NZY Mag Bacterial & Viral RNA/DNA Isolation Kit, IVD, is specifically designed to recover RNA and DNA from viral particles and bacteria cells contained in transport medium from from human respiratory and vaginal/perianal swabs. The kit uses magnetic-bead technology to provide reproducible recovery of nucleic acids. The procedure is based on the reversible adsorption of nucleic acids to paramagnetic beads under appropriate buffer conditions. A homogeneous distribution of the magnetic beads is essential for a high isolation consistency. Therefore, before dispensing NZY Mag Binding Beads make sure that beads are completely resuspended. Sample lysis and binding to the NZY Mag Binding Beads II is achieved by incubation with NZY Mag Binding Buffer II containing chaotropic ions supported by nucleic acid release with NZY Mag Proteinase K digestion. Following nucleic acid magnetic separation, paramagnetic beads holding the RNA/DNA are washed to remove contaminants and salts using NZY Mag Wash Buffer and 80% ethanol. Residual ethanol from previous wash steps is removed by air-drying. Finally, highly pure RNA/DNA is eluted with NZY Mag Elution Buffer. It is highly recommended to use extraction controls, positive and negative controls, internal controls as well as to perform cross-contamination assays during the usage of NZY Mag Bacterial & Viral RNA/DNA Isolation Kit, IVD.

Protocol for NZY Mag Bacterial & Viral RNA/DNA Isolation Kit, IVD, support automated workflows in platforms, such as the KingFisher™ Flex Magnetic Particle Processor with a 96 deep well head. Automated workflows allow for 96 swab specimens to be processed in <30 minutes. In addition, a flexible protocol accommodates sample volume inputs of 200 μL of transport medium with an elution volume of 50 μL. High-quality nucleic acids are subsequently ready to use for detection using different amplification strategies such as qPCR or RT-qPCR. NZY Mag Bacterial & Viral RNA/DNA Isolation Kit, IVD, 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 depending on the target pathogen. Any diagnostic results generated using nucleic acids isolated with the NZY Mag Bacterial & Viral RNA/DNA Isolation Kit, IVD, in conjunction with an in vitro diagnostic assay should be interpreted considering additional clinical or laboratory findings.