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Performance characteristics of finger-stick dried blood spots (DBS) on the determination of human immunodeficiency virus (HIV) treatment failure in a pediatric population in Mozambique.

Performance characteristics of finger-stick dried blood spots (DBS) on the determination of human immunodeficiency virus (HIV) treatment failure in a pediatric population in Mozambique.
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Chang J, de Sousa A, Sabatier J, Assane M, Zhang G, Bila D, Vaz P, Alfredo C, Cossa L, Bhatt N, Koumans EH, Yang C, Rivadeneira E, Jani I, Houston JC,


Chang J, de Sousa A, Sabatier J, Assane M, Zhang G, Bila D, Vaz P, Alfredo C, Cossa L, Bhatt N, Koumans EH, Yang C, Rivadeneira E, Jani I, Houston JC, (click to view)

Chang J, de Sousa A, Sabatier J, Assane M, Zhang G, Bila D, Vaz P, Alfredo C, Cossa L, Bhatt N, Koumans EH, Yang C, Rivadeneira E, Jani I, Houston JC,

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PloS one 2017 07 1312(7) e0181054 doi 10.1371/journal.pone.0181054

Abstract

Quantitative plasma viral load (VL) at 1000 copies /mL was recommended as the threshold to confirm antiretroviral therapy (ART) failure by the World Health Organization (WHO). Because of ongoing challenges of using plasma for VL testing in resource-limited settings (RLS), especially for children, this study collected 717 DBS and paired plasma samples from children receiving ART ≥1 year in Mozambique and compared the performance of DBS using Abbott’s VL test with a paired plasma sample using Roche’s VL test. At a cut-off of 1000 copies/mL, sensitivity of DBS using Abbott DBS VL test was 79.9%, better than 71.0% and 63.9% at 3000 and 5000 copies/mL, respectively. Specificities were 97.6%, 98.8%, 99.3% at 1000, 3000, and 5000 copies/mL, respectively. The Kappa value at 1000 copies/mL, 0.80 (95% CI: 0.73, 0.87), was higher than 0.73 (95% CI: 0.66, 0.80) and 0.66 (95% CI: 0.59, 0.73) at 3000, 5000 copies/mL, respectively, also indicating better agreement. The mean difference between the DBS and plasma VL tests with 95% limits of agreement by Bland-Altman was 0.311 (-0.908, 1.530). Among 73 children with plasma VL between 1000 to 5000 copies/mL, the DBS results were undetectable in 53 at the 1000 copies/mL threshold. While one DBS sample in the Abbott DBS VL test may be an alternative method to confirm ART failure at 1000 copies/mL threshold when a plasma sample is not an option for treatment monitoring, because of sensitivity concerns between 1,000 and 5,000 copies/ml, two DBS samples may be preferred accompanied by careful patient monitoring and repeat testing.

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