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1.
Sci Rep ; 12(1): 12446, 2022 Jul 20.
Article in English | MEDLINE | ID: covidwho-1947492

ABSTRACT

Ageing is associated with a progressive decline and remodelling of the immune system. Also, the efficacy of COVID-19 vaccines has been observed to depend on subjects' age. The post-vaccination data about patients aged > 90 years old is scarcely represented in the literature. The antibody titre profiles of elderly vaccinated subjects (age > 90 years old) were evaluated and compared with profiles obtained in a younger population (age 23-69 years old). To the best of our knowledge, this is the first report providing post-vaccination serological data in subjects aged 90 + years old. This study suggests that distinct SARS-CoV-2 viral-specific antibody response profiles vary based on anti-N serostatus, age, and sex in the very elderly adults. The data obtained could impact the organisation of the vaccination campaign (i.e., prioritisation strategies, administration of additional doses) and the factors that facilitate intentions to receive the vaccination among elderly adults (i.e., vaccine effectiveness).


Subject(s)
COVID-19 , Viral Vaccines , Adult , Aged , Aged, 80 and over , Antibodies, Viral , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Middle Aged , RNA, Messenger , SARS-CoV-2 , Vaccination , Young Adult
2.
Clin Chem Lab Med ; 60(9): 1463-1477, 2022 08 26.
Article in English | MEDLINE | ID: covidwho-1910718

ABSTRACT

OBJECTIVES: In scenarios of vaccine scarcity or contexts of organizational complexity, it is necessary to define prioritization strategies for allocating vaccine doses in compliance with the criterion of equity and efficiency of health resources. In this context, the COVIDIAGNOSTIX project, based on the health technology assessment (HTA), assessed the role of SARS-CoV-2 serological tests as a companion diagnostic in the definition of the vaccination strategies for the vaccine administration. To guarantee evidence support for health policy choices, two different vaccine strategies were analyzed, one based on administering the vaccine booster dose to the entire population (VACCINE strategy) and the other based on allocation criteria (TEST&VACCINE strategy). METHODS: The decision-oriented HTA (DoHTA) method, integrated with specific modeling and simulation techniques, helped define the perimeter to make health policy choices. RESULTS: The processing of the scores attributed to the key performance indicators concerning all the evaluation domains shows a performance of 94.34% for the TEST&VACCINE strategy and 83.87% for the VACCINE strategy. CONCLUSIONS: TEST&VACCINE strategy can be the most advantageous in various scenarios due to greater speed from an operational and an economic point of view. The assessment schemes defined by COVIDIAGNOSTIX (i.e., technologies/intended use/settings) can easily and quickly be exported and adapted to respond to similar health "policy questions".


Subject(s)
COVID-19 , Vaccines , COVID-19/diagnosis , COVID-19/prevention & control , COVID-19 Testing , Humans , Immunization Programs , SARS-CoV-2 , Serologic Tests , Technology Assessment, Biomedical/methods
3.
Journal of immunological methods ; 2022.
Article in English | EuropePMC | ID: covidwho-1876930

ABSTRACT

Background Real-world population studies have shown waning immunity, over time, after receiving the two doses of the BNT162b2 COVID-19 vaccine. Studies reporting the long-term humoral response are important to drive future vaccination strategies like the introduction of the booster dose. Yet, available literature on long follow-up periods is scarce. Covidiagnostix is a multicenter study aiming to assess the antibody response in >1000 healthcare professionals (HCPs) who received the BNT162b2 vaccine. Methods Serum was tested at time-0 (T0), before the first dose and then at T1, T2, T3 and T4, respectively, 21, 42, 177 and 302 days after T0. Antibodies against the SARS-CoV-2 nucleocapsid-protein were measured to assess SARS-CoV-2 infections, whereas antibodies against the receptor-binding domain of the spike protein were measured to assess vaccine response. Results The antibody titer observed 10 months post-vaccination showed a decrease of approximately 80% from the peak measured at T2, yet the median titer of the seronegatives HCPs was still higher than seropositives before vaccination. We identified 12 post-vaccination infected HCPs within 6 months after receiving the first dose and another 12 post-vaccination infected HCPs between 6 and 10 months post-vaccination. Conclusion Vaccination induced a humoral response which is well detectable even 10 months post-vaccination. Yet a high anti-spike serum antibody titer does not guarantee protection from infection. Differences in symptomatology between SARS-CoV-2 infections occurred within the first 6 months post-vaccination and the following 4 months, and differences in COVID-19 prevalence and vaccination coverage observed in these two time intervals were consistent with a decrease in vaccine efficacy 6 months after receiving the first dose.

