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Related Experiment Video

Updated: Aug 28, 2025

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SARS-CoV-2 Omicron detection by antigen tests using saliva.

Kaoru Murakami1,2, Sumio Iwasaki3, Satoshi Oguri3

  • 1Division of Molecular Psychoimmunology, Institute for Genetic Medicine, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.

Journal of Clinical Virology Plus
|September 19, 2022
PubMed
Summary

Chemiluminescent enzyme immunoassay (CLEIA) efficiently detects the Omicron variant in saliva. Immunochromatographic assay (ICA) also detects high viral load Omicron, aiding rapid outbreak prevention.

Keywords:
ALP, alkaline phosphataseCLEIACLEIA, chemiluminescent enzyme immunoassayCOVID-19Ct, cycle thresholdICAICA, immunochromatographic assayLumipulseNPS, nasopharyngeal swabPCR, polymerase chain reactionRT-PCR, Real-time reverse transcription–quantitative PCRSARS-CoV-2SalivaVOC, variant of concern

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Area of Science:

  • Virology
  • Infectious Diseases
  • Diagnostic Assays

Background:

  • The Omicron variant of SARS-CoV-2 emerged in November 2021 and rapidly became globally predominant.
  • Rapid detection of Omicron is crucial for preventing widespread outbreaks due to its high transmissibility.
  • Antigen tests offer faster results than PCR, but their effectiveness against Omicron was uncertain.

Purpose of the Study:

  • To evaluate the diagnostic performance of immunochromatographic assay (ICA) and chemiluminescent enzyme immunoassay (CLEIA) for detecting the Omicron variant in saliva.
  • To compare the sensitivity and specificity of these antigen tests against PCR results.

Main Methods:

  • Saliva samples were collected from 51 patients with Omicron and 60 PCR-negative individuals.
  • Performance metrics (sensitivity, specificity) of ICA and CLEIA were assessed.
  • Correlation between antigen test results and PCR cycle threshold (Ct) values was analyzed.

Main Results:

  • CLEIA demonstrated high sensitivity (98.0%) and specificity (100.0%) for Omicron detection in saliva, correlating well with Ct values.
  • ICA showed lower overall sensitivity (58.8%) but 100.0% specificity.
  • ICA sensitivity reached 100.0% for samples with PCR Ct values below 25 (indicating high viral load).

Conclusions:

  • CLEIA is an effective method for efficient Omicron variant detection in saliva.
  • ICA can reliably detect Omicron in saliva, particularly in cases with high viral loads.
  • These antigen tests can contribute to rapid diagnostic strategies for managing Omicron outbreaks.