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Sensitivity and specificity of rapid hepatitis C antibody assays in freshly collected whole blood, plasma and serum samples: A multicentre prospective studyстатья
Информация о цитировании статьи получена из
Web of Science,
Scopus
Статья опубликована в журнале из списка Web of Science и/или Scopus
Дата последнего поиска статьи во внешних источниках: 13 января 2021 г.
- Авторы: Vetter Beatrice N., Ongarello Stefano, Tyshkovskiy Alexander, Alkhazashvili Maia, Chitadze Nazibrola, Choun Kimcheng, Sokkab An, De Weggheleire Anja, Vanroye Fien, Reipold Elena Ivanova
- Журнал: PLoS ONE
- Том: 15
- Номер: 12
- Год издания: 2020
- Издательство: Public Library of Science
- Местоположение издательства: United States
- Первая страница: e0243040
- Последняя страница: e0243040
- DOI: 10.1371/journal.pone.0243040
- Аннотация: 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.
- Добавил в систему: Тышковский Александр Эдуардович