Qiagen PreAnalytiX PAXgene User manual

PAXgene®
Blood ccfDNA Tube
®
EN – English

I. Intended Use
The PAXgene Blood ccfDNA Tube is intended for the collection, storage, and transport of human blood and stabilization of DNA
in a closed tube for preparation of circulating, cell-free DNA (ccfDNA) from plasma and genomic DNA (gDNA) from nucleated
cellular fraction for use with molecular test methods that require ccfDNA or gDNA.
The performance characteristics for the PAXgene Blood ccfDNA Tube have been established with 18S ribosomal and DYS14
Y-chromosomal ccfDNA fragments in plasma. Users must validate use of product for their specic molecular diagnostic assay.
Product Features
PAXgene Blood ccfDNA Tube • 768165 CE-IVD • Sterile • 100 tubes/case
10.0 ml draw volume 16 × 100 mm tube • 1.5 ml liquid additive
Safety-engineered BD Hemogard™ closure Blue stopper • Pearlescent shield
• 2D barcode with serial number to uniquely identify the individual tube for sample tracking.
• Demonstrated ccfDNA stability and gDNA yield and purity: blood-lled PAXgene Blood ccfDNA Tubes can be stored for up
to 10 days at temperatures up to 25°C, 7 days at temperatures up to 30°C, or 3 days at temperatures up to 37°C prior to
processing.
Note: Do not store blood-lled tubes below 2°C.
• Compatible with magnetic bead- and silica membrane-based ccfDNA and gDNA isolation and purication methods that
are automated or manual.
• Puried ccfDNA is compatible with PCR and next-generation sequencing (NGS) based molecular test methods.
• For in vitro diagnostic use.
II. Summary and Explanation
The PAXgene Blood ccfDNA Tube provides a means for the collection of whole blood for the isolation of ccfDNA from plasma
and genomic DNA from the buffy coat or nucleated cellular fraction. Blood is collected under a standard phlebotomy protocol
into an evacuated tube that contains a proprietary ccfDNA stabilization additive without formaldehyde or formaldehyde
releasing substances. After collection, the whole blood sample can be stored for up to 10 days for temperatures up to 25°C,
up to 7 days for temperatures up to 30°C, or for up to 3 days at temperatures up to 37°C prior to processing. After tube
centrifugation, ccfDNA isolation from plasma is carried out using manual or automated methods that are based on magnetic
bead or silica membrane technologies for ccfDNA isolation. The remaining buffy coat, a leukocyte and platelet rich layer at the
interface of plasma and red blood cell fractions, or the remaining mixture of the buffy coat and red blood cells (cellular fraction)
can be harvested and used to isolate gDNA using manual or automated methods that are based on magnetic bead or silica
membrane technologies for DNA isolation.
This product was developed in accordance with the European Committee for Standardization Standard ISO 20186-3,
Molecular in vitro diagnostic examinations — Specications for pre-examination processes for venous whole blood —
Part 3: Isolated circulating cell free DNA from plasma.
III. Specimen Collection and Processing
A. Required Blood Collection Accessories (not included with the PAXgene Blood ccfDNA Tube)
1. Blood collection set with tubing such as the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set
(see Section XI. Ordering Information).
2. BD Vacutainer Tube Holder (see Section XI. Ordering Information).
3. Labels for positive patient specimen identication.
4. Alcohol swab for cleansing site.
5. Dry, clean disposable gauze.
6. Tourniquet.
7. Biohazard container for used needle or needle/holder combination.
B. Recommended Order of Draw
When using single venipuncture to collect multiple tubes with different additives for clinical laboratory testing, follow the
recommended tube order of draw per CLSI GP41, 7th ed. Collection of Diagnostic Venous Blood Specimens. PAXgene Blood
ccfDNA Tubes should be collected last to avoid possible test result error due to additive carryover.
1. Tubes for sterile samples.
2. Tubes for coagulation studies (e.g., citrate).
3. Serum tubes with or without gel and clot activator.
4. Tubes with heparin additives.
5. Tubes with other additives (e.g., EDTA, uoride).
6. PAXgene Blood ccfDNA Tube.
(Continued)EN – English 2

C. Prevention of Backow
Since PAXgene Blood ccfDNA Tubes contain a liquid additive, it is important to avoid possible backow from the tube, with the
possibility of adverse subject reactions. To guard against backow, observe the following precautions:
1. Place donor’s arm in a downward position.
2. Hold tube with the stopper uppermost.
3. Release tourniquet as soon as blood starts to ow into tube.
4. Make sure tube additives do not touch stopper or non-patient end of the needle during venipuncture.
D. Procedure for Specimen Collection
1. Ensure that the PAXgene Blood ccfDNA Tube is at room temperature (15–25°C) prior to use.
2. Collect blood into the PAXgene Blood ccfDNA Tube using your institution’s recommended procedure for standard
venipuncture technique. In addition, follow instructions for Prevention of Backow in Section III.C.
