Effectiveness of single-sampling-based detection of multi-virus antigens including SARS-CoV-2: Evaluation of the utility of COVID-19 rapid antigen test kit

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  • SARS-CoV-2を含む多種ウイルス迅速抗原同定定性検査キットの有用性に関する検討
  • SARS-CoV-2 オ フクム タシュ ウイルス ジンソク コウゲン ドウテイ テイセイ ケンサ キット ノ ユウヨウセイ ニ カンスル ケントウ

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Abstract

<p>Background and purpose: SARS-CoV-2 infection (COVID-19) is difficult to diagnose on the basis of symptoms. By using four virus antigen detection kits of ImunoAce Series and nasopharyngeal samples, we investigated the usefulness of a single-sampling-based qualitative detection of multi-virus antigens (SSD-MVA) including SARS-CoV-2 and four other antigens. Methods: From November 1, 2020 to July 31, 2021, patients who visited the Division for Health Service Promotion in the University of Tokyo and gave consent with a fully filled questionnaire were included in this study. Also obtained was another questionnaire regarding the subsequent 14-day observation period. Results: The SSD-MVA was correctly performed in all 111 patients (80 males; mean age, 30.7 ± 10.8 years), and the questionnaire for the observation period was collected from 94 patients (84.7%). Five patients (4.5%; four males; mean age, 42.6 ± 17.5 years) and 83 patients (74.8%) were diagnosed as having COVID-19 and common cold, respectively. The kit for the SARS-CoV-2 antigen showed three positives in three patients with COVID-19, meaning no false positives, and the SSD-MVA did not show any positives for the other four antigens. Two patients (40%) with COVID-19 likely had a false negative result, while one was diagnosed with SARS-CoV-2 infection 14 days after the SSD-MVA. In four patients with COVID-19, the quantitative antigen test using saliva samples performed on the same day showed a discrepancy with a clarity in the positive line of the qualitative detection kit for SARS-CoV-2. Conclusion: The SSD-MVA including the SARS-CoV-2 antigen is beneficial with 60–75% sensitivity and 100% specificity for SARS-CoV-2. The sensitivity could be improved if the qualitative detection kit were available for saliva samples.</p>

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