{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T11:41:53Z","timestamp":1773315713705,"version":"3.50.1"},"reference-count":48,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T00:00:00Z","timestamp":1773187200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100032626","name":"UNITAID","doi-asserted-by":"crossref","award":["UA-HCV01"],"award-info":[{"award-number":["UA-HCV01"]}],"id":[{"id":"10.13039\/100032626","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosglobalpublichealth.org"],"crossmark-restriction":false},"short-container-title":["PLOS Glob Public Health"],"abstract":"<jats:sec id=\"sec180\">\n                    <jats:title\/>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>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\u201398.3) and 88.6% (95%CI: 85.4 \u201391.2) for capillary DBS, 96.1% (95%CI: 93.9 \u201397.5) and 87.8% (95%CI: 85.4 \u201390.4) for venous DBS and 95.2% (95%CI: 92.8 \u201396.8) and 99.6% (95%CI: 98.5 \u201399.9) for venous PSC, on the cobas 4800. The cobas 6800 platform had a sensitivity and specificity of 97.3% (95%CI: 95.4 \u201398.5) and 95.9% (95%CI: 93.7 \u201397.3) on venous DBS, 96.7% (95%CI: 94.6 \u201398.0) and 99.8% (95%CI: 98.8 \u2013 100) on venous PSC, and 96.9% (95%CI: 94.8 \u201398.1) and 99.8% (95%CI: 98.8 \u2013 100) on capillary PSC. The diagnostic accuracy of capillary and venous DBS and PSC for detecting HCV RNA was high on the two platforms evaluated.<\/jats:p>\n                    <jats:p>This study demonstrates that DBS and PSC sample types can be an alternative to plasma to screen for HCV infection, thus facilitating access to testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec001\">\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>Although the use of point-of-care rapid antibody tests for hepatitis C virus (HCV) is increasing, people who test positive must still undergo a confirmatory test before receiving treatment. Confirmatory testing for HCV RNA can be performed using plasma, serum, or capillary whole blood, depending on the available diagnostic platforms and testing algorithms. Plasma samples are more commonly used; however, their collection, storage, transport, and handling can pose significant challenges in low-resource settings. To improve access to HCV testing, there is a need for alternative sample types. Blood samples dried on filter paper cards (dried blood spots, or DBS) can be collected at the community level, have low biohazard risk, can withstand exposure to ambient temperatures, and are easily stored and shipped. Plasma Separation Cards (PSC), which collect plasma rather than whole blood, have similar properties. This study demonstrated that the diagnostic accuracy of DBS and PSC for detecting HCV RNA using the Roche cobas 4800 and 6800 platforms was high, confirming that they could be viable alternatives to plasma sampling for HCV testing.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pgph.0006082","type":"journal-article","created":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T17:32:26Z","timestamp":1773250346000},"page":"e0006082","update-policy":"https:\/\/doi.org\/10.1371\/journal.pgph.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Sensitivity and specificity of Dried Blood Spot and Plasma Separation Card samples for Hepatitis C Virus RNA Testing"],"prefix":"10.1371","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-8602-3011","authenticated-orcid":true,"given":"Agnes","family":"Malobela","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie","family":"Amougou-Atsama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Panagiotis","family":"Iliopoulos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Claude","family":"Mugisha","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nino","family":"Berishvili","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manana","family":"Sologashvili","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Fajardo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francois","family":"Lamoury","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aur\u00e9lien","family":"Mac\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maxwell","family":"Chirehwa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3112-6370","authenticated-orcid":true,"given":"Richard","family":"Njouom","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angelos","family":"Hatzakis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jules","family":"Kabahizi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claude Mambo","family":"Muvunyi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Penny","family":"Buxton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sadaf","family":"Mohiuddin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maia","family":"Alkhazashvili","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2872-5161","authenticated-orcid":true,"given":"Elena