A Highly Sensitive and Specific SARS-CoV-2 Spike- and Nucleoprotein-Based Fluorescent Multiplex Immunoassay (FMIA) to Measure IgG, IgA, and IgM Class Antibodies

Solastie, Anna; Virta, Camilla; Haveri, Anu; Ekström, Nina; Miettinen, Simo; Lempainen, Johanna; Jalkanen, Pinja; Kakkola, Laura; Dub, Timothée; Julkunen, Ilkka; Melin, Merit

doi:10.1128/spectrum.01131-21

Cited by 24 publications

(38 citation statements)

References 27 publications

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“…At the international level, similar studies describing COVID-19 immunoassays have been reported from several research groups [ 29 , 30 , 31 , 32 , 33 , 34 ]. Most of these immunoassays were based on SARS-CoV-2 full-length S, NP, or fragments of S (e.g., receptor binding domain).…”

Section: Development Of Serological Assays For Covid-19supporting

confidence: 53%

“…Most of these immunoassays were based on SARS-CoV-2 full-length S, NP, or fragments of S (e.g., receptor binding domain). In some cases, assays were optimized not only for detection of IgM and IgG, but also for IgA [ 33 ]. Validation of results was also evaluated against RT-PCR, the MN assay, and commercially available kits [ 29 , 30 , 31 , 32 , 33 , 34 ].…”

Section: Development Of Serological Assays For Covid-19mentioning

confidence: 99%

“…In some cases, assays were optimized not only for detection of IgM and IgG, but also for IgA [ 33 ]. Validation of results was also evaluated against RT-PCR, the MN assay, and commercially available kits [ 29 , 30 , 31 , 32 , 33 , 34 ]. Herein, we review several in-house immunoassays developed in Saudi Arabia.…”

Section: Development Of Serological Assays For Covid-19mentioning

confidence: 99%

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Development of Serological Assays and Seroprevalence Studies of the New Coronavirus 2019 (COVID-19): Reports from Saudi Arabia

Alandijany

Faizo

2021

Healthcare

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Serological assays are valuable tools for tracking COVID-19 spread, estimation of herd immunity, and evaluation of vaccine effectiveness. Several reports from Saudi Arabia describe optimized in-house protocols that enable detection of SARS-CoV-2 specific antibodies and measurement of their neutralizing activity. Notably, there were variations in the approaches utilized to develop and validate these immunoassays in term of sample size, validation methodologies, and statistical analyses. The developed enzyme-linked immunoassays (ELISAs) were based on the viral full-length spike (S), S1 subunit, and nucleocapsid (NP), and enabled detection of IgM and/or IgG. ELISAs were evaluated and validated against a microneutralization assay utilizing a local SARS-CoV-2 clinical isolate, FDA-approved commercially available immunoassays, and/or real-time polymerase chain reaction (RT-PCR). Overall, the performance of the described assays was high, reaching up to 100% sensitivity and 98.9% specificity with no cross-reactivity with other coronaviruses. In-house immunoassays, along with commercially available kits, were subsequently applied in a number of sero-epidemiological studies aiming to estimate sero-positivity status among local populations including healthcare workers, COVID-19 patients, non-COVID-19 patients, and healthy blood donors. The reported seroprevalence rates differed widely among these studies, ranging from 0.00% to 32.2%. These variations are probably due to study period, targeted population, sample size, and performance of the immunoassays utilized. Indeed, lack of sero-positive cases were reported among healthy blood donors during the lockdown, while the highest rates were reported when the number of COVID-19 cases peaked in the country, particularly among healthcare workers working in referral hospitals and quarantine sites. In this review, we aim to (1) provide a critical discussion about the developed in-house immunoassays, and (2) summarize key findings of the sero-epidemiological studies and highlight strengths and weaknesses of each study.

