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Evaluation of the QuantiFERON SARS-CoV-2 interferon-ɣ release assay in mRNA-1273 vaccinated health care workers.

ABSTRACT: Current studies focus on cellular and humoral immunity induced by novel SARS-CoV-2 vaccines. Non-responders to vaccinations are not uncommonly encountered in clinical medicine (e.g. in the field of hepatitis B). Whereas vaccine-induced humoral immunity against SARS-CoV-2 is compromised by emerging Variants of Concern (VOCs), cellular immunity against SARS-CoV-2 is emerging as resilient against VOCs. Thus commercially available test kits for diagnostic laboratories designed to evaluate cellular immune responses to SARS-CoV-2 are urgently needed. Here we evaluated the novel QuantiFERON SARS-CoV-2 assay (Qiagen) measuring INF-ɣ release induced by two spike-derived peptide pools (Ag1 and Ag2) in a cohort of health care workers vaccinated with the mRNA-1273 vaccine and confirmed humoral response. Our study indicates the usefulness of this novel assay for routine laboratories to evaluate cellular immunity against SARS-CoV-2 in response to mRNA-1273 vaccination.

SUBMITTER: Kruttgen A

PROVIDER: S-EPMC8452154 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Evaluation of the QuantiFERON SARS-CoV-2 interferon-ɣ release assay in mRNA-1273 vaccinated health care workers.

Krüttgen Alexander A Klingel Hanna H Haase Gerhard G Haefner Helga H Imöhl Matthias M Kleines Michael M

Journal of virological methods 20210920

Current studies focus on cellular and humoral immunity induced by novel SARS-CoV-2 vaccines. Non-responders to vaccinations are not uncommonly encountered in clinical medicine (e.g. in the field of hepatitis B). Whereas vaccine-induced humoral immunity against SARS-CoV-2 is compromised by emerging Variants of Concern (VOCs), cellular immunity against SARS-CoV-2 is emerging as resilient against VOCs. Thus commercially available test kits for diagnostic laboratories designed to evaluate cellular i ...[more]

PMID: 34555429

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Project description:Urgent improvements in the diagnosis and management of Mycobacterium tuberculosis infection are required to reach End TB goals. Conventional interferon-gamma release assays (IGRAs), such as QuantiFERON-TB Gold Plus (QFT-Plus), require substantial laboratory infrastructure and large blood volumes, limiting use in high-burden settings. The QIAreach QuantiFERON-TB (QIAreach QFT) was developed to overcome these challenges but has not previously been evaluated in field conditions in a low-income, high-burden country, or at scale in children. We performed a diagnostic evaluation of QIAreach QFT against QFT-Plus, in a cross-sectional IGRA survey in Blantyre, Malawi. We recruited a population-representative sample of children aged 1-4 years and adolescents and adults aged 10-40 years, from households and primary care. We calculated sensitivity, specificity, and Cohen's kappa for QIAreach QFT against QFT-Plus, and constructed Bayesian hurdle-categorical models to compare quantitative test results. A total of 1,049 participants were recruited (64%: 1-4 years; 13%: 10-19 years; and 23%: 20-40 years). More participants had a positive QIAreach QFT result (32%) compared to QFT-Plus (15%). Over half of positive QIAreach QFT results had time-to-positivity of exactly 20 min, the assay cutoff. There was minimal agreement between QFT-Plus and QIAreach QFT results (κ = 0.26), which was lowest in children aged 1-4 years (κ = 0.13). Sensitivity and specificity of QIAreach QFT relative to QFT-Plus were 62% and 74%, respectively, with poor correlation between quantitative results. The suboptimal performance of QIAreach QFT, particularly in young children, suggests that it cannot currently be recommended for wider use and that the urgent need for an accessible test of Mtb infection remains unmet.ImportanceAlmost a quarter of the world's population has evidence of Mycobacterium tuberculosis (Mtb) infection. Monitoring and addressing this substantial burden of so-called "latent" tuberculosis (TB) infection will be critical to reach End TB targets. However, current interferon-gamma release assays (IGRAs) for Mtb infection are costly, and require a large volume of venous blood and significant laboratory processing, which are major barriers to their wider use in low-income countries. The novel QIAreach QuantiFERON-TB (QIAreach) assay has been designed as a more accessible alternative. We sought to evaluate it against a reference standard of QuantiFERON-TB Gold Plus, in a large cross-sectional survey in Blantyre, Malawi. To our knowledge, this is the first diagnostic evaluation of QIAreach QFT to be performed in a population-based survey in a low-income high-incidence setting, and to specifically focus on young children (a priority group for interventions targeting Mtb infection). In contrast to previous studies in other settings, we observed poor performance of QIAreach QFT, particularly in young children where there was little correlation between the novel test and the reference standard. This leads us to conclude that this test cannot be widely recommended for use in its current form; indeed manufacture is currently suspended. We believe our findings are of urgent importance to policymakers, clinicians, and researchers and underscore the importance of careful evaluation of new diagnostics in the contexts where they are intended to be used.

Project description:BackgroundPatients affected by different types of autoimmune diseases, including common conditions such as multiple sclerosis (MS) and rheumatoid arthritis (RA), are often treated with immunosuppressants to suppress disease activity. It is not fully understood how the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific humoral and cellular immunity induced by infection and/or upon vaccination is affected by immunosuppressants.MethodsThe dynamics of cellular immune reactivation upon vaccination of SARS-CoV-2 experienced MS patients treated with the humanized anti-CD20 monoclonal antibody ocrelizumab (OCR) and RA patients treated with methotrexate (MTX) monotherapy were analyzed at great depth via high-dimensional flow cytometry of whole blood samples upon vaccination with the SARS-CoV-2 mRNA-1273 (Moderna) vaccine. Longitudinal B and T cell immune responses were compared to SARS-CoV-2 experienced healthy controls (HCs) before and 7 days after the first and second vaccination.ResultsOCR-treated MS patients exhibit a preserved recall response of CD8+ T central memory cells following first vaccination compared to HCs and a similar CD4+ circulating T follicular helper 1 and T helper 1 dynamics, whereas humoral and B cell responses were strongly impaired resulting in absence of SARS-CoV-2-specific humoral immunity. MTX treatment significantly delayed antibody levels and B reactivation following the first vaccination, including sustained inhibition of overall reactivation marker dynamics of the responding CD4+ and CD8+ T cells.ConclusionsTogether, these findings indicate that SARS-CoV-2 experienced MS-OCR patients may still benefit from vaccination by inducing a broad CD8+ T cell response which has been associated with milder disease outcome. The delayed vaccine-induced IgG kinetics in RA-MTX patients indicate an increased risk after the first vaccination, which might require additional shielding or alternative strategies such as treatment interruptions in vulnerable patients.FundingThis research project was supported by ZonMw (The Netherlands Organization for Health Research and Development, #10430072010007), the European Union's Horizon 2020 research and innovation program under the Marie Skłodowska-Curie grant agreement (#792532 and #860003), the European Commission (SUPPORT-E, #101015756) and by PPOC (#20_21 L2506), the NHMRC Leadership Investigator Grant (#1173871).

Dataset Information

Evaluation of the QuantiFERON SARS-CoV-2 interferon-ɣ release assay in mRNA-1273 vaccinated health care workers.

Publications

Evaluation of the QuantiFERON SARS-CoV-2 interferon-ɣ release assay in mRNA-1273 vaccinated health care workers.

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