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Clinical validation of quantitative SARS-CoV-2 antigen assays to estimate SARS-CoV-2 viral loads in nasopharyngeal swabs.
Aoki, Kotaro; Nagasawa, Tatsuya; Ishii, Yoshikazu; Yagi, Shintaro; Okuma, Sadatsugu; Kashiwagi, Katsuhito; Maeda, Tadashi; Miyazaki, Taito; Yoshizawa, Sadako; Tateda, Kazuhiro.
  • Aoki K; Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.
  • Nagasawa T; Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.
  • Ishii Y; 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.
  • Yagi S; Fujirebio Inc., 51 Komiya-machi, Hachioji, 192-0031, Tokyo, Japan.
  • Okuma S; Fujirebio Inc., 51 Komiya-machi, Hachioji, 192-0031, Tokyo, Japan.
  • Kashiwagi K; General Medicine and Emergency Center (Internal Medicine), Toho University Omori Medical Center, 6-11-1 Omori-nishi, Ota-ku, 143-8541, Tokyo, Japan.
  • Maeda T; General Medicine and Emergency Center (Internal Medicine), Toho University Omori Medical Center, 6-11-1 Omori-nishi, Ota-ku, 143-8541, Tokyo, Japan.
  • Miyazaki T; General Medicine and Emergency Center (Internal Medicine), Toho University Omori Medical Center, 6-11-1 Omori-nishi, Ota-ku, 143-8541, Tokyo, Japan.
  • Yoshizawa S; Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.
  • Tateda K; Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.
J Infect Chemother ; 27(4): 613-616, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-956008
ABSTRACT

BACKGROUND:

Expansion of the testing capacity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important issue to mitigate the pandemic of coronavirus disease-2019 (COVID-19) caused by this virus. Recently, a sensitive quantitative antigen test (SQT), Lumipulse® SARS-CoV-2 Ag, was developed. It is a fully automated chemiluminescent enzyme immunoassay system for SARS-CoV-2.

METHODS:

In this study, the analytical performance of SQT was examined using clinical specimens from nasopharyngeal swabs using reverse transcription polymerase chain reaction (RT-PCR) as a control.

RESULTS:

Receiver operating characteristic analysis of 24 SARS-CoV-2-positive and 524 -negative patients showed an area under the curve of 0.957 ± 0.063. Using a cut-off value of 1.34 pg/ml, the sensitivity was 91.7%, the specificity was 98.5%, and the overall rate of agreement was 98.2%. In the distribution of negative cases, the 99.5 percentile value was 1.03 pg/ml. There was a high correlation between the viral load calculated using the cycle threshold value of RT-PCR and the concentration of antigen. The tendency for the antigen concentration to decrease with time after disease onset correlated with that of the viral load.

CONCLUSIONS:

Presented results indicate that SQT is highly concordant with RT-PCR and should be useful for the diagnosis of COVID-19 in any clinical setting. Therefore, this fully automated kit will contribute to the expansion of the testing capability for SARS-CoV-2.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Nasopharynx / Viral Load / SARS-CoV-2 / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: J Infect Chemother Journal subject: Microbiology / Drug Therapy Year: 2021 Document Type: Article Affiliation country: J.jiac.2020.11.021

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Nasopharynx / Viral Load / SARS-CoV-2 / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: J Infect Chemother Journal subject: Microbiology / Drug Therapy Year: 2021 Document Type: Article Affiliation country: J.jiac.2020.11.021