The enumeration of lymphocyte subsets is important in a variety of conditions such as primary immunodeficiency (eg Severe Combined Immunodeficiency / SCID) or the monitoring of drug therapies such as retuximab in autoimmune disorders. However the most common use is in the monitoring of Human Immunodeficiency Virus / HIV, a secondary immunodeficiency disorder.
To ensure that the programme meets the requirements of all users, the Immune Monitoring Alternative Technologies Programme is aimed at those centres using new platform technologies such as the Coulter Aquios system.
The programme issues stabilised whole blood, with laboratories required to determine the lymphocyte subsets (CD3+, CD3+/CD4+, CD3+/CD8+, CD19+ and CD16+/56+) in each sample. Laboratories are requested to report both percentage and absolute values (in cells per microlitre).
Performance is monitored using this data, unless a centre chooses to eschew parameters in which case they would not be performance monitored for those parameters. Two samples are issued per trial and this programme issues trials a minimum of 4 times per annum and a maximum of 6.
Pre issue testing of samples for this programme is subcontracted, although the final decision about sample suitability lies with the EQA provider; no other activities in relation to this EQA programme are subcontracted.
This programme is for Beckman Coulter Aquios flow cytometer users or those using similar technologies. All standard flow cytometer technologies can register via this link for the Immune Monitoring programme. If you are unsure which programme to register, please contact firstname.lastname@example.org
From 1st April 2017 (distribution 171801 onwards) the Immune Monitoring (Alternative Technologies) programme will be subject to performance monitoring.
It is essential that your testing repertoire is updated accordingly to reflect current working practices for lymphocyte subsets.
Failure to provide this update could results in classification as a non return if results for these parameters are not submitted
As a result of an internal review we have taken the decision to adjust the performance monitoring limits for quantitative programmes.
• A result between 2.5 and -2.5 will now be classed as satisfactory
• A result between >2.5 and 3.5 or <-2.5 and -3.5 will be classed as an 'Action’ result, which highlights a potential issue to the laboratory. Two ‘Action’ results in a period of 3 samples would result in classification as a ‘Critical’
• A result above 3.5 or below -3.5 is considered to be a ‘critical’ result requiring immediate investigation by the laboratory