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Related Experiment Video

Updated: Nov 6, 2025

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Antigen tests for COVID-19.

Yuta Kyosei1, Sou Yamura1, Mayuri Namba1

  • 1Department of Biology, Waseda University, Shinjuku, Tokyo 162-8480, Japan.

Biophysics and Physicobiology
|May 6, 2021
PubMed
Summary
This summary is machine-generated.

Polymerase chain reaction (PCR) has limitations for diagnosing diseases like COVID-19. This review explores ultrasensitive antigen tests as a superior alternative, potentially becoming the new gold standard for disease diagnostics.

Keywords:
COVID-19SARS-CoV-2antigen testreal-time PCRultrasensitive ELISA

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Area of Science:

  • Medical Diagnostics
  • Biotechnology
  • Infectious Disease Research

Background:

  • Polymerase chain reaction (PCR) is the established gold standard for diagnosing diseases, including coronavirus disease 2019 (COVID-19).
  • PCR methods present significant challenges, including false-positive/negative results, limited sample volume, enzyme deactivation, complex procedures, probe design difficulties, and high costs.
  • There is a critical need for alternative diagnostic methods that overcome PCR's limitations.

Purpose of the Study:

  • To outline the inherent problems associated with PCR diagnostic techniques.
  • To review and discuss the advantages and disadvantages of commercially available antigen tests based on 2020 literature.
  • To introduce a novel, ultrasensitive antigen test developed using enzyme-linked immunosorbent assay (ELISA) technology.

Main Methods:

  • Literature review of PCR limitations and antigen tests published in 2020.
  • Analysis of pros and cons for existing commercial antigen tests.
  • Development and description of a proprietary ultrasensitive ELISA-based antigen test.

Main Results:

  • Identified key limitations of PCR, including specificity issues and operational complexities.
  • Evaluated various antigen tests, highlighting their performance characteristics and limitations.
  • Demonstrated the potential of the developed ultrasensitive ELISA antigen test for high-sensitivity disease detection.

Conclusions:

  • Ultrasensitive antigen tests offer a promising alternative to PCR for disease diagnosis.
  • The developed ultrasensitive ELISA antigen test shows potential to surpass current diagnostic standards.
  • This novel antigen test could become the future gold standard for diagnosing COVID-19 and other diseases.