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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.
J Med Virol. 2021 Dec; 93(12):6778-6781.JM

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.

Authors+Show Affiliations

Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.Department of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.Department of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.Department of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34170555

Citation

Matsuzaki, Nanako, et al. "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." Journal of Medical Virology, vol. 93, no. 12, 2021, pp. 6778-6781.
Matsuzaki N, Orihara Y, Kodana M, et al. 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. J Med Virol. 2021;93(12):6778-6781.
Matsuzaki, N., Orihara, Y., Kodana, M., Kitagawa, Y., Matsuoka, M., Kawamura, R., Takeuchi, S., Imai, K., Tarumoto, N., Maesaki, S., & Maeda, T. (2021). 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. Journal of Medical Virology, 93(12), 6778-6781. https://doi.org/10.1002/jmv.27153
Matsuzaki N, et al. 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. J Med Virol. 2021;93(12):6778-6781. PubMed PMID: 34170555.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Matsuzaki,Nanako, AU - Orihara,Yuta, AU - Kodana,Masahiro, AU - Kitagawa,Yutaro, AU - Matsuoka,Masaru, AU - Kawamura,Rieko, AU - Takeuchi,Shinichi, AU - Imai,Kazuo, AU - Tarumoto,Norihito, AU - Maesaki,Shigefumi, AU - Maeda,Takuya, Y1 - 2021/08/12/ PY - 2021/06/17/received PY - 2021/06/21/accepted PY - 2021/6/26/pubmed PY - 2021/10/28/medline PY - 2021/6/25/entrez KW - CLEIA KW - COVID-19 KW - RT-qPCR KW - SARS-CoV-2 KW - nasopharyngeal swab SP - 6778 EP - 6781 JF - Journal of medical virology JO - J Med Virol VL - 93 IS - 12 N2 - 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. SN - 1096-9071 UR - https://www.unboundmedicine.com/medline/citation/34170555/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_ L2 - https://doi.org/10.1002/jmv.27153 DB - PRIME DP - Unbound Medicine ER -