Compatibility of stabilized whole blood products with CD4 technologies and their suitability for quality assessment programs.

BACKGROUND: CD4 T cell enumeration is the most widely used prognostic marker for management of HIV disease. Internal quality control and external quality assessment (EQA) programs are critical to ensure reliability of clinical measurements. The utility of stabilized whole blood products (SWBP) as a test reagent for EQA programs such as Quality Assessment and Standardization for Immunological measures relevant to HIV/AIDS (QASI) program have been demonstrated previously. Since then, several new commercial SWBPs and alternative CD4 enumeration technologies have become available. Seven SWBPs were evaluated on seven different enumeration platforms to determine which product(s) are most suitable for EQA programs that support multiple analytical technologies. METHOD: Assessment of SWBPs was based on two criteria: (1) accuracy of CD4 T cell measurements and; (2) stability under sub optimal storage conditions. RESULTS: Three SWBPs (Multi-Check, StatusFlow and CD4 Count) showed accurate CD4 T-cell absolute count and percentage values across six of the enumeration platforms. All products retain stability up to 18 days at 21-23°C with the exception of Multi-Check-high on FacsCount and Multi-Check-Low and StatusFlow-Low on Pima. One of the products (CD4 Count) retained stability for three days on all platforms tested when stored at 37°C. CONCLUSION: This study demonstrated that the characteristics of commercially available SWBPs vary across multiple CD4 platforms. The compatibility of testing panels for EQA programs with multiple analytical platforms needs to be carefully considered, especially in large multiplatform CD4 EQA programs. The selection of a suitable cross-platform SWBP is an increasing challenge as more reagents and platforms are introduced for CD4 T-cell enumeration.

QASI, an international quality management system for CD4 T-cell enumeration focused to make a global difference.

BACKGROUND: A significant worldwide mobilization effort to treat people with HIV disease began in 2003. Most guidelines for initiating antiretroviral therapy require reliable and reproducible CD4 T-cell counting. Therefore, any effort that improves global availability of quality managed assessment schemes for CD4 T-cell enumeration is a positive achievement for the clinical management of AIDS on a worldwide scale. METHODS: The Canadian QASI-Quality Management System (QMS) has been in operation for over a decade. More recently, QMS has fine-tuned its strategy to optimize its global impact in the fight against the HIV/AIDS pandemic. Three modifications were implemented: (1) introduction of skills and knowledge transfer workshops pertaining to the initiation of national quality management programs for CD4 counting, (2) introduction of a road map to establish domestic EQAP for countries that are ready, and (3) introduction of a statistical analysis package which permits continuous monitoring of global impact of the QASI-QMS. RESULTS: Based on QASI-QMS distribution of specimens over four consecutive participation cycles, there was decreased interlaboratory variation for both low and medium CD4 T-cell levels. After three cycles of consecutive participation, there is an average of 38 and 26% error reduction reported for the mid and low CD4 levels, respectively. CONCLUSION: The program improvements mentioned earlier appear to have had a profound effect with regard to enhancing the performance of laboratories participating in the QASI-QMS. Specifically, there is a significant reduction in interlaboratory variability of CD4 T-cell counts resulting from continuous participation in the QASI-QMS.