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Clin Infect Dis
. 2026 Jan 9:ciaf660.
doi: 10.1093/cid/ciaf660. Online ahead of print. Independent Testing to Accelerate the Development of Lateral Flow Assays for Influenza A, Influenza B and SARS-COV-2
Anuradha Rao 1 2 , Laura Johnson 2 , Leda Bassit 1 2 3 , Julie Sullivan 1 2 , Heather B Bowers 1 2 3 , Courtney Sabino 1 2 3 , Seegar Swanson 1 , Mark Griffiths 1 2 4 , Cheryl Stone 2 4 , Kaleb B McLendon 5 , Kathy Bifulco 6 , Chelsea Rock 1 7 8 , Julia Tisheh 2 4 , Emily B Kennedy 9 , Eric Lai 10 , Pamela Miller 11 , Raymond F Schinazi 2 3 , Jennifer K Frediani 6 , Annette Esper 1 7 8 12 , Greg S Martin 1 7 8 12 , Wilbur A Lam 1 2 4 13 14 , Gregory L Damhorst 1 8 15
Affiliations
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.
. 2026 Jan 9:ciaf660.
doi: 10.1093/cid/ciaf660. Online ahead of print. Independent Testing to Accelerate the Development of Lateral Flow Assays for Influenza A, Influenza B and SARS-COV-2
Anuradha Rao 1 2 , Laura Johnson 2 , Leda Bassit 1 2 3 , Julie Sullivan 1 2 , Heather B Bowers 1 2 3 , Courtney Sabino 1 2 3 , Seegar Swanson 1 , Mark Griffiths 1 2 4 , Cheryl Stone 2 4 , Kaleb B McLendon 5 , Kathy Bifulco 6 , Chelsea Rock 1 7 8 , Julia Tisheh 2 4 , Emily B Kennedy 9 , Eric Lai 10 , Pamela Miller 11 , Raymond F Schinazi 2 3 , Jennifer K Frediani 6 , Annette Esper 1 7 8 12 , Greg S Martin 1 7 8 12 , Wilbur A Lam 1 2 4 13 14 , Gregory L Damhorst 1 8 15
Affiliations
- PMID: 41510838
- DOI: 10.1093/cid/ciaf660
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.