Evidence map›Paper›PMID 34170555›Full record

ArticleJournal of medical virology2021

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, Yuta Orihara, Masahiro Kodana, Yutaro Kitagawa, Masaru Matsuoka, Rieko Kawamura, Shinichi Takeuchi, Kazuo Imai, Norihito Tarumoto, Shigefumi Maesaki and 1 more

Abstract read
In one paragraph

Article in Journal of medical virology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Nanako MatsuzakiDepartment of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
Yuta OriharaDepartment of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
Masahiro KodanaDepartment of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
Yutaro KitagawaDepartment of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
Masaru MatsuokaDepartment of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
Rieko KawamuraDepartment of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
Shinichi TakeuchiDepartment of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.
Kazuo ImaiDepartment of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.ORCID http://orcid.org/0000-0002-8416-7371
Norihito TarumotoDepartment of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.
Shigefumi MaesakiDepartment of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.
Takuya MaedaDepartment of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.ORCID http://orcid.org/0000-0003-0912-4643

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Antigens, ViralCOVID-19COVID-19 Serological TestingCOVID-19 TestingHumansImmunoenzyme TechniquesImmunologic TestsMass ScreeningNasopharynxReal-Time Polymerase Chain ReactionRNA, ViralSARS-CoV-2Sensitivity and SpecificityViral LoadAntigens, ViralRNA, ViralCLEIACOVID-19nasopharyngeal swabRT-qPCRSARS-CoV-2

Identifiers

PMID34170555
PMCPMC8426666

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.