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Section: Development Of Serological Assays For Covid-19supporting

confidence: 53%

Section: Development Of Serological Assays For Covid-19mentioning

confidence: 99%

Section: Development Of Serological Assays For Covid-19mentioning

confidence: 99%

See 1 more Smart Citation

Development of Serological Assays and Seroprevalence Studies of the New Coronavirus 2019 (COVID-19): Reports from Saudi Arabia

Alandijany

Faizo

2021

Healthcare

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“…Neutralizing antibodies mainly target the RBD and NTD of spike ( 9 , 16 , 17 ). Previous studies have shown that the levels of antibodies against different forms of spike (including S1, S1/S2, and RBD) correlate well with the neutralization capacity of the samples ( 27 – 32 ). However, the relationship between the neutralizing activity of the polyclonal response in each individual and its domain specificity, as well as the variation in this relationship between different hosts, is still poorly characterized.…”

Section: Resultsmentioning

confidence: 95%

Limited Variation between SARS-CoV-2-Infected Individuals in Domain Specificity and Relative Potency of the Antibody Response against the Spike Glycoprotein

et al. 2022

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“…Other studies also suggest that SARS-CoV-2 serology tests cannot be calibrated to the same measurement “ruler” and results compared between assays (Cooper et al, 2018 ; Bradley et al, 2021 ; Castillo-Olivares et al, 2021 ; Giavarina and Carta, 2021 ; Infantino et al, 2021 ; Perkmann et al, 2021 ; Solastie et al, 2021 ; Knezevic et al, 2022 ). It is also important to note that the IU or BAU assigned to the WHO IS is arbitrary and not based on an analytical concentration measurement.…”

Section: Discussionmentioning

confidence: 99%

Harmonization of Multiple SARS-CoV-2 Reference Materials Using the WHO IS (NIBSC 20/136): Results and Implications

et al. 2022

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BackgroundThere is an urgent need for harmonization between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology platforms and assays prior to defining appropriate correlates of protection and as well inform the development of new rapid diagnostic tests that can be used for serosurveillance as new variants of concern (VOC) emerge. We compared multiple SARS-CoV-2 serology reference materials to the WHO International Standard (WHO IS) to determine their utility as secondary standards, using an international network of laboratories with high-throughput quantitative serology assays. This enabled the comparison of quantitative results between multiple serology platforms.MethodsBetween April and December 2020, 13 well-characterized and validated SARS-CoV-2 serology reference materials were recruited from six different providers to qualify as secondary standards to the WHO IS. All the samples were tested in parallel with the National Institute for Biological Standards and Control (NIBSC) 20/136 and parallel-line assays were used to calculate the relevant potency and binding antibody units.ResultsAll the samples saw varying levels of concordance between diagnostic methods at specific antigen–antibody combinations. Seven of the 12 candidate materials had high concordance for the spike-immunoglobulin G (IgG) analyte [percent coefficient of variation (%CV) between 5 and 44%].ConclusionDespite some concordance between laboratories, qualification of secondary materials to the WHO IS using arbitrary international units or binding antibody units per milliliter (BAU/ml) does not provide any benefit to the reference materials overall, due to the lack of consistent agreeable international unit (IU) or BAU/ml conversions between laboratories. Secondary standards should be qualified to well-characterized reference materials, such as the WHO IS, using serology assays that are similar to the ones used for the original characterization of the WHO IS.

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A Highly Sensitive and Specific SARS-CoV-2 Spike- and Nucleoprotein-Based Fluorescent Multiplex Immunoassay (FMIA) to Measure IgG, IgA, and IgM Class Antibodies

Cited by 24 publications

References 27 publications

Development of Serological Assays and Seroprevalence Studies of the New Coronavirus 2019 (COVID-19): Reports from Saudi Arabia

Development of Serological Assays and Seroprevalence Studies of the New Coronavirus 2019 (COVID-19): Reports from Saudi Arabia

Limited Variation between SARS-CoV-2-Infected Individuals in Domain Specificity and Relative Potency of the Antibody Response against the Spike Glycoprotein

Harmonization of Multiple SARS-CoV-2 Reference Materials Using the WHO IS (NIBSC 20/136): Results and Implications

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