Quantification/viability of CD34 and CD45 ISHAGE
Code: CEL007
Type: Control de qualitat de medicaments de teràpia avançada
Clinical information
Diagnostic Utility:
This test quantifies:
- cells positive for the CD34 membrane receptor (hematopoietic progenitors)
- cells positive for CD45 (common leukocyte antigen)
and determines cellular viability. It is a determination used as quality control for units of umbilical cord blood and products for hematopoietic progenitor transplantation.
Method:
Flow Cytometry.
Reference Values
The results are quantitative. CD34 and CD45 concentrations can vary significantly depending on the type of sample/product and whether they come from a healthy donor or a patient. As for cellular viability, the expected values are as follows:
| Sample | CD45 Viability | CD34 Viability |
|---|---|---|
| Fresh CB | ≥85% | ≥85% |
| Thawed CB | ≥40% | ≥70% |
| Fresh/Thawed Progenitors | ≥70% | ≥70% |
Diagnostic Algorithm:
Not applicable.
Turnaround Time:
1 day.
Specimen information
Sample: Peripheral blood, umbilical cord blood, bone marrow, apheresis.
Tube: EDTA K3 tube (peripheral blood) or tube without additive (anticoagulated samples).
Minimum volume: 100 µL
Stability:
- At room temperature: 1 day
- In refrigeration: 1 day
- Cryopreserved between -156oC and -196oC: 20 years
Transport instructions: Preferably peripheral blood at room temperature; umbilical cord blood, bone marrow, apheresis refrigerated.
Reason for rejection: Sample highly hemolyzed or with clots.
Administrative information
BST Code: CEL007
Test Description: Quantification and viability of CD34 and CD45 cells by the ISHAGE method.
Synonyms: R/V CD34, ISHAGE
Section: Cellular Laboratory
BST Rates: Check the updated rates here.
Profiles:
Test CEL007 Quantification/viability of CD34 and CD45 cells by ISHAGE can be requested alone. It is also performed within the following profiles:
| Profile Name | Profile Code |
|---|---|
| SCU PRE | CEL2 |
| SCU THAWED | CEL3 |
| SCU POST | CEL4 |
| SCU POST-WASHED | CEL5 |
| SCU SD | CEL1 |
| SCU INTERNAL CONTROL | CEL6 |
| SP MOBILIZATION CONTROL | CE12 |
| APC INITIAL AUTO | CE14 |
| APC POSTNIGHT AUTO | CE15 |
| APC INITIAL ALLO | CE16 |
| APC POSTNIGHT ALLO | CE17 |
| MNC INITIAL AUTO | CE19 |
| MNC SMART-REDUX AUTO | CE20 |
| MNC POSTNIGHT AUTO | CE21 |
| MNC INITIAL ALLO | CE22 |
| MNC SMART-REDUX ALLO | CE23 |
| MNC POSTNIGHT ALLO | CE24 |
| INITIAL CD34 SEL | CE25 |
| POSTNIGHT CD34 SEL | CE26 |
| POST-MONOCLONAL CD34 SEL | CE27 |
| FR CD34+ SEL | CE28 |
| FR CD34- SEL | CE29 |
| INITIAL CD45RA SEL | CE30 |
| FR CD45RA- SEL | CE31 |
| FR CD45RA+ SEL | CE32 |
| INITIAL CD133 SEL | CE33 |
| POSTNIGHT CD133 SEL | CE34 |
| FR CD133+ SEL | CE35 |
| FR CD133- SEL | CE36 |
| TUBE A AUTO | CEL7 |
| TUBE A ALLO | CEL8 |
| TUBE B/C AUTO | CEL9 |
| TUBE B/C ALLO | CE40 |
| CMO m3 |
References
Sutherland R; Enumeration of CD34+ Cells by Flow Cytometry; Cellular Therapy: Principles, Methods, and Regulations, Chapter 56, 2nd Edition, AABB, 2016.
Quality
BST holds ISO 9001, ISO 14001, and OSHAS 18001 quality certifications, as well as the European Excellence 500+ seal. BST is accredited by CAT, JACIE-FACT, FACT-NETCORD, and EFI, and complies with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines.