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Cell-Free DNA BCT
INSTRUCTIONS FOR USE
Cell-Free DNA BCT
CE is a direct draw whole blood collection tube intended for collection, transport and
®
storage of blood samples. This product is FOR EXPORT ONLY, not to be sold in the United States.
SUMMARY AND PRINCIPLES
Cell-Free DNA BCT CE stabilizes cell-free plasma DNA as well as preserves cellular genomic DNA present in
nucleated blood cells and circulating epithelial cells (tumor cells) found in whole blood.
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 preservative reagent contained in Cell-Free DNA BCT CE 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-DNA. Samples collected in Cell-Free DNA BCT CE are stable for up to 14
days at temperatures between 6 °C to 37 °C, allowing convenient sample collection, transport and storage.
The preservative reagent contained in Cell-Free DNA BCT CE stabilizes circulating epithelial cells (tumor
cells) in whole blood for up to 7 days at temperatures between 15 °C to 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 glass Cell-Free DNA BCT CE.
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.
CAUTION
a. Glass has the potential for breakage; precautionary measures should be taken during handling of
glass tubes.
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.
7. SDS can be obtained at www.streck.com or by calling 800-843-0912.
STORAGE AND STABILITY
1. When stored at 2 °C to 30 °C, empty Cell-Free DNA BCT CE is stable through expiration date.
2. Short-term storage at 2 °C to 40 °C is acceptable for empty Cell-Free DNA BCT CE for up to 14 days.
3. Do not freeze empty Cell-Free DNA BCT CE. Proper insulation may be required for shipment during
extreme temperature conditions.
4. Sample storage/stability:
Cell-Free DNA
Sample Stability
Sample Storage Temperature
6 °C to 37 °C
INDICATIONS OF PRODUCT DETERIORATION
1. Cloudiness or precipitate visible in reagent of empty tube.
2. If indications of product deterioration occur, contact Streck Technical Services at 402-691-7510 or
technicalservices@streck.com.
INSTRUCTIONS FOR USE
For a video demonstration, visit www.streck.com/mixing.
1. Collect specimen by venipuncture according to CLSI GP41
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 GP41
drawn after the EDTA tube and before the fluoride oxalate (glycolytic inhibitor) tube. If a Cell-Free DNA
BCT CE tube immediately follows a heparin tube in the draw order, Streck recommends collecting a
non-additve or EDTA tube as a waste tube prior to collection in the Cell-Free DNA BCT CE.
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 incorrect analytical results or poor product performance. 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.
Note:
1. For best results, a 21G or 22G needle is advised. Slower fill times may be observed when using a smaller
gauge needle.
CE
®
EDTA and a cell preservative in a liquid medium.
3
Sample Type
Cellular Genomic DNA
14 days
14 days
6 °C to 37 °C
.
1
. Cell-Free DNA BCT CE should be
1
©
2. When using a winged (butterfly) collection set for venipuncture and the Streck Cell-Free DNA BCT CE
is the first tube drawn, a non-additive or EDTA discard tube should be partially drawn first in order to
eliminate air or "dead space" from the tubing.
3. Cell-Free DNA BCT CE does not dilute blood samples; therefore, no dilution factor correction is
necessary.
4. 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.
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
Streck has qualified two separate plasma separation spin protocols for your convenience.
Double Spin Protocol 1
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 new conical tube (not provided).
Step 3.
Centrifuge the plasma at 5000 x g for 10 minutes.
Step 4.
Isolate cell-free DNA per kit manufacturer instructions.
Double Spin Protocol 2 (for maximum plasma recovery)
Step 1.
To separate plasma, centrifuge whole blood at 1600 x g for 10 minutes at room temperature.
Step 2.
Remove the upper plasma layer and transfer to a new conical tube (not provided).
Step 3.
Centrifuge the plasma at 16000 x g for 10 minutes.
Step 4.
Isolate cell-free DNA per kit manufacturer instructions.
For optimal results for all of the above protocols, 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.
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.
