ArticleBMC infectious diseases2025
Sensitivity and specificity of dried blood spot samples for hepatitis C virus RNA testing.
Article in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03896087 (Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDried blood spot (DBS) samples can improve access to hepatitis C virus (HCV) testing among hard-to-reach and underserved populations. We conducted a multicentre diagnostic accuracy study to evaluate the clinical performance of the Abbott RealTime HCV assay on the m2000 platform for detecting HCV RNA, using a standardized DBS collection and elution protocol.
methodsThe study was conducted at four sites in Cameroon, Rwanda, Georgia and Greece. DBS prepared from capillary and venous blood samples were collected from three target populations; individuals at risk of HCV infection, persons living with HCV, and individuals previously treated for HCV. Plasma samples tested on the Abbott m2000 platform served as the reference standard.
resultsA total of 936 participants were enrolled, of whom 76.6% were HCV antibody positive. Both capillary and venous DBS demonstrated high diagnostic accuracy. Sensitivity and specificity were 95.2% (95% CI: 92.9-96.8) and 95.6% (95%CI: 93.3-97.1) for capillary DBS, and 95.4% (95% CI: 93.1-97.0) and 96.0% (95% CI: 93.8-97.4) for venous DBS. The Abbot RealTime HCV assay on the Abbott m2000 platform showed strong clinical performance for detecting HCV RNA from DBS.
conclusionThese findings support the use of DBS as a feasible and less resource-intensive alternative to plasma-based testing, potentially expanding HCV screening and diagnosis in decentralized settings. Reliable DBS testing relies on proper sample collection, appropriate handling, and adequate staff training. CLINICALTRIALS: GOV IDENTIFIER: NCT03896087 (registered on 14 March 2019) available here: Study Details | Evaluation of Dried Blood Spot for HCV RNA Testing | https://clinicaltrials.gov/ .
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