{"doi":"10.1101/2020.06.02.131144","title":"SARS-CoV2 Testing: The Limit of Detection Matters","abstract":"Resolving the COVID-19 pandemic requires diagnostic testing to determine which individuals are infected and which are not. The current gold standard is to perform RT-PCR on nasopharyngeal samples. Best-in-class assays demonstrate a limit of detection (LoD) of ~100 copies of viral RNA per milliliter of transport media. However, LoDs of currently approved assays vary over 10,000-fold. Assays with higher LoDs will miss more infected patients, resulting in more false negatives. However, the false-negative rate for a given LoD remains unknown. Here we address this question using over 27,500 test results for patients from across our healthcare network tested using the Abbott RealTime SARS-CoV-2 EUA. These results suggest that each 10-fold increase in LoD is expected to increase the false negative rate by 13%, missing an additional one in eight infected patients. The highest LoDs on the market will miss a majority of infected patients, with false negative rates as high as 70%. These results suggest that choice of assay has meaningful clinical and epidemiological consequences. The limit of detection matters.","journal":"bioRxiv (Cold Spring Harbor Laboratory)","year":2020,"id":118250,"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":169,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9517,"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":262686,"name":"Rose Lee","orcid":"0000-0001-5112-8766","position":1,"is_corresponding":false},{"id":262687,"name":"Ghee Rye Lee","orcid":"0000-0001-6614-0223","position":2,"is_corresponding":false},{"id":262688,"name":"Cody Callahan","orcid":"0000-0002-0267-7096","position":3,"is_corresponding":false},{"id":262690,"name":"Christina Yen","orcid":"0000-0002-6145-4693","position":4,"is_corresponding":false},{"id":335794,"name":"Kenneth P. Smith","orcid":null,"position":5,"is_corresponding":false},{"id":262691,"name":"Rohit Arora","orcid":"0000-0001-7106-9089","position":6,"is_corresponding":false},{"id":262692,"name":"James E. Kirby","orcid":"0000-0003-0392-4500","position":7,"is_corresponding":false},{"id":87122,"name":"Ramy Arnaout","orcid":"0000-0001-6955-9310","position":0,"is_corresponding":true}],"reference_count":12,"raw_metadata":null,"created_at":"2026-07-18T23:13:58.531532Z","pmid":"32577640","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":[]}