Department of Molecular Medicine and Haematology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa; National Health Laboratory Service, Johannesburg, South Africa
Moodley, K., Department of Molecular Medicine and Haematology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa; Coetzee, L.M., National Health Laboratory Service, Johannesburg, South Africa; Glencross, D.K., Department of Molecular Medicine and Haematology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa, National Health Laboratory Service, Johannesburg, South Africa
Background: In light of the HIV pandemic, significant strides have been made in improving treatment options for patients. Technologies to monitor the progress of a patient on such treatment have therefore also been scaled up. Immune activation as measured by CD38 mean fluorescence intensity (MFI) on CD8 T cells has been successfully shown in a clinical trial to predict response to antiretroviral therapy (ART) and reported as a cost effective real time test to supplement more costly VL testing. In this study we report transfer of this technology from the research into the routine environment. Methods: This study was conducted in 2 parts: Firstly, fresh random samples (n = 75) were tested at four time intervals (0, 24, 36 and 48. h) post-venesection to review reproducibility of CD38 MFI expression. Secondly, the CD38 MFI assay was introduced into a pilot regional testing facility and random samples (n = 40) were validated against values obtained on matched samples tested at the reference laboratory. Results: The CD38 assay showed acceptable accuracy and reproducibility up to 36. h (98% similarity) after venesection with some reduction in CD38 MFI to 94% at 48. h (bias < 0.2MFI, %CV < 5).Implementation at the secondary testing site was successful with 98% similarity (% SIM CV < 5%) compared to the reference laboratory. Conclusion: The assay proved stable over time and could be tested until 48. h after venesection with no loss of CD38 MFI. Off-site implementation also proved successful, as such, the CD38 assay offers a reliable real time supplementary test to long-term VL monitoring of HIV infected patients on the national ART programme. © 2012 Elsevier B.V.
CD38 antigen; accuracy; antigen expression; article; CD8+ T lymphocyte; comparative study; controlled study; human; human cell; phlebotomy; postoperative period; priority journal; reproducibility; scale up; standardization; T lymphocyte activation; validation process; Antigens, CD38; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Fluorescence; HIV Infections; HIV-1; Humans; Pilot Projects; Reference Standards; Reproducibility of Results
