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.
Enables isolation of cfDNA, gDNA, and RNA from the same sample. Collected cells are maintained intact, making them suitable for FACS analysis, Cancer Research, and Organ Compatibility assays.
Product Description
HemaSure is a sterile, plastic, single use, prefilled evacuated direct-draw blood collection with stabilization solution. These components serve to transport venous whole blood samples that is designed to protect RNA molecules from degradation by ribonucleases (RNases), prevent induction of gene expression and to use in conjunction with cell-free DNA purification.
The device is intended to be placed inside a device holder or an adaptor that contains a needle designed to pierce the device closure and allow blood to flow into the device. Once the vein has been penetrated (using a standard blood collection needle or winged infusion), the device is pushed into the holder, and the blood enters the device. Once a device has drawn the appropriate amount of blood as per the fill volume range marked on the HemaSure device label, it is disengaged from the holder and inverted gently 10 times to mix the stabilizing additive with the blood. The specimen is then transported to the lab for plasma isolation and extraction of RNA and cfDNA.
Intended Use
HemaSure-OMICS is a direct-draw venous whole blood collection device intended for the collection, storage, and transport of venous whole blood samples and stabilization of cell-free DNA (cfDNA) and allowing subsequent isolation and purification of host intracellular RNA and gDNA. HemaSure-OMICS comes in three product formats: 3, 6, and 9 mL plastic vacuum blood collection devices
Indication for Use (from IFU)
HemaSure-OMICs is a direct-draw venous whole blood collection device intended for the collection, storage, and transport of venous whole blood samples and stabilization of intracellular RNA, cell-free DNA (cfDNA) and genomic DNA, (gDNA).For molecular diagnostic and next-generation sequencing assays that require cfDNA, RNA, or gDNA from whole blood.
Storage and Stability
Pre-collection: 12 months from date of manufacture between 15-30° C. Transport and storage temperature tolerance 4-45°C.
Sample stability and storage, post-collection: Separated plasma can be stored for 14 days at room temperature and several years when stored between 20° and -80°C.
Always separate the plasma before long term storage between -20° and -80°C. Plasma can be thawed up to 3 times, so plan your storage aliquots accordingly.
If longer storage time is required, collected samples can be stored at -20 to -80° C.
Benefits
“Current blood stabilization technologies can contain hazardous formaldehyde or formaldehyde-like fixatives that stabilize cfDNA or gDNA or RNA but not all three from the same sample. These types of fixatives are classified as hazardous and need to be handled with caution. Consequently, the stabilized cfDNA co-purifies with Human gDNA, making it more difficult to analyze, reducing the maximum shelf life of stabilized gDNA to no more than 72 hrs. Whole blood can be a great source of stable RNA, however, commercially available whole blood collection devices for RNA stabilization have a few limitations: Limited blood volume collection (< 3 mL), 72 hours stabilization when transported between 15° – 25° C, cold chain requirements, and complex and specialized RNA extraction procedures.
To overcome these hurdles and enable widespread and efficient collection and analysis of whole blood, Mawi DNA Technologies has developed the HemaSure-OMICs Collection. HemaSure-Omics is a blood stabilizing device that allows for ambient collection, stabilization, and transport of whole blood samples. Blood is particularly fragile and degrades quickly after leaving the internal environment of the body. A crucial component in advancing our understanding of health and disease in humans and animals, RNA, cfDNA, and gDNA from blood samples using HemaSure-OMICS remain stabilized at room temperature and abolishes the need for expensive cold chain involvement or toxic fixatives. “
Features
- Stabilization of whole blood
- Non-Toxic: free of formaldehyde or formaldehyde-like ingredients
- Validated for room temperature stabilization
cfDNA (up to 14 days), gDNA (up to 8 days), and RNA (up to 8 days) are stabilized at room temperature in the same blood device (temperature range of 25° – 45° C) - Multiple sizes: Available in 3, 6, and 9 mL plastic vacuum filled blood collection devices as well as a 250µl microtainer for blood drops for easy shipping and durability
- Compatible with any commercially available manual or automation-enabled kits for purification of cfDNA and gDNA from whole blood.
Features
- Stabilization of whole blood
- Non-Toxic: free of formaldehyde or formaldehyde-like ingredients
- Validated for room temperature stabilization
cfDNA (up to 14 days), gDNA (up to 8 days), and RNA (up to 8 days) are stabilized at room temperature in the same blood device (temperature range of 25° – 45° C) - Multiple sizes: Available in 3, 6, and 9 mL plastic vacuum filled blood collection devices as well as a 250µl microtainer for blood drops for easy shipping and durability
- Compatible with any commercially available manual or automation-enabled kits for purification of cfDNA and gDNA from whole blood.
| Attributes | HemaSure-OMICS-3 |
|---|---|
| Sample | Blood, plasma/serum |
| Use | gDNA, RNA, cfDNA, |
| Collection Volume | 3 mL, 6mL, 9mL |
| Nucleic Acid Yield (μg) | varies** |
| Molecular Weight of DNA | > 23kb |
| Storage and Transport temperature | RT |
| Shelf Life Stability | 18 months |
| Post-collection Stability | "cfDNA: up to 14 days; gDNA: up to 8 days; RNA: up to 8 days" |
| Capability to concentrate sample | No |
| Automation friendly | Yes |
| Liquid Sample | Yes |
| Barcoded | Included for 3ml |
| Compatible Assays | NA |
| Applications | Enables isolation of cfDNA, gDNA, and RNA from the same sample. Collected cells are maintained intact, making them suitable for FACS analysis, Cancer Research, and Organ Compatibility assays. |