{"doi":"10.1101/2020.06.24.20139006","title":"Evaluation of two commercial and two non-commercial immunoassays for the detection of prior infection to SARS-CoV-2","abstract":"Background Seroepidemiology is an important tool to characterize the epidemiology and immunobiology of SARS-CoV-2 but many immunoassays have not been externally validated raising questions about reliability of study findings. To ensure meaningful data, particularly in a low seroprevalence population, assays need to be rigorously characterized with high specificity. Methods We evaluated two commercial (Roche Diagnostics and Epitope Diagnostics IgM/IgG) and two non-commercial (Simoa and Ragon/MGH IgG) immunoassays against 68 confirmed positive and 232 pre-pandemic negative controls. Sensitivity was stratified by time from symptom onset. The Simoa multiplex assay applied three pre-defined algorithm models to determine sample result. Results The Roche and Ragon/MGH IgG assays each registered 1/232 false positive, the primary Simoa model registered 2/232 false positives, and the Epitope registered 2/230 and 3/230 false positives for the IgG and IgM assays respectively. Sensitivity >21 days post symptom-onset was 100% for all assays except Epitope IgM, but lower and/or with greater variability between assays for samples collected 9-14 days (67-100%) and 15-21 days (69-100%) post-symptom onset. The Simoa and Epitope IgG assays demonstrated excellent sensitivity earlier in the disease course. The Roche and Ragon/MGH IgG assays were less sensitive during early disease, particularly among immunosuppressed individuals. Conclusions The Epitope IgG demonstrated good sensitivity and specificity. The Roche and Ragon/MGH IgG assays registered rare false positives with lower early sensitivity. The Simoa assay primary model had excellent sensitivity and few false positives.","journal":"medRxiv","year":2020,"id":120494,"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":10,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9478,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":218345,"name":"Elizabeth W. Karlson","orcid":"0000-0001-5455-7443","position":1,"is_corresponding":false},{"id":76189,"name":"Maia Norman","orcid":"0000-0002-9654-4904","position":2,"is_corresponding":false},{"id":91003,"name":"Tal Gilboa","orcid":"0000-0001-8172-7786","position":3,"is_corresponding":false},{"id":106724,"name":"Stephanie Fischinger","orcid":"0000-0003-2307-3379","position":4,"is_corresponding":false},{"id":106723,"name":"Caroline Atyeo","orcid":"0000-0002-7489-0232","position":5,"is_corresponding":false},{"id":557822,"name":"Guohai Zhou","orcid":"0000-0002-8826-403X","position":6,"is_corresponding":false},{"id":557823,"name":"Christopher Bennett","orcid":"0000-0002-8467-6192","position":7,"is_corresponding":false},{"id":557824,"name":"Nicole V. Tolan","orcid":"0000-0002-7239-1843","position":8,"is_corresponding":false},{"id":558427,"name":"Karina Oganezova","orcid":null,"position":9,"is_corresponding":false},{"id":76195,"name":"David R. Walt","orcid":"0000-0002-5524-7348","position":10,"is_corresponding":false},{"id":106757,"name":"Galit Alter","orcid":"0000-0002-7680-9215","position":11,"is_corresponding":false},{"id":285745,"name":"Daimon P. Simmons","orcid":"0000-0003-1429-4073","position":12,"is_corresponding":false},{"id":478237,"name":"Peter H. Schur","orcid":null,"position":13,"is_corresponding":false},{"id":402513,"name":"Petr Jarolı́m","orcid":"0000-0002-9612-8652","position":14,"is_corresponding":false},{"id":3841,"name":"Lindsey R. Baden","orcid":null,"position":15,"is_corresponding":false},{"id":557821,"name":"Eric J. Nilles","orcid":"0000-0001-7044-5257","position":0,"is_corresponding":true}],"reference_count":35,"raw_metadata":null,"created_at":"2026-07-18T23:14:33.640077Z","pmid":"32607518","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":[]}