Boykyo Cell-Free DNA BCT

Japanese website: www.boykyo.com
Chinese website: www.boykyo.com.cn

Contact information

Company: Shanghai Jinpan Biotech Co Ltd
Phone: +86 15221999938
Tel: +86 021-50837765
QQ: 3188791456
Email: sales@jinpanbio.com
Address: Room 101, Building 38, No.669, Dongjing Rord, Pudong New
Area,Shanghai, China
Website: www.jinpanbio.com www.jinpanbio.cn

Blood Collection Tube

Boykyo Cell-Free DNA BCT is a blood collection tube with a formaldehyde-free preservative stabilizing nucleated blood cells. This unique stabilization prevents the release of genomic DNA, allowing isolation of high-quality cell-free DNA which can be further used for a wide range of downstream applications in clinical research studies, drug discovery and diagnostic assay development.

Boykyo Cell-Free DNA BCT reduces the need for immediate plasma preparation due to its unique stabilization properties. Cell-Free DNA is stable for up to 14 days, while circulating tumor cells are stable for up to 4 days, at room temperature, allowing convenient sample collection, transport and storage.

Boykyo Cell-Free DNA BCT Catalog Number
Cell-Free DNA BCT is For Research Use Only. Not for use in diagnostic procedures in the U.S.
6-Tube Pack 691012
100-Tube Box 691013

INSTRUCTIONS FOR USE
INTENDED USE

Boykyo Cell-Free DNA BCT? is a direct draw whole blood collection tube intended for collection, stabilization and transportation of cell-free plasma DNA. This device also stabilizes and preserves cellular genomic DNA present in nucleated blood cells and circulating epithelial cells (tumor cells) found in whole blood. This product has not been cleared by the U.S. Food and Drug Administration for In Vitro Diagnostic use. The product is For Research Use Only. Not for use in diagnostic procedures.

SUMMARY AND PRINCIPLES

Accurate analysis of cf-DNA can be compromised by sample handling, shipping and processing, causing lysis of nucleated blood cells and subsequent release of cellular genomic DNA. Additionally, degradation of cf-DNA due to nuclease activity can be problematic.

The formaldehyde-free preservative reagent contained in Cell-Free DNA BCT stabilizes nucleated blood cells, preventing the release of cellular genomic DNA, and inhibits nuclease mediated degradation of cf-DNA, contributing to the overall stabilization of cf-DNA3 . Samples collected in Cell-Free DNA BCT are stable for up to 14 days at temperatures between 6 °C-37 °C, allowing convenient sample collection, transport and storage4.

The formaldehyde-free preservative reagent contained in Cell-Free DNA BCT stabilizes circulating epithelial cells (tumor cells) in whole blood for up to 4 days at temperatures between 15 °C-30 °C5.

REAGENTS
Cell-Free DNA BCT contains the anticoagulant K3EDTA and a cell preservative in a liquid medium.

PRECAUTIONS

1. For Research Use Only. Not for use in diagnostic procedures.
2. Do not freeze specimens collected in Cell-Free DNA BCT as breakage could result.
3. Do not use tubes after expiration date.
4. Do not use tubes for collection of materials to be injected into patients.
5. Product is intended for use as supplied. Do not dilute or add other components to Cell-Free DNA BCT.
6. Overfilling or underfilling of tubes will result in an incorrect blood-to-additive ratio and may lead to incorrect analytic results or poor product performance.

CAUTION
a. Glass has the potential for breakage; precautionary measures should be taken during handling.
b. All biological specimens and materials coming in contact with them are considered biohazards and should be treated as if capable of transmitting infection. Dispose of in accordance with federal, state and local regulations. Avoid contact with skin and mucous membranes.
c. Product should be disposed with infectious medical waste.
d. Remove and reinsert stopper by either gently rocking the stopper from side to side or by grasping with a simultaneous twisting and pulling action. A “thumb roll” procedure for stopper removal is NOT recommended as tube breakage and injury may result.
7. SDS can be obtained at www.boykyo.com or by calling +86-021-50837765.

STORAGE AND STABILITY

1. When stored at 18 °C-30 °Cunused Cell-Free DNA BCT is stable through expiration date.
2. Do not freeze unfilled Cell-Free DNA BCT. Proper insulation may be required for shipment during extreme temperature conditions.
3. Blood samples collected in Cell-Free DNA BCT for cf-DNA analysis are stable for 14 days when stored between 6 °C-37 °C.
4. Blood samples collected in Cell-Free DNA BCT for genomic DNA analysis are stable for 14 days when stored between 6 °C-37 °C.
5. Blood samples collected in Cell-Free DNA BCT for circulating epithelial cells (tumor cells) are stable for 4 days when stored between 15 °C-30 °C.
INDICATIONS OF PRODUCT DETERIORATION

1. Cloudiness or precipitate visible in reagent of unused tube.
2. If indications of product deterioration occur, contact Boykyo Technical Services at +86-021-50837765 or service@boykyo.com.

INSTRUCTIONS FOR USE

1. Collect specimen by venipuncture according to CLSI H3-A66.Prevention of Backflow – Since Cell-Free DNA BCT contains chemical additives, it is important to avoid possible backflow from the tube. To guard against backflow, observe the following precautions:

a. Keep patient’s arm in the downward position during the collection procedure.
b. Hold the tube with the stopper in the uppermost position so that the tube contents do not touch the stopper or the end of the needle during sample collection.
c. Release tourniquet once blood starts to flow in the tube, or within 2 minutes of application.

2. Follow recommendations for order of draw outlined in CLSI H3-A66. Cell-Free DNA BCT can be drawn after the EDTA tube and before the Glycolytic inhibitor tube.
3. Fill tube completely.
4. Remove tube from adapter and immediately mix by gentle inversion 8 to 10 times. Inadequate or delayed mixing may result in inaccurate test results. One inversion is a complete turn of the wrist, 180 degrees, and back per the figure below:
5. After collection, transport and store tubes within the recommended temperature range

DNA EXTRACTION

Extraction of cell-free plasma DNA and cellular genomic DNA can be accomplished using most commercially available kits that include a Proteinase K treatment step.
Cell-Free Plasma DNA
Step 1. To separate plasma, centrifuge whole blood at 300 x g for 20 minutes at room temperature.
Step 2. Remove the upper plasma layer and transfer to a fresh tube.
Step 3. Centrifuge the plasma at 5000 x g for 10 minutes.
Step 4. Isolate cell-free DNA per kit manufacturer instructions.

For optimal results, include a Proteinase K treatment step (≥30 mAU/mL digest) at 60 ℃ in the presence of chaotropic salts for 1 hour when extracting cell-free DNA.
Cellular Genomic DNA
Step 1. To separate the white blood cells, either lyse the red blood cells and wash, or centrifuge whole blood and collect the buffy coat layer.
Step 2. Isolate genomic DNA per kit manufacturer instructions. or optimal results, include a Proteinase K treatment step (≥ 30 mAU/ml digest) at 60 ℃in the presence of chaotropic salts for 2 hours when extracting cellular genomic DNA.

Note:
1. Cell-Free DNA BCT does not dilute blood samples; therefore, no dilution factor correction is necessary.
2. As in the case with most clinical laboratory specimens, hemolysis, icterus and lipemia may affect the results obtained on blood samples preserved with Cell-Free DNA BCT.

LIMITATIONS
1. For single use only.
2. Samples drawn in other anticoagulants or preservatives may cause coagulation in Cell-Free DNA BCT.
3. The use of butterfly collection needles for venipuncture is not recommended with the 10ml Cell-Free DNA BCT.

REFERENCES

Can be found online at www.boykyo.com.