For optimal results, include a Proteinase K treatment step (≥ 30 mAU/ml digest) at 60 °C in the
presence of chaotropic salts for 2 hours when extracting cellular genomic DNA.
FREEZING AND THAWING
PLASMA
1. To Freeze: For long-term storage, after spinning, collect and transfer the upper plasma layer to a
cryogenic tube (not provided) and freeze at -20 °C or -80 °C.
2. To Thaw: Thaw cryogenic tubes at appropriate temperature as specified in your protocol.
Note: If cryoprecipitates form in the plasma, vortex the tube for 30 seconds after thawing. Do not
centrifuge the plasma.
LIMITATIONS
1. For single use only.
2. Samples drawn in other anticoagulants or preservatives may cause coagulation in Cell-Free DNA BCT CE.
3. Specimen transport via pneumatic tube system is not advised.
Epithelial Cells
(Tumor Cells)
REFERENCES
1. Clinical and Laboratory Standards Institute. GP41, Procedures for the collection of diagnostic blood
7 days
specimens by venipuncture. Approved Standard - Seventh Edition.
15 °C to 30 °C
ORDERING INFORMATION
Please call our Customer Service Department at 800-228-6090 for assistance. Additional information can be
found online at www.streck.com.
GLOSSARY OF SYMBOLS
See the Instructions (IFU) tab under Resources on the product page at www.streck.com.
Canada Patent 2,690,651; Europe Patent EP2228453; Other Patents Pending
See www.streck.com/patents for patents that may be applicable to this product.
Streck
7002 S. 109 Street, La Vista, NE 68128 USA
EC REP
350648-10
M
M
Europe
®
EDI
ARK
2019-10
11, rue Emile Zola, BP 2332
38033 Grenoble Cedex 2, France
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Related Manuals for Streck Cell-Free DNA BCT CE
Summary of Contents for Streck Cell-Free DNA BCT CE
- Page 1 Note: If cryoprecipitates form in the plasma, vortex the tube for 30 seconds after thawing. Do not 2. Short-term storage at 2 °C to 40 °C is acceptable for empty Cell-Free DNA BCT CE for up to 14 days. centrifuge the plasma.
- Page 2 при наличието на хаотропни соли за 2 часа, когато извличате клетъчна геномна ДНК. СЪХРАНЕНИЕ И СТАБИЛНОСТ 1. Когато се съхранява при температура от 2 °C до 30 °C, празният продукт Cell-Free DNA BCT CE е стабилен ЗАМРАЗЯВАНЕ И РАЗМРАЗЯВАНЕ до изтичане на срока на годност.
- Page 3 Za odvajanje bijelih krvnih stanica lizirajte crvene krvne stanice i isperite ih ili centrifugirajte POHRANJIVANJE I STABILNOST čitavu krv i prikupite leukocitno trombocitni međusloj. 1. Prazna epruveta Cell-Free DNA BCT CE stabilna je tijekom roka valjanosti ako se skladišti na 2 °C do 30 2. korak. Izolirajte genomsku DNK prema uputama proizvođača pribora.
- Page 4 4. Nepoužívejte zkumavky pro odběr materiálů určených k injekčnímu podání pacientům. Protokol 1 se dvojím stočením 5. Výrobek je určen k použití tak, jak je dodáván. Obsah zkumavky Cell-Free DNA BCT CE neřeďte ani k němu Krok 1. K oddělení plazmy centrifugujte plnou krev při 300 x g po dobu 20 minut a při pokojové teplotě.
- Page 5 For at opnå optimale resultater skal der inkluderes et proteinase K-præparationstrin (≥30 mAU/ml 2. Kortere tids opbevaring ved 2 °C til 40 °C er acceptabelt for tomt Cell-Free DNA BCT CE i op til 14 dage. sammendrag) ved 60 °C under tilstedeværelsen af kaotropiske salte i 2 timer ved udtagelsen af 3.