3. Fill the tube to its maximum stated draw volume. Continue blood collection until vacuum is exhausted and blood has
stopped owing into the tube before removing the tube from the holder.
4. After blood collection, gently invert the PAXgene Blood ccfDNA Tube 8 times to mix the blood with the additive.
One complete inversion is dened as turning the lled tube upside-down, and then returning it to an upright position.
5. Store the lled PAXgene Blood ccfDNA Tube at room temperature (15–25°C). See Performance Characteristics for ccfDNA
stability and gDNA yield and purity in blood samples at room temperature (15–25°C), 30°C or 37°C.
E. Plasma Preparation for Isolation of ccfDNA
1. Centrifuge the PAXgene Blood ccfDNA Tube at room temperature (15–25°C) for 15 minutes at 1900 × g using a balanced
swing out bucket centrifuge. If braking is preferred, it is recommended to use medium level braking, but should be
validated for your specic workow.
2. Pipet the plasma into a 15 ml conical bottom centrifugation tube, making sure to not disturb the buffy coat and the
cellular fraction.
Optional second centrifugation: For applications that require further purication of the plasma, centrifuge for 10 minutes
at room temperature (15–25°C) and 1900 × g using a balanced centrifuge. Pipet the plasma into a 15 ml conical bottom
centrifugation tube, making sure to not disturb the residual blood cell pellet, if present.
Note: Do not exceed the secondary tube manufacturer’s maximum recommended centrifugation speed.
3. Process the plasma sample in accordance with the instructions provided with the ccfDNA sample preparation kit,
or freeze the plasma (see Section III.F. Freezing and Thawing Plasma).
Note: For maximum ccfDNA yield, process the maximum volume of plasma available.
Note: When comparing ccfDNA yield to other blood collection tubes, take into account the dilution of the plasma by the
PAXgene Blood ccfDNA Tube additive. If similar input volumes of blood are used, ccfDNA yields will be similar to plasma
from a spray-dried K2EDTA tube separated directly after blood draw. For more information, contact Technical Support.
F. Freezing and Thawing Plasma
1. For long-term storage, aliquot and freeze plasma at −20°C or −70°C / −80°C in cryogenic tubes.
2. Thaw aliquot tubes at room temperature (15–25°C).
Note: Do not thaw at lower temperatures (e.g., 4°C).
3. If cryoprecipitates form in the plasma, vortex the tube for 30 seconds after thawing and continue according to the
instructions provided with the ccfDNA isolation kit.
Note: It is not recommended to centrifuge the plasma to remove cryoprecipitates because they may contain ccfDNA.
Note: To avoid the formation of cryoprecipitates, tubes can be thawed for 30 minutes at 30°C instead of at room
temperature.
G. Isolation of gDNA
After transferring plasma for ccfDNA isolation, the remaining buffy coat or nucleated cellular fraction can be used
to isolate gDNA, if desired. Buffy coat samples can be aspirated and processed in accordance with the buffy coat
processing instructions provided with the DNA sample preparation kit. Kit examples are provided in Section XI. Ordering
Information.
(Continued)EN – English 3

H. Freezing and Thawing the Nucleated Cellular Fraction in the PAXgene Blood ccfDNA Tube
1. Stand the PAXgene Blood ccfDNA Tube upright in a wire rack. Do not freeze tubes upright in an expanded polystyrene
(EPS) tray as this may cause the tubes to crack.
2. The PAXgene Blood ccfDNA Tubes can be stored at −20°C and below. If tubes are to be kept at temperatures below −20°C,
freeze them rst at −20°C for 24 hours, then transfer them to −70°C or −80°C.
3. Thaw the PAXgene Blood ccfDNA Tubes in a wire rack at room temperature (15–25°C).
4. Carefully invert the thawed PAXgene Blood ccfDNA Tubes 10 times.
Note: The frozen PAXgene Blood ccfDNA Tubes are subject to breakage upon impact. To reduce the risk of breakage
during shipment, frozen tubes should be treated in the same manner as glass tubes. Users must validate their own
freezing and shipping protocol for the PAXgene Blood ccfDNA Tubes.
