Evidence map›Paper›PMID 35115008›Full record

ArticleVirology journal2022

Comparison of six antibody assays and two combination assays for COVID-19.

Masaki Yamamoto, Kazuyuki Okazaki, Yoko Kitai, Koh Shinohara, Satomi Yukawa, Taro Noguchi, Michio Tanaka, Yasufumi Matsumura, Yukiko Nishiyama, Miki Nagao

Abstract readComparative Study
In one paragraph

Article in Virology journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Pooled it
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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

10 authors.

Masaki YamamotoDepartment of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan. masakiy@kuhp.kyoto-u.ac.jp.ORCID 0000-0002-7822-3269
Kazuyuki OkazakiDepartment of Clinical Laboratory, Kyoto University Hospital, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
Yoko KitaiDepartment of Clinical Laboratory, Kyoto University Hospital, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
Koh ShinoharaDepartment of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
Satomi YukawaDepartment of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
Taro NoguchiDepartment of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
Michio TanakaDepartment of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
Yasufumi MatsumuraDepartment of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
Yukiko NishiyamaDepartment of Clinical Laboratory, Kyoto University Hospital, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
Miki NagaoDepartment of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn this work, six SARS-CoV-2-specific antibody assays were evaluated, namely, two pan-immunoglobulin (pan-Ig) assays [Roche Elecsys Anti-SARS-CoV-2 (named "Elecsys" in this study) and the PerkinElmer SuperFlex™ Anti-SARS-CoV-2 Ab Assay (SuperFlex_Ab)], two IgM assays [SuperFlex™ Anti-SARS-CoV-2 IgM Assay (SuperFlex_IgM) and YHLO iFlash-SARS-CoV-2 IgM (iFlash_IgM)], and two IgG assays [SuperFlex™ Anti-SARS-CoV-2 IgG Assay (SuperFlex_IgG) and iFlash-SARS-CoV-2 IgG (iFlash_IgG)]. Combination assays of SuperFlex™ (SuperFlex_any) and iFlash (iFlash_any) were also evaluated.

methodsA total of 438 residual serum samples from 54 COVID-19 patients in the COVID-19 group and 100 samples from individuals without evidence of SARS-CoV-2 infection in the negative control group were evaluated.

resultsIn the early stage of COVID-19 infection, within 14 days of symptom onset, the seropositive rate was lower than that of the late stage 15 days after onset (65.4% vs 99.6%). In the total period, the pan-Ig and IgG assays had higher sensitivity (90.8-95.3%) than the IgM assays (36.5-40.7%). SuperFlex_Ab and SuperFlex_any had higher sensitivity than Elecsys and SuperFlex_IgG (p < 0.05). The specificity of all the assays was 100%, except for SuperFlex_IgM (99.0%). The concordance rate between each assay was higher (96.4-100%) in the late stage than in the early stage (77.4-98.1%).

conclusionFor the purpose of COVID-19 diagnosis, antibody testing should be performed 15 days after onset. For the purpose of epidemiological surveillance, highly sensitive assays should be used as much as possible, such as SuperFlex_Ab, iFlash_IgG and their combination. IgM assays were not suitable for these purposes.

Indexed as

COVID-19Antibodies, ViralCOVID-19 Serological TestingHumansImmunoglobulin GImmunoglobulin MSARS-CoV-2Sensitivity and SpecificityAntibodies, ViralImmunoglobulin GImmunoglobulin MAntibody testingCOVID-19SARS-CoV-2Serology

Identifiers

PMID35115008
PMCPMC8811998

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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.