ArticleFrontiers in microbiology2020
Development of an Automated Chemiluminescence Assay System for Quantitative Measurement of Multiple Anti-SARS-CoV-2 Antibodies.
Article in Frontiers in microbiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- GDF15 propeptide promotes bone metastasis of castration-resistant prostate cancer by augmenting the bone microenvironment.Biomarker research · 2024Article
- Development of a fully automated chemiluminescent immunoassay for the quantitative and qualitative detection of antibodies against African swine fever virus p72.Microbiology spectrum · 2024Article
- Traceable value of immunoglobulin G against receptor-binding domain of SARS-CoV-2 confirmation and application to point-of-care testing system development.Mikrochimica acta · 2023Article
- Effect of the third dose of BNT162b2 COVID-19 mRNA vaccine on anti-SARS-CoV-2 antibody levels in healthcare workers.Vaccine · 2023Article
- Prediction models for neutralization activity against emerging SARS-CoV-2 variants: A cross-sectional study.Frontiers in microbiology · 2023Article
- A Cellular Assay for Spike/ACE2 Fusion: Quantification of Fusion-Inhibitory Antibodies after COVID-19 and Vaccination.Viruses · 2022Article
- Antibody titers among healthcare workers for coronavirus disease 2019 at 6 months after BNT162b2 vaccination.Vaccine · 2022Article
- Detecting SARS-CoV-2 neutralizing immunity: highlighting the potential of split nanoluciferase technology.Journal of molecular cell biology · 2022Review
- Persistence of Robust Humoral Immune Response in Coronavirus Disease 2019 Convalescent Individuals Over 12 Months After Infection.Open forum infectious diseases · 2022Article
- Rapid detection of neutralizing antibodies to SARS-CoV-2 variants in post-vaccination sera.Journal of molecular cell biology · 2022Article
- Metal Organic Frameworks as Biosensing Materials for COVID-19.Cellular and molecular bioengineering · 2021Review
- A systematic review and meta-analysis of the sensitivity of antibody tests for the laboratory confirmation of COVID-19.Future virology · 2021Review
- Sustained Neutralizing Antibodies 6 Months Following Infection in 376 Japanese COVID-19 Survivors.Frontiers in microbiology · 2021Article
- Development of a cell-free protein synthesis system for practical use.Proceedings of the Japan Academy. Series B, Physical and biological sciences · 2021Article
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14 authors.
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No grant is acknowledged in the PubMed record.
Abstract
objectivesSerological tests for COVID-19 have been instrumental in studying the epidemiology of the disease. However, the performance of the currently available tests is plagued by the problem of variability. We have developed a high-throughput serological test capable of simultaneously detecting total immunoglobulins (Ig) and immunoglobulin G (IgG) against nucleocapsid protein (NP) and spike protein (SP) and report its performance in detecting COVID-19 in clinical samples.
methodsWe designed and prepared reagents for measuring NP-IgG, NP-Total Ig, SP-IgG, and SP-Total Ig (using N-terminally truncated NP (ΔN-NP) or receptor-binding domain (RBD) antigen) dedicated automated chemiluminescent enzyme immunoassay analyzer AIA-CL1200. After determining the basal thresholds based on 17 sera obtained from confirmed COVID-19 patients and 600 negative sera, the clinical validity of the assay was evaluated using independent 202 positive samples and 1,000 negative samples from healthy donors.
resultsAll of the four test parameters showed 100% specificity individually (1,000/1,000; 95%CI, 99.63-100). The sensitivity of the assay increased proportionally to the elapsed time from symptoms onset, and all the tests achieved 100% sensitivity (153/153; 95%CI, 97.63-100) after 13 days from symptoms onset. NP-Total Ig was the earliest to attain maximal sensitivity among the other antibodies tested.
conclusionOur newly developed serological testing exhibited 100% sensitivity and specificity after 13 days from symptoms onset. Hence, it could be used as a reliable method for accurate detection of COVID-19 patients and to evaluate seroprevalence and possibly for surrogate assessment of herd immunity.
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