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

doi:10.1016/j.jcv.2020.104539

Cited by 90 publications

(91 citation statements)

References 6 publications

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“…Our results seem comparable to previous studies in which the CLA test that we used showed a sensitivity and specificity close to 100% when compared with PCR +/samples [23][24][25], while the LFA [26] and the ELFA [17] appear to be less sensitive and (Table 1).…”

Section: Discussionsupporting

confidence: 89%

Seroprevalence and seroconversion rates to SARS-CoV-2 in interns, residents, and medical doctors in a University Hospital in Bogotá, Colombia

Ariza

Torres-Llanos

Salgado

et al. 2020

Preprint

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Objectives To determine the prevalence of antibodies to SARS-CoV-2 and the incidence of seroconversion in the first month of follow-up among interns, residents, and medical doctors attending patients at a University Hospital, to explore for associations of seroprevalence and seroconversion with risk factors and symptoms compatible with COVID-19, and to explore the concordance of CLA, LFA, and ELFA. Design or methods We conducted a cross-sectional and a prospective study among medical doctors and medical trainees at Hospital Universitario San Ignacio in Bogota (Colombia) during June, July, and August to assess seroprevalence and seroconversion rates in this population was performed using CLA IgG for SARS-CoV-2. LFA IgG and IgM and ELFA IgM were also determined to explore concordance with CLA IgG. Results At baseline, 8 (2.28% 95%CI 1.16-4.43%) individuals were IgG positive for SARS-CoV-2 by CLA. At the end of the study, 21 (5.98% 95%CI 3.94-8.97%) individuals seroconverted by CLA IgG. In all, 29 individuals had IgG by CLA and of these 11 (3.13% 95%CI 1.76-5.52%) were asymptomatic. No associations with risk factors for infection were identified. CLA had moderate concordance with LFA IgG and ELFA, but minimal with LFA IgM. Conclusions Our report is one of the first in Latina America on seroprevalence and seroconversion rates in medical healthcare workers. It emphasizes the importance of avoiding focusing only on symptomatic individuals to screen this population for SARS-CoV-2 infection, since of all individuals that have evidence of previous infection many (37.93%) may be pre-symptomatic or asymptomatic and may contribute to infection/disease spread.

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Section: Discussionsupporting

confidence: 89%

Seroprevalence and seroconversion rates to SARS-CoV-2 in interns, residents, and medical doctors in a University Hospital in Bogotá, Colombia

Ariza

Torres-Llanos

Salgado

et al. 2020

Preprint

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“…Assays to detect nAbs are technically challenging and not routinely performed by clinical laboratories, however the need to determine the nAb titer as part of vaccine clinical trials and initially in convalescent plasma donors prior to transfusion necessitated the availability of such assays; whether the S/Co ratio provided by commercially available assays correlate to nAb levels is yet to be determined. Additionally, as semiquantitative and quantitative antibody assays come to market, correlation between reported values and neutralizing antibody levels will also be important to establish (13)(14)(15).…”

Section: Interpretation Of Serologic Test Resultsmentioning

confidence: 99%

Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization

et al. 2020

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Interest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitations and reporting considerations for laboratories. Assessments concerning single and multi-antibody isotype detection assays, which may provide either differentiated or non-differentiated (i.e., total antibody) antibody class results, are addressed. Additional considerations prior to assay implementation are also discussed, including biosafety, quality control and proficiency testing strategies. As the landscape of SARS-CoV-2 serologic testing is rapidly changing, this document provides updated guidance for laboratorians on application of these assays.

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“…In contrast, the indirect immunofluorescence assay had sensitivities of 58.3%, 85.7%, and 100% at 7, 14, and >14 days, respectively. 25 The study suggests that indirect immunofluorescence assays may be better for detecting SARS-CoV-2 antigens or antibodies at the early stages of infection compared to the Abbott Architect SARS-CoV-2 IgG immunoassay. An Italian study also assessed the sensitivity and specificity of the LIAISON SARS-CoV-2 S1/S2 IgG assay using 1500 clinical samples.…”

Section: Italian Antibody Studiesmentioning

confidence: 90%

“…An Italian study compared the Abbott Architect SARS-CoV-2 IgG immunoassay to an indirect immunofluorescence assay and a neutralization assay from COVID-19 samples collected at different times from symptom onset. 25 The sensitivities of the Abbott Architect SARS-CoV-2 IgG immunoassay at 7, 14, and >14 days were 8.3%, 61.9%, and 100%, respectively. In contrast, the indirect immunofluorescence assay had sensitivities of 58.3%, 85.7%, and 100% at 7, 14, and >14 days, respectively.…”

Section: Italian Antibody Studiesmentioning

confidence: 94%

Antibody tests for COVID-19

Kopel

Goyal

Perisetti

2020

Baylor University Medical Center Proceedings

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The SARS-CoV-2 virus caused a globally growing pandemic called coronavirus disease 2019 (COVID-19) that has disrupted social, political, and medical environments around the world. Nations are assessing ways to reopen businesses while trying to balance health care risks and economic fallouts. Strategies involving antibody testing have been proposed before phased reopening of the economy. Therefore, assessing the sensitivity and specificity of antibody tests for symptomatic and asymptomatic COVID-19 patients remains paramount to prevent COVID-19 outbreaks. The antibody tests for SARS-CoV-2 detect the presence of IgA, IgM, or IgG antibodies produced by B cells. There are four major types of antibody tests: rapid diagnostic tests, enzymelinked immunosorbent assays, neutralization assays, and chemiluminescent immunoassays. Currently, there is no standard antibody test for detecting SARS-CoV-2 antibodies during or after exposure or infection. The antibody tests for SARS-CoV-2 have a low specificity within the first week of exposure and increase in the second and third weeks. The current data on antibody tests have several limitations in quality and the presence of bias. Specifically, many antibody tests have a high false-negative rate and a high risk of bias for participant selection, application of index tests, reference standard used, and flow and timing for antibody tests that may incorrectly report the accuracy of COVID-19 antibody tests. In this review, we summarize the current methods, sensitivity/specificity, and gaps in knowledge concerning COVID-19 antibody testing.

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Performance evaluation of Abbott ARCHITECT SARS-CoV-2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test

Cited by 90 publications

References 6 publications

Seroprevalence and seroconversion rates to SARS-CoV-2 in interns, residents, and medical doctors in a University Hospital in Bogotá, Colombia

Seroprevalence and seroconversion rates to SARS-CoV-2 in interns, residents, and medical doctors in a University Hospital in Bogotá, Colombia

Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization

Antibody tests for COVID-19

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