{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:22:49Z","timestamp":1787239369246,"version":"build-2736575974"},"reference-count":21,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T00:00:00Z","timestamp":1758067200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016545","name":"Roche Diagnostics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016545","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The standard of care for HIV-infected patients on antiretroviral therapy (ART) relies on regular monitoring of HIV viral load. Access to viral load monitoring has improved in recent years, but remains scarce in some settings. Alternatives to plasma, such as dried specimens, can help bring routine viral load testing to remote settings. This study aimed to evaluate performances of the cobas\u00ae plasma separation card (PSC) to detect virological failure at the threshold of 1,000 copies\/mL in real-life conditions in Vietnam.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Patients were enrolled in two hospitals in Hanoi (Vietnam).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This cross-sectional evaluation enrolled 250 HIV-infected adults using convenience sampling. All provided plasma and PSC samples. The sensitivity and specificity of PSC, as compared to plasma, to identify patients in virological failure were estimated. Convenience sampling was used to reach the target numbers of 150 and 100 patients with plasma viral load \u2265 and &lt;1,000 copies\/mL, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 250 patients were enrolled. Of the 127 (50.8%) patients with plasma viral load \u22651,000 copies\/mL, the PSC viral load was also \u22651,000 copies\/mL in 126 (sensitivity (95% confidence interval (CI)): 99.2% (95.7\u201399.9)). Of the 123 (49.2%) patients with plasma viral load &lt;1,000 copies\/mL, the PSC viral load was also &lt;1,000 copies\/mL in 108 (specificity (95% CI): 87.8% (80.7\u201393.0)). Overall, the concordance rate was 93.6%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec005\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This field evaluation of the cobas\u00ae PSC showed its high effectiveness in identifying patients in virological failure. The specificity was 87.8%, lower than in previous reports. However, in cases of discrepancy, the PSC viral load level was never far from the 1,000 copies\/mL threshold, which may be due to measurement error inherent to the technique.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0329841","type":"journal-article","created":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T17:31:01Z","timestamp":1758130261000},"page":"e0329841","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":2,"title":["Evaluation of the cobas plasma separation card to identify HIV-infected patients in virological failure in real-life conditions in Vietnam"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5188-4043","authenticated-orcid":true,"given":"Hanh Thi Hong","family":"Ngo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Binh Thanh","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tram Thi Phuong","family":"Pham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nhung Thi Hong","family":"Le","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hien Ba","family":"Pham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trang Thi Thu","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohand","family":"Ait-Ahmed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tuan Anh","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thang Hong","family":"Pham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6201-1261","authenticated-orcid":true,"given":"Yoann","family":"Madec","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,9,17]]},"reference":[{"key":"pone.0329841.ref001","volume-title":"Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. 2021 update","author":"World Health Organization","year":"2021"},{"key":"pone.0329841.ref002","unstructured":"2025 AIDS targets. [cited 2023 October 1]. Available from: https:\/\/www.unaids.org\/sites\/default\/files\/2025-AIDS-Targets_en.pdf"},{"key":"pone.0329841.ref003","unstructured":"Global HIV & AIDS statistics \u2014 Fact sheet. [cited 2 May 2023]. Available: https:\/\/www.unaids.org\/en\/resources\/fact-sheet"},{"issue":"8","key":"pone.0329841.ref004","doi-asserted-by":"crossref","first-page":"1043","DOI":"10.1093\/cid\/ciw001","article-title":"Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges","volume":"62","author":"T Roberts","year":"2016","journal-title":"Clin Infect Dis"},{"issue":"2","key":"pone.0329841.ref005","doi-asserted-by":"crossref","DOI":"10.1002\/rmv.2165","article-title":"HIV-1 viral load testing in resource-limited settings: Challenges and solutions for specimen integrity","volume":"31","author":"H Newman","year":"2021","journal-title":"Rev Med Virol"},{"issue":"2","key":"pone.0329841.ref006","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1089\/apc.2022.0135","article-title":"Performances of dried blood spots and point-of-care devices to identify virological failure in hiv-infected patients: a systematic review and meta-analysis","volume":"37","author":"LBL