Abstract
Bead-based single platform cytometry technology (SPT) is the gold standard when performing CD4 absolute counting. However, it presents drawbacks as precision depends on various critical steps (for example, pipetting methodology, overtime stability of beads, stability of fluidics, regular recalibration…) and thus requires skilled operators. The fully automated volumetric SPT AQUIOS CL (Beckman Coulter) has recently emerged as an alternative with no need of beads. It may help improving results standardisation and fulfilling requirements for certification (ISO 15189). In this study, we assessed SPT AQUIOS CL performances in accordance to requirements for ISO 15189 accreditation. We evaluated repeatability and reproducibility (precision), bias (trueness), uncertainty (total error), range limits (linearity, quantification, detection limits), and inter-reagent/inter-sample contaminations in enumerating CD4+ T-cells. Concomitantly, we compared AQUIOS CL CD4+ T-cell values with the results obtained with our routine bead-based SPT (that is, FC500 Beckman Coulter, bead-based SPT), on blood samples from 148 patients representative of clinical laboratory routine workload. Every result (repeatability, reproducibility, trueness, total error)...Continue Reading
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