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Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test.
Meschi, Silvia; Colavita, Francesca; Bordi, Licia; Matusali, Giulia; Lapa, Daniele; Amendola, Alessandra; Vairo, Francesco; Ippolito, Giuseppe; Capobianchi, Maria Rosaria; Castilletti, Concetta.
  • Meschi S; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
  • Colavita F; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
  • Bordi L; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
  • Matusali G; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
  • Lapa D; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
  • Amendola A; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
  • Vairo F; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
  • Ippolito G; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
  • Capobianchi MR; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy. Electronic address: maria.capobianchi@inmi.it.
  • Castilletti C; National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Rome, Italy.
J Clin Virol ; 129: 104539, 2020 08.
Article in English | MEDLINE | ID: covidwho-633896
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Serologic Tests / Neutralization Tests / Coronavirus Infections / Fluorescent Antibody Technique, Indirect / Clinical Laboratory Techniques / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Infant / Male / Middle aged Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: J.jcv.2020.104539

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Serologic Tests / Neutralization Tests / Coronavirus Infections / Fluorescent Antibody Technique, Indirect / Clinical Laboratory Techniques / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Infant / Male / Middle aged Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: J.jcv.2020.104539