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

¹The Atlanta Center for Microsystems-Engineered Point-of-Care Technologies, Atlanta, Georgia, USA.
²Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.
³Center for ViroScience and Cure, Laboratory of Biochemical Pharmacology, Department of Pediatrics, Emory University, Atlanta, Georgia, USA.
⁴Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
⁵Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
⁶Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA.
⁷Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Emory University, Atlanta, Georgia, USA.
⁸Department of Medicine, Emory University, Atlanta, Georgia, USA.
⁹OOMVELT, LLC, Lakewood, Ohio, USA.
¹⁰PharmaDx, LLC, San Diego, California, USA.
¹¹Echo Consulting, Excelsior, Minnesota, USA.
¹²Grady Health System, Atlanta, Georgia, USA.
¹³Aflac Cancer and Blood Disorders Center at Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
¹⁴Wallace H. Coulter Department of Biomedical Engineering, Emory University and Georgia Institute of Technology, Atlanta, Georgia, USA.
¹⁵Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.

⁰The Atlanta Center for Microsystems-Engineered Point-of-Care Technologies, Atlanta, Georgia, USA.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America +

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January 9, 2026

View abstract on PubMed

Summary

The Independent Test Assessment Program (ITAP) evaluated SARS-CoV-2 and influenza A&B lateral flow assays (LFAs), providing crucial performance data. This feedback facilitated regulatory authorization for several over-the-counter diagnostic tests.

Area Of Science

Infectious disease diagnostics
Medical device evaluation
Regulatory science

Background

The Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program (ITAP) served as a verification core.
Independent performance testing of SARS-CoV-2 and influenza A&B lateral flow assays (LFAs) was conducted.
Testing occurred prior to formal clinical studies for Food and Drug Administration (FDA) submission.

Purpose Of The Study

To assess the analytical and clinical performance of SARS-CoV-2 and influenza A&B LFAs.
To provide rapid feedback to manufacturers and federal agencies.
To support the regulatory authorization process for diagnostic tests.

Main Methods

Bench testing involved determining the limit of detection (LOD) using serially diluted virus panels.
Field studies involved participant interpretation of LFA results.
Sensitivity and specificity were determined using RT-PCR as the reference standard.

Main Results

30 iterations of 14 LFAs were tested between February 2023 and February 2025.
LODs varied across targets, with SARS-CoV-2 ranging from 53,277-1,393,314 GE/mL.
Specificity was high (0.91-1.00), while sensitivity varied (0.57-1.00 for SARS-CoV-2, 0.64-0.85 for influenza A).

Conclusions

ITAP provided timely performance data on LFAs for SARS-CoV-2 and influenza.
This assessment contributed to the successful regulatory authorization or clearance of multiple devices.
The program accelerated the availability of over-the-counter diagnostic tests.