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Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test.
J Clin Virol. 2020 08; 129:104539.JC

Abstract

BACKGROUND

Serological tests for anti-SARS-CoV-2 antibodies are becoming of great interest to determine seroprevalence in a given population, define previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic.

OBJECTIVES

We evaluated the diagnostic performance of the Abbott ARCHITECT SARS-CoV-2 IgG test, a fully automated indirect immunoassay that detects antibodies directed to a recombinant SARS-CoV-2 Nucleocapsid antigen.

STUDY DESIGN

Abbott ARCHITECT SARS-CoV-2 IgG immunoassay was compared to an indirect immunofluorescence assay (IFA) on sera from patients with COVID-19 collected at different days after symptoms onset or infected by other human coronaviruses. Comparison with neutralization test was also performed.

RESULTS

After 7, 14 and >14 days after onset ARCHITECT was positive on 8.3 %; 61.9 % and 100 % of the tested samples compared to 58.3 %; 85.7 % and 100 % by IFA. The sensitivity was 72 % vs. IFA and 66.7 % vs. a real-time PCR, the specificity was 100 %. On 18 samples with neutralizing activity, 17 were positive by Abbott ARCHITECT SARS-CoV-2 IgG.

CONCLUSIONS

In our study, Abbott ARCHITECT SARS-CoV-2 IgG assay showed a satisfactory performance, with a very high specificity. IgG reactivity against SARSCoV-2 N antigen was detectable in all patients by two weeks after symptoms onset. In addition, concordance between this serological response and viral neutralization suggests that a strong humoral response may be predictive of a neutralization activity, regardless of the target antigens. This finding supports the use of this automated serological assay in diagnostic algorithm and public health intervention, especially for high loads of testing.

Authors+Show Affiliations

National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy. Electronic address: maria.capobianchi@inmi.it.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32679298

Citation

Meschi, Silvia, et al. "Performance Evaluation of Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay in Comparison With Indirect Immunofluorescence and Virus Microneutralization Test." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 129, 2020, p. 104539.
Meschi S, Colavita F, Bordi L, et al. Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test. J Clin Virol. 2020;129:104539.
Meschi, S., Colavita, F., Bordi, L., Matusali, G., Lapa, D., Amendola, A., Vairo, F., Ippolito, G., Capobianchi, M. R., & Castilletti, C. (2020). Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 129, 104539. https://doi.org/10.1016/j.jcv.2020.104539
Meschi S, et al. Performance Evaluation of Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay in Comparison With Indirect Immunofluorescence and Virus Microneutralization Test. J Clin Virol. 2020;129:104539. PubMed PMID: 32679298.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test. AU - Meschi,Silvia, AU - Colavita,Francesca, AU - Bordi,Licia, AU - Matusali,Giulia, AU - Lapa,Daniele, AU - Amendola,Alessandra, AU - Vairo,Francesco, AU - Ippolito,Giuseppe, AU - Capobianchi,Maria Rosaria, AU - Castilletti,Concetta, AU - ,, Y1 - 2020/07/06/ PY - 2020/06/23/received PY - 2020/07/05/accepted PY - 2020/7/18/pubmed PY - 2020/8/12/medline PY - 2020/7/18/entrez KW - CLIA KW - COVID-19 KW - IgG KW - Immunofluorescence assay KW - SARS-CoV-2 KW - Serological assay SP - 104539 EP - 104539 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - BACKGROUND: Serological tests for anti-SARS-CoV-2 antibodies are becoming of great interest to determine seroprevalence in a given population, define previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic. OBJECTIVES: We evaluated the diagnostic performance of the Abbott ARCHITECT SARS-CoV-2 IgG test, a fully automated indirect immunoassay that detects antibodies directed to a recombinant SARS-CoV-2 Nucleocapsid antigen. STUDY DESIGN: Abbott ARCHITECT SARS-CoV-2 IgG immunoassay was compared to an indirect immunofluorescence assay (IFA) on sera from patients with COVID-19 collected at different days after symptoms onset or infected by other human coronaviruses. Comparison with neutralization test was also performed. RESULTS: After 7, 14 and >14 days after onset ARCHITECT was positive on 8.3 %; 61.9 % and 100 % of the tested samples compared to 58.3 %; 85.7 % and 100 % by IFA. The sensitivity was 72 % vs. IFA and 66.7 % vs. a real-time PCR, the specificity was 100 %. On 18 samples with neutralizing activity, 17 were positive by Abbott ARCHITECT SARS-CoV-2 IgG. CONCLUSIONS: In our study, Abbott ARCHITECT SARS-CoV-2 IgG assay showed a satisfactory performance, with a very high specificity. IgG reactivity against SARSCoV-2 N antigen was detectable in all patients by two weeks after symptoms onset. In addition, concordance between this serological response and viral neutralization suggests that a strong humoral response may be predictive of a neutralization activity, regardless of the target antigens. This finding supports the use of this automated serological assay in diagnostic algorithm and public health intervention, especially for high loads of testing. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32679298/Performance_evaluation_of_Abbott_ARCHITECT_SARS_CoV_2_IgG_immunoassay_in_comparison_with_indirect_immunofluorescence_and_virus_microneutralization_test_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30281-X DB - PRIME DP - Unbound Medicine ER -