4.
J Clin Lab Anal ; 36(5): e24363, 2022 May.
Article in English | MEDLINE | ID: covidwho-1763247

ABSTRACT

BACKGROUND: Serological tests can be used to detect antibodies in the serum of subject's after SARS-CoV-2 infection and vaccination. Currently, variability in antibody titers and the availability of a multiplicity of serological tests have made it necessary to highlight their appropriateness and limitations in various diagnostic settings. METHODS: This study is part of Covidiagnostix, a multicenter project aimed at the assessment of the health technology used in SARS-CoV-2 serological tests. Based on data gained from the analysis of over 5000 subjects, a selected number of serum samples, representative of different diagnostic settings, were analyzed first by qualitative immunoassays (IgA, M, and G MILLIPLEX® SARS-CoV-2 tests based on Luminex® ) to define the immunoglobulins serum composition and subsequently by four serological diagnostic tests (Elecsys Anti-SARS-CoV-2 and Elecsys Anti-SARS-CoV-2 S by Roche, SARS-CoV-2 IgG by Siemens Healthcare, and CHORUS SARS-CoV-2 "NEUTRALIZING" Ab by DIESSE). The first WHO International Standard for SARS-CoV-2 was also analyzed using the same methods. RESULTS: This study evaluated the antibody content and titer of the WHO Standard and serum of subjects with/without previous infection and before/after vaccination for SARS-CoV-2. CONCLUSION: The definition of antibodies in the WHO standard and the analysis of serum samples allowed for the identification of the appropriateness of serological tests in each diagnostic setting, increasing the effectiveness of the resulting laboratory data. Furthermore, we found that it would be optimal to produce new international standards against the S1 domain and RBD of the SARS-CoV-2 spike protein for a more effective serological monitoring of vaccination.


Subject(s)
COVID-19 , SARS-CoV-2 , Antibodies, Viral , COVID-19/diagnosis , Humans , Serologic Tests , Spike Glycoprotein, Coronavirus
5.
Vaccines (Basel) ; 9(11)2021 Nov 19.
Article in English | MEDLINE | ID: covidwho-1524229

ABSTRACT

BACKGROUND: Studies reporting the long-term humoral response after receiving the BNT162b2 COVID-19 vaccine are important to drive future vaccination strategies. Yet, available literature is scarce. Covidiagnostix is a multicenter study designed to assess the antibody response in >1000 healthcare professionals (HCPs) who received the BNT162b2 vaccine. METHODS: Serum was tested at time-0 (T0), before the first dose, T1, T2, and T3, respectively, 21, 42, and 180 days after T0. Antibodies against the SARS-CoV-2 nucleocapsid-protein were measured to assess SARS-CoV-2 infections, whereas antibodies against the receptor-binding domain of the spike protein were measured to assess the vaccine response. Neutralization activity against the D614G, B.1.1.7, and B.1.351 variants were also analyzed. RESULTS: Six months post-vaccination HCPs showed an antibody titer decrease of approximately 70%, yet, the titer was still one order of magnitude higher than that of seropositive individuals before vaccination. We identified 12 post-vaccination infected HCPs. None showed severe symptoms. Interestingly, most of them showed titers at T2 above the neutralization thresholds obtained from the neutralization activity experiments. CONCLUSION: Vaccination induces a humoral response which is well detectable even six months post-vaccination. Vaccination prevents severe COVID-19 cases, yet post-vaccination infection is possible even in the presence of a high anti-S serum antibody titer.

6.
Clin Chem Lab Med ; 59(12): 2019-2026, 2021 Nov 25.
Article in English | MEDLINE | ID: covidwho-1456116

ABSTRACT

OBJECTIVES: After exceptional research efforts, several vaccines were developed against SARS-CoV-2 which sustains the pandemic COVID-19. The Comirnaty vaccine showed high efficacy in clinical trials and was the first to be approved for its distribution to the general population. We evaluated the immune response induced by the first vaccine dose in different sex/age groups and subjects with or without naturally present anti-SARS-CoV-2 antibodies. METHODS: As part of an Italian multicenter project (Covidiagnostix), serum samples from 4,290 health-professionals were serologically tested the day of the first vaccination dose, and 21 days later, using two different instrumentations (Siemens-Healthineers and Roche). RESULTS: In total, 97% of samples showed the presence of specific antibodies 21 days after the vaccination dose; the percentage of non-responders increased with age in both genders. Remarkably, naturally seropositive individuals showed antibody persistence up to 11 months and an exceptionally higher vaccination response compared to subjects never infected by SARS-CoV-2. CONCLUSIONS: This study highlighted the importance of the serological test i) to identify naturally SARS-CoV-2 seropositive individuals and ii) to evaluate the antibody level elicited by the first vaccination dose. Both tests, highlighted differences in the immune response, when subjects were stratified by sex and age, and between naturally seropositive and seronegative subjects. The data obtained show how serological tests could play a crucial role in the triage of the population subjected to the vaccination campaign for COVID-19. The definition of suitable instrumentation-specific thresholds is needed to correctly follow eventually acquired post-vaccination immunity in the general population.


