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10.1016/j.jiac.2021.03.021

http://scihub22266oqcxt.onion/10.1016/j.jiac.2021.03.021
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suck abstract from ncbi


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pmid33840598      J+Infect+Chemother 2021 ; 27 (7): 1039-1042
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  • Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19 #MMPMID33840598
  • Asai N; Sakanashi D; Ohashi W; Nakamura A; Kawamoto Y; Miyazaki N; Ohno T; Yamada A; Chida S; Shibata Y; Kato H; Shiota A; Hagihara M; Koita I; Yamagishi Y; Suematsu H; Ohta H; Mikamo H
  • J Infect Chemother 2021[Jul]; 27 (7): 1039-1042 PMID33840598show ga
  • 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(?)) 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.
  • |*COVID-19[MESH]
  • |*Saliva[MESH]
  • |Humans[MESH]
  • |Immunoenzyme Techniques[MESH]
  • |Japan[MESH]
  • |SARS-CoV-2[MESH]


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