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. 2021 Dec;93(12):6778-6781.
doi: 10.1002/jmv.27153. Epub 2021 Aug 12.

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

Nanako Matsuzaki  1 , Yuta Orihara  1 , Masahiro Kodana  1 , Yutaro Kitagawa  1 , Masaru Matsuoka  1 , Rieko Kawamura  1 , Shinichi Takeuchi  1 , Kazuo Imai  2 , Norihito Tarumoto  2 , Shigefumi Maesaki  2 , Takuya Maeda  1
Affiliations

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

Nanako Matsuzaki et al. J Med Virol. 2021 Dec.

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.

Keywords: CLEIA; COVID-19; RT-qPCR; SARS-CoV-2; nasopharyngeal swab.

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Conflict of interest statement

The authors declare that there are no conflict of interests.

Figures

Figure 1
Figure 1
Correlations between Ct values obtained with reverse‐transcription polymerase chain reaction (RT‐qPCR) and antigen levels obtained by each automated antigen‐detection test. The antigen level in (A) the VITROS® SARS‐CoV‐2 Antigen Test and (B) the LUMIPULSE® SASR‐CoV‐2 Ag Test were plotted relative to RT‐qPCR Ct value. The diagonal line shows the cut‐off value
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