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 Rack
Product Full Name: iSWAB™-Respiratory Tract Sample Collection Media-Extraction-Less Rack
Part Number: IRC-T-EL-R
Units: 800uL x 50 Units
50 iSWAB™-RC-EL Device
1 Rack Case
Labels (Upon Request)
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.
|Saliva and Nasal
|2 or 1
|Nucleic Acid Yield (μg)
|Storage and Transport temperature
|Shelf Life Stability
|28; 33 Days (Nasal; Saliva)
|Suitable for all population segments
|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.
|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.