دورية أكاديمية
أعرض في EDS

Clinical Evaluation of an Affordable Qualitative Viral Failure Assay for HIV Using Dried Blood Spots in Uganda.

التفاصيل البيبلوغرافية
العنوان: Clinical Evaluation of an Affordable Qualitative Viral Failure Assay for HIV Using Dried Blood Spots in Uganda.
المؤلفون: Balinda SN; Joint Clinical Research Center, P.O. Box 10005, Kampala, Uganda., Ondoa P; Amsterdam Institute for Global Health and Development, Department of Global Health, Academic medical Center, Trinity C Building, Pietersbergweg 17, 1105 BM, Amsterdam, the Netherlands., Obuku EA; Joint Clinical Research Center, P.O. Box 10005, Kampala, Uganda., Kliphuis A; PharmAccess International, Amsterdam, Trinity Building C Pietersbergweg 17, 1105 BM, Amsterdam, the Netherlands., Egau I; Joint Clinical Research Center, P.O. Box 10005, Kampala, Uganda., Bronze M; Wits Health Consortium, University of the Witwatersrand, 1 Jan Smuts Avenue, Braamfontein 2000, Johannesburg, South Africa., Kasambula L; Joint Clinical Research Center, P.O. Box 10005, Kampala, Uganda., Schuurman R; University Medical Centre Utrecht, P.O. Box 80125, 3508 TC, Utrecht, the Netherlands., Spieker N; PharmAccess International, Amsterdam, Trinity Building C Pietersbergweg 17, 1105 BM, Amsterdam, the Netherlands., Rinke de Wit TF; Amsterdam Institute for Global Health and Development, Department of Global Health, Academic medical Center, Trinity C Building, Pietersbergweg 17, 1105 BM, Amsterdam, the Netherlands., Kityo C; Joint Clinical Research Center, P.O. Box 10005, Kampala, Uganda.
مؤلفون مشاركون: ART–A consortium
المصدر: PloS one [PLoS One] 2016 Jan 29; Vol. 11 (1), pp. e0145110. Date of Electronic Publication: 2016 Jan 29 (Print Publication: 2016).
نوع المنشور: Evaluation Study; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: HIV Infections/*virology , Specimen Handling/*economics , Viral Load/*economics, Adolescent ; Adult ; Anti-Retroviral Agents/therapeutic use ; Child ; Child, Preschool ; Cross-Sectional Studies ; Female ; HIV Infections/drug therapy ; HIV Infections/economics ; Humans ; Male ; Middle Aged ; Specimen Handling/methods ; Uganda ; Young Adult
مستخلص: Background: WHO recommends regular viral load (VL) monitoring of patients on antiretroviral therapy (ART) for timely detection of virological failure, prevention of acquired HIV drug resistance (HIVDR) and avoiding unnecessary switching to second-line ART. However, the cost and complexity of routine VL testing remains prohibitive in most resource limited settings (RLS). We evaluated a simple, low-cost, qualitative viral-failure assay (VFA) on dried blood spots (DBS) in three clinical settings in Uganda.
Methods: We conducted a cross-sectional diagnostic accuracy study in three HIV/AIDS treatment centres at the Joint Clinical Research Centre in Uganda. The VFA employs semi-quantitative detection of HIV-1 RNA amplified from the LTR gene. We used paired dry blood spot (DBS) and plasma with the COBASAmpliPrep/COBASTaqMan, Roche version 2 (VLref) as the reference assay. We used the VFA at two thresholds of viral load, (>5,000 or >1,000 copies/ml).
Results: 496 paired VFA and VLref results were available for comparative analysis. Overall, VFA demonstrated 78.4% sensitivity, (95% CI: 69.7%-87.1%), 93% specificity (95% CI: 89.7%-96.4%), 89.3% accuracy (95% CI: 85%-92%) and an agreement kappa = 0.72 as compared to the VLref. The predictive values of positivity and negativity among patients on ART for >12 months were 72.7% and 99.3%, respectively.
Conclusions: VFA allowed 89% of correct classification of VF. Only 11% of the patients were misclassified with the potential of unnecessary or late switch to second-line ART. Our findings present an opportunity to roll out simple and affordable VL monitoring for HIV-1 treatment in RLS.
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المشرفين على المادة: 0 (Anti-Retroviral Agents)
تواريخ الأحداث: Date Created: 20160130 Date Completed: 20160726 Latest Revision: 20191210
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC4732948
DOI: 10.1371/journal.pone.0145110
PMID: 26824465
قاعدة البيانات: MEDLINE
الوصف
تدمد:1932-6203
DOI:10.1371/journal.pone.0145110