Abstract
This study evaluated performance of two hepatitis C virus (HCV) rapid diagnostic tests (RDTs) performed by intended users in resource-limited settings. Testing was conducted at three facilities in two countries (Georgia, Cambodia) using matched fingerstick whole blood, plasma and serum samples. Investigational RDTs were compared with a composite reference standard (CRS) comprised of three laboratory tests, and a reference RDT. In matched samples from 489 HCV positive and 967 HCV negative participants, specificity with both investigational RDTs was high using either reference method (≥98.4% in all sample types). Sensitivity was lower in whole blood versus plasma and serum for both RDTs compared with the CRS (86.5-91.4% vs 97.5-98.0% and 97.3-97.1%) and reference RDT (93.6-97.8% vs 100% and 99.4%). Sensitivity improved when considering only samples with detectable HCV viral load. Sensitivity was highest in serum and plasma versus whole blood. The World Health Organization prequalification criterion (≥98%) was narrowly missed by both RDTs in serum, and one in plasma, possibly due to the intended user factor. Performance in whole blood was considered adequate, given potential roles of HCV infection history, improved sensitivity with detectable viral load and performance similarities to the reference RDT.
Highlights
World Health Organization (WHO) member states have committed to the elimination of viral hepatitis as a public health threat by 2030 [1]
Sensitivity was lower in whole blood versus plasma and serum for both rapid diagnostic tests (RDTs) compared with the composite reference standard (CRS) (86.5–91.4% vs 97.5–98.0% and 97.3–97.1%) and reference RDT (93.6–97.8% vs 100% and 99.4%)
hepatitis C virus (HCV) RDTs in whole blood, serum & plasma whole blood, plasma and serum samples: a multicentre prospective study was published in Harvard Dataverse: https://dataverse.harvard.edu/ dataset.xhtml?persistentId=doi:10.7910/DVN/ W88BHP
Summary
World Health Organization (WHO) member states have committed to the elimination of viral hepatitis as a public health threat by 2030 [1]. According to WHO recommendations, screening should be performed through the detection of HCV-specific antibodies using a single quality-assured serological in vitro diagnostic test, which can be either a laboratory-based immunoassay or a rapid diagnostic test (RDT) [2]. WHO prequalification status intents to indicate that an RDT is likely to have reliable performance in LMICs, as it requires the generation of performance data in LMICs in intended use settings by intended users, with at least a portion of these data generated using freshly collected samples [4]. The scarcity of quality-assured RDTs is an important barrier to HCV screening in LMICs on a large scale [6]. This study evaluated performance of two hepatitis C virus (HCV) rapid diagnostic tests (RDTs) performed by intended users in resource-limited settings
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