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1.
Autoimmun Rev ; 20(12): 102985, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1491722

ABSTRACT

INTRODUCTION: The first wave of COVID-19 pandemic has disrupted almost all areas of the health care services to some extent throughout the world. Although the negative impact of COVID-19 on patients with autoimmune diseases has also been recognized, available data in this regard are limited. In the current study of the European Autoimmunity Standardisation Initiative (EASI) we aimed to provide reliable data on the extent of the impact of COVID-19 pandemic on test requests for different autoantibodies in European countries. METHODS: Data on test numbers and on the number of positive results were collected in 97 clinical laboratories from 15 European countries on a monthly basis for the year before (2019) and the year during (2020) the COVID-19 pandemic. RESULTS: A reduction in the number of autoantibody tests was observed in all European countries in the year 2020 compared to 2019. The reduction affected all autoantibody tests with an overall decrease of 13%, ranging from 1.4% (Switzerland) to 25.5% (Greece). In all countries, the decrease was most pronounced during the first wave of the pandemic (March-May 2020) with an overall decrease in those three months of 45.2%. The most affected autoantibodies were those commonly requested by general practitioners (anti-tTG IgA (-71%), RF IgM (-66%) and ACPA (-61%)). In the second wave of the pandemic (October-December 2020) the decrease was less pronounced (6.8%). With respect to the rate of positive results, subtle differences were observed for distinct autoantibodies during the pandemic, but the total rate of positive results was similar in both years. CONCLUSIONS: Our study demonstrated a strong decrease in autoantibody requests during the first wave of the COVID-19 pandemic in 15 European countries. The second wave was characterized by a less pronounced impact, with some participating countries hardly affected, while some other countries experienced a second decline. The decrease was clearly associated with the level of lock-down and with the required adjustments in the health care systems in different countries, supporting the importance of an effective strategy for the coordination of autoimmune testing in challenging situations as the COVID-19 pandemic.

3.
Int Immunopharmacol ; 100: 108095, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1377734

ABSTRACT

BACKGROUND AND AIMS: SARS-CoV-2 antibody assays are relevant in managing the COVID-19 pandemic, providing valuable data on the immunization status of the population. However, current serology tests are highly variable, due to their different characteristics and to the lack of reference materials. The aim of the World Health Organization (WHO) first International Standard (IS) for anti-SARS-CoV-2 immunoglobulin is to harmonize humoral immune response assessment after natural infection or vaccination, and recommend reporting the results for binding activity in Binding Antibody Units (BAU). MATERIALS AND METHODS: This study analyzed six commercial quantitative anti-SARS-CoV-2 S-protein assays in a head-to-head comparison, using the manufacturers' conversion factors for the WHO IS to obtain BAU/mL values. RESULTS: Our data showed good alignment up to 1000 BAU/mL, then began to disperse, exhibiting some discrepancies. Moreover, correlations among methods varied with Cohen's Kappa ranging from 0.580 to 1.00, with the lowest agreement values for kits using different target antigens or different antibody isotypes, making it clear that the laboratory report should include this information. Values expressed as BAU/ml showed a reduced between-assays variability compared to AU/ml (median coefficients of variation 0.38 and 0.68, respectively; p < 0.001). CONCLUSION: On the basis of these data at present anti-SARS CoV-2 serological assays' results are not interchangeable, and, more importantly, individual immune monitoring should be performed with the same method.


Subject(s)
Antibodies, Viral/blood , COVID-19 Serological Testing/standards , COVID-19/diagnosis , SARS-CoV-2/immunology , Spike Glycoprotein, Coronavirus/immunology , Adult , Aged , Female , Humans , Immunoglobulin G/blood , Male , Middle Aged , World Health Organization
4.
Immunol Res ; 69(6): 576-583, 2021 12.
Article in English | MEDLINE | ID: covidwho-1366407

ABSTRACT

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.


