Saliva/Swab RNA Purification Kit, column format- CE-marked (for IVD)

Product Description

• CE-IVD marked in accordance with EU Directive 98/79/EC
• Fits into in vitro diagnostic workflows
• For High quality total RNA, including viral RNA,
• For 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, no need for carrier RNA
• Purified RNA for many downstream applications, incl. Small RNA Sequencing

Norgen’s Saliva/Swab RNA Purification Kit Dx provides a rapid method for the purification of total RNA from non-preserved saliva and nasal/throat swabs, and from preserved saliva collected on Norgen’s Saliva RNA Collection and Preservation Devices Dx or preserved swabs collected in Norgen’s Total Nucleic Acid Preservative Tubes Dx. Purification is based on using Norgen’s proprietary resin separation matrix. RNA is preferentially purified from other cellular components such as proteins, without the use of phenol or chloroform. The chemistry employed in the kit allows the purification of total RNA, including viral and bacterial RNA, irrespective of size or GC content. The purified RNA is ideal for in vitro diagnostic use for medical purposes.

This kit is optimized to be used with any downstream application employing enzymatic amplification or other enzymatic modifications of RNA followed by signal detection or amplification. 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 be interpreted with regard to other clinical or laboratory findings.

SARS-CoV-2 E-gene and RdRP Amplification

Fig.1. SARS-CoV-2 E-gene and RdRP Amplification from preserved swabs and saliva. Duplicate Nasopharyngeal Swabs, Oropharyngeal Swabs and Saliva samples were collected from different donors. The figure shows the linear recovery of the different spike-in amounts indicating the high sensitivity of the isolation procedure as well as the high quality of the purified RNA.

To minimize irregularities in diagnostic results, suitable controls for downstream applications should be used.

Norgen’s Saliva / Swab RNA Purification Kit Dx is intended for use by professional users such as technicians, 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 sole responsibility of the user to use and validate the kit in conjunction with a downstream in vitro diagnostic assay.