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.
Microbiome analysis of human fecal samples for qPCR, microarray, and NGS for microbiome research in health, wellness, and forensics.
Product Description
The iSWAB™-Microbiome (iSWAB™-MB) collection device consists of a collection device that is pre-filled with 1.0 mL of the iSWAB™-MB 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 buffer is designed to maintain the status quo of samples at the time of collection, providing a representative snapshot of the microbial community that remains unchanged from the point of collection to processing.
Intended Use
iSWAB™-Microbiome collection device is a non-invasive, non-toxic sample collection technology intended for stable ambient transport and storage of microbial DNA and RNA from various sample types including fecal, vaginal, skin, soil, nasal, oral, and saliva. Purified microbial DNA or RNA isolated from collected samples are compatible with qPCR, microarray, and NGS for microbiome research in health, wellness, and forensics.
Indication for Use (from IFU)
The iSWAB™-Microbiome sample collection technology is intended for specimen collection of biological samples. It is a non-invasive, non-toxic sample collection method and is intended to be used for long-term room temperature, stable transport, and storage of microbial DNA and RNA from various sample types including fecal, vaginal, skin, soil, nasal, and oral. The iSWAB-Microbiome device is designed to recover and stabilize collected samples from a nylon flocked or molded swab head and then the swab is discarded at the point of collection. For saliva collection, only a spit funnel is needed to facilitate the collection of saliva into the iSWAB™-Microbiome device
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: 21 days for SARS-CoV-2 RNA and 40 days for microbial DNA at 15-30° C; if longer storage time is required, collected samples can be stored at -20 to -80° C.
Benefits
Microbial content and diversity within collected gut and rectal samples can provide a wealth of clues about human and animal health. However, current microbiome collection methods subject the samples to harsh and stressful stabilization techniques such as freezing or harsh organic solvents. Both stabilization approaches have a high probability of altering the microbial representation in the sample, which could offer misleading results and hinder proper modeling or data analysis. Freezing the collected sample requires well-monitored cold chain storage and transport, increasing associated costs. Transport alone may alter the microbial representation from point of collection to processing. Thawing samples requires pre-processing which affects DNA quality and somewhat limits re-culturing of samples, therefore affecting proper modeling or data analysis. The use of toxic organic solvents requires strict regulations for transport and handling procedures, they also alter microbial representation from the point of collection to processing, limiting DNA and RNA analysis. The iSWAB-MB offers a non-toxic, non-organic solvent, free from hazardous fixatives and detergents, allowing the microbial representation to remain intact from the time of collection to several weeks at room temperature (real time testing ongoing).
Features
- Non-toxic stabilization; no organic, hazardous solvent fixatives or detergents.
- Microbial representation maintained intact from time of collection for weeks at room temperature (real time testing ongoing).
- No bloom effect correction needed for microbiome data. Both aerobic and anaerobic bacterial communities stabilized from collection to processing.
- Ambient temperature transport and storage with no cold chain involvement.
- The stabilization buffer effectively inactivates bacteria, fungi, and spores allowing safe transport of biological samples.
- Purified microbial DNA or RNA isolated from collected samples are high-quality and compatible with qPCR, microarray and NGS based applications.
- Scalable and customizable platform capable of stabilizing up to 20g of fecal or soil material in standard collection containers.
- Swab-free transport allows for a smaller transportation and in-lab storage footprint.
| Attributes | MAW-iSWAB-MBF-1200 |
|---|---|
| Sample | gut and rectal samples |
| Use | Microbial/ Viral DNA and RNA |
| # Swabs | 2 or 1 |
| Collection Volume | 1.0mL |
| Nucleic Acid Yield (μg) | varies* |
| Storage and Transport temperature | RT |
| Shelf Life Stability | 18 months |
| Post-collection Stability | 40 days (DNA), 21 days (RNA) |
| Capability to concentrate sample | Yes |
| Suitable for all population segments | Yes |
| Automation friendly | Yes |
| Liquid Sample | Yes |
| Barcoded | Included |
| Compatible Assays | ZymoBiomics DNA/RNA MiniPrep Kit (Cat. # R2002, Zymo Research), Nextera XT DNA Library Preparation Kit (Illumina), NEBNext Ultra II with RiboZero Plus (New England BioLabs), Bioanalyzer RNA 6000 Nano (Agilent) |
| Applications | Microbiome analysis (Fecal, skin, vaginal, soil, etc.), qPCR, Microarray |