Introduction There is an increasing body of evidence surrounding the importance of a T cell-mediated response to SARS-CoV-2 infection and after COVID-19 vaccination. In this internal feasibility study, we evaluated both the total antibody (IgA, IgM, and IgG) and T cell responses in a cohort of COVID-19 convalescents and vaccinated individuals. Methods Whole blood specimens were collected weekly from 12 subjects at different time points within/after the COVID-19 mRNA vaccination regimen, and from 4 PCR-confirmed convalescent donors to measure durability of humoral and cell-mediated immune response. T cell and antibody responses were evaluated via the QuantiFERON SARS-CoV-2 research use only (QFN SARS-CoV-2) assay which is an interferon gamma release assay (IGRA) and QIAreach Anti-SARS-CoV-2 total (Anti-CoV-2) test, respectively. Results In a cohort of recently vaccinated individuals, subjects demonstrated robust total antibody and CD4+/CD8+ T cell response to SARS-CoV-2 mRNA vaccines when followed for 2 months post-2nd dose. In most individuals, T cell response declined between the 1st and 2nd doses suggesting a need for a booster or the completion of the 2-dose vaccine series. In a group of convalescent donors tested with QFN SARS-CoV-2 and Anti-CoV-2 tests, all patients had an antibody and T cell response up to 1 year after natural infection. Conclusion This small feasibility study demonstrates that the QFN-SARS-CoV-2 test is able to identify CD4+ and CD8+ T cell-mediated responses in SARS-CoV-2-vaccinated subjects and those recovered from COVID-19, alongside a qualitative antibody response detectable via the QIAreach Anti-CoV2 test.

Introduction: There is an increasing body of evidence surrounding the importance of a T-cell mediated response to SARS-CoV-2 infection and after COVID-19 vaccination. In this internal feasibility study, we evaluated both the total antibody (IgA, IgM, and IgG) and T-cell responses in a cohort of COVID-19 convalescents and vaccinated individuals.Methods: Whole blood specimens were collected weekly from 12 subjects at different timepoints within/after the COVID-19 mRNA vaccination regimen and from 4 PCR-confirmed convalescent donors to measure durability of humoral and cell-mediated immune response. T-cell and Antibody responses were evaluated via the QuantiFERON SARS-CoV-2 Research Use Only (QFN SARS-CoV-2) assay which is an interferon gamma release assay (IGRA) and QIAreach Anti-SARS-CoV-2 Total (Anti-CoV-2) Test, respectively.Results: In a cohort of recently vaccinated individuals, subjects demonstrated robust total antibody and CD4+/CD8+ T-cell response to SARS-CoV-2 mRNA vaccines when followed for 2 months post 2nd dose. In most individuals, T-cell response declined between 1st and 2nd dose suggesting need for booster or completion of the 2-dose vaccine series. In a group of convalescent donors tested with QFN SARS-CoV-2 and Anti-CoV-2 tests, all patients had an antibody and T-cell response up to 1 year after natural infection.Conclusion: This small feasibility study demonstrates that QFN-SARS-CoV-2 test is able to identify CD4+ and CD8+ T-cell mediated responses in SARS-CoV-2 vaccinated subjects and those recovered from COVID-19, alongside a qualitative antibody response detectable via the QIAreach Anti-CoV2 Test.

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BACKGROUND: Programmatic management of TB infection is a critical component of the WHO End TB Strategy. Interferon-gamma release assays (IGRAs) overcome some limitations of the tuberculin skin test, but implementation of IGRA testing in low-resource settings is challenging.METHODS: In this feasibility study, we evaluated performance of a novel digital lateral-flow assay, the QIAreach® QuantiFERON® TB (QIAreach-QFT) test, against the QuantiFERON®-TB Gold Plus (QFT-Plus) assay. A population with a mix of risk factors for TB infection (111 donors) were sampled over multiple days. A total of 207 individual blood samples were tested according to the manufacturer´s instructions.RESULTS: The overall percentage agreement was 95.6% (two-sided 95% CI 91.8–98), with a positive percentage agreement (i.e., sensitivity) of 100% (95% CI 94.7–100) and a negative percentage agreement (i.e., specificity) of 95.6% (95% CI 90.6–98.4). All QFT-Plus positive specimens with TB1-Nil and TB2-Nil values less than 1 IU/ml tested positive on QIAreach-QFT.CONCLUSIONS: QIAreach QFT is a deployable, accurate testing solution for decentralised testing. It has the potential to overcome key hurdles for TB infection screening in high-burden settings thus helping to achieve the WHO End TB programme goals.

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Highlights The QIAreach™ Anti-SARS-CoV-2 Total Test (Anti-CoV2) is a rapid, qualitative serological test. Anti-CoV2 uses nanoparticle fluorescence technology to detect total antibody against SARS-CoV-2. Anti-CoV2 had 100 % sensitivity (PPA; 95 % CI 88.4–100 %) and 100 % specificity (NPA; 95 % CI 95.2–100 %). No cross-reactivity observed with seasonal coronaviruses or other respiratory pathogens tested. Anti-CoV2 provides accurate qualitative detection of total antibodies against SARS-CoV-2.