Volume 2, Pages 22-28 (August 2018) Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence

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Volume 2, Pages 22-28 (August 2018) Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence Monica Gandhi, Peter Bacchetti, Warren C. Rodrigues, Matthew Spinelli, Catherine A. Koss, Paul K. Drain, Jared M. Baeten, Nelly R. Mugo, Kenneth Ngure, Leslie Z. Benet, Hideaki Okochi, Guohong Wang, Michael Vincent EClinicalMedicine Volume 2, Pages 22-28 (August 2018) DOI: 10.1016/j.eclinm.2018.08.004 Copyright © 2018 Terms and Conditions

Fig. 1 Schema of immunoassay development. EClinicalMedicine 2018 2, 22-28DOI: (10.1016/j.eclinm.2018.08.004) Copyright © 2018 Terms and Conditions

Fig. 2 Dose–response curve for quantification of tenofovir concentrations in urine by immunoassay. %B/Bo represents the percent of the sample bound to the antibody divided by the maximal possible binding to the antibody. The dose–response shows a strong inverse relationship between signal and TFV urinary concentrations with this antibody. EClinicalMedicine 2018 2, 22-28DOI: (10.1016/j.eclinm.2018.08.004) Copyright © 2018 Terms and Conditions

Fig. 3 2 × 2 table of LC–MS/MS vs ELISA immunoassay results from banked negative urine samples and participants in PUMA study. 115 banked negative samples +102 urine samples from patients taking TDF/FTC in PUMA study; LC–MS/MS gold standard. TP = True positive; FP = false positive; FN = false negative; TN = true negative. EClinicalMedicine 2018 2, 22-28DOI: (10.1016/j.eclinm.2018.08.004) Copyright © 2018 Terms and Conditions

Fig. 4 Scatterplot of TFV concentrations in urine measured via ELISA immunoassay vs LCMS/MS Red line indicates the linear regression line between the two sets of values; the rank correlation coefficient is 0.96; the median (range) of TFV concentrations in urine in the 70 samples from the PUMA participants' positive by LC–MS/MS was 12,450 (723–98,100) ng/mL. EClinicalMedicine 2018 2, 22-28DOI: (10.1016/j.eclinm.2018.08.004) Copyright © 2018 Terms and Conditions