Description
SWAB™-Respiratory Tract Sample Collection Media-Extraction-Less Bag; 800uL x 500 Units
This product has been approved for in vitro diagnostic use. For the collection of human DNA. iSWAB-RC-EL has been cleared for in vitro diagnostic use of SARS-CoV-2 testing in the U.S.A. K221802
Devices only for collecting microbial DNA/RNA from nasal and saliva samples.
Infectious disease detection of SARS-CoV-2 (from nasal and saliva samples) using legally marketed molecular diagnostic assays.
Product Description
The iSWAB™-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB™-RC-EL) collection device consists of a collection tube that is pre-filled with 800 μL of the iSWAB™-RC-EL non-toxic, stabilizing buffer and fitted with a proprietary insert. The insert is designed to optimize the release of specimens collected with swabs into the stabilizing buffer, creating a minimal footprint and allowing for swab-free transport of specimens. The iSWAB™-RC-EL collection device eliminates the costly and time-consuming RNA isolation step from diagnostic workflows.
Benefits
Mawi DNA developed this innovative bio sampling device for surveillance testing of infectious diseases including COVID-19 and its variants. The iSWAB-RC-EL has received acclaim for its ability to skip the RNA extraction step in the PCR testing protocol and for its non-toxic formulation that inactivates viruses to decrease potential spread and exposure, especially among lab personal processing these samples. The iSWAB-RC-EL is currently being used worldwide for population-scale sampling to mitigate the impact of COVID spread and assist in detection of other infectious diseases. Now granted with FDA approval, the iSWAB-RC-EL can be used for any clinical application.
Features
- Extraction-less RT-PCR or RT-LAMP, samples can be processed on arrival to labs
- Reduce processing time and costs by eliminating the extraction step
- Effectively inactivates SARS-CoV-2 virus, to allow safe transport of biological samples.
- Inactivation of samples decreases the risk of infection of lab staff during sample processing
- Long- term room temperature stabilization up to 14 days for increased detection/sensitivity.
- Compatible with nasal and saliva samples
- Swab-free transport of samples for a concentrated, liquid sample with a minimal footprint
- Non-toxic and non-hazardous free of guanidine salts
- Barcoded for sample traceability and testing accuracy
Intended Use
Intended for the stabilization and inactivation of human upper respiratory and saliva bio specimens suspected of containing SARS-CoV-2, and can be used for collection, transport, and storage at ambient temperature. Specimens collected in the iSWAB-RC-EL collection device are suitable for use with legally marketed molecular diagnostic tests.
Indication for Use (from IFU)
The iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device is intended for the stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device are suitable for use with legally marketed molecular diagnostic tests.
Storage and Stability
Pre-collection: 15 months from date of manufacture between 15-30° C.
Transport temperature, post-collection: 15-30° C.
Sample stability and storage 15-30° C: 28 days for nasal specimens and 33 days for saliva specimens.
If longer storage time is required, collected samples can be stored at -20 to -80° C.
Attachments
WARNING AND PRECAUTIONS
For external use and single use only. DO NOT drink, touch, or remove the buffer from the device. Do Not use if device is broken, leaking, or visibly damaged. These products should only be used in accordance with the instructions provided. Avoid eye contact with the liquid in the device. IF IN EYES: Rinse cautiously with water for several minutes. IF INGESTED: Call POISON CENTER. Rinse mouth. Not a Hazardous Combustion Product. Device cap can be a choking hazard. Do not ingest.