- Page 6 1. samm. Plasma eraldamiseks tsentrifuugige täisverd 300 x g juures 20 minutit toatemperatuuril. 5. Toode on mõeldud kasutamiseks tarnitud kujul. Ärge lahjendage seadet Cell-Free DNA BCT CE ega lisage 2. samm. Eemaldage ülemine plasmakiht ja viige see üle uude koonuskatsutisse (ei ole komplektis).
- Page 7 Voit saavuttaa optimaaliset tulokset lisäämällä proteinaasi K -käsittelyvaiheen (≥30 mAU/ml sulatus) SÄILYTYS JA VAKAUS 60 °C:ssa kaotrooppisten suolojen ollessa läsnä 2 tunnin ajan genomisen solu-DNA:n keruun 1. Tyhjä Cell-Free DNA BCT CE -putki on vakaa viimeiseen voimassaolopäivään asti, kun sitä säilytetään yhteydessä. 2–30 °C:n lämpötilassa.
- Page 8 En outre, la dégradation de l’ADN acellulaire sous l’effet des nucléases peut présenter un problème. 2. Si un set de prélèvement à ailettes est utilisé pour la ponction veineuse et que le tube Cell-Free DNA BCT CE de Streck est le premier dans l’ordre de prélèvement, effectuer d’abord un prélèvement partiel dans un tube sans Le réactif de conservation contenu dans Cell-Free DNA BCT CE stabilise les globules sanguins nucléés, prévenant...
- Page 9 Verfallsdatum stabil. zentrifugieren und die Leukozytenmanschette entnehmen. 2. Die kurzfristige Lagerung bei 2 °C bis 40 °C ist für ein leeres Cell-Free DNA BCT CE Röhrchen bis zu 14 Tage lang Schritt 2. Die Genom-DNA gemäß den Anweisungen des Kit-Herstellers isolieren.
- Page 10 του cf-DNA που μεταφέρεται μέσω της νουκλεάσης, ενισχύοντας τη συνολική σταθεροποίηση του cf-DNA. Δείγματα δύνανται να επηρεάσουν τα αποτελέσματα που λαμβάνονται στα δείγματα αίματος που διατηρούνται με το που συλλέχθηκαν σε Cell-Free DNA BCT CE είναι σταθερά για έως 14 ημέρες σε θερμοκρασίες μεταξύ 6°C έως 37°C, σωληνάριο Cell-Free DNA BCT CE.
- Page 11 1. כדי להקפיא: לצורך אחסון ארוך-טווח, לאחר הסחרור, יש לאסוף ולהעביר את שכבת הפלסמה העליונה למבחנה קריוגנית .° 04 לטווח קצר, למשך 41 יום לכל היותרC ° 2 עדC ריקה בטמפרטורה שלCell-Free DNA BCT CE 2. ניתן להחזיק -80 ºC -20 ואºC )לא...
- Page 12 A Cell-Free DNA BCT CE eszköz emellett stabilizálja a sejtmentes plazma-DNS-t, és tartósítja a teljes vérben 2. Ha a vénaszúráshoz szárnyas („pillangó”) vérvételi készletet használ, és a Streck Cell-Free DNS BCT CE az első található, maggal rendelkező vérsejtekben és keringő epiteliális sejtekben (tumorsejtekben) jelen lévő celluláris vérvételi cső, először egy adalékanyagot nem tartalmazó...
- Page 13 è possibile osservare tempi di riempimento più lenti. 2. Se si utilizza un set di raccolta a farfalla per venipuntura e la provetta Streck Cell-Free DNA BCT CE è la prima Il reagente conservante contenuto in Cell-Free DNA BCT CE stabilizza le cellule ematiche nucleate, prevenendo il...
- Page 14 DNS atbrīvošanu, un inhibē nukleāzes izraisītu bezšūnu DNS sabrukšanu, veicinot vispārējo bezšūnu DNS komplektu, kuros iekļauts proteināzes K apstrādes cikls. stabilizāciju. Stobriņā Cell-Free DNA BCT CE ņemtie paraugi ir stabili līdz pat 14 dienām 6 °C līdz 37 °C temperatūrā, tādējādi nodrošinot ērtu paraugu ņemšanu, transportēšanu un uzglabāšanu.
