VanGenes® cfDNA Preservative Tube（In Vitro Diagnostic Use）
Overview
VanGenes Cell-Free DNA preservative tube is a direct draw whole blood collection tube intended for collection, stabilization and transportation of cell-free DNA in plasma or serum and cellular genomic DNA present in nucleated cells.
It is widely used in the collection, transportation and storage of blood samples of pregnant women for Non-invasive Prenatal Test (NIPT) , Non-invasive Prenatal Paternity Test (NIPPT) and cancer early screening.
VanGenes cfDNA preservative tube has been registered with CIBG, Ministry of VWS, Netherlands. It complies with The European Commission’s (EC) In Vitro Diagnostic Regulation (EU IVDR 2017/746) and can be used for in vitro diagnostics in EU countries.
VanGens's manufacturing department's Quality Management System has been certificated by POSI against the provision of ISO13485:2016.
Advantage
- High Stability: Effectively avoids cfDNA degradation and genomic DNA release to maintain the concentration of cfDNA.
- High Tolerance: With VanGenes proprietary reagents, VanGenes cfDNA BTC preserves cfDNA for 14 days at 6~37℃ or 72 hours in shipment.
- Easy Downstream Operation: Extraction of plasma cfDNA and celluar genomic DNA can be accomplished using most commercially available kits.
- High-performance Reagent: Anticoagulant K3EDTA and VanGenes proprietary reagents added do not dilute blood samples.
- VanGenes cfDNA BTC is a CE marked In Vitro Diagnostic(IVD) device
- Wide Application: Liquid biopsies for oncology, infection, prenatal diagnosis, etc.
Scientific Research Articles for Reference
- Multiple z-Score Based Method for Noninvasive Prenatal Test Using Cell-Free DNA in Maternal Plasma, DOI: 10.4236/ojgen.2017.71001
- Noninvasive Prenatal Testing for Fetal Chromosomal Abnormalities Using Massively Parallel Sequencing: Clinical Experience from 7910 Korean Pregnancies, DOI: 10.4236/ojgen.2018.83005
- Statistical analysis of mutant allele frequency level of circulating cell-free DNA and blood cells in healthy individuals, DOI: https://doi.org/10.1038/s41598-017-06106-1
- Baseline mutation profiling of 1134 samples of circulating cell-free DNA and blood cells from healthy individuals, DOI: https://doi.org/10.1101/089813
Specifications
| Sample Type | Whole blood |
|---|---|
| Volume | 5.0ml / 10ml |
| Tube Material | Glass |
| Intended to Use | Preserve, transport cfDNA and prevent cfDNA degradation. |
| Reagents | K3EDTA and VanGenes proprietary mixing cell protective reagent |
|
Storage Temperature before Use |
Room temperature (6~37℃) |
| Sample Storage Temperature | Room temperature (6~37℃) |
| Shelf Life | 1 year |
Catalog
| Volume Type | Catalog Number |
|---|---|
| VanGenes cf-DNA preservative tube（IVD）5ml | ZXDNA0501 |
| VanGenes cf-DNA preservative tube（IVD）10ml | ZXDNA1001 |
Certificate
| Registration Number | Fujian Device Registration Approval: 20212220076 |
|---|---|
| Registration Type | Registration Certificate for Medical Device of the People's Republic of China |
| Registered Specification | 5ml, 10ml |
Vangenes Cell-free DNA Preservative Tubes preserve fetal DNA in the blood of pregnant women. Fetal cfDNA concentration is estimated from the proportion of Y chromosome reads in next-generation sequencing data.
After Vangenes Cell-free DNA Preservative Tubes preserve fetal DNA in the blood samples from pregnant women for 3 days and 7 days at ambient temperature, the fetal cfDNA concentrations are compared to that of freshly collected blood samples.