Preparation And Storage
Store BD Trucount™ Tubes in their original foil pouch at 2–25 °C. To avoid potential condensation, open the pouch only after it has reached room temperature and carefully reseal the pouch immediately after removing a tube. Do not remove the desiccant pack from the pouch. Use tubes within 1 hour after removalfrom the foil pouch.• BD Trucount™ Tubes in an unopened pouch are stable until the expiration date shown on the packaging. Do not use tubes after the expiration date.• Tubes in an opened pouch are stable for 1 month after the date of opening, when stored as directed. Write the date when you first open the pouch in the space provided on the label.
Recommended Assay Procedures
BD Trucount™ Tubes contain a known number of fluorescent beads, which is specified on the pouch label. This bead count is used by the flow cytometer software to calculate absolute counts of cells.BD Trucount™ Tubes are used with BD Multitest™ and BD Tritest™ reagents. See the instructions for use (IFU) for each reagent for the specific clinical applications.
BD Trucount™ Tubes can be used with the specimen types specified in the reagent IFU. See the appropriate reagent IFU for information about supported specimens, collection, storage, and preparation.
Reagents and materials provided.
BD Trucount™ Tubes come with two pouches of tubes. Each pouch contains 25 tubes, sufficient for 25 tests. Reagents and materials required but not provided.
• BD Multitest™ or BD Tritest™ reagent (see the reagent IFU for more information)
• BD FACS™ Lysing Solution (Catalog No. 349202)
The lysing solution is provided as a 10X concentrate and it contains diethylene glycol and formaldehyde. See the BD FACS™ Lysing Solution instructions for use (IFU) for precautions and warnings.
• Vortex mixer
• Micropipettor with tips
Reverse Pipetting
Accurate pipetting is critical when using a BD Trucount™ Tube. Use the reverse pipetting technique to add the sample to a BD Trucount™ Tube. For reverse pipetting, depress the button to the second stop. Release the button to draw excess sample into the tip. Press the button to the first stop to expel a precise volume of sample, leaving excess sample in the tip.
Staining the Cells
Stain specimens following specific instructions in the appropriate reagent IFU. Use care to protect the tubes from direct light. Perform the procedure at room temperature (20–25 °C).
Product Notices
- EU Only: Users shall report any serious incident related to the device to the Manufacturer and National Competent Authority.Outside EU: Contact your local BD representative for any incident or inquiry related to this device. Refer to the Eudamed website: https://ec.europa.eu/tools/eudamed for Summary of Safety and Performance.
Development References (2)
-
Centers for Disease Control and Prevention. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. Available: https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html March 12, 2019. View Reference
-
Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline- Fourth Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2014:CLSI document M29-A4.
Please refer to Support Documents for Quality Certificates
Global - Refer to manufacturer's instructions for use and related User Manuals and Technical data sheets before using this products as described
Comparisons, where applicable, are made against older BD Technology, manual methods or are general performance claims. Comparisons are not made against non-BD technologies, unless otherwise noted.
For In Vitro Diagnostic Use.
23-22942-00
Documents are subject to revision without notice. Please verify you have the correct revision of the document, and always refer back to BD's eIFU website for the latest and most up to date information.
