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Evaluation of a chemiluminescent enzyme immunoassay-based high-throughput SARS-CoV-2 antigen assay for the diagnosis of COVID-19: The VITROS® SARS-CoV-2 Antigen Test.
Matsuzaki, Nanako; Orihara, Yuta; Kodana, Masahiro; Kitagawa, Yutaro; Matsuoka, Masaru; Kawamura, Rieko; Takeuchi, Shinichi; Imai, Kazuo; Tarumoto, Norihito; Maesaki, Shigefumi; Maeda, Takuya.
  • Matsuzaki N; Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
  • Orihara Y; Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
  • Kodana M; Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
  • Kitagawa Y; Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
  • Matsuoka M; Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
  • Kawamura R; Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
  • Takeuchi S; Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
  • Imai K; Department of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.
  • Tarumoto N; Department of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.
  • Maesaki S; Department of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.
  • Maeda T; Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
J Med Virol ; 93(12): 6778-6781, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1544295
ABSTRACT
A high-throughput, fully automated antigen detection test for SARS-CoV-2 is a viable alternative to reverse-transcription polymerase chain reaction (RT-qPCR) for mass screening during outbreaks. In this study, we compared RT-qPCR for viral load and the VITROS® SARS-CoV-2 Antigen Test with reference to the results of the LUMIPULSE® SARS-CoV-2 Ag Test. Of 128 nasopharyngeal swab specimens taken from patients suspected of being infected with SARS-CoV-2, 49 were positive and 79 were negative according to RT-qPCR. Consistent dose-dependent detection with VITROS® assay was successfully achieved when using nasopharyngeal swab specimens with Ct values of 32.0 or lesser, whereas the CLEIA-based LUMIPULSE® assay was able to detect lower viral loads compared with the VITROS® assay. Our results show that the performance of the VITROS® assay was satisfactory for the diagnosis of contagious COVID-19 patients in the clinical setting. Highlights The performance of the VITROS® SARS-CoV-2 Antigen Test was sufficient for the diagnosis of contagious COVID-19. This test showed high sensitivity and specificity in the detection of SARS-CoV-2 in samples with a Ct value of 32 or less.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunologic Tests / Immunoenzyme Techniques / COVID-19 Testing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: J Med Virol Year: 2021 Document Type: Article Affiliation country: Jmv.27153

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunologic Tests / Immunoenzyme Techniques / COVID-19 Testing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: J Med Virol Year: 2021 Document Type: Article Affiliation country: Jmv.27153