Analytical performance of rapid antigen tests for the detection of SARS-CoV-2 during widespread circulation of the Omicron variant

  1. Hiromichi Suzuki
  2. Yusaku Akashi
  3. Daisuke Kato
  4. Yuto Takeuchi
  5. Yoshihiko Kiyasu
  6. Norihiko Terada
  7. Yoko Kurihara
  8. Miwa Kuwahara
  9. Shino Muramatsu
  10. Atsuo Ueda
  11. Shigeyuki Notake
  12. Koji Nakamura

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Abstract

Introduction

Antigen testing is essential in the clinical management of COVID-19. However, most evaluations of antigen tests have been performed before the emergence of the Omicron variant. Thus, an assessment of the diagnostic performance of antigen tests for the detection of SARS-CoV-2 during the circulation of Omicron variant is required.

Methods

This prospective observational study evaluated QuickNavi-COVID19 Ag, a rapid antigen detection test between December 2021 and February 2022 in Japan, using real-time reverse transcription (RT)-PCR as a reference. Two nasopharyngeal samples were simultaneously collected for antigen testing and for RT-PCR. Variant analysis of the SARS-CoV-2 genomic sequencing was also performed.

Results

In total, nasopharyngeal samples were collected from 1,073 participants (417 positive; 919 symptomatic; 154 asymptomatic) for analysis. Compared with those of RT-PCR, the sensitivity, specificity, positive predictive value, and negative predictive value were 94.2% (95% CI: 91.6%–96.3%), 99.5% (95% CI: 98.7%–99.9%), 99.2% (95% CI: 97.8%–99.8%), and 96.5% (95% CI: 94.8%–97.7%), respectively. The sensitivity among symptomatic individuals was 94.3% (95% CI: 91.5%–96.4%). Overall, 85.9% of sequences were classified as Omicron sublineage BA.1, 12.4% were Omicron sublineage BA.2, and 1.6% were Delta B.1.617.2. (Delta variant). Most of the samples (87.1%) had Ct values <25.

Conclusions

The QuickNavi-COVID19 Ag test showed high diagnostic performance for the detection of the SARS-CoV-2 Omicron sublineages BA.1 and BA.2 from nasopharyngeal samples.

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    SciScore for 10.1101/2022.05.17.22275034: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsConsent: Informed consent was verbally obtained from all participants and was documented in their electronic medical record to prevent infection transmission, written informed consent was not obtained.
    IRB: The ethics board of the University of Tsukuba Hospital approved the study (approval number: R03-042), including the method of obtaining informed consent.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This study has some limitations. First, the samples were collected at one site in Japan, and most samples were collected soon after symptom onset. The sample size for asymptomatic individuals might have been insufficient. Second, the assessment of lateral flow device results can vary among examiners [27]. Third, the reference RT-PCR examinations were performed with frozen samples, and the storage and transportation processes may have affected the test results. In addition, study samples were collected from the nasopharyngeal tract, and anterior nasal samples were not analyzed. In conclusion, the current study showed that the QuickNavi-COVID19 Ag test had a high diagnostic performance for the detection of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in nasopharyngeal samples.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a protocol registration statement.

    Results from scite Reference Check: We found no unreliable references.

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  2. Version published to 10.1101/2022.05.17.22275034v1 on medRxiv