Evidence map›Paper›PMID 32355546›Full record

ArticleAmerican journal of translational research2020

Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG.

Bo Shen, Yufen Zheng, Xiaoyan Zhang, Weituo Zhang, Donglian Wang, Jie Jin, Rong Lin, Ying Zhang, Guangjun Zhu, Hongguo Zhu and 35 more

Open access · greenAbstract read
PubMed Full text at PMC
In one paragraph

Article in American journal of translational research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 6 pooled it
2.1field-weighted citation impact, top 7% 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

51 citing papers in PubMed, 6 syntheses or guidelines pooled it, 90 citations in OpenAlex.

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  20. Lateral Flow Immunoassays for SARS-CoV-2.Diagnostics (Basel, Switzerland) · 2022
    Review
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

45 authors at 2 institutions in 1 country.

Bo ShenTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Yufen ZhengTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Xiaoyan ZhangInstitute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tongji University Shanghai 200065, China.
Weituo ZhangHongqiao International Institute of Medicine, Shanghai Tongren Hospital and Clinical Research Institute, Shanghai Jiao Tong University School of Medicine Shanghai 200025, China.
Donglian WangTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Jie JinNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Rong LinUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan 430022, China.
Ying ZhangTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Guangjun ZhuTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Hongguo ZhuTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Jun LiTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Jiaqin XuTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Xianhong DingTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Shiyong ChenTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Ruyue LuTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Zebao HeTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Haihong ZhaoTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Lingjun YingTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Chao ZhangTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Dongqing LvTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Baofu ChenTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Jiya ChenTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Jiansheng ZhuTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Bingjie HuTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Chenliang HongTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Xiangyu XuTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Jiaxi ChenTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Chong LiuTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Kai ZhouTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Jing LiNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Guoling ZhaoNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Weixiang ShenInstitute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tongji University Shanghai 200065, China.
Chunfeng ChenNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Chunyan ShaoNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Xiaoying ShenNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Jingjing SongNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Zhipeng WangNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Ying MengNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Chao WangNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Junsong HanNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Aojun ChenNational Engineering Center for Biochip at Shanghai Shanghai 201203, China.
Daru LuState Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University Shanghai 200433, China.
Biyun QianHongqiao International Institute of Medicine, Shanghai Tongren Hospital and Clinical Research Institute, Shanghai Jiao Tong University School of Medicine Shanghai 200025, China.
Haixiao ChenTaizhou Hospital, Wenzhou Medical University Linhai 317000, China.
Hengjun GaoInstitute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tongji University Shanghai 200065, China.
Fudan University · CNHuazhong University of Science and Technology · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSince December 2019, there had been an outbreak of COVID-19 in Wuhan, China. At present, diagnosis COVID-19 were based on real-time RT-PCR, which have to be performed in biosafe laboratory and is unsatisfactory for suspect case screening. Therefore, there is an urgent need for rapid diagnostic test for COVID-19.

objectiveTo evaluate the diagnostic performance and clinical utility of the colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body detection in suspected COVID-19 cases.

methodsIn the prospective cohort, 150 patients with fever or respiratory symptoms were enrolled in Taizhou Public Health Medical Center, Taizhou Hospital, Zhejiang province, China, between January 20 to February 2, 2020. All patients were tested by the colloidal gold immunochromatography assay for COVID-19. At least two samples of each patient were collected for RT-PCR assay analysis, and the PCR results were performed as the reference standard of diagnosis. Meanwhile 26 heathy blood donor were recruited. The sensitivity and specificity of the immunochromatography assay test were evaluated. Subgroup analysis were performed with respect to age, sex, period from symptom onset and clinical severity.

resultsThe immunochromatography assay test had 69 positive result in the 97 PCR-positive cases, achieving sensitivity 71.1% [95% CI 0.609-0.797], and had 2 positive result in the 53 PCR-negative cases, achieving specificity 96.2% [95% CI 0.859-0.993]. In 26 healthy donor blood samples, the immunochromatography assay had 0 positive result. In subgroup analysis, the sensitivity was significantly higher in patients with symptoms more than 14 days 95.2% [95% CI 0.741-0.998] and patients with severe clinical condition 86.0% [95% CI 0.640-0.970].

conclusionsThe colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body had 71.1% sensitivity and 96.2% specificity in this population, showing the potential for a useful rapid diagnosis test for COVID-19. Further investigations should be done to evaluate this assay in variety of clinical settings and populations.

Indexed as

COVID-19immunoglobulin M/immunoglobulin Grapid diagnosis

Identifiers

PMID32355546
PMCPMC7191168
OpenAlexW3020954282

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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.