ArticleClinical biochemistry2020
High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies.
Article in Clinical biochemistry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
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Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Diagnostic Efficacy of 11 SARS-CoV-2 Serological Assays for COVID-19: A Meta-Analysis and Adjusted Indirect Comparison of Diagnostic Test Accuracy.Immunity, inflammation and disease · 2024Pooled it
- Antibody tests for identification of current and past infection with SARS-CoV-2.The Cochrane database of systematic reviews · 2022Pooled it
- High SARS-CoV-2 infection rate in children unvaccinated with COVID-19 vaccine in Changzhou, China, shortly after lifting zero-COVID-19 policy in December 2022.BMC infectious diseases · 2024Article
- Evaluation of Three Quantitative Anti-SARS-CoV-2 Antibody Immunoassays.Microbiology spectrum · 2021Article
- Performance of a SARS CoV-2 antibody ELISA based on simultaneous measurement of antibodies against the viral nucleoprotein and receptor-binding domain.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021Article
- Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays.Practical laboratory medicine · 2021Article
- Neutralizing Antibodies in COVID-19 Patients and Vaccine Recipients after Two Doses of BNT162b2.Viruses · 2021Article
- Cross-Reactivity of Two SARS-CoV-2 Serological Assays in a Setting Where Malaria Is Endemic.Journal of clinical microbiology · 2021Article
- Multiplex quantitative detection of SARS-CoV-2 specific IgG and IgM antibodies based on DNA-assisted nanopore sensing.Biosensors & bioelectronics · 2021Article
- Clinical performance of the Panbio assay for the detection of SARS-CoV-2 IgM and IgG in COVID-19 patients.Journal of medical virology · 2021Article
- Landscape of humoral immune responses against SARS-CoV-2 in patients with COVID-19 disease and the value of antibody testing.Heliyon · 2021Review
- Current methods and prospects of coronavirus detection.Talanta · 2021Review
- Clinical performance of three fully automated anti-SARS-CoV-2 immunoassays targeting the nucleocapsid or spike proteins.Journal of medical virology · 2021Article
- Article
- Correlation of SARS-CoV-2 Serology and Clinical Phenotype Amongst Hospitalised Children in a Tertiary Children's Hospital in India.Journal of tropical pediatrics · 2021Article
- Family Transmission of COVID-19 Including a Child with MIS-C and Acute Pancreatitis.International medical case reports journal · 2021Article
- An Original ELISA-Based Multiplex Method for the Simultaneous Detection of 5 SARS-CoV-2 IgG Antibodies Directed against Different Antigens.Journal of clinical medicine · 2020Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesSeveral serological SARS-CoV-2 immunoassays have been developed recently but require external validation before widespread use. This study aims at assessing the analytical and clinical performance of the iFlash® anti-SARS-CoV-2 chemiluminescence assay for the detection of both IgM and IgG antibodies. The kinetics of the antibody response was also evaluated. DESIGN &
methodsThe precision, carry-over, linearity, limit of blank, detection and quantification were assessed. Sensitivity analysis was performed by using 178 sera collected from 154 RT-PCR confirmed COVID-19 patients. The specificity analysis was performed from 75 selected non-SARS-CoV-2 sera with a potential cross-reaction to the SARS-CoV-2 immunoassay.
resultsThis iFlash® SARS-CoV-2 assay showed excellent analytical performance. After 2 weeks since symptom onset, the sensitivities for IgM and IgG were 62.2% (95% CI: 52.3-71.2%) and 92.9%% (95% CI: 85.7-96.7%), respectively by using the cut-off provided by the manufacturer. After cut-off optimization (i.e. >2.81 for IgM and >4.86 for IgG), the sensitivity for IgM and IgG were 81.6 (95% CI: 72.7-88.1%) and 95.9% (95% CI: 89.4-98.7%), respectively. Optimized cut-off for IgG improved the sensitivity to reach 100% (95%CI: 87.6-100) from 28 days since symptom onset.
conclusionsThis study shows that the iFlash® SARS-CoV-2 assay from YHLO biotechnology, has satisfactory analytical performance. Nevertheless, the sensitivity of the IgM is limited for a proper clinical use compared to IgG. The determination of anti-SARS-CoV-2 IgG antibodies from 28 days since symptom onset was associated with high sensitivity, especially using optimized cut-offs (i.e. 100%).
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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.