Sensitivity and specificity of Dried Blood Spot and Plasma Separation Card samples for Hepatitis C Virus RNA Testing

Oct 5, 2026

Uploaded by Oliver

Dried blood spots (DBS) and plasma separation cards (PSC) can expand access to hepatitis C virus (HCV) testing. This multicenter study assessed two HCV RNA assay platforms using capillary or venous DBS and PSC. Participants in Cameroon, Rwanda, Georgia, and Greece included individuals at risk, people living with HCV, and previously treated patients. Among 936 participants, DBS and PSC showed high diagnostic accuracy for HCV RNA detection, with performance measured against plasma reference results on cobas 4800 and cobas 6800 platforms.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages17

Reading Time43 min

AccessFree to download

Abstract

Study design and participants

Diagnostic platforms and reference standard

Results on sensitivity and specificity

OPEN ACCESS Citation: Malobela A, Amougou-Atsama M, Iliopoulos P, Mugisha J-C, Berishvili N, Sologashvili M, et al. (2026) Sensitivity and specificity of Dried Blood Spot and Plasma Separation Card samples for Hepatitis C Virus RNA Testing. PLOS Glob Public Health 6(3): e0006082. [https://doi.org/10.1371/journal](https://doi.org/10.1371/journal). pgph.0006082 Editor: Guillaume Fontaine, McGill University, CANADA Received: August 8, 2025 Accepted: February 13, 2026 Published: March 11, 2026 Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: [https://doi.org/10.1371/journal](https://doi.org/10.1371/journal). pgph.0006082 Copyright: © 2026 Malobela et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, RESEARCH ARTICLE Sensitivity and specificity of Dried Blood Spot and Plasma Separation Card samples for Hepatitis C Virus RNA Testing Agnes Malobela1*, Marie Amougou-Atsama2, Panagiotis Iliopoulos3, Jean-Claude Mugisha4, Nino Berishvili5, Manana Sologashvili6, Emmanuel Fajardo1, Francois Lamoury1, Aurélien Macé1, Maxwell Chirehwa7, Richard Njouom2, Angelos Hatzakis3, Jules Kabahizi4, Claude Mambo Muvunyi8, Penny Buxton9, Sadaf Mohiuddin9, Maia Alkhazashvili5, Elena Ivanova Reipold1* 1 FIND, the global alliance for diagnostics, Geneva, Switzerland, 2 Centre Pasteur du Cameroun, Yaoundé, Cameroon, 3 Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases, Athens, Greece, 4 Rwanda Military Hospital, Kigali, Rwanda, 5 National Center for Disease Control and Public Health, Tbilisi, Georgia, 6 Hepa Plus, Tbilisi, Georgia, 7 University of Cape Town, Cape Town, South Africa, 8 Rwanda Biomedical Center, Kigali, Rwanda, 9 National Reference Laboratory, Victoria, Australia * [agnes.malobela@finddx.org](agnes.malobela@finddx.org) (AM), [elena.reipold@protonmail.com](elena.reipold@protonmail.com) (EIR) Abstract Dried blood spots (DBS) and plasma separation cards (PSC) have the potential to improve access to hepatitis C virus (HCV) testing. This multicenter study evaluated the performance of two HCV RNA assay platforms using capillary or venous DBS and PSC. Participants were enrolled in Cameroon, Rwanda, Georgia, and Greece. DBS and PSC 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. The diagnostic accuracy of DBS and PSC for detecting HCV RNA was assessed using the cobas HCV nucleic assay on the cobas 4800 and cobas 6800 platforms (Roche), with plasma samples tested using these platforms serving as the reference standard. A total of 936 participants were enrolled. Capillary, venous DBS and venous PSC demonstrated high diagnostic accuracy. Sensitivity and specificity were 97.2%(95% CI: 95.2–98.3) and 88.6%(95%CI: 85.4 –91.2) for capillary DBS, 96. 1%(95%CI: 93.9 –97.5) and 87.8%(95%CI: 85.4 –90.4) for venous DBS and 95.2%(95%CI: 92.8 –96.8) and 99.6%(95%CI: 98.5 –99.9) for venous PSC, on the cobas 4800. The cobas 6800 platform had a sensitivity and specificity of 97.3%(95%CI: 95.4 –98.5) and 95.9%(95%CI: 93.7 –97.3) on venous DBS, 96.7%(95%CI: 94.6 –98.0) and 99.8%(95%CI: 98.8 – 100) on venous PSC, and 96.9%(95%CI: 94.8 –98. 1) and PLOS Global Public Health | [https://doi.org/10.1371/journal.pgph.0006082](https://doi.org/10.1371/journal.pgph.0006082) March 11, 2026 1 / 17 which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data availability statement: The datasets analysed during the current study are available in the Figshare repository. Where applic

FAQs

What specimen types were evaluated for HCV RNA testing?

The study evaluated dried blood spots (DBS) and plasma separation cards (PSC) prepared from capillary and/or venous blood samples.

Which assay platforms were used in the study?

HCV RNA performance was assessed using the cobas HCV nucleic assay on the cobas 4800 and cobas 6800 platforms (Roche).

What was the study’s overall conclusion about DBS and PSC?

DBS and PSC sample types demonstrated high diagnostic accuracy and can serve as alternatives to plasma for screening HCV infection, improving access to testing.

Oct 5, 2026

Uploaded by Oliver