Flow rate calibration II: A clinical evaluation study using PanLeucoGating as a single-platform protocol

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Abstract
Background CD4+ T‐lymphocyte enumeration is vital for monitoring disease progression in individuals positive for the human immunodeficiency virus (HIV), and as a result, there is a need to develop cost‐effective protocols that provide accuracy, precision, and affordability. Recently, PanLeucoGating has been shown to fulfill these requirements; however, although comparable to state‐of‐the‐art single‐platform protocols (SP), there is still a requirement for an accurate total white cell count. To overcome this limitation, we recently developed a flow‐rate based calibration method that enables the PanLeucoGating protocol to be used as a SP approach, and in this study show that this approach can be used for CD4+ T‐lymphocyte enumeration. Methods A total of 113 HIV samples were analyzed using three protocols: (a) state‐of‐the art SP bead‐based method (MultiSet; predicate protocol), (b) PanLeucoGating protocol used as a dual‐platform (DP) approach, and (c) the newly developed flow rate–based SP approach. We demonstrate that flow rate calibration can be achieved easily and that the method is highly comparable to the state‐of‐the‐art SP method. Results A high correlation was observed between the predicate protocol and the SP PanLeucoGating approach over the whole range of CD4 counts tested (r2 = 0.9928; bias 8 cells/μl), including the clinically relevant range (e.g., 0–200 CD4 cells/μl; bias 0 cells/μl). For batched samples, the cost of providing a CD4+ T‐lymphocyte count was reduced to approximately US $1. Conclusions The SP PanLeucoGating is a cost‐effective approach to CD4+ T‐lymphocyte enumeration that maintains accuracy and precision. Cytometry Part B (Clin. Cytometry) 55B:8–13, 2003.

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