From research tool to routine test: CD38 monitoring in
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From research tool to routine test: CD38 monitoring in
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Original Article
From Research Tool to Routine Test: CD38 Monitoring in HIV Patients Lindi M. Coetzee,1 Szun Szun Tay,2 Denise Lawrie,1 George Janossy,1 and Deborah K. Glencross1* 1
National Health Laboratory Service and Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 2 The Collaborative Transplantation Research Group, The University of Sydney, Sydney, NSW, Australia
Background: CD38 expression on CD81 T lymphocytes in HIV-infected patients is monitored by flow cytometry (FCM). There is however no consensus re CD38 protocols, analyses or result reporting within/ between laboratories. Internal quality control measures (QC) were established for a standardized CD38 protocol and a system proposed for reporting CD38 fluctuation in longitudinal HIV1 patient monitoring. Methods: A single-platform (SP) CD38/CD8 protocol was ‘‘piggy-backed’’ onto the standardized ‘‘panleucogating’’ CD45/CD41 protocol. A weekly QC was established to monitor instrument stability (FlowSETTM) and absolute cell count accuracy and reproducibility (stabilized blood product, Immuno-TrolTM). The Mean Fluorescence Intensity (MFI) of CD38 expression on CD81-lymphocytes was monitored on both stabilized blood and HIV-control samples. Linearized MFI values were determined from biological controls, i.e. healthy donor monocytes and granulocytes, and tested as a method of reporting CD38 expression on selected HIV1 patients on ART. Results: The CD45/CD4/CD8/CD3 method for lymphocyte enumeration compared well with the CD38 protocol (CD45/CD4/CD8/CD38) with excellent similarity (6100%) and precision for absolute CD4 and CD8 counts (CVs < 5%). Fluorosphere MFI- (FlowSetTM, FlowCountTM) and color compensation values were exceptionally stable over time. CD38 MFI values established on monocytes as biological control was 4.0 and
