{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T13:00:42Z","timestamp":1785416442307,"version":"3.56.0"},"reference-count":22,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T00:00:00Z","timestamp":1781222400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Program Management Unit for Competitiveness Enhancement 2021","award":["C10F640049"],"award-info":[{"award-number":["C10F640049"]}]},{"DOI":"10.13039\/501100016204","name":"Ministry of Higher Education, Science, Research and Innovation, Thailand","doi-asserted-by":"crossref","award":["R2568A030"],"award-info":[{"award-number":["R2568A030"]}],"id":[{"id":"10.13039\/501100016204","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100016204","name":"Ministry of Higher Education, Science, Research and Innovation, Thailand","doi-asserted-by":"crossref","award":["R2568A027"],"award-info":[{"award-number":["R2568A027"]}],"id":[{"id":"10.13039\/501100016204","id-type":"DOI","asserted-by":"crossref"}]},{"award":["R2568A030"],"award-info":[{"award-number":["R2568A030"]}],"id":[{"id":"https:\/\/ror.org\/03cqd2v24","id-type":"ROR","asserted-by":"publisher"}]},{"award":["R2568A027"],"award-info":[{"award-number":["R2568A027"]}],"id":[{"id":"https:\/\/ror.org\/03cqd2v24","id-type":"ROR","asserted-by":"publisher"}]},{"name":"Frontier Research and Innovation Cluster Fund, Naresuan University","award":["R2569C003"],"award-info":[{"award-number":["R2569C003"]}]},{"award":["R2569C003"],"award-info":[{"award-number":["R2569C003"]}],"id":[{"id":"https:\/\/ror.org\/03e2qe334","id-type":"ROR","asserted-by":"publisher"}]},{"name":"Faculty of Allied Health Sciences, Naresuan University, Thailand"},{"id":[{"id":"https:\/\/ror.org\/03e2qe334","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: Reliable quality control (QC) materials are essential for maintaining the analytical performance of hepatitis C virus (HCV) screening assays. Rapid diagnostic tests (RDTs) are widely used for point-of-care HCV screening; however, standardized plasma-based internal quality control (IQC) materials compatible with both rapid tests and automated immunoassays remain limited. This study aimed to develop and evaluate plasma-based QC materials applicable to multiple anti-HCV RDTs and automated immunoassays. Methods: QC materials were prepared from pooled HCV-positive plasma at strong-positive, weak-positive, and negative levels in liquid and lyophilized formats. Lyophilized preparations were produced with and without trehalose, while liquid samples were prepared with and without a stabilizer. Performance was evaluated using five anti-HCV RDT kits and the Elecsys Anti-HCV II automated immunoassay platform. Stability was assessed under accelerated temperature conditions (45 \u00b0C for 28 days) and long-term storage (2\u20138 \u00b0C and 20\u201330 \u00b0C for six months). Signal trends were analyzed using linear regression (p &gt; 0.05), and homogeneity was evaluated using one-way analysis of variance and Cochran\u2019s C test. Results: All QC formulations demonstrated consistent qualitative reactivity across the evaluated RDT kits and stable responses on the automated immunoassay platform. Lyophilized plasma containing trehalose maintained stable cut-off index (COI) values during accelerated and long-term storage, with no significant time-dependent trends (p &gt; 0.05). Conclusions: Trehalose-stabilized lyophilized materials demonstrated enhanced stability and acceptable homogeneity, supporting practical applicability under the tested storage conditions across the evaluated rapid tests, and within the evaluated moderate-to-high positive analytical ranges on the automated anti-HCV immunoassay platform.<\/jats:p>","DOI":"10.3390\/diagnostics16121813","type":"journal-article","created":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T06:53:10Z","timestamp":1781247190000},"page":"1813","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and Characterization of Dual-Platform Lyophilized Plasma-Based Quality Control Materials for Hepatitis C Virus Antibody Testing"],"prefix":"10.3390","volume":"16","author":[{"given":"Wipawee","family":"Thanyacharern","sequence":"first","affiliation":[{"name":"Reference Materials and Innovation Research Unit for Medical Laboratory, Faculty of Allied Health Sciences, Naresuan University, Phitsanulok 65000, Thailand"},{"name":"Department of Medical Sciences, Ministry of Public Health, Nonthaburi 11000, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3436-0106","authenticated-orcid":false,"given":"Wanvisa","family":"Treebuphachatsakul","sequence":"additional","affiliation":[{"name":"Reference Materials and Innovation Research Unit for Medical Laboratory, Faculty of Allied Health Sciences, Naresuan University, Phitsanulok 65000, Thailand"},{"name":"Department of Medical Technology, Faculty of Allied Health Sciences, Naresuan University, Phitsanulok 65000, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6105-6556","authenticated-orcid":false,"given":"Supaporn","family":"Suparak","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, Ministry of Public Health, Nonthaburi 11000, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nam K.","family":"Tran","sequence":"additional","affiliation":[{"name":"Computational Pathology and AI Center of Excellence (CPACE), School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9994-8146","authenticated-orcid":false,"given":"Napaporn","family":"Apiratmateekul","sequence":"additional","affiliation":[{"name":"Reference Materials and Innovation Research Unit for Medical Laboratory, Faculty of Allied Health Sciences, Naresuan University, Phitsanulok 65000, Thailand"},{"name":"Department of Medical Technology, Faculty of Allied Health Sciences, Naresuan University, Phitsanulok 65000, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Baumert, T.F., J\u00fchling, F., Ono, A., and Hoshida, Y. 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