Diagnostic performance and characteristics of anterior nasal collection for the SARS-CoV-2 antigen test: a prospective study

  1. Yuto Takeuchi
  2. Yusaku Akashi
  3. Daisuke Kato
  4. Miwa Kuwahara
  5. Shino Muramatsu
  6. Atsuo Ueda
  7. Shigeyuki Notake
  8. Koji Nakamura
  9. Hiroichi Ishikawa
  10. Hiromichi Suzuki

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Abstract

The clinical utility of antigen test using anterior nasal samples has not been well evaluated. We conducted a prospective study in a drive-through testing site located at a PCR center to evaluate the diagnostic performance of the antigen test QuickNavi-COVID19 Ag using anterior nasal samples and to compare the degrees of coughs or sneezes induction and the severity of pain between anterior nasal collection and nasopharyngeal collection. The study included a total of 862 participants, of which 91.6% were symptomatic. The median duration from symptom onset to sample collection was 2.0 days. Fifty-one participants tested positive for severe acute respiratory syndrome coronavirus 2 on reverse transcription PCR (RT-PCR) with nasopharyngeal samples, and all of them were symptomatic. In comparison to the findings of RT-PCR, the antigen test using anterior nasal samples showed 72.5% sensitivity (95% confidence interval [CI] 58.3–84.1%) and 100% specificity (95% CI 99.3–100%). Anterior nasal collection was associated with a significantly lower degree of coughs or sneezes induction and the severity of pain in comparison to nasopharyngeal collection ( p  < 0.001). The antigen test using anterior nasal samples showed moderate sensitivity in symptomatic patients who were at the early stages of the disease course but was less painful and induced fewer coughs or sneezes.

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  1. Version published to 10.1038/s41598-021-90026-8
  2. ScreenIT

    SciScore for 10.1101/2021.03.03.21252425: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: After receiving the participants’ informed consent, additional anterior nasal samples for the antigen test were collected and their clinical information was obtained.
    IRB: The present study was approved by the ethics committee of Tsukuba Medical Center Hospital (approval number: 2020-033).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The calibration curves were generated with 5, 50, and 500 copies/reaction of positive control (EDX SARS-CoV-2 Standard; Bio-Rad Laboratories, Inc., Hercules, CA, USA).
    Bio-Rad Laboratories
    suggested: (Bio-Rad Laboratories, RRID:SCR_008426)

    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:
    The present study was associated with some limitations. First, the samples used for the reference real-time RT-PCR test were frozen and transported. Although the samples were frozen at −80°C, the viral loads may have been decreased during the storage and transport process. Nevertheless, in the case of discrepancy with in-house PCR, re-evaluation was performed and did not affect the calculation of the sensitivity of the antigen test. Second, asymptomatic SARS-CoV-2 positive patients were unintentionally not included in this study. Further study is required to evaluate the clinical performance of the antigen test in those patients. Finally, this study was conducted at a single center, although participants were referred from multiple primary facilities. Further research should be conducted to assess the generalizability of the findings. In conclusion, the QuickNavi-COVID19 Ag test with an anterior nasal sample showed 100% specificity; however, the sensitivity in the detection of SARS-CoV-2 was lower in comparison to the QuickNavi-COVID19 Ag test with nasopharyngeal samples. Anterior nasal collection was less invasive and induced fewer coughs or sneezes, which may be more comfortable for the patient and may reduce the risk of droplet exposure to healthcare workers.

    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.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.03.03.21252425 on medRxiv