Ivanova","family":"Reipold","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2026,3,11]]},"reference":[{"key":"pgph.0006082.ref001","volume-title":"Updated recommendations on treatment of adolescents and children with chronic HCV infection, and HCV simplified service delivery and HCV diagnostics","author":"World Health Organization","year":"2022"},{"issue":"7","key":"pgph.0006082.ref002","doi-asserted-by":"crossref","first-page":"1333","DOI":"10.4254\/wjh.v14.i7.1333","article-title":"Challenge of managing hepatitis B virus and hepatitis C virus infections in resource-limited settings","volume":"14","author":"ZNA Said","year":"2022","journal-title":"World J Hepatol"},{"issue":"4","key":"pgph.0006082.ref003","doi-asserted-by":"crossref","first-page":"371","DOI":"10.2217\/fvl.13.11","article-title":"Viral hepatitis in resource-limited countries and access to antiviral therapies: current and future challenges","volume":"8","author":"M Lemoine","year":"2013","journal-title":"Future Virol"},{"issue":"1","key":"pgph.0006082.ref004","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0210556","article-title":"Evaluation of five rapid diagnostic tests for detection of antibodies to hepatitis C virus (HCV): A step towards scale-up of HCV screening efforts in India","volume":"14","author":"A Mane","year":"2019","journal-title":"PLoS One"},{"issue":"12","key":"pgph.0006082.ref005","doi-asserted-by":"crossref","first-page":"1889","DOI":"10.1093\/infdis\/jiy114","article-title":"Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay","volume":"217","author":"FMJ Lamoury","year":"2018","journal-title":"J Infect Dis"},{"issue":"7","key":"pgph.0006082.ref006","doi-asserted-by":"crossref","first-page":"514","DOI":"10.1016\/S2468-1253(17)30075-4","article-title":"Evaluation of the Xpert HCV Viral Load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort study","volume":"2","author":"J Grebely","year":"2017","journal-title":"Lancet Gastroenterol Hepatol"},{"issue":"12","key":"pgph.0006082.ref007","doi-asserted-by":"crossref","first-page":"2043","DOI":"10.1093\/infdis\/jiaa037","article-title":"Time to Detection of Hepatitis C Virus Infection With the Xpert HCV Viral Load Fingerstick Point-of-Care Assay: Facilitating a More Rapid Time to Diagnosis","volume":"221","author":"J Grebely","year":"2020","journal-title":"J Infect Dis"},{"issue":"4","key":"pgph.0006082.ref008","article-title":"Decentralisation, integration, and task-shifting in hepatitis C virus infection testing and treatment: a global systematic review and meta-analysis","volume":"9","author":"E Oru","year":"2021","journal-title":"Lancet Glob Health"},{"issue":"4","key":"pgph.0006082.ref009","doi-asserted-by":"crossref","first-page":"916","DOI":"10.1016\/j.jhep.2018.05.017","article-title":"New virological tools for screening, diagnosis and monitoring of hepatitis B and C in resource-limited settings","volume":"69","author":"S Chevaliez","year":"2018","journal-title":"J Hepatol"},{"issue":"4","key":"pgph.0006082.ref010","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.01336-18","article-title":"Separation of plasma from whole blood by use of the cobas plasma separation card: a compelling alternative to dried blood spots for quantification of HIV-1 viral load","volume":"57","author":"S Carmona","year":"2019","journal-title":"J Clin Microbiol"},{"key":"pgph.0006082.ref011","doi-asserted-by":"crossref","first-page":"700","DOI":"10.1186\/s12879-017-2777-y","article-title":"Diagnostic accuracy of serological diagnosis of hepatitis C and B using dried blood spot samples (DBS): two systematic reviews and meta-analyses","volume":"17","author":"B Lange","year":"2017","journal-title":"BMC Infect Dis"},{"issue":"3","key":"pgph.0006082.ref012","doi-asserted-by":"crossref","DOI":"10.3390\/diagnostics11030473","article-title":"Utility of the cobas plasma separation card as a sample collection device for serological and virological diagnosis of hepatitis c virus infection","volume":"11","author":"F Vel\u00e1squez-Orozco","year":"2021","journal-title":"Diagnostics"},{"issue":"1","key":"pgph.0006082.ref013","doi-asserted-by":"crossref","DOI":"10.1093\/clinchem\/hvab170","article-title":"Clinical evaluation of plasma separation cards as a tool to collect, store, and test blood samples for hepatitis B and C serological markers","volume":"68","author":"G Colucci","year":"2022","journal-title":"Clin Chem"},{"issue":"6","key":"pgph.0006082.ref014","doi-asserted-by":"crossref","first-page":"1005","DOI":"10.1093\/infdis\/jiac049","article-title":"Diagnostic Accuracy of Assays Using Point-of-Care Testing or Dried Blood Spot Samples for the Determination of Hepatitis C Virus RNA: A Systematic Review","volume":"226","author":"B Catlett","year":"2022","journal-title":"J Infect Dis"},{"issue":"3","key":"pgph.0006082.ref015","doi-asserted-by":"crossref","first-page":"752","DOI":"10.1002\/hep.23407","article-title":"Dried