Description
Applications
*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.
Product Description
The iSWAB™-Microbiome-EL (iSWAB™-MB-EL) collection device consists of a collection device that is pre-filled with 800 μL of the iSWAB™-MB-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™-MB-EL collection device eliminates the costly and time-consuming RNA isolation step from diagnostic workflows.
Intended Use
The iSWAB™-Microbiome-EL collection device is intended for the stabilization and inactivation of human specimens suspected of containing an infectious disease. This Device can be used for the collection, transport, and storage of specimens at ambient temperature (15-30 °C) and allows for the transportation of samples without a swab. Specimens collected in the iSWAB™-Microbiome-EL collection device are suitable for use with marketed molecular diagnostic tests for infectious diseases without the need for an RNA extraction step.
Indication for Use (from IFU)
The iSWAB™-Microbiome-EL collection device is intended for the stabilization and inactivation of microbial, viral, fungal, and spore DNA and RNA from various sample types including nasal, oral, vaginal, and skin. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Microbiome-EL collection device are suitable for use with marketed molecular diagnostic tests for infectious diseases.
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.
Features
- Extraction-less RT-PCR or RT-LAMP
- Reduce processing time and costs by eliminating the extraction step
- Effectively inactivates viruses, bacteria, fungi and spores 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
- Compatible with nasal and saliva samples
- Swab-free transport of samples for a concentrated, liquid sample with a minimal footprint that can be processed on arrival to labs
- Non-toxic long-term room temperature stabilization of samples for increased detection/sensitivity.
- Barcoded for sample traceability and testing accuracy
| Attributes | iSWAB-Microbiome-EL |
|---|---|
| Sample | Saliva and Nasal |
| Use | Viral RNA |
| # 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 |
| Automation friendly | Yes |
| Liquid Sample | Yes |
| Barcoded | Included |
| Compatible Assays | RT-PCR, LAMP assays, Bio-Rad Reliance SARs CoV-2 RT Assays Kit, Prime Discoveries: Prime COVID-19 Extraction Less High Throughput LAMP Assay, SeqOnce Bio AzureSeq Direct One Step Universal RT-qPCRSARS CoV-2, 3CR Bio: ProbeSure COVID-19 One Step RT-PCR, Takara: One Step PrimeScript III RT-PCR |
| Applications | Microbiome analysis, infectious disease detection of SARS-CoV-2 (Saliva and Nasal) |