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.
Product Common Name: iSWAB™-RC-EL
Product Full Name: iSWAB™-Respiratory Tract Sample Collection Media-Extraction-Less
Part Number: IRC-T-EL
This product has been approved For in vitro diagnostic use. For 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.
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.
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.
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.
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.
|Sample||Saliva and Nasal|
|# Swabs||2 or 1|
|Collection Volume||800 µl|
|Nucleic Acid Yield (μg)||varies*|
|Storage and Transport temperature||RT|
|Shelf Life Stability||15 Months|
|Post-collection Stability||28; 33 Days (Nasal; Saliva)|
|Suitable for all population segments||Yes|
|Compatible Assays||CDC 2019-Novel Coronavirus (2019-nCoV) RT-PCR Diagnostic Panel (with TaqPath 1-Step Multiplex Master Mix, the BGI Real- Time Fluorescent RT-PCR Kit, Bio- Rad’s Reliance SARS-CoV-2 RT- PCR Assay, the PRIME CovidDetect RT-LAMP-based assay, and the UCSD RT-LAMP and LFIA test for the detection of SARS-CoV-2. Compatibility is not limited to these assays.|
|Applications||For in vitro diagnostic use. For 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.|
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.