blood spot for hepatitis C virus serology and molecular testing","volume":"51","author":"E Tuaillon","year":"2010","journal-title":"Hepatology"},{"issue":"1","key":"pgph.0006082.ref016","doi-asserted-by":"crossref","first-page":"17063","DOI":"10.1038\/s41598-021-96350-3","article-title":"A novel model of care for simplified testing of HBV in African communities during the COVID-19 pandemic in Spain","volume":"11","author":"CA Picchio","year":"2021","journal-title":"Sci Rep"},{"key":"pgph.0006082.ref017","doi-asserted-by":"crossref","DOI":"10.1002\/rmv.70059","article-title":"Dried blood spots and plasma separation cards can broaden access to molecular testing for HBV, HCV and HIV","volume":"35","author":"JV Lazarus","year":"2025","journal-title":"Reviews in Medical Virology"},{"key":"pgph.0006082.ref018","article-title":"Evaluation of the cobas HCV test for quantifying HCV RNA in dried plasma spots collected using the cobas Plasma Separation Card","author":"EG Marins","year":"2020","journal-title":"J Virol Methods"},{"issue":"11","key":"pgph.0006082.ref019","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2016-012799","article-title":"STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration","volume":"6","author":"JF Cohen","year":"2016","journal-title":"BMJ Open"},{"key":"pgph.0006082.ref020","volume-title":"Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection","author":"World Health Organization WH","year":"2018"},{"issue":"2","key":"pgph.0006082.ref021","doi-asserted-by":"crossref","first-page":"1","DOI":"10.15585\/mmwr.rr6902a1","article-title":"CDC Recommendations for Hepatitis C Screening Among Adults - United States, 2020","volume":"69","author":"S Schillie","year":"2020","journal-title":"MMWR Recomm Rep"},{"key":"pgph.0006082.ref022","article-title":"Disparate detection outcomes for anti-HCV IgG and HCV RNA in dried blood spots","author":"A Tejada-Strop","year":"2015","journal-title":"J Virol Methods"},{"issue":"6","key":"pgph.0006082.ref023","doi-asserted-by":"crossref","DOI":"10.1111\/add.15812","article-title":"Ongoing HIV transmission following a large outbreak among people who inject drugs in Athens, Greece (2014\u201320)","volume":"117","author":"S Roussos","year":"2022","journal-title":"Addiction"},{"key":"pgph.0006082.ref024","author":"Lamoury Francois","year":"2019"},{"key":"pgph.0006082.ref025","article-title":"Multicenter comparison study of both analytical and clinical performance across four Roche hepatitis C virus RNA assays utilizing different platforms","author":"J Vermehren","year":"2017","journal-title":"J Clin Microbiol"},{"key":"pgph.0006082.ref026","doi-asserted-by":"crossref","DOI":"10.1002\/rmv.2320","article-title":"Laboratory-based testing for hepatitis C infection using dried blood spot samples: A systematic review and meta-analysis of diagnostic accuracy","volume":"32","author":"PG Carty","year":"2022","journal-title":"Reviews in Medical Virology"},{"issue":"2","key":"pgph.0006082.ref027","article-title":"Usefulness of dried blood spot samples for monitoring hepatitis C treatment outcome and reinfection among people who inject drugs in a test-and-treat program","volume":"95","author":"A Not","year":"2023","journal-title":"J Med Virol"},{"key":"pgph.0006082.ref028","doi-asserted-by":"crossref","DOI":"10.4414\/SMW.2021.w30089","article-title":"HCV RNA quantification in capillary dried blood spots with the Xpert\u00ae HCV Viral Load test for diagnosing chronic HCV infection, monitoring treatment and detecting reinfection","volume":"151","author":"A Bregenzer","year":"2021","journal-title":"Swiss Med Wkly"},{"key":"pgph.0006082.ref029","article-title":"Hepatitis C virus RNA in dried serum spotted onto filter paper is stable at room temperature","author":"K Abe","year":"1998","journal-title":"J Clin Microbiol"},{"issue":"4","key":"pgph.0006082.ref030","doi-asserted-by":"crossref","first-page":"353","DOI":"10.1111\/jvh.12345","article-title":"Dried blood spot in the genotyping, quantification and storage of HCV RNA: a systematic literature review","volume":"22","author":"J Greenman","year":"2015","journal-title":"J Viral Hepat"},{"key":"pgph.0006082.ref031","author":"Clinton Health Access Initiative (CHAI)"},{"issue":"3","key":"pgph.0006082.ref032","article-title":"Systematic review of the use of dried blood spots for monitoring HIV viral load and for early infant diagnosis","volume":"9","author":"PW Smit","year":"2014","journal-title":"PLoS One"},{"issue":"7","key":"pgph.0006082.ref033","doi-asserted-by":"crossref","first-page":"1917","DOI":"10.1093\/jac\/dky103","article-title":"Low prevalence of transmitted HIV-1 drug resistance detected by a dried blood spot (DBS)-based next-generation sequencing (NGS) method in newly diagnosed individuals in Cameroon in the years 2015-16","volume":"73","author":"HA Mbunkah","year":"2018","journal-title":"Journal of Antimicrobial