ArticleEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2020
Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak.
Article in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 7 of them syntheses that pooled it.
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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.
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Who cites it
67 citing papers in PubMed, 7 syntheses or guidelines pooled it, 116 citations in OpenAlex.
- Antibody tests for identification of current and past infection with SARS-CoV-2.The Cochrane database of systematic reviews · 2022Pooled it
- A systematic review and meta-analysis of the accuracy of SARS-COV-2 IGM and IGG tests in individuals with COVID-19.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2022Pooled it
- A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19.Systematic reviews · 2021Pooled it
- Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays.Reproductive biomedicine online · 2020Pooled it
- Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2020Pooled it
- Antibody tests for identification of current and past infection with SARS-CoV-2.The Cochrane database of systematic reviews · 2020Pooled it
- Meta-analysis of diagnostic performance of serological tests for SARS-CoV-2 antibodies up to 25 April 2020 and public health implications.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2020Pooled it
- Development of a Novel Homogeneous Liposome-Based One-Step Assay for SARS-CoV-2 Antibody Detection in Human Serum Based on Fluorescent Liposomes and Complement Activity.Analytical chemistry · 2025Article
- Diagnostics and analysis of SARS-CoV-2: current status, recent advances, challenges and perspectives.Chemical science · 2023Review
- A Systematic Review and Meta-Analysis Comparing the Diagnostic Accuracy Tests of COVID-19.Diagnostics (Basel, Switzerland) · 2023Review
- Diagnostic TR-FRET assays for detection of antibodies in patient samples.Cell reports methods · 2023Article
- Polydopamine Nanoparticles-Based Three-Line Lateral Flow Immunoassay for COVID-19 Detection.Biosensors · 2023Article
- COVID-19 diagnostics: Molecular biology to nanomaterials.Clinica chimica acta; international journal of clinical chemistry · 2023Review
- SARS-CoV-2 Seroprevalence among Health-Care Workers in Isfahan, Iran.Advanced biomedical research · 2023Article
- Screening and confirmation tests for SARS-CoV-2: benefits and drawbacks.Beni-Suef University journal of basic and applied sciences · 2023Review
- Label-free impedimetric immunosensor for point-of-care detection of COVID-19 antibodies.Microsystems & nanoengineering · 2023Article
- Sensitivity of three commercial tests for SARS-CoV-2 serology in children: an Italian multicentre prospective study.Italian journal of pediatrics · 2022Article
- Clinical Validation of Standard Q COVID-19 Antigen and IgM/IgG Combo Kit Assay at a Tertiary Care Center in Northern India.Journal of laboratory physicians · 2022Article
- SARS-CoV-2 detection methods: A comprehensive review.Saudi journal of biological sciences · 2022Review
- An Internet-of-Disease System for COVID-19 Testing Using Saliva by an AI-Controlled Microfluidic ELISA Device.Advanced materials technologies · 2022Article
7 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
Abstract
We developed a chemiluminescence immunoassay method based on the recombinant nucleocapsid antigen and assessed its performance for the clinical diagnosis of severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infections by detecting SARS-CoV-2-specific IgM and IgG antibodies in patients. Full-length recombinant nucleocapsid antigen and tosyl magnetic beads were used to develop the chemiluminescence immunoassay approach. Plasmas from 29 healthy cohorts, 51 tuberculosis patients, and 79 confirmed SARS-CoV-2 patients were employed to evaluate the chemiluminescence immunoassay method performance for the clinical diagnosis of SARS-CoV-2 infections. A commercial ELISA kit (Darui Biotech, China) using the same nucleocapsid antigen was used for the in-parallel comparison with our chemiluminescence immunoassay method. The IgM and IgG manner of testing in the chemiluminescence immunoassay method showed a sensitivity and specificity of 60.76% (95% CI 49.1 to 71.6) and 92.25% (95% CI 83.4 to 97.2) and 82.28% (95% CI 72.1 to 90.0) and 97.5% (95% CI 91.3 to 99.7), respectively. Higher sensitivity and specificity were observed in the chemiluminescence immunoassay method compared with the Darui Biotech ELISA kit. The developed high sensitivity and specificity chemiluminescence immunoassay IgG testing method combined with the RT-PCR approach can improve the clinical diagnosis for SARS-CoV-2 infections and thus contribute to the control of COVID-19 expansion.
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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.