{"doi":"10.1101/2022.01.24.22269785","title":"Clinical evaluation of the Diagnostic Analyzer for Selective Hybridization (DASH): a point-of-care PCR test for rapid detection of SARS-CoV-2 infection","abstract":"BACKGROUND: Rapid and accurate testing for SARS-CoV-2 is an essential tool in the medical and public health response to the COVID-19 pandemic. An ideal test for COVID-19 would combine the sensitivity of laboratory-based PCR combined with the speed and ease of use of point-of-care (POC) or home-based rapid antigen testing. METHODS: To evaluate the performance of the Diagnostic Analyzer for Selective Hybridization (DASH) SARS-CoV-2 POC PCR (sample insertion to result time of 16 minutes), we conducted a cross-sectional study of adults with and without symptoms of COVID-19 at four clinical sites. We collected two bilateral anterior nasal swabs from each participant and information on COVID-19 symptoms, vaccination, and exposure. One swab was tested with the DASH SARS-CoV-2 POC PCR and the second in a central laboratory using Cepheid Xpert Xpress SARS-CoV-2 PCR. We assessed test concordance and calculated sensitivity, specificity, negative and positive predictive values using Xpert as the \"gold standard.\" RESULTS: We enrolled 315 and analyzed 313 participants with median age 42 years; 65% were female, 62% symptomatic, 75% had received ≥2 doses of mRNA COVID-19 vaccine, and 16% currently COVID-19 positive. There were concordant results for 307 tests indicating an overall agreement for DASH of 0.98 [95% CI 0.96, 0.99] compared to Xpert. DASH performed at 0.96 [95% CI 0.86, 1.00] sensitivity and 0.98 [95% CI 0.96, 1.00] specificity, with a positive predictive value of 0.85 [95% CI 0.73, 0.96] and negative predictive value of 0.996 [95% CI 0.99, 1.00]. The six discordant tests between DASH and Xpert all had high Ct values (>30) on the respective positive assay. DASH and Xpert Ct values were highly correlated (R=0.89 [95% CI 0.81, 0.94]). CONCLUSIONS: DASH POC SARS-CoV-2 PCR was accurate, easy to use, and provided fast results in real-life clinical settings with an overall performance similar to an EUA-approved laboratory-based PCR. Its compact design and ease of use are optimal for a variety of healthcare, and potentially community settings, including areas with lack of access to central laboratory-based PCR testing. SUMMARY: DASH is an accurate, easy to use, and fast point-of-care test with applications for diagnosis and screening of SARS-CoV-2 infection.","journal":"medRxiv","year":2022,"id":300887,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9617,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":947223,"name":"Matthew Caputo","orcid":"0000-0002-7408-6084","position":1,"is_corresponding":false},{"id":411273,"name":"Claudia Hawkins","orcid":"0000-0001-7228-6317","position":2,"is_corresponding":false},{"id":373367,"name":"Lauren C. Balmert","orcid":"0000-0001-5476-4514","position":3,"is_corresponding":false},{"id":283130,"name":"Chao Qi","orcid":"0000-0003-0741-3070","position":4,"is_corresponding":false},{"id":947670,"name":"Joseph Odorisio","orcid":null,"position":5,"is_corresponding":false},{"id":379942,"name":"Etienne Dembele","orcid":null,"position":6,"is_corresponding":false},{"id":947224,"name":"Alema Jackson","orcid":"0000-0002-8231-9351","position":7,"is_corresponding":false},{"id":947225,"name":"Hiba Abbas","orcid":"0000-0002-8383-2747","position":8,"is_corresponding":false},{"id":377303,"name":"Jennifer K. Frediani","orcid":"0000-0002-4634-0591","position":9,"is_corresponding":false},{"id":336427,"name":"Joshua M. Levy","orcid":"0000-0001-5907-3421","position":10,"is_corresponding":false},{"id":616964,"name":"Paulina A. Rebolledo","orcid":null,"position":11,"is_corresponding":false},{"id":332451,"name":"Russell R. Kempker","orcid":"0000-0002-7188-4996","position":12,"is_corresponding":false},{"id":645801,"name":"Annette Esper","orcid":"0000-0002-2104-3523","position":13,"is_corresponding":false},{"id":337554,"name":"Wilbur A. Lam","orcid":"0000-0002-0325-7990","position":14,"is_corresponding":false},{"id":24174,"name":"Greg S. Martin","orcid":"0000-0002-9684-7593","position":15,"is_corresponding":false},{"id":379943,"name":"Robert L Murphy","orcid":null,"position":16,"is_corresponding":false},{"id":283131,"name":"Chad J. Achenbach","orcid":"0000-0003-4847-7249","position":0,"is_corresponding":true}],"reference_count":52,"raw_metadata":null,"created_at":"2026-07-19T00:31:57.812980Z","pmid":"35118476","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":[]}