tetano
Editor, Senior Moderator
J Infect Chemother
. 2021 Apr 2;S1341-321X(21)00102-1.
doi: 10.1016/j.jiac.2021.03.021. Online ahead of print.
Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19
Nobuhiro Asai[SUP] 1 [/SUP], Daisuke Sakanashi[SUP] 2 [/SUP], Wataru Ohashi[SUP] 3 [/SUP], Akiko Nakamura[SUP] 2 [/SUP], Yuzuka Kawamoto[SUP] 4 [/SUP], Narimi Miyazaki[SUP] 4 [/SUP], Tomoko Ohno[SUP] 4 [/SUP], Atsuko Yamada[SUP] 4 [/SUP], Sumie Chida[SUP] 4 [/SUP], Yuichi Shibata[SUP] 4 [/SUP], Hideo Kato[SUP] 2 [/SUP], Arufumi Shiota[SUP] 4 [/SUP], Mao Hagihara[SUP] 5 [/SUP], Isao Koita[SUP] 4 [/SUP], Yuka Yamagishi[SUP] 2 [/SUP], Hiroyuki Suematsu[SUP] 4 [/SUP], Hirotoshi Ohta[SUP] 4 [/SUP], Hiroshige Mikamo[SUP] 6 [/SUP]
Affiliations
Abstract
Introduction: The pandemic of a novel coronavirus disease 2019 (COVID-19) caused by a severe acute respiratory coronavirus 2 (SARS-CoV-2) infection has been problematic worldwide. A new SARS-CoV-2 antigen test (LUMIPULSE[SUP]?[/SUP]) was licensed and widely used in Japan since May 2020. We conducted this study intending to whether the automated quantitative CLEIA antigen test using a saliva sample is effective and valid for the diagnosis of COVID-19.
Patients and methods: We analyzed and compared the diagnostic accuracy of both the automated quantitative CLEIA antigen test and real-time RT-PCR (rRT-PCR) using a saliva sample from individuals suspected as having COVID-19.
Results: A total of 305 samples were collected and tested in Aichi Medical University Hospital and affiliated facilities from December 2020 until January 2021 at our institute. Using reverse-transcription PCR as a reference, the AUROC of the automated quantitative CLEIA antigen test was 0.903 (95% confidential interval 0.845-0.962, p < 0.001). The appropriate cut-off antigen level was 4.0 pg/mL and had a sensitivity of 77.8%, a specificity of 99.6%, a positive predictive value of 98%, and a negative predictive value of 94.5%. On the other hand, the diagnostic accuracy of the antigen test decreased among patients among patients with COVID-19 with threshold cycle (Ct-value)?27, which shows the AUROC was 0.795 (95%CI 0.687-0.907, p < 0.001).
Conclusion: While the automated quantitative CLEIA antigen test from saliva specimen could be one of the most useful diagnostic tests for the diagnosis of COVID-19 in general practice, clinicians should know the limitations of the antigen test.
Keywords: COVID-19; Quantitative chemiluminescent enzyme immunoassay; RT-PCR; SARS-CoV-2; Saliva.
. 2021 Apr 2;S1341-321X(21)00102-1.
doi: 10.1016/j.jiac.2021.03.021. Online ahead of print.
Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19
Nobuhiro Asai[SUP] 1 [/SUP], Daisuke Sakanashi[SUP] 2 [/SUP], Wataru Ohashi[SUP] 3 [/SUP], Akiko Nakamura[SUP] 2 [/SUP], Yuzuka Kawamoto[SUP] 4 [/SUP], Narimi Miyazaki[SUP] 4 [/SUP], Tomoko Ohno[SUP] 4 [/SUP], Atsuko Yamada[SUP] 4 [/SUP], Sumie Chida[SUP] 4 [/SUP], Yuichi Shibata[SUP] 4 [/SUP], Hideo Kato[SUP] 2 [/SUP], Arufumi Shiota[SUP] 4 [/SUP], Mao Hagihara[SUP] 5 [/SUP], Isao Koita[SUP] 4 [/SUP], Yuka Yamagishi[SUP] 2 [/SUP], Hiroyuki Suematsu[SUP] 4 [/SUP], Hirotoshi Ohta[SUP] 4 [/SUP], Hiroshige Mikamo[SUP] 6 [/SUP]
Affiliations
- PMID: 33840598
- DOI: 10.1016/j.jiac.2021.03.021
Abstract
Introduction: The pandemic of a novel coronavirus disease 2019 (COVID-19) caused by a severe acute respiratory coronavirus 2 (SARS-CoV-2) infection has been problematic worldwide. A new SARS-CoV-2 antigen test (LUMIPULSE[SUP]?[/SUP]) was licensed and widely used in Japan since May 2020. We conducted this study intending to whether the automated quantitative CLEIA antigen test using a saliva sample is effective and valid for the diagnosis of COVID-19.
Patients and methods: We analyzed and compared the diagnostic accuracy of both the automated quantitative CLEIA antigen test and real-time RT-PCR (rRT-PCR) using a saliva sample from individuals suspected as having COVID-19.
Results: A total of 305 samples were collected and tested in Aichi Medical University Hospital and affiliated facilities from December 2020 until January 2021 at our institute. Using reverse-transcription PCR as a reference, the AUROC of the automated quantitative CLEIA antigen test was 0.903 (95% confidential interval 0.845-0.962, p < 0.001). The appropriate cut-off antigen level was 4.0 pg/mL and had a sensitivity of 77.8%, a specificity of 99.6%, a positive predictive value of 98%, and a negative predictive value of 94.5%. On the other hand, the diagnostic accuracy of the antigen test decreased among patients among patients with COVID-19 with threshold cycle (Ct-value)?27, which shows the AUROC was 0.795 (95%CI 0.687-0.907, p < 0.001).
Conclusion: While the automated quantitative CLEIA antigen test from saliva specimen could be one of the most useful diagnostic tests for the diagnosis of COVID-19 in general practice, clinicians should know the limitations of the antigen test.
Keywords: COVID-19; Quantitative chemiluminescent enzyme immunoassay; RT-PCR; SARS-CoV-2; Saliva.