TY - JOUR
T1 - Clinical evaluation of the abbott alinity sars-cov-2 spike-specific quantitative igg and igm assays among infected, recovered, and vaccinated groups
AU - Narasimhan, Madhusudhanan
AU - Mahimainathan, Lenin
AU - Araj, Ellen
AU - Clark, Andrew E.
AU - Markantonis, John
AU - Green, Allen
AU - Xu, Jing
AU - SoRelle, Jeffrey A.
AU - Alexis, Charles
AU - Fankhauser, Kimberly
AU - Parikh, Hiren
AU - Wilkinson, Kathleen
AU - Reczek, Annika
AU - Kopplin, Noa
AU - Yekkaluri, Sruthi
AU - Balani, Jyoti
AU - Thomas, Abey
AU - Singal, Amit G.
AU - Sarode, Ravi
AU - Muthukumar, Alagarraju
N1 - Publisher Copyright:
© 2021 American Society for Microbiology.
PY - 2021/7
Y1 - 2021/7
N2 - The coronavirus disease 19 (COVID-19) pandemic continues to impose a significant burden on global health infrastructure. While identification and containment of new cases remain important, laboratories must now pivot and consider an assessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunity in the setting of the recent availability of multiple COVID-19 vaccines. Here, we have utilized the latest Abbott Alinity semiquantitative IgM and quantitative IgG spike protein (SP) serology assays (IgMSP and IgGSP) in combination with Abbott Alinity IgG nucleocapsid (NC) antibody test (IgGNC) to assess antibody responses in a cohort of 1,236 unique participants comprised of naive, SARS-CoV-2-infected, and vaccinated (including both naive and recovered) individuals. The IgMSP and IgGSP assays were highly specific (100%) with no cross-reactivity to archived samples collected prior to the emergence of SARS-CoV-2, including those from individuals with seasonal coronavirus infections. Clinical sensitivity was 96% after 15 days for both IgMSP and IgGSP assays individually. When considered together, the sensitivity was 100%. A combination of NC- and SP-specific serologic assays clearly differentiated naive, SARS-CoV-2-infected, and vaccine-related immune responses. Vaccination resulted in a significant increase in IgGSP and IgMSP values, with a major rise in IgGSP following the booster (second) dose in the naive group. In contrast, SARS-CoV-2- recovered individuals had several-fold higher IgGSP responses than naive following the primary dose, with a comparatively dampened response following the booster. This work illustrates the strong clinical performance of these new serological assays and their utility in evaluating and distinguishing serological responses to infection and vaccination.
AB - The coronavirus disease 19 (COVID-19) pandemic continues to impose a significant burden on global health infrastructure. While identification and containment of new cases remain important, laboratories must now pivot and consider an assessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunity in the setting of the recent availability of multiple COVID-19 vaccines. Here, we have utilized the latest Abbott Alinity semiquantitative IgM and quantitative IgG spike protein (SP) serology assays (IgMSP and IgGSP) in combination with Abbott Alinity IgG nucleocapsid (NC) antibody test (IgGNC) to assess antibody responses in a cohort of 1,236 unique participants comprised of naive, SARS-CoV-2-infected, and vaccinated (including both naive and recovered) individuals. The IgMSP and IgGSP assays were highly specific (100%) with no cross-reactivity to archived samples collected prior to the emergence of SARS-CoV-2, including those from individuals with seasonal coronavirus infections. Clinical sensitivity was 96% after 15 days for both IgMSP and IgGSP assays individually. When considered together, the sensitivity was 100%. A combination of NC- and SP-specific serologic assays clearly differentiated naive, SARS-CoV-2-infected, and vaccine-related immune responses. Vaccination resulted in a significant increase in IgGSP and IgMSP values, with a major rise in IgGSP following the booster (second) dose in the naive group. In contrast, SARS-CoV-2- recovered individuals had several-fold higher IgGSP responses than naive following the primary dose, with a comparatively dampened response following the booster. This work illustrates the strong clinical performance of these new serological assays and their utility in evaluating and distinguishing serological responses to infection and vaccination.
KW - Antibody
KW - COVID-19
KW - IgG
KW - IgM
KW - Immunoassays
KW - Nucleocapsid
KW - SARS-CoV-2
KW - Spike
KW - Vaccine
UR - http://www.scopus.com/inward/record.url?scp=85104768367&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85104768367&partnerID=8YFLogxK
U2 - 10.1128/JCM.00388-21
DO - 10.1128/JCM.00388-21
M3 - Article
C2 - 33827901
AN - SCOPUS:85104768367
SN - 0095-1137
VL - 59
JO - Journal of clinical microbiology
JF - Journal of clinical microbiology
IS - 7
M1 - e00388-21
ER -