Abstract
Objective: To evaluate the dynamics and longevity of the humoral immune response to SARS-CoV-2 infection and assess the performance of professional use of the UK-RTC AbC-19 Rapid Test lateral flow immunoassay (LFIA) for the target condition of SARS-CoV-2 spike protein IgG antibodies.
Design: Nationwide serological study.
Setting: Northern Ireland, UK, May 2020-February 2021.
Participants: Plasma samples were collected from a diverse cohort of individuals from the general public (n=279), Northern Ireland healthcare workers (n=195), pre-pandemic blood donations and research studies (n=223) and through a convalescent plasma programme (n=183). Plasma donors (n=101) were followed with sequential samples over 11 months post-symptom onset.
Main outcome measures: SARS-CoV-2 antibody levels in plasma samples using Roche Elecsys Anti-SARS-CoV-2 IgG/IgA/IgM, Abbott SARS-CoV-2 IgG and EuroImmun IgG SARS-CoV-2 ELISA immunoassays over time. UK-RTC AbC-19 LFIA sensitivity and specificity, estimated using a three-reference standard system to establish a characterised panel of 330 positive and 488 negative SARS-CoV-2 IgG samples.
Results: We detected persistence of SARS-CoV-2 IgG antibodies for up to 10 months post-infection, across a minimum of two laboratory immunoassays. On the known positive cohort, the UK-RTC AbC-19 LFIA showed a sensitivity of 97.58% (95.28% to 98.95%) and on known negatives, showed specificity of 99.59% (98.53 % to 99.95%).
Conclusions: Through comprehensive analysis of a cohort of pre-pandemic and pandemic individuals, we show detectable levels of IgG antibodies, lasting over 46 weeks when assessed by EuroImmun ELISA, providing insight to antibody levels at later time points post-infection. We show good laboratory validation performance metrics for the AbC-19 rapid test for SARS-CoV-2 spike protein IgG antibody detection in a laboratory-based setting.
Keywords: COVID-19; diagnostic microbiology; molecular diagnostics.
【저자키워드】 COVID-19, Diagnostic microbiology, molecular diagnostics, 【초록키워드】 convalescent plasma, IgG, pandemic, antibody, SARS-COV-2 infection, Test, diagnostic, outcome, anti-SARS-CoV-2, diagnostics, healthcare worker, ELISA, Spike protein, Laboratory, molecular diagnostics, immunoassays, immunoassay, lateral flow immunoassay, sensitivity, specificity, Cohort, IgG antibody, SARS-CoV-2 antibody, Rapid test, Sensitivity and specificity, IgG antibodies, persistence, SARS-CoV-2 IgG antibody, SARS-CoV-2 spike protein, Research, Rapid, Ireland, antibody levels, humoral immune response, LFIA, molecular, Longevity, Roche, serological, Euroimmun, SARS-CoV-2 IgG, Blood, Donor, Blood donations, Abbott, Post-infection, Performance metrics, comprehensive analysis, individual, plasma samples, post-symptom onset, SARS-CoV-2 IgG antibodies, minimum, positive, Elecsys, Abbott SARS-CoV-2 IgG, plasma sample, collected, evaluate, detectable, individuals, Elecsy, SARS-CoV-2 ELISA, 【제목키워드】 SARS CoV-2, cross-sectional, Infection, lateral flow, IgG antibody, longitudinal analysis,