Streck BCT Instrucciones De Uso

Cell-Free DNA BCT
INSTRUCTIONS FOR USE
INTENDED USE
Cell-Free DNA BCT CE 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 is FOR
EXPORT ONLY, not to be sold in the United States.
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 CE
cells, preventing the release of cellular genomic DNA, and inhibits nuclease mediated degradation of cf-DNA,
contributing to the overall stabilization of cf-DNA
up to 14 days at temperatures between 6-37° C, allowing convenient sample collection, transport and storage
The formaldehyde-free preservative reagent contained in Cell-Free DNA BCT CE stabilizes circulating epithelial
cells (tumor cells) in whole blood for up to 4 days at temperatures between 15-30° C
REAGENTS
Cell-Free DNA BCT CE contains the anticoagulant K
PRECAUTIONS
1. For In Vitro Diagnostic Use.
2. Do not freeze specimens collected in Cell-Free DNA BCT CE 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 CE.
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.
7. 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 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. Reinsert stopper by gently pushing stopper onto tube with a simultaneous
twisting action.
8. SDS can be obtained at www.streck.com or by calling 402-333-1982.
STORAGE AND STABILITY
1. When stored at 18-30° C, unused Cell-Free DNA BCT CE is stable through expiration date.
2. Do not freeze unfilled Cell-Free DNA BCT CE. Proper insulation may be required for shipment during extreme
temperature conditions.
3. Blood samples collected in Cell-Free DNA BCT CE for cf-DNA analysis are stable for 14 days when stored
between 6-37° C.
4. Blood samples collected in Cell-Free DNA BCT CE for genomic DNA analysis are stable for 14 days when
stored between 6-37° C.
5. Blood samples collected in Cell-Free DNA BCT CE for circulating epithelial cells (tumor cells) are stable for
4 days when stored between 15°-30° C.
INDICATIONS OF PRODUCT DETERIORATION
1. Cloudiness or precipitate visible in reagent of unused tube.
2. If indications of product deterioration occur, contact Streck Technical Services at 402-691-7510 or
technicalservices@streck.com.
INSTRUCTIONS FOR USE
1. Collect specimen by venipuncture according to CLSI H3-A6
Prevention of Backflow - Since Cell-Free DNA BCT CE 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-A6
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.
6. Perform extraction in accordance with instrument manufacturer's instructions. For optimal results, please
follow the directions for cell-free plasma DNA and cellular genomic DNA extraction.
®
CE
stabilizes nucleated blood
1,2
. Samples collected in Cell-Free DNA BCT CE are stable for
3
.
5
EDTA and a cell preservative in a liquid medium.
3
6 .
.
6
CELL-FREE PLASMA DNA AND CELLULAR GENOMIC DNA EXTRACTION
1. Extraction of cell-free plasma DNA and cellular genomic DNA can be accomplished using most commercially
available kits.
2. For optimal results, include a Proteinase K treatment step (≥ 30 mAU/ml digest) at 60° C in the presence of
chaotropic salts for 1 hour when extracting cell-free DNA and for 2 hours when extracting cellular genomic
DNA.
Note:
a. Cell-Free DNA BCT CE does not dilute blood samples; therefore, no dilution factor correction is necessary
to obtain absolute count values.
b. 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 CE.
LIMITATIONS
1. Unused tubes to be stored between 18-30° C.
.
4
2. Samples drawn in other anticoagulants or preservatives may cause coagulation in Cell-Free DNA BCT CE.
REFERENCES
1. Das, K., Dumais, J., Basiaga, S., and Krzyzanowski, G., (2012). Carbon-13 Nuclear Magnetic Resonance
Analysis of Formaldehyde Free Preservatives. Acta Histochemica, 115: 481-486.
2. Das, K., Fernando, M.R., Basiaga, S., Wigginton, S., and Williams, T. (2013). Effects of a Novel Cell
Stabilizing Reagent on DNA Amplification by PCR as Compared to Traditional Stabilizing Reagents. Acta
Histochemica, 116: 55-60.
3. Norton, S.E., Lechner, J.M., Williams, T., and Fernando, M.R., (2013). A Stabilizing Reagent Prevents
Cell-free DNA Contamination by Cellular DNA in Plasma during Blood Sample Storage and Shipping as
Determined by Digital PCR. Clinical Biochemistry, 46: 1561-1565.
4. Norton, S.E., Luna, K.K., Lechner, J.M., Qin, J., and Fernando, M.R., (2013). A New Blood Collection Device
Minimizes Cellular DNA Release During Sample Storage & Shipping When Compared to a Standard Device."
Journal of Clinical Laboratory Analysis, 27: 305-311.
5. Qin, J., Alt, J.R., Hunsley, B., Williams, T., and Fernando, M.R. (2013). Stabilization of Circulating Tumor Cells
in Blood Using a Collection Device with a Preservative Reagent. Cancer Cell International, 14:23.
6. Clinical and Laboratory Standards Institute. H3-A6, Procedures for the Collection of Diagnostic Blood
Specimens by Venipuncture; Approved Standard-Sixth Edition.
ORDERING INFORMATION
Please call our Customer Service Department at 402-333-1982 for assistance. Additional information can be
found online at www.streck.com.
GLOSSARY OF HARMONIZED SYMBOLS
EC REP LOT
Authorized Batch
Representative in Code
the European
Community
IVD
In Vitro Diagnostic Manufacturer
Medical Device
Glossary of symbols may contain symbols not used in the labeling of this product.
See www.streck.com/patents for patents that may be applicable to this product.
Streck
7002 S. 109 Street Omaha, NE 68128 USA
REF
Biological Risk Catalog
Number
Consult Temperature Do Not Re-use
Instructions Limitation
For Use
EC REP
M M ® Europe
EDI ARK
11, rue Emile Zola, BP 2332
38033 Grenoble Cedex 2, France
Use By
350648
2014-09