Clonogenic Culture
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.
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.