{"doi":"10.1093/jalm/jfab072","title":"Evaluation of Three Commercial and Two Non-Commercial Immunoassays for the Detection of Prior Infection to SARS-CoV-2","abstract":"BACKGROUND: Serological testing provides a record of prior infection with SARS-CoV-2, but assay performance requires independent assessment. METHODS: We evaluated 3 commercial (Roche Diagnostics pan-IG, and Epitope Diagnostics IgM and IgG) and 2 non-commercial (Simoa and Ragon/MGH IgG) immunoassays against 1083 unique samples that included 251 PCR-positive and 832 prepandemic samples. RESULTS: The Roche assay registered the highest specificity 99.6% (3/832 false positives), the Ragon/MGH assay 99.5% (4/832), the primary Simoa assay model 99.0% (8/832), and the Epitope IgG and IgM 99.0% (8/830) and 99.5% (4/830), respectively. Overall sensitivities for the Simoa, Roche pan-IG, Epitope IgG, Ragon/MGH IgG, and Epitope IgM were 92.0%, 82.9%, 82.5%, 64.5% and 47.0%, respectively. The Simoa immunoassay demonstrated the highest sensitivity among samples stratified by days postsymptom onset (PSO), <8 days PSO (57.69%) 8-14 days PSO (93.51%), 15-21 days PSO (100%), and > 21 days PSO (95.18%). CONCLUSIONS: All assays demonstrated high to very high specificities while sensitivities were variable across assays.","journal":"The Journal of Applied Laboratory Medicine","year":2021,"id":186513,"datarank":0.4636563680037475,"base_score":3.091042453358316,"endowment":3.091042453358316,"self_citation_contribution":0.4636563680037475,"citation_network_contribution":0.0,"self_endowment_contribution":0.4636563680037475,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":21,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9034,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","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":16976,"name":"Ann E. Woolley","orcid":"0000-0002-2810-1618","position":15,"is_corresponding":false},{"id":3841,"name":"Lindsey R. Baden","orcid":null,"position":16,"is_corresponding":false},{"id":557821,"name":"Eric J. Nilles","orcid":"0000-0001-7044-5257","position":0,"is_corresponding":true}],"reference_count":16,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-18T23:48:46.850806Z","pmid":"34196711","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":[]}