{"doi":"10.1093/cid/ciaf660","title":"Independent Testing to Accelerate the Development of Lateral Flow Assays for Influenza A, Influenza B and SARS-COV-2","abstract":"BACKGROUND: As the test verification core for the Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program (ITAP), we conducted independent bench- and field-based performance testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A&B lateral flow assays (LFAs) prior to formal clinical studies for Food and Drug Administration (FDA) submission. METHODS: During bench testing, the limit of detection (LOD) was approximated using serially diluted panels of laboratory-propagated virus. In field studies, LFA results were interpreted by study participants, and sensitivity and specificity were determined using reverse transcription polymerase chain reaction (RT-PCR) (Xpert CoV-2/Flu/RSV plus) from a concurrent nasal swab as the reference standard. RESULTS: Between February 2023 and February 2025, we tested 30 iterations of 14 LFAs. LODs were 53 277-1 393 314 genome equivalents (GE)/mL for SARS-CoV-2, 85 027-1 731 676 for influenza A, and 11 688-2 960 941 for influenza B. Field studies enrolled 27 to 126 participants per LFA with most enrolling at least 50 participants. When minimum 5 positive cases were enrolled, sensitivity ranged from 0.57-1.00 for SARS-CoV-2 and 0.64-0.85 for influenza A. Influenza B case enrollment was low. Specificity ranged from 0.91-1.00 across all targets. Eleven of 14 devices underwent at least two iterations of testing. Following ITAP assessment, 7 devices received FDA emergency use authorization, and 3 ultimately received de novo marketing approval or 510 (k) clearance. CONCLUSIONS: The ITAP enabled rapid feedback to federal agencies and manufacturers on the analytical and clinical performance of over-the-counter LFAs for SARS-CoV-2 and influenza, ultimately contributing to success in regulatory authorization or clearance.","journal":"Clinical Infectious Diseases","year":2025,"id":549863,"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":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9079,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":71082,"name":"Laura Johnson","orcid":"0000-0002-5368-224X","position":1,"is_corresponding":false},{"id":314483,"name":"Leda Bassit","orcid":"0000-0001-9894-5587","position":2,"is_corresponding":false},{"id":1445240,"name":"Julie A. 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Kennedy","orcid":null,"position":13,"is_corresponding":false},{"id":1444566,"name":"Eric Lai","orcid":"0000-0001-5850-7451","position":14,"is_corresponding":false},{"id":1190226,"name":"Pamela N. Miller","orcid":null,"position":15,"is_corresponding":false},{"id":1445243,"name":"Raymond F Schinazi","orcid":null,"position":16,"is_corresponding":false},{"id":377303,"name":"Jennifer K. Frediani","orcid":"0000-0002-4634-0591","position":17,"is_corresponding":false},{"id":112497,"name":"Annette Esper","orcid":null,"position":18,"is_corresponding":false},{"id":560984,"name":"Greg Martin","orcid":"0000-0003-4647-8627","position":19,"is_corresponding":false},{"id":337554,"name":"Wilbur A. Lam","orcid":"0000-0002-0325-7990","position":20,"is_corresponding":false},{"id":681966,"name":"Gregory L. 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