- Page 15 4. Kaip ir daugumos kitų klinikinių laboratorinių mėginių atveju rezultatus, gautus ištyrus mėgintuvėlyje paimti į mėgintuvėlį „Cell-Free DNA BCT CE“, išlieka stabilūs iki 14 dienų, laikant nuo 6 °C iki 37 °C „Cell-Free DNA BCT CE“ konservuotus kraujo mėginius, gali paveikti hemolizė, gelta ar lipemija.
- Page 16 For å separere de hvite blodcellene, skal enten de røde blodcellene lyses og vaskes eller OPPBEVARING OG STABILITET helblod sentrifuges og buffy coat-laget samles inn. 1. Når det oppbevares ved 2 °C til 30 °C, er ufylt Cell-Free DNA BCT CE stabil til og med utløpsdatoen. Trinn 2. Isoler genomisk DNA ifølge settfabrikantens anvisninger.
- Page 17 1 godzinę. +1 402-691-7510. I STABILNOŚĆ 1. Pusta probówka Cell-Free DNA BCT CE przechowywana w temp. od 2°C do 30°C jest stabilna do upływu terminu Komórkowe DNA genomowe ważności. Krok 1. Aby oddzielić białe krwinki, należy zlizować i odmyć czerwone krwinki lub odwirować krew pełną i 2.
- Page 18 ADN genómico celular 1. Quando conservados a uma temperatura entre 2 °C a 30 °C, os tubos Cell-Free DNA BCT CE vazios são estáveis Passo 1. Para separar os glóbulos brancos, provoque a lise dos glóbulos vermelhos e lave, ou centrifugue, o até...
- Page 19 DEPOZITARE ȘI STABILITATE stratul leucotrombocitar. 1. Atunci când sunt depozitate la Între 2 °C și 30 °C, eprubetele Cell-Free DNA BCT CE goale sunt stabile până Pasul 2. Izolați ADN-ul genomic în conformitate cu instrucțiunile producătorului kit-ului. la data expirării.
- Page 20 За оптималне резултате, укључите корак третмана протеиназом К (дигестија при ≥30 mAU/ml) на 60 °C у 1. Празни Cell-Free DNA BCT CE је стабилан током рока трајања, када се чува на 2 °C do 30 °C. присуству хаотропних соли током 2 сата када издвајате ћелијску геномску ДНК.
- Page 21 SKLADOVANIE A STABILITA 30 mAU/ml) pri 60 °C v prítomnosti chaotropných solí po dobu 2 hodín pri extrakcii celulárnej genomickej DNA. 1. Nepoužité skúmavky Cell-Free DNA BCT CE budú pri skladovaní v teplotách 2 až 30 °C stabilné až do dátumu spotreby.
- Page 22 ADN genómico celular; además inhibe la degradación por nucleasas del ADN libre, lo 3. Cell-Free DNA BCT CE no diluye muestras de sangre; por tanto, no se requiere realizar una corrección del factor que contribuye a la estabilización general del mismo. Las muestras recolectadas en tubos Cell-Free DNA BCT CE de dilución.
- Page 23 DNA, och hämmar nukleasorsakad nedbrytning av cf-DNA att eliminera luft eller dödutrymme från slangen. vilket bidrar till allmän stabilisering av cf-DNA. Prover som tas i Cell-Free DNA BCT CE är hållbara i upp till 3. Cell-Free DNA BCT CE späder inte blodprov; spädningsfaktorskorrigering krävs därför inte.
- Page 24 Beyaz kan hücrelerini ayırmak için ya kırmızı kan hücrelerini çözün ve yıkayın ya da tüm 2. Boş Cell-Free DNA BCT CE’ler için 2 °C ila 40 °C arasında 14 güne kadar kısa süreli depolama kabul kanı sentrifüjleyin ve beyaz kan hücreleri katmanını alın.
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Questions and answers
If a DNA BCT tube has expired can you use another type of tube