Clinical information

Diagnostic utility:

This test evaluates the clonogenic efficiency or capacity of CD34+ hematopoietic progenitor cells to generate CFU-GM (white series), CFU/BFU-E (red series) and CFU-GEMM (mixed) colonies when cultured in a specific medium for 10-14 days.

It is a determination used as a potency test in the quality control of umbilical cord blood units and products for hematopoietic progenitor transplantation (fresh and thawed).

NOTE: depending on the type of sample (such as the positive fraction of a positive CD34 selection, thawed progenitor products, etc.), duplicate testing may be required. In this case, the associated test is CEL002.

Method:

Cell Culture.

Reference values:

The results are semi-quantitative. The expected CLONE (fresh samples)/E-CLONE (thawed samples) values are as follows:

Sample Type CLONE/E-CLONE (%)
Fresh UCB ≥30
Thawed UCB ≥10
Bone Marrow ≥10
Fresh/Thawed Progenitors ≥15

Diagnostic algorithm:

Not applicable.

Turnaround time:

14 days.

Specimen information

Sample: sterile sample of umbilical cord blood, bone marrow, apheresis/lymphapheresis.
Tube: Additive-free tube (anticoagulated samples).
Minimum volume: 100 μL.
Stability:

  • Fresh samples: 1 day
  • Thawed samples: 1 hour

Transport instructions: Fresh samples at room temperature; thawed samples in refrigeration.
Reason for rejection: Highly hemolyzed sample or samples with clots.

Administrative information

BST Code: CEL001 (Duplicate clonogenic culture: CEL002)
Test Description: Clonogenic culture of hematopoietic progenitor cells.
Synonyms: Not applicable
Section: Cellular Laboratory
BST Fee: Check the updated fees here.


Profiles:
The CEL001 Clonogenic Culture test can be requested on its own. It is also performed within the following profiles:

Profile Name Profile Code
SEL FR CD45RA- CE31
SEL INICIAL CD133 CE33
SEL POSTNIGHT CD133 CE34
SEL FR CD133+ CE35
TUB A AUTO CEL7
TUB A ALLO CEL8
TUB B/C AUTO CEL9
TUB B/C ALLO CEL10

References

Atlas of Hematopoietic colonies. StemCell Technologies. 2017.
Atlas of Hematopoietic colonies from cord blood. StemCell Technologies. 2010.