Objectives We assessed the antibody response to BNT162b2 mRNA COVID-19 vaccine in a cohort of health care workers (HCW), comparing subjects with previous SARS-CoV-2 infection and naïve subjects. Methods HCW were tested at T0 (day of first dose), T1 (day of second dose), and T2 (2-3 weeks after) for IgG anti nucleocapside protein, IgM anti spike protein and IgG anti receptor binding domain (IgG-RBD-S). The antibody response was compared between 4 main groups: A) Subjects with previous infection and positive antibodies at baseline; B) subjects with same history but negative antibodies; C) subjects with no infection history but positive antibodies; D) naïve subjects. Repeated measures analysis was used to compare results over time points. Results 1,935 HCW were included. Median IgG-RBD-S titre was significantly higher for group A (232 subjects) than for group B (56 subjects) both at T1 (A: 22,763 AU/mL, IQR 14,222-37,204; B: 1,373 AU/mL, IQR 783-3,078, p=0.0003) and T2 (A: 30,765 AU/mL, IQR 19,841-42,813; B:13,171 AU/mL, IQR 2,324-22,688, p=0.0038) and for group D (1563 subjects): 796 AU/mL, IQR 379-1,510 at T1; 15,494 AU/mL, IQR 9,122-23,916 at T2, p<0.0001 both timepoints. T1 values of group A were also significantly higher than T2 values of group D (p<0.0001). Presence of symptoms, younger age and female gender were associated with stronger antibody response. HCW infected in March showed a significantly stronger response (T1: 35,324 AU/mL, IQR 22,003-44,531; T2: 37,648 AU/mL, IQR 27,088-50,451) than those infected in November (T1: 18,499 AU/mL, IQR 11,492-27,283; T2: 23,210 AU/mL, IQR 18,074-36,086): p<0.0001, both timepoints. Conclusions Subjects with past COVID-19 infection had a strong antibody response after one single vaccine shot. A single dose might be sufficient for this group, regardless the time elapsed since infection, however the clinical correlation with antibody response needs to be studied.
Background: We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. Methods: A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was performed using Latent Class Analysis combined with clinical re-assessment of incongruous cases. Results: Out of these, 24.6% of patients were classified as infected. The molecular test RQ-SARS-nCoV-2 showed the highest performance with 91.8% sensitivity, 100% specificity, 100.0% PPV and 97.4% NPV respectively. Considering the single gene targets, S and RdRp of RQ-SARS-nCoV-2 had the highest sensitivity (94.1%). The in-house RdRp presented the lowest sensitivity (62.4%). The specificity ranged from 99.2% for in-house RdRp and N2 to 95.0% for E. The PPV ranged from 97.1% of N2 to 85.4% of E and the NPV from 98.1% of S to 89.0% of in-house RdRp. All serological tests had < 50% sensitivity and low PPV and NPV. VivaDiag IgM (RDT) had 98.5% specificity, with 84.0% PPV, but 24.7% sensitivity. Conclusion: Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. Serological tests have limited utility in a clinical context.
BackgroundThe host immune response has a prominent role in the progression and outcome of SARS-CoV-2 infection. Lymphopenia has been described as an important feature of SARS-CoV-2 infection and has been associated with severe disease manifestation. Lymphocyte dysregulation and hyper-inflammation have been shown to be associated with a more severe clinical course; however, a T cell subpopulation whose dysfunction correlate with disease progression has yet to be identify.MethodsWe performed an immuno-phenotypic analysis of T cell sub-populations in peripheral blood from patients affected by different severity of COVID-19 (n=60) and undergoing a different clinical evolution. Clinical severity was established based on a modified WHO score considering both ventilation support and respiratory capacity (PaO2/FiO2 ratio). The ability of circulating cells at baseline to predict the probability of clinical aggravation was explored through multivariate regression analyses.ResultsThe immuno-phenotypic analysis performed by multi-colour flow cytometry confirmed that patients suffering from severe COVID-19 harboured significantly reduced circulating T cell subsets, especially for CD4+ T, Th1, and regulatory T cells. Peripheral T cells also correlated with parameters associated with disease severity, i.e., PaO2/FiO2 ratio and inflammation markers. CD4+ T cell subsets showed an important significant association with clinical evolution, with patients presenting markedly decreased regulatory T cells at baseline having a significantly higher risk of aggravation. Importantly, the combination of gender and regulatory T cells allowed distinguishing between improved and worsened patients with an area under the ROC curve (AUC) of 82%.ConclusionsThe present study demonstrates the association between CD4+ T cell dysregulation and COVID-19 severity and progression. Our results support the importance of analysing baseline regulatory T cell levels, since they were revealed able to predict the clinical worsening during hospitalization. Regulatory T cells assessment soon after hospital admission could thus allow a better clinical stratification and patient management.
Background. Chronic infection with Schistosoma haematobium may lead to serious complications, including bladder carcinoma. Although it is recommended that only bladder masses not regressing within 6 months after praziquantel intake should be investigated invasively, cystoendoscopy is still often performed at diagnosis even in the absence of further signs of concern. No prospective study so far evaluated the evolution of bladder lesions after treatment in case of no risk of reinfection, which could inform case management. Methods. Adult African migrants with active S. haematobium infection, as assessed by positive urine PCR or microscopy for eggs in urine or bladder biopsy, underwent urinary tract ultrasound at enrolment and at 1, 3, 6, 12, and 24 months after praziquantel treatment. Patients in advanced pregnancy or with known Schistosoma-unrelated chronic pathology of the urinary tract were excluded. Results. Twenty-one patients, aged 18-29 years, participated in the study; 10 (47.6%) had bladder masses on ultrasound. Follow-up ≥6 months was completed by 16 (76.2%) patients; ≥12 months by 14 (66.7%), and 24 months by 11 (52.4%). All patients with bladder lesions on enrolment completed a follow-up of ≥6 months. Lesions resolved completely by 6 months in all cases and no new development/re-appearance was observed. Conclusions. This is the first prospective, long-term follow-up study with ultrasound of patients with urinary schistosomiasis outside endemic areas. Mucosal masses in young patients regressed after treatment without recurrence, supporting the recommendation that invasive procedures should be avoided unless lesions or other symptoms/signs of concern persist for > 6 months. Further studies should assess the evolution of bladder lesions after treatment in larger populations, including older age groups, and, ideally, with parallel assessment of other biomarkers of urinary pathology and of residual S. haematobium active infection.
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