Evaluation of clinical utility of novel coronavirus antigen detection reagent, Espline® SARS-CoV-2.

Abstract

BACKGROUND:

To prevent the novel coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), it is necessary to perform early identification and isolation of people shedding the infectious virus in biological materials with high viral loads several days prior to symptom onset. Rapid antigen tests for infectious diseases are useful to prevent the pandemic spread in clinical settings.

METHODS:

We evaluated a SARS-CoV-2 antigen test, Espline® SARS-CoV-2 reagent, with reverse transcription polymerase chain reaction (RT-PCR) as reference test, using 129 nasopharyngeal swab specimens collected from COVID-19 hospitalized patients or from patients suspected having COVID-19-like symptoms. Out of these, 63 RT-PCR positive and 66 RT-PCR negative specimens were identified.

RESULTS:

Among 63 RT-PCR positive specimens, 25 were positive in the Espline test. Test sensitivity was estimated based on the 532.4 copies/reaction of SARS-CoV-2 RNA obtained through receiver operating characteristic analysis. When the specimens were classified based on time since symptom onset, Espline test sensitivity were 73.3% and 29.2% in specimens collected before day 9 and after day 10, respectively.

CONCLUSION:

Although the overall sensitivity of the Espline® SARS-CoV-2 reagent compared with RT-PCR is less, this antigen test can be useful in identifying people with high risk of virus transmission with high viral loads in order to prevent the pandemic and is useful for diagnosing COVID-19 within 30 min.

• Authors: Kotaro Aoki, Tatsuya Nagasawa, Yoshikazu Ishii, Shintaro Yagi, Katsuhito Kashiwagi, Taito Miyazaki, Kazuhiro Tateda
• Journal: Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy (J Infect Chemother) Vol. 27 Issue 2 Pg. 319-322 (Feb 2021) ISSN: 1437-7780 [Electronic] Netherlands
• PMID: 33388232 (Publication Type: Journal Article)
• Copyright: Copyright © 2020 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Antigens, Viral
• Indicators and Reagents
• RNA, Viral

Topics

• Antigens, Viral (analysis)
• COVID-19 (diagnosis, virology)
• COVID-19 Serological Testing (methods)
• Humans
• Indicators and Reagents
• Nasopharynx (virology)
• Pandemics
• RNA, Viral
• ROC Curve
• Reverse Transcriptase Polymerase Chain Reaction (methods)
• SARS-CoV-2 (immunology, isolation & purification)
• Sensitivity and Specificity
• Viral Load