The development of vaccines to prevent SARS-CoV-2 infection has mainly relied on the induction of neutralizing antibodies (nAbs) to the Spike protein of SARS-CoV-2, but there is growing evidence that T cell immune response can contribute to protection as well. In this study, an anti-receptor binding domain (RBD) antibody assay and an INFγ-release assay (IGRA) were used to detect humoral and cellular responses to the Pfizer-BioNTech BNT162b2 vaccine in three separate cohorts of COVID-19-naïve patients: 108 healthcare workers (HCWs), 15 elderly people, and 5 autoimmune patients treated with immunosuppressive agents. After the second dose of vaccine, the mean values of anti-RBD antibodies (Abs) and INFγ were 123.33 U/mL (range 27.55–464) and 1513 mIU/mL (range 145–2500) in HCWs and 210.7 U/mL (range 3–500) and 1167 mIU/mL (range 83–2500) in elderly people. No correlations between age and immune status were observed. On the contrary, a weak but significant positive correlation was found between INFγ and anti-RBD Abs values ( rho = 0.354, p = 0.003). As to the autoimmune cohort, anti-RBD Abs were not detected in the two patients with absent peripheral CD19 + B cells, despite high INFγ levels being observed in all 5 patients after vaccination. Even though the clinical relevance of T cell response has not yet been established as a correlate of vaccine-induced protection, IGRA testing has showed optimal sensitivity and specificity to define vaccine responders, even in patients lacking a cognate antibody response to the vaccine.

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Background Recently many serological assays for detection of antibodies to SARS-COV-2 virus were introduced on the market. Aim of this study was to assess the diagnostic performance of an automated CLIA for quantitative detection of anti-SARS-CoV-2 IgM and IgG antibodies. Methods A total of 354 sera, 89 from consecutive patients diagnosed with COVID-19 (43 mild, 32 severe and 13 critical) and 265 from asymptomatic and negative on rRT-PCR testing healthcare workers, were evaluated for IgM and IgG anti-SARS-CoV-2 antibodies with MAGLUMI immunoasay. Results The overall sensitivity and specificity were 86.5% (95%CI: 77.6-92.8) and 98.5% (95%CI:96.2-99.6), respectively. PPV, PPN, LR+, LR- and OR were 95.1 (95%CI: 87.8-98.6), 95.6 (95%CI: 92.4-97.7), 57.3 (95%CI: 21.6-152.1), 7.3 (95%CI: 4.31-12.4) and 418.6 (95%CI: 131.2-1335.2), respectively. The levels of SARS-CoV-2 IgM and IgG antibodies were 1.22±1.2 AU/mL and 15.86±24.83 AU/mL, 2.86±2.4 AU/mL and 69.3±55.5 AU/mL, 2.47±1.33 AU/mL and 83.9±83.9 AU/mL in mild, severe and critical COVID-19 groups, respectively. A significant difference in antibody levels between mild and severe/critical subjects has been shown. Conclusions The CLIA assay showed good diagnostic performance and a significant association between antibody levels and severity of the disease was found.

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QuantiFERON –TB Gold plus (QFT-plus) represents the latest generation of interferon-gamma release assays (IGRAs), eliciting a response from CD8 T- cells in addition to CD4-T cells, with the aim to improve detection of latent M.tuberculosis infection (LTBI) with respect to its predecessor QuantiFERON-TB Gold In-Tube (QFT-GIT), even if no significant differences have been shown between the two tests (1, 2).…