Test Catalog

Quantification/viability CD3 and CD45

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.