Chemotherapy"},{"key":"pgph.0006082.ref034","volume-title":"Summary of WHO prequalification assessment for Abbott RealTime HCV","author":"World Health Organization","year":"2021"},{"key":"pgph.0006082.ref035","volume-title":"WHO Prequalification of In Vitro Diagnostics Public Report Product: Abbott RealTime HCV WHO Reference Number: PQDx 0450-027-00 Summary of WHO Prequalification Assessment for Abbott RealTime HCV","author":"WHO","year":"2016"},{"issue":"1","key":"pgph.0006082.ref036","doi-asserted-by":"crossref","first-page":"7316","DOI":"10.1038\/s41598-019-41139-8","article-title":"Evaluation of the diagnostic accuracy of laboratory-based screening for hepatitis C in dried blood spot samples: A systematic review and meta-analysis","volume":"9","author":"S V\u00e1zquez-Mor\u00f3n","year":"2019","journal-title":"Sci Rep"},{"issue":"1","key":"pgph.0006082.ref037","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1111\/liv.15070","article-title":"Optimizing diagnostic algorithms to advance Hepatitis C elimination in Italy: A cost effectiveness evaluation","volume":"42","author":"A Marcellusi","year":"2022","journal-title":"Liver Int"},{"issue":"4","key":"pgph.0006082.ref038","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0231385","article-title":"Dried blood spot self-sampling at home is a feasible technique for hepatitis C RNA detection","volume":"15","author":"T Prinsenberg","year":"2020","journal-title":"PLoS One"},{"key":"pgph.0006082.ref039","volume-title":"Recommendations and guidance on hepatitis C virus self-testing","author":"World Health Organization","year":"2021"},{"key":"pgph.0006082.ref040","doi-asserted-by":"crossref","DOI":"10.1016\/j.jhep.2020.08.018","article-title":"EASL recommendations on treatment of hepatitis C: final update of the series - European Association for the Study of the Liver* - Clinical Practice Guidelines Panel","volume":"73","author":"JM Pawlotsky","year":"2020","journal-title":"J Hepatol"},{"key":"pgph.0006082.ref041","volume-title":"Guidelines on Hepatitis B and C Testing","author":"World Health Organisation","year":"2017"},{"key":"pgph.0006082.ref042","doi-asserted-by":"crossref","DOI":"10.3389\/fmicb.2020.00373","article-title":"Dried Blood Spot Tests for the Diagnosis and Therapeutic Monitoring of HIV and Viral Hepatitis B and C","volume":"11","author":"E Tuaillon","year":"2020","journal-title":"Frontiers in Microbiology"},{"key":"pgph.0006082.ref043","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1004076","article-title":"The performance of using dried blood spot specimens for HIV-1 viral load testing: A systematic review and meta-analysis","volume":"19","author":"L Vojnov","year":"2022","journal-title":"PLoS Medicine"},{"key":"pgph.0006082.ref044","doi-asserted-by":"crossref","DOI":"10.3390\/diagnostics10040248","article-title":"Dried blood spot in laboratory: directions and prospects","volume":"10","author":"K Malsagova","year":"2020","journal-title":"Diagnostics"},{"key":"pgph.0006082.ref045","article-title":"Regulation of blood-screening in vitro diagnostics in sub-Saharan African countries remains a challenge","volume":"10","author":"G Abdurrahman","year":"2023","journal-title":"Front Med (Lausanne)"},{"issue":"7","key":"pgph.0006082.ref046","doi-asserted-by":"crossref","first-page":"1087","DOI":"10.1093\/infdis\/jiv423","article-title":"Dried Blood Spots: A Tool to Ensure Broad Access to Hepatitis C Screening, Diagnosis, and Treatment Monitoring","volume":"213","author":"A Soulier","year":"2016","journal-title":"J Infect Dis"},{"issue":"1","key":"pgph.0006082.ref047","doi-asserted-by":"crossref","DOI":"10.1016\/S0168-8278(17)31900-1","article-title":"Field evaluation of Xpert HCV viral load point-of-care test for detection of hepatitis C virus infection by venipuncture-collected and finger-stick capillary whole-blood samples","volume":"66","author":"J Grebely","year":"2017","journal-title":"J Hepatol"},{"key":"pgph.0006082.ref048","doi-asserted-by":"crossref","DOI":"10.1016\/j.jhep.2016.08.002","article-title":"Who to test and how to test for chronic hepatitis C infection \u2013 2016 WHO testing guidance for low- and middle-income countries","volume":"65","author":"PJ Easterbrook","year":"2016","journal-title":"Journal of Hepatology"}],"container-title":["PLOS Global Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pgph.0006082","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T17:32:36Z","timestamp":1773250356000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pgph.0006082"}},"subtitle":[],"editor":[{"given":"Guillaume","family":"Fontaine","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2026,3,11]]},"references-count":48,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,3,11]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pgph.0006082","relation":{},"ISSN":["2767-3375"],"issn-type":[{"value":"2767-3375","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,11]]}}}