Subject(s)
Antibodies, Viral/blood , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Immunization Programs , Adult , Aged , Aged, 80 and over , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/immunology , Female , Health Personnel , Humans , Immunity, Humoral , Immunoassay , Male , Middle Aged , SARS-CoV-2/isolation & purification , Young Adult
7.
Clin Chim Acta ; 522: 144-151, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1363909

ABSTRACT

BACKGROUND AND AIMS: Vaccines, to limit SARS-CoV-2 infection, were produced and reliable assays are needed for their evaluation. The WHO produced an International-Standard (WHO-IS) to facilitate the standardization/comparison of serological methods. The WHO-IS, produced in limited amount, was never tested for reproducibility. This study aims at developing a reproducible and accessible working standard (WS) to complement the WHO-IS. MATERIALS AND METHODS: Sera from vaccinated individuals were used to produce the WSs. The WHO-IS, the WSs and single serum samples (n = 48) were tested on 6 quantitative serological devices. Neutralization assays were performed for the 48 samples and compared with their antibody titers. RESULTS: The WS carry an antibody titer 20-fold higher than the WHO-IS. It was reproducible, showed both good linearity and insignificant intra- and inter-laboratory variability. However, the WSs behave differently from the WHO-IS. Analysis of the 48 samples showed that single correlation factors are not sufficient to harmonize results from different assays. Yet, all the devices predict neutralization activity based on the antibody titer. CONCLUSIONS: A reproducible and highly concentrated WS, specific for IgG against SARS-CoV-2 Spike-glycoprotein was produced. Such characteristics make it particularly suited for the harmonization of commercially available assays and the consequent evaluation of post-vaccinated individuals.


Subject(s)
COVID-19 , SARS-CoV-2 , Antibodies, Neutralizing , Antibodies, Viral , Humans , Neutralization Tests , Reproducibility of Results
8.
Pacing Clin Electrophysiol ; 44(3): 552-556, 2021 03.
Article in English | MEDLINE | ID: covidwho-1358629

ABSTRACT

We present, to our knowledge, the first case of immunosuppressive therapy (IST) application in a 12-year-old child with arrhythmogenic inflammatory cardiomyopathy resulting from the overlap between autoimmune myocarditis and primary arrhythmogenic cardiomyopathy. Indication to off-lable IST was compelling, because of recurrent drug-refractory ventricular arrhythmias (VAs). We show that IST was feasible, safe, and effective on multiple clinical endpoints, including symptoms, VA recurrences, and T-troponin release. Remarkably, all diagnostic and therapeutic strategies were worked out by a dedicated multidisciplinary team, including specialized pediatric immunologists.


Subject(s)
Arrhythmogenic Right Ventricular Dysplasia/drug therapy , Arrhythmogenic Right Ventricular Dysplasia/immunology , Azathioprine/therapeutic use , Biomarkers/blood , Child , Echocardiography , Electrocardiography , Humans , Magnetic Resonance Imaging , Male , Myocarditis/drug therapy , Myocarditis/immunology , Prednisone/therapeutic use , Recurrence , Risk Factors
9.
Vaccine ; 39(31): 4256-4260, 2021 07 13.
Article in English | MEDLINE | ID: covidwho-1267952

ABSTRACT

BACKGROUND: The first COVID-19 vaccines are being distributed to the general population. However, the shortage of doses is slowing down the goal of reaching herd immunity. The aim of the study was to verify whether previously SARS-CoV-2 infected subjects, a considerable portion of the population, should receive the same vaccination treatment of seronegative individuals. METHODS: Health-professionals either recovered from COVID-19 or never infected by SARS-CoV-2 were serologically tested at different time-points right before, and several days after, vaccination. RESULTS: Previously infected individuals showed humoral immune responses, 21 days after the first dose, that was approximately 10-folds higher than the seronegative group 21 days after the second dose. Seropositivity persists for at least 11 months. CONCLUSION: During a shortage of COVID-19 vaccine doses, previously SARS-CoV-2 infected individuals should be dispensed from the vaccination campaign. When dose availability returns to normality, injection of a single dose for seropositive individuals should be considered.


