iSWAB®-DNA-250 Collection Kit

Applications

Product Common Name: iSWAB®-DNA-250 Kit

Product Full Name: iSWAB®-DNA Collection Kit

Part Number: iSWAB®-DNA-250

Units: 600uL

Includes:
1 iSWAB®-DNA-250 Device
2 Swabs
Plastic “biohazard” bag w/ absorbent pad
Extra barcode label (for lab use only)
“Exempt Human Specimen” label
Outer box (used to mail sample back)

*iSPIT Funnel Sold Separately

*The products shown contain the CE Mark and are approved for IVD use in countries recognizing this standard. In the USA, products are designated For Research Use Only and not for use in diagnostic procedures and will be labeled accordingly.

For DNA Sample Collection.

DNA Collection Kit devices are only for collecting human DNA samples via spit or buccal cells.

Population Genomics, Cancer research HLA typing, DNA sequencing; Sanger and Next generation sequencing, Epidemiology

Product Description

Each iSWAB®-DNA-250 collection device consists of a collection tube that is pre-filled with 600 µL of the nontoxic iSWAB®-DNA buffer and fitted with a proprietary insert. The insert is designed to optimize the release of specimens collected with swabs into the gentle lytic buffer, creating a minimal footprint and allowing for swab-free transport of specimens. Self-collection or assisted collection can be achieved in less than 5 minutes and is suitable for all population segments including infants, toddlers, and elderlies. iSWAB®-DNA-250 is pre- barcoded for a traceability and storage, and is easy to process via manual and automated applications. The device is human gDNA and PCR inhibitor free and collected samples are stable at room temperature (15-30 °C) for 60 days.

Intended Use

The iSWAB®-DNA-250 collection device is a DNA sample collection device for the collection, stabilization, concentration, transport, and storage of DNA samples. It is a non-invasive swab-based sampling applicator and is intended to be used for sample collection of buccal cells. The DNA collection kit for humans can capture samples producing high yields of double-stranded, long fragmented DNA between 5-15μg (iSWAB®-DNA-250) with <3% bacterial contamination using traditional sampling swabs.

Indication for Use (from IFU)

The iSWAB®-DNA-250 collection device is intended for the collection of double-stranded, large-fragment DNA at the point of collection without the need for swab inclusion. The gentle collection and lysis chemistry of the nontoxic iSWAB®-DNA buffer allows for the recovery of DNA comparable to the genomic DNA generated from blood, making it suitable for complex genomics downstream assays such as microarrays, NGS, and Sanger sequencing. The device can be used for ambient temperature (15-30 °C) transport and storage. Ideal for: paternity testing, genealogy, ancestry, population genomics, cancer research, HLA typing, and epidemiology.

Storage and Stability

“Pre-collection: 3 years from date of manufacture between 15-30° C.
Transport temperature, post-collection: 15-30° C.
Sample stability and storage, post-collection: 60 days real time and 3 years accelerated time; if longer storage time is required, collected samples can be stored at -20 to -80° C.”