Announcement

Collapse
No announcement yet.

J Infect Chemother . Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • J Infect Chemother . Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19


    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 1 , Daisuke Sakanashi 2 , Wataru Ohashi 3 , Akiko Nakamura 2 , Yuzuka Kawamoto 4 , Narimi Miyazaki 4 , Tomoko Ohno 4 , Atsuko Yamada 4 , Sumie Chida 4 , Yuichi Shibata 4 , Hideo Kato 2 , Arufumi Shiota 4 , Mao Hagihara 5 , Isao Koita 4 , Yuka Yamagishi 2 , Hiroyuki Suematsu 4 , Hirotoshi Ohta 4 , Hiroshige Mikamo 6



    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?) 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.

Working...
X