{"doi":"10.1093/infdis/jiaf608","title":"Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH Rapid Polymerase Chain Reaction System","abstract":"BACKGROUND: Hepatitis C virus (HCV) infection is a major public health problem despite the availability of highly effective and curative direct-acting antiviral treatments. Low diagnostic rates, driven in part by a 2-step diagnostic process and the need for molecular confirmation, pose a significant barrier to timely treatment. Here we describe the development, analytical characterization, and a preliminary clinical validation study of a rapid, user-friendly, sensitive, qualitative molecular test for point-of-care HCV testing. METHODS: This study evaluated the analytical performance of a 15-minute time to result qualitative molecular test for HCV on the sample-to-answer point-of-care DASH Rapid PCR System. The dynamic range, limit of detection, analytical specificity, and the equivalent detection of genotypes 1-6 were assessed. A small clinical validation study was independently conducted by Johns Hopkins University investigators using retrospectively collected specimens. RESULTS: The Research Use Only DASH HCV assay has wide dynamic range, can detect HCV genotypes 1-6, and has a detection limit of 200 IU/mL with 100 μL specimen volume addition. In a preliminary study of 97 plasma specimens, the DASH HCV assay demonstrated 100% positive percent agreement and 100% negative percent agreement when compared to commercial platforms. CONCLUSIONS: The DASH HCV test holds potential to enable same-day diagnosis and treatment in support of HCV elimination efforts.","journal":"The Journal of Infectious Diseases","year":2025,"id":525025,"datarank":0.24141568686511508,"base_score":1.6094379124341003,"endowment":1.6094379124341003,"self_citation_contribution":0.24141568686511508,"citation_network_contribution":0.0,"self_endowment_contribution":0.24141568686511508,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":4,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9561,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":719994,"name":"Matthew A. Butzler","orcid":null,"position":1,"is_corresponding":false},{"id":411273,"name":"Claudia Hawkins","orcid":"0000-0001-7228-6317","position":2,"is_corresponding":false},{"id":237961,"name":"Yukari C. Manabe","orcid":"0000-0001-8619-5598","position":3,"is_corresponding":false},{"id":1182904,"name":"Jeffrey P. Holden","orcid":null,"position":4,"is_corresponding":false},{"id":237962,"name":"David L. Thomas","orcid":"0000-0002-0749-925X","position":5,"is_corresponding":false},{"id":355240,"name":"Andrea L. Cox","orcid":"0000-0002-9331-2462","position":6,"is_corresponding":false},{"id":719312,"name":"Sally M. McFall","orcid":"0000-0001-5554-6615","position":7,"is_corresponding":false},{"id":892109,"name":"Jennifer L. Reed","orcid":"0000-0001-8006-8555","position":0,"is_corresponding":true}],"reference_count":20,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-19T02:50:16.562292Z","pmid":"41369203","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}