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Journal Article > Research

Prospective evaluation of the diagnostic accuracy of dried blood spots from finger-prick for the determination of HIV-1 viral load with the NucliSENS Easy-Q HIV-1 v2.0 in Malawi

Farjardo E, Metcalf CJ, Chaillet P, Aleixo L, Pannus P, Panunzi I, Trivino L, Ellman T, Likaka A, Mwenda R
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Abstract
HIV-1 viral load (VL) testing is not widely available in resource-limited settings. Use of finger-prick dried blood spot (FP-DBS) samples could remove barriers related to sample collection and transport. Measurement of VL using DBS from EDTA venous blood (VB-DBS) in place of plasma has previously been validated using the NucliSENS EasyQ HIV-1 v2.0 assay, but information on the accuracy of FP-DBS samples for measuring VL is limited. This prospective study, conducted at Thyolo District Hospital in Southern Malawi, compared VL levels measured on FP-DBS samples and plasma, using the NucliSENS EasyQ HIV-1 v2.0 assay. Comparability was assessed by means of agreement and correlation (131 patients with VLs ≥100 copies/ml), and sensitivity and specificity (612 patients on ART). Samples of EDTA venous blood and FP-DBS from 1,009 HIV-infected individuals were collected and prepared in the laboratory. Bland-Altman analysis found good agreement between plasma and FP-DBS VL levels, with a mean difference of -0.35 log10, and 95% limits of agreement from -1.26 to 0.55 log10. FP-DBS had a sensitivity of 88.7% (95% confidence interval [CI]: 81.1 - 94.4%) and specificity of 97.8% (95% CI: 96.1 - 98.9%) using a 1,000 copies/ml cut-point; and a sensitivity of 83.0% (95% CI: 73.4 - 90.1%) and specificity of 100% (95% CI: 99.3-100%) using a 5,000 copies/ml cut-point. This study shows that FP-DBS is an acceptable alternative to plasma for measuring VL using the NucliSENS EasyQ HIV-1 v2.0. We are conducting a second study to assess the proficiency of health workers at preparing FP-DBS in primary healthcare clinics.
Countries
Malawi
Subject Area
diagnosticsHIV/AIDS
DOI
10.1128/JCM.03519-13
Published Date
01-May-2014
PubMed ID
24501032
Languages
English
Journal
Journal of Clinical Microbiology
Volume / Issue / Pages
Volume 52, Issue 5, Pages 1343-1351
Issue Date
05-Feb-2014
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