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    Jan 17, 2021
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    Field Suitability and Diagnostic Accuracy of the Biocentric Open Real-Time PCR Platform for Dried Blood Spot-Based HIV Viral Load Quantification in Eswatini.

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    Name:
    Kerschberger et al 2019 Field ...
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    Authors
    Kerschberger, B
    Ntshalintshali, N
    Mpala, Q
    Diaz Uribe, PA
    Maphalala, G
    Kalombola, S
    Telila, AB
    Chawinga, T
    Maphalala, M
    Jani, A
    Phugwayo, N
    de la Tour, R
    Nyoni, N
    Goiri, J
    Dlamini, S
    Ciglenecki, I
    Fajardo, E
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    Issue Date
    2019-09-01
    Submitted date
    2019-10-24
    
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    Journal
    Journal of Acquired Immune Deficiency Syndromes
    Abstract
    BACKGROUND: To assess the performance and suitability of dried blood spot (DBS) sampling using filter paper to collect blood for viral load (VL) quantification under routine conditions. METHODS: We compared performance of DBS VL quantification using the Biocentric method with plasma VL quantification using Roche and Biocentric as reference methods. Adults (≥18 years) were enrolled at 2 health facilities in Eswatini from October 12, 2016 to March 1, 2017. DBS samples were prepared through finger-prick by a phlebotomist (DBS-1), and through the pipetting of whole venous blood by a phlebotomist (DBS-2) and by a laboratory technologist (DBS-3). We calculated the VL-testing completion rate, correlation, and agreement, as well as diagnostic accuracy estimates at the clinical threshold of 1000 copies/mL. RESULTS: Of 362 patients enrolled, 1066 DBS cards (DBS-1: 347; DBS-2: 359; DBS-3: 360) were tested. Overall, test characteristics were comparable between DBS-sampling methods, irrespective of the reference method. The Pearson correlation coefficients ranged from 0.67 to 0.82 (P < 0.001) for different types of DBS sampling using both reference methods, and the Bland-Altman difference ranged from 0.15 to 0.30 log10 copies/mL. Sensitivity estimates were from 85.3% to 89.2% and specificity estimates were from 94.5% to 98.6%. The positive predictive values were between 87.0% and 96.5% at a prevalence of 30% VL elevations, and negative predictive values were between 93.7% and 95.4%. CONCLUSIONS: DBS VL quantification using the newly configured Biocentric method can be part of contextualized VL-testing strategies, particularly for remote settings and populations with higher viral failure rates.
    Publisher
    Lippincott, Williams & Wilkins
    URI
    http://hdl.handle.net/10144/619494
    Language
    en
    Collections
    HIV/AIDS

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