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Related Experiment Video

Updated: Sep 26, 2025

Large-Scale SARS-CoV-2 Testing Utilizing Saliva and Transposition Sample Pooling
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Large-Scale SARS-CoV-2 Antigen Testing With Real-World Specimens.

Ashish Parikh1, Lauren Cooper2, Daniel Frogel1

  • 1CityMD/Summit Medical Group, New York, NY, United States.

Frontiers in Public Health
|April 22, 2022
PubMed
Summary

Real-world data show rapid antigen tests (RATs) are effective for SARS-CoV-2 screening, especially in symptomatic individuals. Test performance aligns with manufacturer claims, supporting RATs for ongoing public health surveillance.

Keywords:
BD VeritorCOVID-19RT-PCRSARS-CoV-2point-of-carerapid antigen testingreal-world evidence (RWE)

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Area of Science:

  • Infectious Diseases
  • Public Health
  • Diagnostic Testing

Background:

  • Real-world data are crucial for validating SARS-CoV-2 rapid antigen tests (RATs).
  • The BD Veritor™ System for Rapid Detection of SARS-CoV-2 antigen (Veritor) was used for screening.
  • RT-PCR served as the confirmatory test.

Purpose of the Study:

  • To evaluate the real-world performance of SARS-CoV-2 RATs.
  • To assess diagnostic accuracy across symptomatic and asymptomatic populations.
  • To provide evidence supporting RAT efficacy in public health surveillance.

Main Methods:

  • Analysis of 1,952,931 upper respiratory specimens from October 2020 to March 2021.
  • Comparison of RAT results with reflex RT-PCR testing.
  • Application of verification bias adjustment for missing RT-PCR results using two model assumptions.

Main Results:

  • RATs showed high specificity (97.9-99.9%) across all groups.
  • Sensitivity estimates varied: worst-case (77.2% symptomatic, 38.5% asymptomatic), best-case (85.6% symptomatic, 84.2% asymptomatic).
  • Positive predictive values were high (86.9-99.0%) at 10% prevalence; negative predictive values exceeded 95%.

Conclusions:

  • The Veritor RAT demonstrated performance consistent with manufacturer instructions, particularly in symptomatic individuals.
  • Real-world evidence supports the utility of RATs for SARS-CoV-2 screening.
  • Ongoing data collection is vital as SARS-CoV-2 continues to be a public health concern.