Roche Whole Blood Collection Tube

Intended Use

The Roche Whole Blood Collection Tube is a direct draw whole blood collection tube. It is intended for the collection, transport, storage and lysis of whole blood and subsequent stabilization of DNA and RNA for use with the cobas® Babesia test and the cobas® Malaria test. It is used in settings where a venous blood sample is collected by a trained healthcare worker.

Materials for Use

Roche Whole Blood Collection Tube

All unopened kits shall be stored as recommended in Table 1.

* Product safety labeling primarily follows EU GHS guidance

** Hazardous substance

Additional Materials Required (But Not Provided)

Precautions and Handling Requirements

Warnings and Precautions

• For in vitro diagnostic use only.
• Do not use products after their expiration date.
• Avoid contact of reagents with skin, eyes or mucus membranes. In case of eye contact, rinse thoroughly with plenty of water for at least 15 minutes. In case of skin contact, wash off with soap and plenty of water.
• Treat all biological specimens and materials coming in contact with them as biohazards. Handle with proper caution and dispose of in accordance with the policies and procedures of your facility.
• Practice universal precautions. Use protective personal equipment and other engineering controls to protect from blood splatter, blood leakage and potential exposure to blood borne pathogens.
• Handle all biological samples and blood collection “sharps” (lancets, needles, luer adapters and blood collection sets) according to the policies and procedures of your facility.
• Use caution when handling to avoid dropping or breakage of the Roche Whole Blood Collection Tube. If the chaotropic reagent is spilled, FIRST clean with a suitable laboratory detergent and water, and then with 0.5% sodium hypochlorite.
• Do not use the Roche Whole Blood Collection Tube for collection of materials intended for injection.
• Do not use the Roche Whole Blood Collection Tube if the contents are cloudy or if foreign matter is present.
• Do not transfer a collection specimen into Roche Whole Blood Collection Tube using a needle and syringe.
• Additional manipulation of sharps increases the risk of injury.
• Check venipuncture collection system before use.
• Blood should be aspirated fully to avoid an incorrect reagent to blood ratio that could affect results.
• The quantity of blood drawn varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure and filling technique.
• Ensure that collected specimens are packaged and labeled following all of the requirements for transportation of biohazardous materials.
• Safety Data Sheets (SDS) are available upon request from your local Roche office.
• Inform your local competent authority and manufacturer about any serious incidents which may occur when using this assay.

Good Laboratory Practice

• Always follow Good Laboratory Practices/Good Clinical Practices (GLP/GCP).
• Wear protective disposable gloves, coats, and eye protection when collecting and handling specimens. Wash hands thoroughly after handling specimens.

Specimen Collection, Transport and Storage

Note: Handle all samples and controls as if they are capable of transmitting infectious agents.

• Store all donor samples at specified temperatures.
• Sample stability is affected by elevated temperatures.
• Centrifuge samples at 1000 RCF (relative centrifugal force) for 2 minutes.

Prior to blood collection, the Roche Whole Blood Collection Tube is stable when stored between 2°C and 25°C. Whole blood collected in the Roche Whole Blood Collection Tube may be stored for up to 60 days with the following conditions:

• For storage above 8°C, samples may be stored for 72 hours at up to 25°C, and up to 30°C for 24 hours during the 72 hours.

Other than noted above, samples are stored at 2-8°C. In addition, the Roche Whole Blood Collection Tube may be stored within the first 12 days after collection for up to 12 months at -20°C (± 5°C) with three freeze/thaw cycles. Refer to Figure 1.

Figure 1: Sample Storage Conditions for Samples Collected in the Roche Whole Blood Collection Tube

Whole blood in the Roche Whole Blood Collection Tube:

• Up to 60 days at 2-8°C.
• Up to 72 hours at 8-25°C.
• Up to 24 hours at up to 30°C (within the 72-hour window).

Frozen tube (Freeze-thaw up to 3 times):

• Up to 12 months at -20°C (± 5°C) within the first 12 days after collection.

Transportation of collected specimens must comply with all applicable regulations for the transport of etiologic agents.

Instructions for Use

Procedural Notes

• Do not use Roche Whole Blood Collection Tubes after their expiry dates.
• Roche Whole Blood Collection Tubes are for one-time use only.

