards. Norgen’s contract manufacturing services are catered to each individual’s needs, and we are fully committed to supplying high quality products and services. We offer best-in-class products, fast delivery time, and personable, highly competent, and unparalleled services.
cGMP
All of Norgen’s products are manufactured according to the ISO 13485:2016 standard, which meets or exceeds cGMP compliance. From our fully validated equipment and manufacturing premises to our highly trained personnel, we meet all the requirements of GMP. All of our manufacturing processes are strictly controlled by SOPs, ensuring batch to batch consistency and full traceability for all products manufactured in our facility. In addition to the manufacture of own products and medical devices, we also offer contract manufacturing to the life science and medical device community.
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