The iSWAB™-Microbiome-EL (iSWAB™ MB-EL) collection device is a non-toxic, sample stabilizing technology that inactivates viruses, allowing for the safe collection, transport, and long-term ambient temperature stabilization of COVID-19 bio-samples. The MB-EL buffer stabilizes nucleic acids from samples, allowing for direct Extraction-Less testing in molecular diagnostic assays, eliminating the costly and time-consuming RNA extraction step from diagnostic workflows.
The iSWAB™-MB-EL™ collection device consists of a collection tube that is pre-filled with 800 µL of the iSWAB™-MB-EL™ 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. Nasal samples can be collected in the iSWAB™-MB-EL device using swabs, such as the NextSWAB and traditional flocked swabs. Saliva can be collected into the iSWAB™-MB-EL device directly using the iSPIT Funnel for ease of use.
The iSWAB™-MB-EL collection device is compatible with an array of COVID testing procedures, including EUA-approved RT-qPCR and RT-LAMP based molecular diagnostic assays, and may be purchased as racks of 50 devices or in large bulk quantities for mass sample collection and testing. The devices are barcoded for sample traceability throughout the entire testing workflow. Sample collection can be performed by professionals or at home via self-collection by patients.
The iSWAB™-MB-EL has been proven to be compatible with rapid, specific, Extraction-Less, and cost-effective RT-LAMP tests for the detection of SARS-CoV-2 in clinical specimens.
Research using iSWAB™-MB-EL for room-temperature post-collection sample storage and for Extraction-Less assessment with rapid diagnostic solutions is accumulating in studies of various infections (including respiratory, gastrointestinal, and sexually transmitted pathogens).
iSWAB™-Microbiome-EL collection device is a non-invasive, nasal, or saliva-based sample collection technology intended for the collection, long-term stabilization, and inactivation of biological samples at ambient temperature for use in molecular assays without RNA extraction. The iSWAB™-MB-EL collection device is designed to recover and stabilize nucleic acids from upper and lower respiratory human specimens collected with the iSPIT Funnel, NextSWAB, or traditional flocked swabs.
The collection swab or funnel is then properly disposed after use, and does not travel with the sample. Multiple swabs can be used with one iSWAB™-MB-EL collection device to create a concentrated liquid sample that can be transported with a minimal footprint and processed on arrival to labs. The iSWAB™-MB-EL solution is designed to eliminate the RNA extraction step in the COVID-19 molecular testing workflow, allowing laboratories to perform direct RT-PCR or RT-LAMP on individual and pooled samples.
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 COVID-19 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.
- Extraction-less RT-PCR or RT-LAMP
- Reduce processing time and costs by eliminating the extraction step
- Effectively inactivates SARS-CoV-2 virus and other viruses, 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 any nasal and or/ saliva collection swabs
- 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
- RT-PCR, qPCR
- Bio-RAD Reliance SARs CoV-2 RT Assays Kit, Cat. #12014115 (EUA Granted)
- Prime Discoveries: Prime COVID-19 Extraction Less High Throughput LAMP Assay Kit (EUA Pending)
- SeqOnce Bio AzureSeq Direct One Step Universal RT-qPCR Kit SARS CoV-2, Ca# ASD-200 (EUA-Validated, not EUA- Authorized)
- 3CR Bio: ProbeSure COVID-19 One Step RT-PCR Kit, CA #COV 1001-3
- Takara: One Step PrimeScript III RT-PCR Kit, Cat. no. RR600A, RR600S, RR600B
- BGI Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (EUA Granted)
- CDC 2019-nCoV RT-PCR Diagnostic Panel (Using IDT 2019-nCoV Kit Primers and Thermofisher TaqPath™ 1-Step RT-qPCR Master Mix, CG)
Infectious disease detection of SARS-CoV-2 (from oral and nasal samples) using legally marketed molecular diagnostic assays.
Storage and Stability
Pre-collection: 18 months from date of manufacture between 15-30° C. Transport temperature, post-collection: 15-30° C. Sample stability and storage, post-collection: 14 days for microbial nucleic acids at 15-30° C; if longer storage time is required, collected samples can be stored at -20 to -80° C.