IV. Performance Characteristics
A. ccfDNA Performance:
The performance characteristics of the PAXgene Blood ccfDNA Tube for ccfDNA stability were established using two validated
qPCR assays (targeting 18S rDNA and DYS14 Y-chromosomal DNA sequences).
After blood is collected into the tube, the ccfDNA remains stable in whole blood for up to 10 days at temperatures up to 25°C.
Based on ccfDNA stability studies, blood can be stored in the tube for up to 10 days at temperatures up to 25°C, 7 days at
temperatures up to 30°C, or 3 days at temperatures up to 37°C (Figure 1).
Figure 1. ccfDNA Relative Yield for Blood Samples Stored in the PAXgene Blood ccfDNA Tube
Change in plasma ccfDNA yield after whole blood sample storage in
comparison to plasma separated within 2 hours of blood collection
(Day 0). Blood was drawn from a donor pool of approximately
200 consented, apparently healthy adult subjects and stored at
various temperatures for the indicated number of days followed
by tube centrifugation and ccfDNA purication from plasma using
the QIAsymphony PAXgene Blood ccfDNA Kit on the QIAGEN
QIAsymphony instrument. The relative ccfDNA yield was calculated as
the ratio of the 18S rDNA CTvalue after sample storage compared to
the CT value at Day 0. Medians and the 25th and 75th percentiles are
denoted with box plots.
Table 1: Performance testing summary (automated, magnetic bead-based ccfDNA purication)
Relative Yield Compared to
EDTA Plasma at Day 0
Relative Yield (In Situ Stability) Compared to Day 0
Day 10, 25°C Day 7, 30°C Day 3, 37°C
n120 120 120 120
Mean ± SD 0.92 ± 0.26 1.30 ± 0.54 1.37 ± 0.59 1.52 ± 0.81
Median 0.93 1.21 1.24 1.27
Interquartile range 0.74–1.05 0.97–1.52 1.00–1.62 1.00–1.78
Range 0.26–1.87 0.32–3.15 0.31–3.27 0.48–4.26
95% of samples 0.33–1.50 0.51–2.86 0.50–3.15 0.59–4.82
B. gDNA Performance
The performance characteristics of the PAXgene Blood ccfDNA Tube for gDNA were established measuring integrity,
concentration, and purity.
After blood is collected into the tube, the gDNA remains stable in whole blood for up to 10 days at temperatures up to 25°C.
Based on gDNA stability studies, blood can be stored in the tube for up to 10 days at temperatures up to 25°C, 7 days at
temperatures up to 30°C, or 3 days at temperatures up to 37°C (Figure 2).
(Continued)EN – English 4
25°C
10 days
30°C
7 days
37°C
3 days
0
1
2
3
4
5
Relative YieldComparedtoDay 0
Temperature
Time

Figure 2. gDNA Concentration for Blood Samples Stored in the PAXgene Blood ccfDNA Tube
gDNA Concentration, Yield, and Purity using an Automated,
Magnetic Bead-Based DNA Purication System: Blood was drawn
from a donor pool of approximately 200 consented, apparently
healthy adult subjects into PAXgene Blood ccfDNA Tubes. Tubes
were centrifuged within 2 hours of blood collection, and an
aliquot was extracted from 400 µl of nucleated cellular fraction for
processing. The remaining sample in each tube were stored at
25°C, 30°C, or 37°C for the indicated number of days. DNA was
puried from 180 specimens using the QIAsymphony DSP DNA
Mini Kit (elution volume: 400 μl) on the QIAGEN QIAsymphony
instrument. Medians and the 25th and 75th percentiles are denoted
with box plots.