Subject(s)
COVID-19 Vaccines/immunology , Immunity, Cellular/immunology , Immunity, Humoral/immunology , Immunocompromised Host/immunology , SARS-CoV-2/immunology , Adult , Aged , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Autoimmune Diseases/immunology , B-Lymphocytes/immunology , COVID-19/immunology , COVID-19/prevention & control , Female , Health Personnel/statistics & numerical data , Humans , Immunogenicity, Vaccine/immunology , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/therapeutic use , Interferon-gamma/blood , Lymphocyte Count , Male , Middle Aged , Protein Domains/immunology , Spike Glycoprotein, Coronavirus/immunology , T-Lymphocytes/immunology , Vaccination , Young Adult
8.
Clinical and experimental rheumatology ; 39(1):196-202, 2021.
Article in English | ProQuest Central | ID: covidwho-1235491

ABSTRACT

Since January 2020, the whole world has been facing the worst epidemic for a century. SARS-CoV- 2 infection has so far caused more than one million deaths, with the only measures capable of containing the spread of the virus being social distancing, frequent hand washing, and the wearing of masks. Vaccine development was urgently needed and there are now more than 90 candidate vaccines being developed using different technologies. The European Medicines Agency has recently approved a second mRNA-based vaccine, but the introduction of vaccines has raised some doubts about patients with rheumatic disease, who are at high risk of infection because of disease activity and the therapies used to treat it. The aim of this study was to investigate how vaccines may interact with the immune system and treatment of such patients, and how to monitor the post-vaccine antibody titres and T cell responses in order to assess their efficacy and safety.

9.
J Med Virol ; 93(3): 1436-1442, 2021 03.
Article in English | MEDLINE | ID: covidwho-1196450

ABSTRACT

During coronavirus disease 2019 (COVID-19) pandemic, the early diagnosis of patients is a priority. Serological assays, in particular immunoglobulin (Ig)M and IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), have today several applications but the interpretation of their results remains an open challenge. Given the emerging role of the IgA isotype in the COVID-19 diagnostics, we aimed to identify the SARS-CoV-2 IgA antibodies in a COVID-19 population seronegative for IgM. A total of 30 patients hospitalized in San Giovanni di Dio Hospital (Florence, Italy) for COVID-19, seronegative for IgM antibodies, have been studied for anti-SARS-CoV-2 antibodies. They all had a positive oro/nasopharyngeal swab reverse transcription-polymerase chain reaction result. Assays used were a chemiluminescent assay measuring SARS-CoV-2 specific IgM and IgG (S + N) and an ELISA, measuring specific IgG (S1) and IgA antibodies against SARS-CoV-2. Among the 30 patients, eight were positive for IgA, seven were positive for IgG (N + S), and two for IgG (S1), at the first point (5-7 days from the onset of symptoms). The IgA antibodies mean values at the second (9-13 days) and third (21-25 days) time points were even more than twice as high as IgG assays. The agreement between the two IgG assays was moderate (Cohen's K = 0.59; SE = 0.13). The inclusion of the IgA antibodies determination among serological tests of the COVID-19 diagnostic is recommended. IgA antibodies may help to close the serological gap of the COVID-19. Variations among anti-SARS-CoV-2 IgG assays should be considered in the interpretation of results.


Subject(s)
Antibodies, Viral/blood , COVID-19 Serological Testing , COVID-19/diagnosis , Immunoglobulin A/blood , SARS-CoV-2/immunology , Adult , Aged , COVID-19/immunology , Enzyme-Linked Immunosorbent Assay , Female , Humans , Immunoassay , Immunoglobulin G/blood , Immunoglobulin M/blood , Luminescent Measurements , Male , Middle Aged , Sensitivity and Specificity
10.
Expert Rev Clin Immunol ; 17(5): 431-443, 2021 05.
Article in English | MEDLINE | ID: covidwho-1145097

ABSTRACT

INTRODUCTION: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Although demographic and clinical parameters such as sex, age, comorbidities, genetic background and various biomarkers have been identified as risk factors, there is an unmet need to predict the risk and onset of severe inflammatory disease leading to poor clinical outcomes. In addition, very few mechanistic biomarkers are available to inform targeted treatment of severe (auto)-inflammatory conditions associated with COVID-19. Calprotectin, also known as S100A8/S100A9, MRP8/14 (Myeloid-Related Protein) or L1, is a heterodimer involved in neutrophil-related inflammatory processes. In COVID-19 patients, calprotectin levels were reported to be associated with poor clinical outcomes such as significantly reduced survival time, especially in patients with severe pulmonary disease. AREAS COVERED: Pubmed was searched using the following keywords: Calprotectin + COVID19, S100A8/A9 + COVID19, S100A8 + COVID-19, S100A9 + COVID-19, MRP8/14 + COVID19; L1 + COVID-19 between May 2020 and 8 March 2021. The results summarized in this review provide supporting evidence and propose future directions that define calprotectin as an important biomarker in COVID-19. EXPERT OPINION: Calprotectin represents a promising serological biomarker for the risk assessment of COVID-19 patients.


