ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
Independent Testing to Accelerate the Development of Lateral Flow Assays for Influenza A, Influenza B and SARS-COV-2.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Respiratory Viral Burden and Healthcare Utilization Among Pediatric Patients With Acute Respiratory Viral Infections in a Tertiary Care Center.Health science reports · 2026Article
- Analytical comparison of over-the-counter multiplex tests for influenza A, influenza B, and SARS-CoV-2.Microbiology spectrum · 2026Article
Corrections and comments
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Authors and funding
22 authors.
Funding
Abstract
backgroundAs 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.
methodsDuring 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.
resultsBetween 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.
conclusionsThe 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.
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