Table 2: Performance testing summary (automated, magnetic bead-based DNA purication)
Yield
(μg DNA / 400 μl input sample volume)
Purity
(A260/A280)
Day 0 Day 10, 25°C Day 7, 30°C Day 3, 37°C Day 0 Day 10, 25°C Day 7, 30°C Day 3, 37°C
n120 120 120 120 120 120 120 120
Mean ± SD 16.61 ± 5.54 17.80 ± 4.95 17.03 ± 4.95 16.80 ± 4.76 1.83 ± 0.07 1.84 ± 0.06 1.84 ± 0.07 1.85 ± 0.06
Median 16.30 17.62 17.04 16.82 1.83 1.84 1.82 1.84
Interquartile range 12.73–19.69 14.08–20.12 12.93–20.34 13.06–19.95 1.79–1.86 1.80–1.88 1.79–1.87 1.81–1.88
Range 5.74–36.68 8.08–32.76 8.02–28.82 8.18–34.34 1.58–2.02 1.74–2.05 1.68–2.09 1.71–2.05
95% of samples ≥8.27 ≥9.89 ≥9.19 ≥9.34 1.68–1.98 1.71–1.98 1.69–1.98 1.71–1.98
Figure 3. gDNA Integrity after Storage
Blood was drawn from 20 consented, apparently
healthy adult subjects into PAXgene Blood ccfDNA
Tubes. Total gDNA was puried from 400 μl of
nucleated cellular fraction using the QIAsymphony
DSP DNA Mini Kit (elution volume: 400 μl) on
the QIAGEN QIAsymphony instrument. For each
subject, 400 ng gDNA was separated by agarose
gel electrophoresis (lanes 2–21). In lane 1 and 22,
a Lambda x Hind III marker was loaded. The upper
band of this marker represents a DNA fragment of
23 kb. The image shows gDNA isolation after storage
at 30°C for 7 days. The data for all other time and
temperature processing conditions are similar.
V. Limitations
1. The quantity of blood drawn should be approximately 10.0 ml per PAXgene Blood ccfDNA Tube, but this volume may vary
depending on various factors such as altitude, ambient temperature, barometric pressure, tube age, venous pressure, and
lling technique.
2. The PAXgene Blood ccfDNA Tube is not designed for use with open blood collection systems (manual lling of tube with
the BD Hemogard closure removed) due to the increased risk of blood exposure and risk of causing incorrect blood-to-
additive ratio that may affect product performance. Blood should be collected directly into the tube, or a transfer device
should be used if blood is collected and transferred from a syringe.
3. ccfDNA and gDNA yields depend on the patient, the quality of the specimen, and the method used for isolation.
(Continued)EN – English 5
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
25
°
C
Day 0
25
°
C
10 days
30
°
C
7 days
37
°
C
3 days
0
20
40
60
80
100
120
140
160
DNA Concentration (ng DNA /µleluate)
Temperature
Time

VI. Warnings and Precautions
A. Precautions:
1. Examine tubes prior to use. Do not use tubes if foreign matter is present inside the tube.
2. Since this PAXgene Blood ccfDNA Tube contains a liquid additive, precautions should be taken to prevent possible
backow from the tube during blood draw (see Section III.C. Prevention of Backow).
3. Do not shake vigorously since this may cause hemolysis.
4. If tubes are not mixed 8 times immediately after collection, clotting of blood or brin formation may occur. This may also
reduce effectiveness of blood stabilization that requires mixing with the additive immediately upon collection for best
performance.
5. Remove BD Hemogard closures with a twist and pull motion. Removal by rolling with the thumb is not recommended
(for detailed instructions see Section VIII. Removal of BD Hemogard Closure).
6. After venipuncture, the top of the stopper may contain residual blood. Take proper precautions when handling tubes to
avoid contact with this blood.
7. Under-lling of PAXgene Blood ccfDNA Tubes will result in an incorrect blood-to-additive ratio and may lead to incorrect
analytical results or poor product performance.
8. Endotoxin is not controlled. Blood and blood components collected and processed in the tube are not intended for
infusion or introduction into the human body.
B. Warnings:
1. The liquid additive in this tube is a mild irritant and may cause irritation to the eyes and skin upon direct contact:
• After skin contact, wash skin with soap and water. Get medical attention if irritation persists after washing.
• After eye contact, ush eyes with water as a precaution. If irritation occurs, get medical assistance.
• After swallowing, rinse mouth. Get medical attention if any discomfort occurs.
2. Practice universal precautions. Use gloves, gowns, eye protection, other personal protective equipment, and engineering
controls to protect from blood splatter, blood leakage, and potential exposure to blood borne pathogens.
3. Handle all blood samples and blood collection devices (needles, luer adapters, and blood collection sets) according to
the policies and procedures of your facility. Obtain appropriate medical attention in the event of any blood exposure
(for example, through a needlestick injury), since there is a risk of transmission of viral hepatitis, HIV, or other infectious
diseases. Utilize any built-in needle protector after blood collection if the blood collection device provides one.
PreAnalytiX does not recommend re-shielding used needles; however, the policies and procedures of your facility may
differ and must always be followed.
