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The workflow showed an average number of HIV samples tested as 17.5 per hour or 122.5 per 8-hour shift for one technician, including passing quality controls. The 95% reference interval (2.5th - 97.5th) for the CD4+ count was 453-1534 cells/ µL and the percentage was 30.5% - 63.4%. Upward and downward misclassification at various CD4 thresholds was ≤ 2.4% and ≤ 11.1%. Mean absolute and relative count bias between AQUIOS PLG and Flowcare PLG was -41 cells/ µL and -7.8%. Workflow was investigated testing 440 samples over 5 days. A reference interval was determined using 155 samples from healthy, non-HIV adults. Two-hundred and forty samples from HIV-positive adult and paediatric patients were used to compare the performances of AQUIOS PLG and Flowcare PLG on a FC500 flow cytometer (Flowcare PLG) in determining CD4+ absolute count and percentage. The study was conducted between November 2014 and March 2015 at 5 different centres located in Canada Paris, France Lyon, France the United States and South Africa. This study compared the performance of AQUIOS PLG with the Flowcare PLG method and performed a reference interval for comparison with those previously published. Beckman Coulter has developed a single platform test for CD4+ T-cell lymphocyte count and percentage using PanLeucogating (PLG) technology on the automated AQUIOS flow cytometer (AQUIOS PLG). 11 National Health Laboratory Services, Johannesburg, South Africa.įlow cytometry has been the approach of choice for enumerating and documenting CD4-cell decline in HIV monitoring.10 Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.9 National Health Laboratory Service, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa.8 Clinical affairs, Beckman Coulter Incorporated, Miami, Florida, United States.7 Life Science Flow Cytometry, Beckman Coulter Incorporated, Miami, Florida, United States.5 London Health Sciences Centre, London, Ontario, Canada.4 Department of Immunology, University Hospital, Paris, France.Joseph's Health Care, Victoria Hospital, London, Ontario, Canada. 3 Lawson Health Research Institute, London Health Sciences Centre and St.2 Immunology Laboratory, Assistance Publique Hopitaux De Paris, Paris, France.1 Clinical Affairs, Beckman Coulter Immunotech, Marseille, France.
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