Nguyen","year":"2023","journal-title":"AIDS Patient Care STDS"},{"issue":"1","key":"pone.0329841.ref007","doi-asserted-by":"crossref","first-page":"140","DOI":"10.3390\/diagnostics11010140","article-title":"Costs of point-of-care viral load testing for adults and children living with HIV in Kenya","volume":"11","author":"MA Bulterys","year":"2021","journal-title":"Diagnostics (Basel)"},{"issue":"8","key":"pone.0329841.ref008","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 Med"},{"issue":"6","key":"pone.0329841.ref009","doi-asserted-by":"crossref","first-page":"1641","DOI":"10.1128\/JCM.03372-15","article-title":"Estimation of HIV-1 DNA level interfering with reliability of HIV-1 RNA quantification performed on dried blood spots collected from successfully treated patients","volume":"54","author":"S Zida","year":"2016","journal-title":"J Clin Microbiol"},{"issue":"3","key":"pone.0329841.ref010","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1097\/QAI.0000000000002855","article-title":"Diagnostic accuracy of dried plasma spot specimens for HIV-1 viral load testing: a systematic review and meta-analysis","volume":"89","author":"Y Fong","year":"2022","journal-title":"J Acquir Immune Defic Syndr"},{"issue":"4","key":"pone.0329841.ref011","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"},{"issue":"5","key":"pone.0329841.ref012","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0232122","article-title":"Accurate HIV viral load measurement in primary health care settings using the cobas\u00ae plasma separation card","volume":"15","author":"A Vubil","year":"2020","journal-title":"PLoS One"},{"key":"pone.0329841.ref013","doi-asserted-by":"crossref","first-page":"104839","DOI":"10.1016\/j.jcv.2021.104839","article-title":"Classification of HIV-1 virological treatment failure using the Roche cobas plasma separation card on cobas 8800 compared to dried blood spots on Abbott RealTime HIV-1","volume":"140","author":"L Hans","year":"2021","journal-title":"J Clin Virol"},{"issue":"3","key":"pone.0329841.ref014","doi-asserted-by":"crossref","DOI":"10.1093\/ofid\/ofw142","article-title":"Evaluation of Two Techniques for Viral Load Monitoring Using Dried Blood Spot in Routine Practice in Vietnam (French National Agency for AIDS and Hepatitis Research 12338)","volume":"3","author":"F Taieb","year":"2016","journal-title":"Open Forum Infect Dis"},{"issue":"2","key":"pone.0329841.ref015","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1016\/S2055-6640(20)30466-0","article-title":"Factors associated with HIV viral load suppression on antiretroviral therapy in Vietnam","volume":"2","author":"S Rangarajan","year":"2016","journal-title":"J Virus Erad"},{"issue":"3","key":"pone.0329841.ref016","doi-asserted-by":"crossref","first-page":"16","DOI":"10.5365\/wpsar.2018.9.1.008","article-title":"Viral load suppression and acquired HIV drug resistance in adults receiving antiretroviral therapy in Viet Nam: results from a nationally representative survey","volume":"9","author":"VQ Dat","year":"2018","journal-title":"Western Pac Surveill Response J"},{"issue":"2","key":"pone.0329841.ref017","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0281857","article-title":"Assessment of HIV viral load monitoring in remote settings in Vietnam - comparing people who inject drugs to the other patients","volume":"18","author":"LH Lefrancois","year":"2023","journal-title":"PLoS One"},{"key":"pone.0329841.ref018","unstructured":"Cobas\u00ae HIV-1 - Nucleic acid test for use on the cobas\u00ae 4800 System. Available from: https:\/\/elabdoc-prod.roche.com\/eLD\/api\/downloads\/97f62509-a790-ef11-2b91-005056a71a5d?countryIsoCode=vn"},{"issue":"6","key":"pone.0329841.ref019","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pgph.0002099","article-title":"The plasma separation card as a novel solution for enhancing central laboratory capability for HIV-1 viral load monitoring in limited-access settings","volume":"3","author":"C Kiyaga","year":"2023","journal-title":"PLOS Glob Public Health"},{"issue":"4","key":"pone.0329841.ref020","doi-asserted-by":"crossref","DOI":"10.1128\/jcm.01649-23","article-title":"Assessment of the performance of the plasma separation card for HIV-1 viral load monitoring in South Africa","volume":"62","author":"L Chimoyi","year":"2024","journal-title":"J Clin Microbiol"},{"issue":"4","key":"pone.0329841.ref021","doi-asserted-by":"crossref","first-page":"1131","DOI":"10.1128\/JCM.02193-16","article-title":"Multicenter Comparison Study of both Analytical and Clinical Performance across Four Roche Hepatitis C Virus RNA Assays Utilizing Different Platforms","volume":"55","author":"J Vermehren","year":"2017","journal-title":"J Clin Microbiol"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0329841","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T17:31:05Z","timestamp":1758130265000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0329841"}},"subtitle":[],"editor":[{"given":"Kenji","family":"Fujiwara,","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,9,17]]},"references-count":21,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,9,17]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0329841","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,17]]}}}