Sensitivity and specificity of rapid hepatitis C antibody assays in freshly collected whole blood, plasma and serum samples: a multicentre prospective study

Beatrice N Vetter, Stefano Ongarello, Alexander Tyshkovskiy, Maia Alkhazashvili, Nazibrola Chitadze, Kimcheng Choun, An Sokkab, Anja De Weggheleire, Fien Vanroye, Elena Ivanova Reipold

Research output: Contribution to journalA1: Web of Science-article

Abstract

BACKGROUND: This study evaluated performance of two hepatitis C virus (HCV) rapid diagnostic tests (RDTs) performed by intended users in resource-limited settings.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

Original languageEnglish
Article numbere0243040
JournalPLoS ONE
Volume15
Issue number12
Number of pages14
ISSN1932-6203
DOIs
Publication statusPublished - 2020

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