Diagnostic accuracy of detection and quantification of HBV-DNA and HCV-RNA using dried blood spot (DBS) samples – a systematic review and meta-analysis

BMC Infectious Diseases

Research

Luke Messac¹  Jennifer Cohn¹  Jamie Greenman¹  Johannes Camp²  Christine Pichler²  Berit Lange³  Teri Roberts⁴  Claudia M. Denkinger⁴  Azumi Ishizaki⁵  Philippa Easterbrook⁵  Philippe van de Perre⁶  Edouard Tuaillon⁶ 

[1] Department of Infectious Diseases, University of Pennsylvania, Philadelphia, PA, USA;Division of Infectious Diseases, Department of Medicine II, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany;Division of Infectious Diseases, Department of Medicine II, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany;Centre for Chronic Immunodeficiency, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany;FIND, Geneva, Switzerland;Global Hepatitis Programme, HIV Department, World Health Organization, Geneva, Switzerland;Pathogenesis and Control of Chronic Infections UMR 1058, INSERM/Université Montpellier/Etablissement Français du Sang, 34394, INSERM, Cedex 5, Montpellier, France;Centre Hospitalier Universitaire (CHU) de Montpellier, département de bactériologie-virologie, Montpellier, France;

关键词: Dried blood spots (DBS);    HCV RNA;    HBV DNA;    Virological testing;    Diagnostic accuracy;   

DOI  :  10.1186/s12879-017-2776-z

来源: Springer

【 摘 要 】

BackgroundThe detection and quantification of hepatitis B (HBV) DNA and hepatitis C (HCV) RNA in whole blood collected on dried blood spots (DBS) may facilitate access to diagnosis and treatment of HBV and HCV infection in resource-poor settings. We evaluated the diagnostic performance of DBS compared to venous blood samples for detection and quantification of HBV-DNA and HCV-RNA in two systematic reviews and meta-analyses on the diagnostic accuracy of HBV DNA and HCV RNA from DBS compared to venous blood samples.MethodsWe searched MEDLINE, Embase, Global Health, Web of Science, LILAC and Cochrane library for studies that assessed diagnostic accuracy with DBS. Heterogeneity was assessed and where appropriate pooled estimates of sensitivity and specificity were generated using bivariate analyses with maximum likelihood estimates and 95% confidence intervals. We also conducted a narrative review on the impact of varying storage conditions or different cut-offs for detection from studies that undertook this in a subset of samples. The QUADAS-2 tool was used to assess risk of bias.ResultsIn the quantitative synthesis for diagnostic accuracy of HBV-DNA using DBS, 521 citations were identified, and 12 studies met the inclusion criteria. Overall quality of studies was rated as low. The pooled estimate of sensitivity and specificity for HBV-DNA was 95% (95% CI: 83–99) and 99% (95% CI: 53–100), respectively. In the two studies that reported on cut-offs and limit of detection (LoD) – one reported a sensitivity of 98% for a cut-off of ≥2000 IU/ml and another reported a LoD of 914 IU/ml using a commercial assay. Varying storage conditions for individual samples did not result in a significant variation of results. In the synthesis for diagnostic accuracy of HCV-RNA using DBS, 15 studies met the inclusion criteria, and this included six additional studies to a previously published review. The pooled sensitivity and specificity was 98% (95% CI:95–99) and 98% (95% CI:95–99.0), respectively. Varying storage conditions resulted in a decrease in accuracy for quantification but not for reported positivity.ConclusionsThese findings show a high level of diagnostic performance for the use of DBS for HBV-DNA and HCV-RNA detection. However, this was based on a limited number and quality of studies. There is a need for development of standardized protocols by manufacturers on the use of DBS with their assays, as well as for larger studies on use of DBS conducted in different settings and with varying storage conditions.

【 授权许可】

CC BY   
© World Health Organization. 2017