Clinical information
Diagnostic utility:
This test quantifies:
- cells positive for the CD3 membrane receptor (T lymphocyte antigen)
- cells positive for CD45 (common leukocyte antigen)
and determines cellular viability. It is a determination used as a quality control for units of umbilical cord blood and products for hematopoietic progenitor transplantation.
Method:
Flow Cytometry.
Reference values
The results are quantitative. CD3 and CD45 concentrations can vary greatly 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 | CD3 Viability | CD45 Viability |
|---|---|---|
| Thawed CB samples | ≥70% | ≥40% |
| 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: CEL006
Test Description: Quantification and viability of CD3 and CD45 cells.
Synonyms: R/V CD3 and CD45.
Section: Cellular Laboratory
BST Rate: Check updated rates here.
Profiles:
Test CEL006 Quantification/viability CD3 and CD45 can be requested individually. It is also performed within the following profiles:
| Profile Name | Profile Code |
| AFE AUTO INITIAL | CE14 |
| AFE ALLO INITIAL | CE16 |
| AFE ALLO POSTNIGHT | CE17 |
| AFE LIMFOAFERESIS | CE18 |
| AFE CART | CE37 |
| MO ALLO INITIAL | CE22 |
| MO ALLO SMART-REDUX | CE23 |
| MO ALLO POSTNIGHT | CE24 |
| INITIAL SEL CD34 | CE25 |
| POSTNIGHT SEL CD34 | CE26 |
| FR SEL CD34+ | CE28 |
| FR SEL CD34- | CE29 |
| INITIAL SEL CD45RA | CE30 |
| FR SEL CD45RA- | CE31 |
| FR SEL CD45RA+ | CE32 |
| INITIAL SEL CD133 | CE33 |
| POSTNIGHT SEL CD133 | CE34 |
| FR SEL CD133+ | CE35 |
| FR SEL CD133- | CE36 |
| TUB A AUTO | CEL7 |
| TUB A ALLO | CEL8 |
| TUB B/C ALLO | CEL10 |
| TUB A/B/C ALLO ALIQUOTE/ CART | CEL11 |
References
- NCF Parte IV: Directrices sobre normas de correcta fabricación específicas para Medicamentos de Terapia Avanzada.
- FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration.