Evidence map›Paper›PMID 32104917›Full record

ArticleJournal of medical virology2020

Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.

Zhengtu Li, Yongxiang Yi, Xiaomei Luo, Nian Xiong, Yang Liu, Shaoqiang Li, Ruilin Sun, Yanqun Wang, Bicheng Hu, Wei Chen and 14 more

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Journal of medical virology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 868 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
868citing papers in PubMed, 5 pooled it
44.6field-weighted citation impact, top 1% 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.

NCT04360954 completednot on this map

Evaluation of Commerical Antibody Tests for COVID-19

TypeobservationalSponsorWashington University School of MedicineRan2020 to 2020Enrolled461ConditionsCOVID, CoronavirusArmsDiagnostic test
NCT04627623 unknown statusnot on this map

Prevalence and Risk Factors of COVID-19 Infection in the Upper Silesian Agglomeration Population in 2020

TypeobservationalSponsorMedical University of SilesiaRan2020 to 2021Enrolled6,000ConditionsCovid19, Respiratory Tract Infections, Severe Acute Respiratory Syndrome, Corona Virus InfectionArmsIgM and IgG antibodies assay
3 · Its place in the literature

Who cites it

868 citing papers in PubMed, 5 syntheses or guidelines pooled it, 1,882 citations in OpenAlex.

  1. Pooled it
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  6. Gut microbial allies and adversaries in SARS-CoV-2 infection.Current research in microbial sciences · 2026
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808 more citing papers are in PubMed but not listed here.

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

24 authors at 10 institutions in 1 country.

Zhengtu LiState Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Yongxiang YiThe 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.
Xiaomei LuoChongqing Public Health Medical Center, Chongqing, China.
Nian XiongUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Yang LiuThe 1st Affiliated Hospital of Nanchang University, Nanchang, China.
Shaoqiang LiState Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Ruilin SunDepartment of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.
Yanqun WangState Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Bicheng HuWuhan No. 1 Hospital, Wuhan, China.
Wei ChenThe 1st Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Yongchen ZhangThe 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.
Jing WangChongqing Public Health Medical Center, Chongqing, China.
Baofu HuangJiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.
Ye LinState Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Jiasheng YangDepartment of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.
Wensheng CaiJiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.
Xuefeng WangJiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.ORCID http://orcid.org/0000-0001-8854-275X
Jing ChengState Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Zhiqiang ChenJiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.
Kangjun SunJiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.
Weimin PanJiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.
Zhifei ZhanHunan Provincial Center for Disease Control and Prevention, Changsha, China.
Liyan ChenState Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Feng YeState Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
First Affiliated Hospital of Guangzhou Medical University · CNMedomics (China) · CNChongqing Public Health Medical Center · CNGuangdong Provincial People's Hospital · CNNanjing University of Chinese Medicine · CNHunan Provincial Center for Disease Control and Prevention · CNNanchang University · CNSecond Affiliated Hospital of Xi'an Jiaotong University · CNWuhan No.1 Hospital · CNWuhan Union Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.

Indexed as

ImmunoassayAntibodies, ViralCOVID-19HumansImmunoglobulin GImmunoglobulin MPoint-of-Care TestingReagent Kits, DiagnosticReagent StripsSARS-CoV-2Sensitivity and SpecificityAntibodies, ViralImmunoglobulin GImmunoglobulin MReagent Kits, DiagnosticReagent StripsCOVID-19fingerstick bloodlateral flow immunoassaypoint-of-care testingrapid IgM-IgG combined testSARS-CoV-2 virus infection

Identifiers

PMID32104917
PMCPMC7228300
OpenAlexW3007104924

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.