Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months

Louise Robertson; Julie Moore; Kevin Blighe; Kok Yew Ng; Nigel Quinn; Fergal Jennings; Gary Warnock; Peter Sharpe; Mark Clarke; Kathryn Maguire; Sharon  Rainey; RK Price; William Burns; Amanda Kowalczyk; Agnes Awuah; Sara Mc Namee; Gayle Wallace; David Hunter; Steve Sager; Connie Chao-Shern; M. Andrew Nesbit; James McLaughlin; Tara C. B. Moore

doi:10.1136/bmjopen-2020-048142

Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months

Louise Robertson
, Julie Moore
, Kevin Blighe
, Kok Yew Ng
, Nigel Quinn
, Fergal Jennings
, Gary Warnock
, Peter Sharpe
, Mark Clarke
, Kathryn Maguire
, Sharon Rainey
, RK Price
, William Burns
, Amanda Kowalczyk
, Agnes Awuah
, Sara Mc Namee
, Gayle Wallace
, David Hunter
, Steve Sager
, Connie Chao-Shern

M. Andrew Nesbit, James McLaughlin, Tara C. B. Moore

Research output: Contribution to journal › Article › peer-review

19 Citations (Scopus)

106 Downloads (Pure)

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.

Original language	English
Journal	BMJ Open
Volume	11
Issue number	6
Early online date	29 Jun 2021
DOIs	https://doi.org/10.1136/bmjopen-2020-048142
Publication status	Published online - 29 Jun 2021

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Antibodies, Viral
Antibody Formation
COVID-19
Covid-19
Cross-Sectional Studies
Diagnostic Microbiology
Humans
Immunization, Passive
Immunoassay
Immunoglobulin G
Molecular Diagnostics
Northern Ireland
SARS-CoV-2
Sensitivity and Specificity
Spike Glycoprotein, Coronavirus
molecular diagnostics
diagnostic microbiology

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10.1136/bmjopen-2020-048142Licence: CC BY-NC

e048142.fullFinal published version, 905 KBLicence: CC BY-NC

Cite this

Robertson, L., Moore, J., Blighe, K., Ng, K. Y., Quinn, N., Jennings, F., Warnock, G., Sharpe, P., Clarke, M., Maguire, K., Rainey, S., Price, RK., Burns, W., Kowalczyk, A., Awuah, A., Mc Namee, S., Wallace, G., Hunter, D., Sager, S., ... Moore, T. C. B. (2021). Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months. BMJ Open, 11(6). Advance online publication. https://doi.org/10.1136/bmjopen-2020-048142

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title = "Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months",

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 = "Antibodies, Viral, Antibody Formation, COVID-19, Covid-19, Cross-Sectional Studies, Diagnostic Microbiology, Humans, Immunization, Passive, Immunoassay, Immunoglobulin G, Molecular Diagnostics, Northern Ireland, SARS-CoV-2, Sensitivity and Specificity, Spike Glycoprotein, Coronavirus, molecular diagnostics, diagnostic microbiology",

author = "Louise Robertson and Julie Moore and Kevin Blighe and Ng, \{Kok Yew\} and Nigel Quinn and Fergal Jennings and Gary Warnock and Peter Sharpe and Mark Clarke and Kathryn Maguire and Sharon Rainey and RK Price and William Burns and Amanda Kowalczyk and Agnes Awuah and \{Mc Namee\}, Sara and Gayle Wallace and David Hunter and Steve Sager and Connie Chao-Shern and Nesbit, \{M. Andrew\} and James McLaughlin and Moore, \{Tara C. B.\}",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2021",

month = jun,

day = "29",

doi = "10.1136/bmjopen-2020-048142",

language = "English",

volume = "11",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "6",

}

Robertson, L, Moore, J, Blighe, K, Ng, KY, Quinn, N, Jennings, F, Warnock, G, Sharpe, P, Clarke, M, Maguire, K, Rainey, S, Price, RK, Burns, W, Kowalczyk, A, Awuah, A, Mc Namee, S, Wallace, G, Hunter, D, Sager, S, Chao-Shern, C, Nesbit, MA , McLaughlin, J & Moore, TCB 2021, 'Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months', BMJ Open, vol. 11, no. 6. https://doi.org/10.1136/bmjopen-2020-048142

TY - JOUR

T1 - Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months

AU - Robertson, Louise

AU - Moore, Julie

AU - Blighe, Kevin

AU - Ng, Kok Yew

AU - Quinn, Nigel

AU - Jennings, Fergal

AU - Warnock, Gary

AU - Sharpe, Peter

AU - Clarke, Mark

AU - Maguire, Kathryn

AU - Rainey, Sharon

AU - Price, RK

AU - Burns, William

AU - Kowalczyk, Amanda

AU - Awuah, Agnes

AU - Mc Namee, Sara

AU - Wallace, Gayle

AU - Hunter, David

AU - Sager, Steve

AU - Chao-Shern, Connie

AU - Nesbit, M. Andrew

AU - McLaughlin, James

AU - Moore, Tara C. B.

N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021/6/29

Y1 - 2021/6/29

N2 - 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.

AB - 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.

KW - Antibodies, Viral

KW - Antibody Formation

KW - COVID-19

KW - Covid-19

KW - Cross-Sectional Studies

KW - Diagnostic Microbiology

KW - Humans

KW - Immunization, Passive

KW - Immunoassay

KW - Immunoglobulin G

KW - Molecular Diagnostics

KW - Northern Ireland

KW - SARS-CoV-2

KW - Sensitivity and Specificity

KW - Spike Glycoprotein, Coronavirus

KW - molecular diagnostics

KW - diagnostic microbiology

UR - https://www.scopus.com/pages/publications/85110017433

U2 - 10.1136/bmjopen-2020-048142

DO - 10.1136/bmjopen-2020-048142

M3 - Article

C2 - 34187827

SN - 2044-6055

VL - 11

JO - BMJ Open

JF - BMJ Open

IS - 6

ER -

Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months

Abstract

Bibliographical note

UN SDGs

Keywords

Access to Document

Other files and links

Fingerprint

SARS-CoV-2 antibody testing in a UK population: detectable IgG for up to 20 weeks post infection

Preclinical development of genes therapies in a genetic eye disease

Using the eye to predict risk for cardiovascular disease: the living lab

Cite this

Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months

Abstract

Bibliographical note

UN SDGs

Keywords

Access to Document

Other files and links

Fingerprint

Research output

SARS-CoV-2 antibody testing in a UK population: detectable IgG for up to 20 weeks post infection

Student theses

Preclinical development of genes therapies in a genetic eye disease

Using the eye to predict risk for cardiovascular disease: the living lab

Cite this