Routine haematological testing requires the use of reference material during machine set up such that validation prior to analysis of patient samples can be performed. Many also require repeat use of reference controls throughout the running period of the machine, ensuring sample processing, equipment and operators are all performing optimally, thereby providing quality assurance.
In Flow Cytometry however, it has not been the norm to use reference material since it has not previously been possible to stabilise samples for use as a reference. Using proprietary blood stabilisation technology, Cytomark can now produce stabilised human whole blood with both normal and low CD4 counts for use as blood controls. The stabilisation process is robust resulting in controls that are stable for up to 90 days from the date of manufacture when stored at 2 – 8°C, and an open vial stability of 1 month.
The stabilised controls allow gating, and forward and side scatter flow cytometric effects to be determined during machine set up and before and during analysis of patient samples.
The ISO standard entitled ‘ISO 15189: Medical laboratories – Particular requirements for quality and competence‘, refers to the requirement for reference samples during machine set up and running. Stabilised human whole blood and CD4 low and normal controls provide suitable reference samples for this purpose; each reference being provided with a QC certificate detailing the expected count and range for T cells (CD3+), T helper cells (CD3+CD4+), T suppressor cells (CD3+CD8+), NK cells (CD56+)and B cells (CD19+).
Products Available
Stabilised Human Whole Blood (1.5ml)
Stabilised levels of lymphocyte subsets that are within the following ranges:
T cells (CD3+/CD45+) 690 – 2540 cells/μl
T suppressor cells (CD3+CD8+/CD45+) 190 – 1140 cells/μl
T helper cells (CD3+CD4+/CD45+) 410 – 1590 cells/μl
NK cells (CD56+/CD45+) 90 – 590 cells/μl
B cells (CD19+/CD45+) 90 – 660 cells/μl
CD4 Low Blood Control (1.5ml)
CD4+ T cells in the low range (200-300 cells/µl)
CD4 Normal Blood Control (1.5ml)
CD4+ T cells in the normal range (410-1590 cells/µl)
CD4 Low & Normal Blood Control Set (1.5ml)
If you are interested in alternative volumes of Cytomark’s Blood Controls, please contact us.