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ISM T EL R iSWAB

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iSWAB™-Microbiome-EL Collection Device Bag
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Benefits

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During the height of the COVID-19 pandemic, viral testing became the most effective tool to help bring outbreaks and surges under control. However, this comprehensive testing effort resulted in huge supply chain pressures, especially for lab consumables such as swabs and viral extraction reagents. Mawi DNA Technologies developed a modified “Extraction-Less” version of the non-invasive iSWAB™ technology. The iSWAB™-Microbiome-EL is designed to eliminate the RNA extraction step in the molecular testing workflow, allowing laboratories to perform direct RT-PCR and RT-LAMP on individual and pooled samples, eliminating or reducing the possibility of human error during long extraction protocols and the cost of extraction reagents, while increasing testing throughput. Additionally, the ambient temperature stabilization capacity of iSWAB™-MB-EL maintains the integrity of samples in cases of shipping delays/long shipping times or lab backlogs. This reduces the chances of false negatives and the need for patient re-sampling. Mawi DNA Technologies is committed to the creation of innovative technologies for effective and safe sample collection accessible to any person around the globe.

Product detail

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 for 28-33 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

iSWAB™-Microbiome -Extraction-Less Rack

Applications

Product Common Name: iSWAB™-MB-EL Rack

Product Full Name: iSWAB™-Microbiome-EL Collection Device Rack

Part Number: ISM-T-EL-R

Units: 800ul x 50 units

Includes:
50 iSWAB™-MB-EL Devices
1 Rack Case
Labels (Upon Request)

*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.

Resources

Product
iSWAB-MB-EL
Pre-Collection
Time Temp (C)
18 mo. DOM 15-30
18 mo. DOM 15-30
Transport
Temp (C)
15-30
15-30
Analyte
Type
Microbial RNA- Nasal
Microbial RNA- Saliva
Post Collection
Time Temp (C)
28 Days 15-30
33 Days 15-30
Cryo Storage
Temp (C)
-20- to -80
-20- to -80
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)

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. Refer to SDS.