ArticleInternational immunopharmacology2021
The WHO International Standard for COVID-19 serological tests: towards harmonization of anti-spike assays.
Article in International immunopharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers.
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Who cites it
79 citing papers in PubMed.
- Dosing of Convalescent Plasma and Hyperimmune Anti-SARS-CoV-2 Immunoglobulins: A Phase I/II Dose-Finding Study.Clinical pharmacokinetics · 2024Trial
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- Bronchiectasis, Low IgG Levels and Lack of Vaccination are Risk Factors for Covid-19 Hospitalization in X-linked Agammaglobulinemia - A Retrospective Multicenter Study.Journal of clinical immunology · 2025Article
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- SARS-CoV-2 Variant-Specific Antibodies in Vaccinated Inflammatory Bowel Disease Patients.Vaccines · 2025Article
- IPNA clinical practice recommendations on care of pediatric patients with pre-existing kidney disease during seasonal outbreak of COVID-19.Pediatric nephrology (Berlin, Germany) · 2025Review
- Uncertainty quantification of antibody measurements: Physical principles and implications for standardization.Physical review. E · 2025Article
- Patterns of SARS-CoV-2-specific humoral and cellular immune response in actively treated patients with solid cancer following prime BNT162b2 COVID-19 vaccination: results from phase IV CoVigi trial.Therapeutic advances in medical oncology · 2025Article
- A SARS-CoV-2 minimum data standard to support national serology reporting.Annals of clinical biochemistry · 2024Article
- Anti-severe acute respiratory syndrome coronavirus 2 spike receptor-binding domain antibody levels in patients with systemic lupus erythematosus based on vaccination status and related factors in Indonesia.Clinical and experimental vaccine research · 2024Article
- Overcoming the age-dependent SARS-CoV-2 vaccine response through hybrid immunity: analysis of humoral and cellular immunity with mass cytometry profiling.Immunity & ageing : I & A · 2024Article
- A Paper-Based Multiplexed Serological Test to Monitor Immunity against SARS-COV-2 Using Machine Learning.ACS nano · 2024Article
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- Vaccination in twin pregnancies: comparison between immunization before conception and during pregnancy.Scientific reports · 2024Article
- The Equal Neutralizing Effectiveness of BNT162b2, ChAdOx1 nCoV-19, and Sputnik V Vaccines in the Palestinian Population.Vaccines · 2024Article
- Comparison Study of the Bio-Plex and Meso Scale Multiplexed SARS-CoV-2 Serology Assays Reveals Evidence of Diminished Host Antibody Responses to SARS-CoV-2 after Monoclonal Antibody Treatment.Pathogens & immunity · 2024Article
- Immunogenicity and reactogenicity of heterologous prime-boost vaccination with inactivated COVID-19 and ChAdOx1 nCoV-19 (AZD1222) vaccines, a quasi-experimental study.Human vaccines & immunotherapeutics · 2023Article
- Safety and immunogenicity of the third and fourth doses of vaccine against SARS-CoV-2 following a 2-dose regimen of inactivated whole-virion SARS-CoV-2 vaccine.Scientific reports · 2023Article
19 more citing papers are in PubMed but not listed here.
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsSARS-CoV-2 antibody assays are relevant in managing the COVID-19 pandemic, providing valuable data on the immunization status of the population. However, current serology tests are highly variable, due to their different characteristics and to the lack of reference materials. The aim of the World Health Organization (WHO) first International Standard (IS) for anti-SARS-CoV-2 immunoglobulin is to harmonize humoral immune response assessment after natural infection or vaccination, and recommend reporting the results for binding activity in Binding Antibody Units (BAU). MATERIALS AND
methodsThis study analyzed six commercial quantitative anti-SARS-CoV-2 S-protein assays in a head-to-head comparison, using the manufacturers' conversion factors for the WHO IS to obtain BAU/mL values.
resultsOur data showed good alignment up to 1000 BAU/mL, then began to disperse, exhibiting some discrepancies. Moreover, correlations among methods varied with Cohen's Kappa ranging from 0.580 to 1.00, with the lowest agreement values for kits using different target antigens or different antibody isotypes, making it clear that the laboratory report should include this information. Values expressed as BAU/ml showed a reduced between-assays variability compared to AU/ml (median coefficients of variation 0.38 and 0.68, respectively; p < 0.001).
conclusionOn the basis of these data at present anti-SARS CoV-2 serological assays' results are not interchangeable, and, more importantly, individual immune monitoring should be performed with the same method.
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