Guidelines for organizing national external quality assessment scheme for performing CD4+ T-lymphocyte determinations in persons infected with HIV in resource-limited settings

Abstract

© 2015, Springer-Verlag Berlin Heidelberg. CD4 testing is important for the clinical monitoring of patients with HIV/AIDS. Quality assurance is therefore an essential element to ensure that the test results are reliable, reproducible, traceable, and auditable. An external quality assessment scheme (EQAS) provides an assessment of the entire testing process, including pre- and post-analytical procedures. At present, there is an increased demand for EQAS owing to an increasing number of CD4 testing laboratories in many countries. However, participating in the existing international EQAS is extremely expensive, making its implementation in resource-limited settings difficult. An ideal alternative is to have an equally qualified local or regional CD4 EQAS, which is more practical and will have a more obvious impact on these countries. The present communication aims to establish the requirements and guidelines for implementing EQAS for CD4+ T-lymphocyte determination in individuals with HIV-1 infection in resource-limited regions, particularly in sub-Saharan African countries and in some countries in Southeast Asia. Guidelines including the recruitment of CD4 testing laboratories, pre-participation EQA workshops, and management of EQA blood samples along with the evaluation of the performance data are described. An example of participants’ registration form, details of EQAS blood panels, participants’ report form, and EQAS performance report form are also included in the guidelines. The guidelines presented herein will lay a foundation to help improve the reliability of CD4+ T-lymphocyte determination in resource-limited settings.