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

Hdl Handle:
http://hdl.handle.net/10144/316222
Title:
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
Authors:
Fajardo, Emmanuel; Metcalf, Carol A; Chaillet, Pascale; Aleixo, Lucia; Pannus, Pieter; Panunzi, Isabella; Triviño, Laura; Ellman, Tom; Likaka, Andrew; Mwenda, Reuben
Journal:
Journal of Clinical Microbiology
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.
Publisher:
American Society for Microbiology
Issue Date:
5-Feb-2014
URI:
http://hdl.handle.net/10144/316222
DOI:
10.1128/JCM.03519-13
PubMed ID:
24501032
Language:
en
ISSN:
1098-660X
Appears in Collections:
HIV/AIDS

Full metadata record

DC FieldValue Language
dc.contributor.authorFajardo, Emmanuelen_GB
dc.contributor.authorMetcalf, Carol Aen_GB
dc.contributor.authorChaillet, Pascaleen_GB
dc.contributor.authorAleixo, Luciaen_GB
dc.contributor.authorPannus, Pieteren_GB
dc.contributor.authorPanunzi, Isabellaen_GB
dc.contributor.authorTriviño, Lauraen_GB
dc.contributor.authorEllman, Tomen_GB
dc.contributor.authorLikaka, Andrewen_GB
dc.contributor.authorMwenda, Reubenen_GB
dc.date.accessioned2014-04-29T21:35:52Z-
dc.date.available2014-04-29T21:35:52Z-
dc.date.issued2014-02-05-
dc.identifier.citationProspective 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. 2014: J. Clin. Microbiol.en_GB
dc.identifier.issn1098-660X-
dc.identifier.pmid24501032-
dc.identifier.doi10.1128/JCM.03519-13-
dc.identifier.urihttp://hdl.handle.net/10144/316222-
dc.description.abstractHIV-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.en_GB
dc.languageENG-
dc.language.isoenen
dc.publisherAmerican Society for Microbiologyen_GB
dc.rightsPublished by the American Society for Microbiology - Archived on this site with kind permission from the American Society for Microbiologyen_GB
dc.subjectDiagnosticsen_GB
dc.subjectHIV/AIDSen_GB
dc.titleProspective 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 Malawien
dc.identifier.journalJournal of Clinical Microbiologyen_GB

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