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Evaluation of clinical utility of novel coronavirus antigen detection reagent, Espline® SARS-CoV-2.
J Infect Chemother. 2021 Feb; 27(2):319-322.JI

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+Show Affiliations

Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan. Electronic address: yishii@med.toho-u.ac.jp.Fujirebio Inc., 51 Komiya-machi, Hachioji, 192-0031, Tokyo, Japan.General Medicine and Emergency Center (Internal Medicine), Toho University Omori Medical Center, 6-11-1 Omori-nishi, Ota-ku, 143-8541, Tokyo, Japan.General Medicine and Emergency Center (Internal Medicine), Toho University Omori Medical Center, 6-11-1 Omori-nishi, Ota-ku, 143-8541, Tokyo, Japan.Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33388232

Citation

Aoki, Kotaro, et al. "Evaluation of Clinical Utility of Novel Coronavirus Antigen Detection Reagent, Espline® SARS-CoV-2." Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy, vol. 27, no. 2, 2021, pp. 319-322.
Aoki K, Nagasawa T, Ishii Y, et al. Evaluation of clinical utility of novel coronavirus antigen detection reagent, Espline® SARS-CoV-2. J Infect Chemother. 2021;27(2):319-322.
Aoki, K., Nagasawa, T., Ishii, Y., Yagi, S., Kashiwagi, K., Miyazaki, T., & Tateda, K. (2021). Evaluation of clinical utility of novel coronavirus antigen detection reagent, Espline® SARS-CoV-2. Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy, 27(2), 319-322. https://doi.org/10.1016/j.jiac.2020.11.015
Aoki K, et al. Evaluation of Clinical Utility of Novel Coronavirus Antigen Detection Reagent, Espline® SARS-CoV-2. J Infect Chemother. 2021;27(2):319-322. PubMed PMID: 33388232.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of clinical utility of novel coronavirus antigen detection reagent, Espline® SARS-CoV-2. AU - Aoki,Kotaro, AU - Nagasawa,Tatsuya, AU - Ishii,Yoshikazu, AU - Yagi,Shintaro, AU - Kashiwagi,Katsuhito, AU - Miyazaki,Taito, AU - Tateda,Kazuhiro, Y1 - 2020/12/23/ PY - 2020/08/31/received PY - 2020/10/19/revised PY - 2020/11/11/accepted PY - 2021/1/4/pubmed PY - 2021/1/30/medline PY - 2021/1/3/entrez KW - Antigen detection KW - COVID-19 KW - Diagnosis KW - Immunochromatography KW - SARS-CoV-2 SP - 319 EP - 322 JF - Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy JO - J Infect Chemother VL - 27 IS - 2 N2 - 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. SN - 1437-7780 UR - https://www.unboundmedicine.com/medline/citation/33388232/Evaluation_of_clinical_utility_of_novel_coronavirus_antigen_detection_reagent_Espline®_SARS_CoV_2_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1341-321X(20)30422-0 DB - PRIME DP - Unbound Medicine ER -