Procedure

1. General guidelines for specimen collection can be found in Clinical and Laboratory Standards Institute (CLSI) H3-A6, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture.
2. Whole blood can be collected either directly from the vein using a winged blood collection set only or from a diversion collection bag using a collection line that prevents any backflow into the diversion collection bag.
3. Allow the Roche Whole Blood Collection Tube to come to room temperature prior to use.
4. Attach the Roche Whole Blood Collection Tube to the needle/tube holder and needle (not supplied with product) and perform phlebotomy. Blood will be aspirated up to the correct total volume and no further. Blood should be aspirated fully to avoid an incorrect additive to blood ratio that could affect results.
5. Because the Roche Whole Blood Collection Tube contains a chemical additive, it is important to avoid possible backflow. To prevent backflow during blood collection:
   1. Place the patient's arm in a downward position.
   2. Hold the tube in vertical orientation below donor's arm.
   3. Release the tourniquet as soon as blood begins to collect in tube.
   4. Ensure that tube additive does not touch stopper or end of needle.
6. If the Roche Whole Blood Collection Tube is the first tube drawn, it is recommended that a discard tube be used to fill the blood collection tubing's "dead space" with blood. This step will ensure the correct blood-additive ratio of the specimen.
7. Additional tubes should not be drawn with the same butterfly or winged blood collection set to ensure there is no cross-contamination from the needle and the chaotropic reagent to the additional tubes.
8. Remove the tube from the needle holder and immediately mix the whole blood and collection additive by gently inverting the tube 5 to 10 times (Figure 2). Do not shake or vortex. Vigorous mixing can cause foaming.

Figure 2: Tube Inversion

Gently invert the tube 5 to 10 times. Do not shake or vortex.

Additional Information

Symbols

• ? Age/DOB: Age or Date of Birth
• ? Ancillary Software: Ancillary Software
• ? Assigned Range [copies/mL]: Assigned Range (copies/mL)
• ? ❌ Device not for near-patient testing: Device not for near-patient testing
• ?‍⚕️ ❌ Device not for self-testing: Device not for self-testing
• ? Distributor: Distributor (Note: The applicable country/region may be designated beneath the symbol)
• ? ❌ Do not re-use: Do not re-use
• ♀️ Female: Female
• ? For IVD performance evaluation only: For IVD performance evaluation only
• ? GTIN: Global Trade Item Number
• ? Importer: Importer
• ? IVD: In vitro diagnostic medical device
• ? LLR: Lower Limit of Assigned Range
• ♂️ Male: Male
• ? Manufacturer: Manufacturer
• ➖ CONTROL: Negative control
• ?✨ Non-sterile: Non-sterile
• ? ? Patient Name: Patient Name
• ? # Patient number: Patient number
• ✋ Peel here: Peel here
• ➕ CONTROL +: Positive control
• ? QS IU/PCR: QS IU per PCR reaction, use the QS International Units (IU) per PCR reaction in calculation of the results.
• ? SN: Serial number
• ? Site: Site
• ✅ Procedure Standard: Standard Procedure
• ? STERILE EO: Sterilized using ethylene oxide
• ? Store in dark: Store in dark
• ?️ Temperature limit: Temperature limit
• ? TDF: Test Definition File
• ⬆️ This way up: This way up
• ✨ Procedure UltraSensitive: Ultrasensitive Procedure
• ? UDI: Unique Device Identifier
• ? ULR: Upper Limit of Assigned Range
• ? Urine Fill Line: Urine Fill Line
• ? Rx Only: US Only: Federal law restricts this device to sale by or on the order of a physician.
• ? Use-by date: Use-by date

Technical Support

For technical support (assistance) please reach out to your local affiliate: https://www.roche.com/about/business/roche_worldwide.htm

Manufacturer, Importer, and Distributor

Manufactured for:

Roche Molecular Systems, Inc.
1080 US Highway 202 South
Branchburg, NJ 08876 USA
www.roche.com

Made in Austria

EC Importer

Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany

Distributed by:

Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250-0457 USA
(For Technical Assistance call the Roche Response Center toll-free: 1-800-526-1247)

¹ Symbol text required by USA only.

² For USA only.

Trademarks and Patents

See https://diagnostics.roche.com/us/en/about-us/patents

Copyright

©2024 Roche Molecular Systems, Inc.

EC REP Roche Diagnostics GmbH
Sandhofer Str. 116
68305 Mannheim
Germany

CE IVD

References

1. International Air Transport Association. Dangerous Goods Regulations. 59th edition. 2018.
2. Clinical and Laboratory Standards Institute (CLSI). H3-A6, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Sixth Edition. CLSI Document H3-A6:Wayne, PA;CLSI, 2007.

Document Revision