Subject(s)
COVID-19 , SARS-CoV-2 , Antibodies, Viral , COVID-19 Vaccines , Humans , Vaccination
10.
Vaccines (Basel) ; 9(5)2021 May 18.
Article in English | MEDLINE | ID: covidwho-1234846

ABSTRACT

Healthcare professionals are considered to be at high risk of exposure and spread of SARS-CoV-2, and have therefore been considered a priority group in COVID-19 vaccination campaign strategies. However, it must be assumed that the immune response is influenced by numerous factors, including sex and gender. The analysis of these factors is an impact element for stratifying the population and targeting the vaccination strategy. Therefore, a large cohort of healthcare workers participating in the Italian vaccination campaign against SARS-CoV-2 has been studied to establish the impact of sex and gender on vaccination coverage using the Gender Impact Assessment approach. This study shows a significant difference in the antibody titers among different age and sex groups, with a clear decreasing trend in antibody titers in the older age groups. Overall, the serological values were significantly higher in females; the reported side effects are more frequent in females than in males. Therefore, disaggregated data point out how the evaluation of gender factors could be essential in COVID-19 vaccination strategies. On this biomedical and social basis, suggestions are provided to improve the SARS-CoV-2 vaccination campaign in healthcare professionals. Still, they could be adapted to other categories and contexts.

11.
Acta Biomed ; 91(4): e2020156, 2020 11 10.
Article in English | MEDLINE | ID: covidwho-1058714

ABSTRACT

BACKGROUND: The Lombardy region, Italy, has been severely affected by COVID-19. During the epidemic peak, in March 2020, patients needing intensive care unit treatments were approximately 10% of those infected. This fraction decreased to approximately 2% in the second part of April, and to 0.4% at the beginning of July. COVID-19 is characterized by several biochemical abnormalities whose discrepancy from normal values was associated to the severity of the disease. The aim of this retrospective study was to compare the biochemical patterns of patients during and after the pandemic peak in order to verify whether later patients were experiencing a milder COVID-19 course, as anecdotally observed by several clinicians of the same Hospital. MATERIAL AND METHODS: The laboratory findings of two equivalent groups of 84 patients each, admitted at the emergency department of the San Raffaele Hospital (Milan, Italy), during March and April respectively, were analyzed and compared.  Results. White blood cell, platelets, lymphocytes and lactate dehydrogenase showed a statistically significant improvement (i.e. closer or within the normal clinical range) in the April group compared to March. Creatinine, C-reactive protein, Calcium and liver enzymes, were also pointing in that direction, although the differences were not significant. DISCUSSION: The laboratory findings analyzed in this study were consistent with a milder COVID-19 course in the April group. After excluding several hypotheses, we concluded that our observation was likely the consequence of the lockdown strategy enforcement, which, by imposing social distancing and the use of respiratory protective devices, reduced viral loads upon infection.


Subject(s)
COVID-19/blood , COVID-19/epidemiology , Quarantine , Biomarkers/blood , Emergency Service, Hospital , Female , Hospitalization , Humans , Italy/epidemiology , Male , Middle Aged , Retrospective Studies
12.
Clin Chem Lab Med ; 59(2): 421-431, 2020 10 21.
Article in English | MEDLINE | ID: covidwho-881170

ABSTRACT

Objectives: The rRT-PCR test, the current gold standard for the detection of coronavirus disease (COVID-19), presents with known shortcomings, such as long turnaround time, potential shortage of reagents, false-negative rates around 15-20%, and expensive equipment. The hematochemical values of routine blood exams could represent a faster and less expensive alternative. Methods: Three different training data set of hematochemical values from 1,624 patients (52% COVID-19 positive), admitted at San Raphael Hospital (OSR) from February to May 2020, were used for developing machine learning (ML) models: the complete OSR dataset (72 features: complete blood count (CBC), biochemical, coagulation, hemogasanalysis and CO-Oxymetry values, age, sex and specific symptoms at triage) and two sub-datasets (COVID-specific and CBC dataset, 32 and 21 features respectively). 58 cases (50% COVID-19 positive) from another hospital, and 54 negative patients collected in 2018 at OSR, were used for internal-external and external validation. Results: We developed five ML models: for the complete OSR dataset, the area under the receiver operating characteristic curve (AUC) for the algorithms ranged from 0.83 to 0.90; for the COVID-specific dataset from 0.83 to 0.87; and for the CBC dataset from 0.74 to 0.86. The validations also achieved good results: respectively, AUC from 0.75 to 0.78; and specificity from 0.92 to 0.96. Conclusions: ML can be applied to blood tests as both an adjunct and alternative method to rRT-PCR for the fast and cost-effective identification of COVID-19-positive patients. This is especially useful in developing countries, or in countries facing an increase in contagions.


Subject(s)
Blood Chemical Analysis/methods , COVID-19 Testing/methods , COVID-19/blood , Hematologic Tests/methods , Machine Learning , Algorithms , Area Under Curve , Blood Cell Count , Datasets as Topic , Humans , SARS-CoV-2 , Sensitivity and Specificity
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