Evidence map›Paper›PMID 36693058›Full record

ArticlePloS one2023

Performance evaluation of the Ortho VITROS SARS-CoV-2 Spike-Specific Quantitative IgG test by comparison with the surrogate virus neutralizing antibody test and clinical assessment.

Maika Takahashi, Kaori Saito, Tomohiko Ai, Shuko Nojiri, Abdullah Khasawneh, Faith Jessica Paran, Yuki Horiuchi, Satomi Takei, Takamasa Yamamoto, Mitsuru Wakita and 5 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 28% of its field
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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

15 authors at 2 institutions in 1 country.

Maika TakahashiDepartment of Clinical Laboratory, Juntendo University Hospital, Bunkyo City, Tokyo, Japan.
Kaori SaitoDepartment of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.
Tomohiko AiDepartment of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.
Shuko NojiriMedical Technology Innovation Center, Juntendo University, Bunkyo City, Tokyo, Japan.
Abdullah KhasawnehDepartment of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.ORCID 0000-0002-8324-4048
Faith Jessica ParanDepartment of Research Support Utilizing Bioresource Bank, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.ORCID 0000-0003-1149-5048
Yuki HoriuchiDepartment of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.
Satomi TakeiDepartment of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.
Takamasa YamamotoDepartment of Clinical Laboratory, Juntendo University Hospital, Bunkyo City, Tokyo, Japan.
Mitsuru WakitaDepartment of Clinical Laboratory, Juntendo University Hospital, Bunkyo City, Tokyo, Japan.
Makoto HikiDepartment of Emergency Medicine, Juntendo University Faculty of Medicine, Bunkyo City, Tokyo, Japan.
Takashi MiidaDepartment of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.ORCID 0000-0002-4294-8030
Toshio NaitoDepartment of Research Support Utilizing Bioresource Bank, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.ORCID 0000-0003-1646-9930
Kazuhisa TakahashiDepartment of Research Support Utilizing Bioresource Bank, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.
Yoko TabeDepartment of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Bunkyo City, Tokyo, Japan.ORCID 0000-0002-3734-0346
Juntendo University · JPJuntendo University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite the worldwide campaigns of COVID-19 vaccinations, the pandemic is still a major medical and social problem. The Ortho VITROS SARS-CoV-2 spike-specific quantitative IgG (VITROS S-IgG) assay has been developed to assess neutralizing antibody (NT antibody) against SARS-CoV-2 spike (S) antibodies. However, it has not been evaluated in Japan, where the total cases and death toll are lower than the rest of the world.

methodsThe clinical performance of VITROS S-IgG was evaluated by comparing with the NT antibody levels measured by the surrogate virus neutralizing antibody test (sVNT). A total of 332 serum samples from 188 individuals were used. Of these, 219 samples were from 75 COVID-19 patients: 96 samples from 20 severe/critical cases (Group S), and 123 samples from 55 mild/moderate cases (Group M). The remaining 113 samples were from 113 healthcare workers who had received 2 doses of the BNT162b2 vaccine.

resultsVITROS S-IgG showed good correlation with the cPass sVNT assay (Spearman rho = 0.91). Both VITROS S-IgG and cPass sVNT showed significantly higher plateau levels of antibodies in Group S compared to Group M. Regarding the humoral immune responses after BNT162b2 vaccination, individuals who were negative for SARS-CoV-2 nucleocapsid (N)-specific antibodies had statistically lower titers of both S-IgG and sVNT compared to individuals with a history of COVID-19 and individuals who were positive for N-specific antibodies without history of COVID-19. In individuals who were positive for N-specific antibodies, S-IgG and sVNT titers were similar to individuals with a history of COVID-19.

conclusionsAlthough the automated quantitative immunoassay VITROS S-IgG showed a reasonable correlation with sVNT antibodies, there is some discrepancy between Vitros S-IgG and cPass sVNT in milder cases. Thus, VITROS S-IgG can be a useful diagnostic tool in assessing the immune responses to vaccination and herd immunity. However, careful analysis is necessary to interpret the results.

Indexed as

Blood Group AntigensCOVID-19Antibodies, BlockingAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 TestingHumansImmunoglobulin GSARS-CoV-2Antibodies, BlockingAntibodies, NeutralizingAntibodies, ViralBlood Group AntigensBNT162 VaccineImmunoglobulin G

Identifiers

PMID36693058
PMCPMC9873150
OpenAlexW4317851274

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.