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A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
Published on: April 6, 2021
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Rapid Antigen Test Sensitivity for Asymptomatic COVID-19 Screening.
Alyssa M Indelicato1, Zacharia H Mohamed1, Mantosh J Dewan1
1SUNY Upstate Medical University, Syracuse, NY.
Primer (Leawood, Kan.)
|July 11, 2022
Summary
Rapid antigen tests (RATs) for severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) have low sensitivity in asymptomatic individuals, misidentifying infected students as negative. This impacts the safety of in-person instruction at higher education institutions.
Area of Science:
- Public Health
- Infectious Disease Epidemiology
- Diagnostic Test Evaluation
Background:
- Institutions of higher education (IHEs) faced challenges operating during the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) pandemic.
- Identifying asymptomatic SARS-CoV-2 cases in students is critical to prevent widespread transmission.
- Rapid antigen tests (RATs) have shown limitations in detecting infections in asymptomatic populations.
Purpose of the Study:
- To evaluate the performance of RATs in identifying asymptomatic SARS-CoV-2 infections among students at IHEs.
- To review published data on the sensitivity and specificity of RATs used with asymptomatic individuals in the United States.
- To determine the appropriateness of using RATs for screening asymptomatic populations in IHE settings.
Main Methods:
- A rapid review of published evaluations of RATs was conducted.
- Studies reporting sensitivity and specificity specifically for asymptomatic populations in the United States were included.
- Data were extracted and presented narratively, as a meta-analysis was not feasible due to heterogeneity.
Main Results:
- Eleven articles representing four manufacturers were analyzed.
- Sensitivity of RATs in asymptomatic individuals ranged from 35.8% to approximately 71%.
- Specificity was high, ranging from 97.8% to 100%, but RATs identified only about half of infected individuals compared to RT-PCR.
Conclusions:
- RATs demonstrate significant limitations in accurately identifying asymptomatic SARS-CoV-2 infections.
- The low sensitivity of RATs poses a risk of misclassifying infected individuals as negative.
- This finding has critical implications for infection control strategies in IHEs and other settings with asymptomatic populations.

