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  • Title: Decentralised CD38 activation monitoring: aspects of practical implementation and standardisation.
    Author: Moodley K, Coetzee LM, Glencross DK.
    Journal: J Immunol Methods; 2012 Apr 30; 378(1-2):121-7. PubMed ID: 22398190.
    Abstract:
    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.
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