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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.

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Authors+Show Affiliations

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.

MeSH

Antigens, ViralCOVID-19COVID-19 Serological TestingCOVID-19 TestingHumansImmunoenzyme TechniquesImmunologic TestsMass ScreeningNasopharynxRNA, ViralReal-Time Polymerase Chain ReactionSARS-CoV-2Sensitivity and SpecificityViral Load

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 -