4. A blood collection set must be used with the PAXgene Blood ccfDNA Tube (see Section XI. Ordering Information).
5. Excessive centrifugation speed (over 10,000 x g) may cause PAXgene Blood ccfDNA Tube breakage, exposure to blood and
possible injury.
6. Transferring a blood sample from a syringe with a needle into the PAXgene Blood ccfDNA Tube is not recommended due
to the increased risk for both needlestick injury and incorrect blood-to-additive ratio.
7. If blood is collected from an intravenous (I.V.) line, ensure that line has been cleared of I.V. solution before beginning to
ll blood collection tubes. This is critical to avoid erroneous laboratory test results due to I.V. uid contamination.
8. After use, discard all blood collection tubes and accessories in biohazard containers approved for their disposal.
9. Do not re-use the PAXgene Blood ccfDNA Tubes.
10. Do not use the PAXgene Blood ccfDNA Tubes after the expiration date printed on the tube label.
VII. Storage
Store the unused PAXgene Blood ccfDNA Tubes at 4–25°C. Brief temperature excursions from −10°C to 50°C are permitted.
The PAXgene Blood ccfDNA Tube additive may have a slightly yellow appearance; this does not affect the performance of the
additive. Do not use tubes after their expiration date
VIII. Removal of BD Hemogard Closure
1. Grasp the PAXgene Blood ccfDNA Tube with one hand, placing the
thumb under the BD Hemogard closure. (For added stability, place
arm on solid surface). With the other hand, twist the BD Hemogard
closure while simultaneously pushing up with the thumb of the
other hand ONLY UNTIL THE TUBE STOPPER IS LOOSENED.
2. Move thumb away before lifting closure. DO NOT use thumb to push
closure off tube. If the tube contains blood, an exposure hazard exists.
3. Lift closure off tube. In the unlikely event of the plastic shield separating from the rubber stopper, DO NOT REASSEMBLE
CLOSURE. Carefully remove rubber stopper from tube.
(Continued)EN – English 6

IX. Reinsertion of BD Hemogard Closure
1. Replace closure over tube.
2. Twist and push down rmly until stopper is fully reseated. Complete reinsertion of
the stopper is necessary for the closure to remain securely on the tube during handling.
X. Technical Assistance
If you have any questions regarding the PAXgene Blood ccfDNA Tube, contact one of the BD Technical Services Departments
listed in the BD - Customer Service section.
XI. Ordering Information
PAXgene Products
PAXgene Blood ccfDNA Tube / 768165
Content: 100 blood collection tubes.
10.0 ml • 16 × 100 mm 1.5 ml additive Sterile
BD Hemogard closure 100 tubes/case CE-IVD
The PAXgene Blood ccfDNA Tube (CE-IVD) is available in Europe and some parts of the world outside the United States.
For more information please visit www.preanalytix.com.
To order PAXgene Blood ccfDNA Tubes or Kits:
Go to: www.preanalytix.com
BD Products*
BD Vacutainer UltraTouch Push Button Blood Collection Set / 367364
Content: 23G 3/4 inch (0.8 × 19 mm) needle, 12 inch (305 mm) tubing with luer adapter. 50/box, 200/case
BD Vacutainer Safety-Lok™ Blood Collection Set / 367281 US / 367286 CE
Content: 21G 3/4 inch (0.8 × 19 mm) needle, 12 inch (305 mm) tubing with luer adapter. 50/box, 200/case
BD Vacutainer One Use Holder / 364815
Content: Case only for 13 mm and 16 mm diameter. 1000/case
* These catalog numbers represent typical products that can be used with the PAXgene Blood ccfDNA Tube.
For more information on BD Blood Collection Accessories:
Go to: www.bd.com
QIAGEN Products*
To order QIAGEN ccfDNA Preparation Kits:
Go to: www.qiagen.com/shop
For Genomic DNA Isolation:
QIAsymphony DSP DNA Mini Kit (192) / 937236
2 reagent cartridges and enzyme racks and accessories.
* These catalog numbers represent typical sample preparation kits that can be used with the PAXgene Blood ccfDNA Tube.
