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HALO®-96 SPC-QC

Stem and Progenitor Cell Quality Control Assays for the Stem Cell Processing Laboratory

Stem Cell "Quality" and Stem Cell Potency

- Stem cell "quality" is the ability of stem cells to proliferate.
- Stem cell "quality" cannot be measured using a CFU assay, which detects the ability of stem cells to differentiate and mature (see HALO® and CFC Assays).
- Stem cell "quality" does not measure stem cell potency. However, a stem cell potency assay can measure stem cell "quality" (see HALO®-96 PQR, Potency, Quality, Release).

HALO®-96 SPC-QC Applications

- For quantifying the "quality" of stem cells in a stem cell product prior to use.
- To determine whether a processing procedure affects stem cell "quality".
- To determine stem cell "quality" pre- and post cryopreservation.
- To determine stem cell processing consistency and stability.
NOTE: Although the community norm is to use the colony-forming unit (CFU) assay, such as CAMEO™-4, an equivalent and alternative assay, such as HALO®-96 SPC-QC is acceptable by the FDA, since it satisfies "the requirements of the applicable statutes and regulations". In addition, AABB Standards for Cellular Therapy Services also allows "equivalent functional assays for any product", and the National Marrow Donor Program (NMDP) allows testing "consistent with AABB Standards".

Advantages to using HALO®-96 SPC-QC in the Stem Cell Processing Laboratory

- HALO®-96 SPC-QC quantitatively measures proliferation ability and cellular functionality that cannot be enumerated using total nucleated counts (TNC), viability or flow cytometric detection of membrane expression markers.
- HALO®-96 SPC-QC determines the "quality" of mature, multipotential hematopoietic stem cells (CFC-GEMM) and more primitive lympho-hematopoietic stem cells (HPP-SP).
- Instrument-based, incorporating an external standard and controls for assay standardization and validation according to FDA regulations.
- Compare results over time for intra- and inter-laboratory comparison studies.
- Assay can be completed on day 5, 6 or 7 of culture (see below).
- An FDA and AABB alternative "quality" assay.
- Faster, easier to use and more accurate than any traditional CFU assay, even using automated colony counting.
- HALO®-96 SPC-QC utilizes Suspension Expansion Culture (SEC) and bioluminomics™ Technology, the most advanced and cost-effective lympho-hematopoietic in vitro assay system available for the stem cell processing laboratory.

Tissues

- Mobilized peripheral blood
- Umbilical cord blood
- Bone marrow
- Purified cells from the above tissues

Stem Cells Detected

- In vitro, hematopoietic multipotential stem cell (CFC-GEMM 1)
- In vitro, lympho-hematopoietic primitive stem cell (HPP-SP 2)

HALO®-96 SPC-QC and HALO®-96 PCAEQ

Please note that although both these assays incorporate SEC and bioluminomics™ technology, they do not measure the same cell populations and therefore one cannot be used in place of the other.

Use

For Research Use Only. Not for clinical diagnostic use.

Major Equipment Required

Plate luminometer or multiparameter plate reader with "glow" luminescence measuring capability.

Kit Contents

- HALO®-96 SPC-QC Master Mix for HPP-SP and/or CFC-GEMM and/or background control
- ATP standard
- ATP high and low controls
- ATP Enumeration Reagent
- Sterile, 96-well plates
- Non-sterile, 96-well plates
- Sterile, adhesive foil covers
- Instruction manual