{"doi":"10.1093/clinchem/hvaa262","title":"Commercial Serology Assays Predict Neutralization Activity against SARS-CoV-2","abstract":"BACKGROUND: It is unknown whether a positive serology result correlates with protective immunity against SARS-CoV-2. There are also concerns regarding the low positive predictive value of SARS-CoV-2 serology tests, especially when testing populations with low disease prevalence. METHODS: A neutralization assay was validated in a set of PCR-confirmed positive specimens and in a negative cohort. In addition, 9530 specimens were screened using the Diazyme SARS-CoV-2 IgG serology assay and all positive results (N = 164 individuals) were reanalyzed using the neutralization assay, the Roche total immunoglobin assay, and the Abbott IgG assay. The relationship between the magnitude of a positive SARS-CoV-2 serology result and neutralizing activity was determined. Neutralizing antibody titers (50% inhibitory dilution, ID50) were also longitudinally monitored in patients confirmed to have SARS-CoV-2 by PCR. RESULTS: The SARS-CoV-2 neutralization assay had a positive percentage agreement (PPA) of 96.6% with a SARS-CoV-2 PCR test and a negative percentage agreement (NPA) of 98.0% across 100 negative control individuals. ID50 neutralization titers positively correlated with all 3 clinical serology platforms. Longitudinal monitoring of hospitalized PCR-confirmed patients with COVID-19 demonstrated they made high neutralization titers against SARS-CoV-2. PPA between the Diazyme IgG assay alone and the neutralization assay was 50.6%, while combining the Diazyme IgG assay with either the Roche or Abbott platforms increased the PPA to 79.2 and 78.4%, respectively. CONCLUSIONS: These 3 clinical serology assays positively correlate with SARS-CoV-2 neutralization activity observed in patients with COVID-19. All patients confirmed SARS-CoV-2 positive by PCR develop neutralizing antibodies.","journal":"Clinical Chemistry","year":2020,"id":59693,"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":66,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9508,"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":314430,"name":"Melissa Hoffman","orcid":"0000-0002-4682-8861","position":1,"is_corresponding":false},{"id":108972,"name":"Deli Huang","orcid":"0000-0002-6989-639X","position":2,"is_corresponding":false},{"id":297046,"name":"Jenny Tuyet Tran","orcid":null,"position":3,"is_corresponding":false},{"id":315986,"name":"Michael J. Kelner","orcid":null,"position":4,"is_corresponding":false},{"id":314431,"name":"Sharon L. Reed","orcid":"0000-0001-7615-9366","position":5,"is_corresponding":false},{"id":315987,"name":"Ronald W. McLawhon","orcid":null,"position":6,"is_corresponding":false},{"id":109547,"name":"James E. Voss","orcid":"0000-0002-4777-1596","position":7,"is_corresponding":false},{"id":109546,"name":"David Nemazee","orcid":"0000-0002-4769-6311","position":8,"is_corresponding":false},{"id":314432,"name":"Robert L. Fitzgerald","orcid":"0000-0001-6050-8525","position":9,"is_corresponding":false},{"id":314429,"name":"Raymond T. Suhandynata","orcid":"0000-0002-4767-7639","position":0,"is_corresponding":true}],"reference_count":37,"raw_metadata":null,"created_at":"2026-07-18T21:08:26.834549Z","pmid":"33084854","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":[]}