To order QIAGEN gDNA Preparation Kits:
Go to: www.qiagen.com/shop
(Continued)EN – English 7

BD – Customer Service
Argentina, Uruguay and Paraguay
Orders: 0800.444.5523
E-mail: [email protected]
Australia
Orders: 1.800.656.100
Fax: 1.800.656.110
E-mail: [email protected]
Austria
Orders: 43.1.7063660
Fax: [phone]
E-mail: [email protected]
Belgium
Orders: 32.53.720.556
Fax: [phone]
E-mail: [email protected]
Brazil
Orders: 0800.055.56.54
E-mail: [email protected]
Canada
Technical support: 1.800.631.0174
Orders: 1.866.979.9408
Fax: [phone]
E-mail: customer[email protected]
Central and Eastern Europe
Orders: 48.22.377.11.11
Fax: [phone]
Bulgaria orders: [email protected]
Czech Republic orders: [email protected]
Croatia orders: [email protected]
Hungary orders: [email protected]
Poland orders: [email protected]
Romania orders: [email protected]
Southeast Europe orders: [email protected]
Serbia orders: [email protected]
Slovakia orders: [email protected]
Slovenia orders: [email protected]
Denmark
Orders: 45.43.43.45.66
Fax: [phone]
Orders: [email protected]
Technical support: [email protected]
Finland
Orders: 358.9.88.70.780
Fax: [phone]
Orders: tilaukset.@bd.com
E-mail: [email protected]
France
Orders: 33.476.68.36.36
Fax: [phone]
E-mail: [email protected]
Orders: [email protected]
Technical support: [email protected]
Germany
Orders: 49.6221.3050
Fax: [phone]
E-mail: [email protected]
India
Orders: 91.124.3949390
Orders: [email protected]
Ireland (Aquilant Specialist Healthcare Services)
Customer support: 353.1.404.8350
Fax: [phone]
E-mail: contactus@aquilantscientic.ie
Israel (Lapidot Medical)
Customer Support: 972.700.70.90.22
E-mail: [email protected]
Italy
Orders: 39.02.48240.500
Fax: [phone]
Technical support: 39.3450655140
E-mail: [email protected]
Middle East & Africa
Orders: 971.45.592.555
Fax: [phone]
E-mail: EMA_P[email protected]
The Netherlands
Orders: 31.20.582.94.20
Fax: [phone]
Orders: [email protected]
New Zealand
Orders: 0800.572.468
Fax: [phone]
E-mail: [email protected]
Norway
Customer Support: 64.00.99.00
E-mail: [email protected]
Orders: [email protected]
Southeast Asia
E-mail: P[email protected]
Indonesia orders: 622.1577.1920
Malaysia orders: 603.2093.8788
Philippines orders: 63.2478.8881
Singapore orders: 65.6861.0633
Thailand orders: 662.646.1800
Vietnam orders: 848.3822.7409
(Continued)EN – English 8

South Korea
Orders: 02.3404.3706
Fax: [phone]
Technical: 02.3404.3706
Technical support: Korea_P[email protected]
Spain, Portugal and Andorra
Orders: 34.91.848.8174
Customer support: 34.902.27.17.27
Fax: [phone]
E-mail: [email protected]
Sweden
Orders: 46.8.775.51.00
Fax: [phone]
Orders: order[email protected]
Technical support: [email protected]
Switzerland
Orders: 41.61.485.22.24
Fax: [phone]
E-mail: [email protected]
UK
Orders: 0800.917.8776
E-mail: [email protected]
USA
Customer support: 800.631.0174
E-mail: [email protected]
QIAGEN – Customer Service
Ordering www.qiagen.com/shop | Technical Support support.qiagen.com | Website www.qiagen.com
(Continued)EN – English 9

Batch Code
In Vitro Diagnostic Medical Device
Sterilized Using Irradiation
Catalog Number
Keep Away from Sunlight
Temperature Limit
Do Not Reuse
Manufacturer
Use-By Date
Recyclable
This End Up
Fragile, Handle With Care
Contains sufcient for <n> tests
Telephone Instructions for Use
Online Instructions for Use
CE Marking
Symbol and Mark Key
EN – English 10
The PAXgene Blood ccfDNA Tube is made in the UK by BD for PreAnalytiX GmbH.
PAXgene and PreAnalytiX are trademarks of PreAnalytiX GmbH; QIAGEN and QIAsymphony are trademarks of QIAGEN NV;
all other trademarks are property of Becton, Dickinson and Company.
© 2019 PreAnalytiX GmbH. Unless otherwise noted, PreAnalytiX, the PreAnalytiX Logo and all other trademarks are property of
PreAnalytiX GmbH, Hombrechtikon, CH.
PreAnalytiX GmbH, Feldbachstrasse, 8634 Hombrechtikon, CH
05/2020
VDP40336-WEB-04