Technology and Preparation of CD4 Blood Controls

CD4 stabilised blood controls are prepared using the proprietary CytoFix^® blood stabilisation technology. The stabilisation process is robust resulting in controls that are stable for up to 90 days when stored at 2 - 8°C.

Two CD4 stabilised blood controls are available; a normal CD4 blood cell profile (product number: CF04-N) and a low CD4 profile (product number: CF04-L). These controls can be purchased separately or as a pair (CF04-Duo). Each control is 1.5ml in volume, evaluation samples are available, please contact us for details.

In the controls, the white cell profile is adjusted to give a specific CD4+ count. The normal CD4 control (CF04-N) has a CD4+ absolute count within the normal healthy range (between 410 and 1590 cells/µl of blood). The low CD4+ control (CF04-L) has a CD4+ absolute count of between 200 and 300 cells/µl, which simulates CD4 levels in advanced HIV/AIDS patients.

Quality control analysis is performed on a BD FACSCalibur with BD MultiTest^™ reagents and Trucount^™ tubes using the Lyse/No Wash method. All CD4 stabilised blood controls are supplied with a detailed QC certificate detailing the average count and range for CD4+ lymphocytes, CD8+ T cells, NK and B cells.

CD4 blood controls prepared using the Cytofix^® technology can also be used in External Quality Assurance (EQA) programmes due to their exceptional stability.

CD4 Normal (CF04-N)

Graphs A) and B) show the typical profile for CD4 Normal.

CD4 Low (CF04-L)

Graphs C) and D) show the typical profile for CD4 Low

Storage and Stability

The CD4+ blood controls are stored at 2- to 8°C. They have a closed vial stability of 90 days and open vial stability of 30 days.

Safety

Human source material used to manufacture these products is tested for all known UK and European required communicable disease agents by UK NEQAS approved testing methods.