Evidence map›Paper›PMID 33067888›Full record

ArticleJournal of clinical laboratory analysis2021

Development and clinical application of a rapid SARS-CoV-2 antibody test strip: A multi-center assessment across China.

Mengting Liao, Jiawei Yan, Xinfeng Wang, Huimin Qian, Chao Wang, Dan Xu, Bin Wang, Bo Yang, Shaohui Liu, Mao Zhou and 5 more

Open access · goldAbstract readEvaluation StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical laboratory analysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 33% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Development of practical techniques for simultaneous detection and distinction of current and emerging SARS-CoV-2 variants.Analytical sciences : the international journal of the Japan Society for Analytical Chemistry · 2023
    Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2021
    Article
  9. 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 5 institutions in 1 country.

Mengting LiaoHealth Management Center, Xiangya Hospital of Central South University, Changsha, China.ORCID https://orcid.org/0000-0002-7444-2579
Jiawei YanInfectious Diseases Hospital of Xuzhou City, Xuzhou, China.
Xinfeng WangChest Hospital of Shandong Province, Jinan, China.
Huimin QianThe Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
Chao WangEye Center of Xiangya Hospital, Central South University, Changsha, China.
Dan XuDepartment of Clinical Laboratory, the First Hospital of Changsha, Changsha, China.
Bin WangDepartment of Clinical Laboratory, the First Hospital of Changsha, Changsha, China.
Bo YangDepartment of Clinical Laboratory, the First Hospital of Changsha, Changsha, China.
Shaohui LiuHealth Management Center, Xiangya Hospital of Central South University, Changsha, China.
Mao ZhouDepartment of Clinical Laboratory, Xiangya Hospital of Central South University, Changsha, China.ORCID https://orcid.org/0000-0003-3544-072X
Qian GaoDepartment of Clinical Laboratory, Xiangya Hospital of Central South University, Changsha, China.
Qian ZhouSinocare Inc., Changsha, China.
Jiquan LuoSinocare Inc., Changsha, China.
Zongxiang LiSinocare Inc., Changsha, China.
Wenen LiuDepartment of Clinical Laboratory, Xiangya Hospital of Central South University, Changsha, China.
Central South University · CNThe First Hospital of Changsha · CNJiangsu Provincial Center for Disease Control and Prevention · CNJiangsu University · CNShandong Chest Hospital · CN

Funding

National Natural Science Foundation of China 81672066
6 · The paper itself

Abstract

backgroundThe ongoing coronavirus disease 19 (COVID-19) is posing a threat to the public health globally. Serological test for SARS-CoV-2 antibody can improve early diagnosis of COVID-19 and serves as a valuable supplement to RNA detection.

methodA SARS-CoV-2 IgG/IgM combined antibody test strip based on colloidal gold immunochromatography assay was developed, with both spike protein and nucleocapsid protein of SARS-CoV-2 antigen used for antibody detection. From 3 medical institutions across China, serum or plasma of 170 patients with confirmed COVID-19 diagnosis and 300 normal controls were collected and tested with the strip. Sensitivity, specificity, kappa coefficient, receiver operating characteristic (ROC) curve, and area under the curve (AUC) were analyzed. Positive rates in different medical centers, age group, gender, and different disease course were compared.

results158 out 170 samples from confirmed COVID-19 patients had positive results from the test, and 296 out of 300 samples from normal controls had negative results. The kit was 92.9% sensitive and 98.7% specific. The positive rate was 77.3% during the first week after disease onset, but reached 100% since day 9. AUC and kappa coefficient were 0.958 and 0.926, respectively, which showed the consistency of the test results with the standard diagnosis. Age or gender caused little variations in the kit sensitivity.

conclusionThe rapid, easy-to-use SARS-CoV-2 IgG/IgM combined antibody test kit has a superior performance, which can help with accurate diagnosis and thus timely treatment and isolation of COVID-19 patients, that contributes to the better control of the global pandemic.

Indexed as

AdultAntibodies, ViralAntigens, ViralCase-Control StudiesChinaCOVID-19 TestingFemaleGold ColloidHumansImmunoassayImmunoglobulin GImmunoglobulin MMaleMiddle AgedNucleocapsidReagent StripsAntibodies, ViralAntigens, ViralGold ColloidImmunoglobulin GImmunoglobulin MReagent StripsSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2colloidal gold immunochromatography assayCOVID-19multi-center assessmentperformance evaluationSARS-CoV-2serological test

Identifiers

PMID33067888
PMCPMC7645889
OpenAlexW3093236451

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.