Subject(s)
ATP-Binding Cassette Transporters , COVID-19 , Calgranulin A , Calgranulin B , Severity of Illness Index , ATP-Binding Cassette Transporters/blood , ATP-Binding Cassette Transporters/immunology , Biomarkers/blood , COVID-19/blood , COVID-19/immunology , Calgranulin A/blood , Calgranulin A/immunology , Calgranulin B/blood , Calgranulin B/immunology , Humans
11.
Clin Exp Rheumatol ; 39(1): 196-202, 2021.
Article in English | MEDLINE | ID: covidwho-1068420

ABSTRACT

Since January 2020, the whole world has been facing the worst epidemic for a century. SARS-CoV- 2 infection has so far caused more than one million deaths, with the only measures capable of containing the spread of the virus being social distancing, frequent hand washing, and the wearing of masks. Vaccine development was urgently needed and there are now more than 90 candidate vaccines being developed using different technologies. The European Medicines Agency has recently approved a second mRNA-based vaccine, but the introduction of vaccines has raised some doubts about patients with rheumatic disease, who are at high risk of infection because of disease activity and the therapies used to treat it. The aim of this study was to investigate how vaccines may interact with the immune system and treatment of such patients, and how to monitor the post-vaccine antibody titres and T cell responses in order to assess their efficacy and safety.


Subject(s)
COVID-19 , Rheumatic Diseases , Vaccines , Humans , SARS-CoV-2 , Vaccination , Vaccines/adverse effects
15.
Riv. Ital. Med. Labor. ; 1(16): 7-17, 20200301.
Article in Italian | ELSEVIER | ID: covidwho-659439

ABSTRACT

COVID-19 infection (SARS-CoV-2) is a viral disease first encountered in Wuhan, China, in December 2019, then rapidly spreading around the world. During this current public health emergency of international concern, screening and diagnosing patients quickly in order to aid containment is a priority. Most of our knowledge on diagnostics comes from previous studies on SARSCoV. Since SARS-CoV-2 belongs to the same large family of viruses as those that cause the MERS and SARS outbreak, we could assume that its antibody generation process should be similar. The high contagiousness and the characteristics of high lethality of the epidemic require efficient diagnostics, able to quickly identify the sources of the infection. The identification of patients with active SARS-CoV-2 infection is currently based on the amplification of a viral genome sequence using molecular biology techniques (real-time polymerase chain reaction), which can be subsequently confirmed by gene sequencing. However, the variability linked to the execution of the swab and the limitations of the test (complexity, biosecurity levels, costs and long response times) makes molecular diagnostics unsuitable for use in the field. Consequently, new tools such as serological tests capable of tracking the virus through each phase of the disease are in great demand. Serological antibody tests are already being developed and have already been introduced to the market. To date, however, there is no robust scientific evidence on the clinical-diagnostic reliability of these tests which therefore, at the moment, cannot replace the molecular test. The few studies in the literature are of limited thickness, sometimes discordant with each other and conducted on a small scale mainly on the Chinese population. In the absence of specific references, there is an open debate on the best use of these serological tests and on the ideal moment of their execution. In this review we describe the main characteristics of the SARS-CoV-2 virus, the diagnostic molecular strategies available today, and the first experimental data on the determination of antibodies directed towards SARS-CoV-2.

18.
J Med Virol ; 92(9): 1671-1675, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-116658

ABSTRACT

A pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been spreading throughout the world. Though molecular diagnostic tests are the gold standard for COVID-19, serological testing is emerging as a potential surveillance tool, in addition to its complementary role in COVID-19 diagnostics. Indubitably quantitative serological testing provides greater advantages than qualitative tests but today there is still little known about serological diagnostics and what the most appropriate role quantitative tests might play. Sixty-one COVID-19 patients and 64 patients from a control group were tested by iFlash1800 CLIA analyzer for anti-SARS CoV-2 antibodies IgM and IgG. All COVID-19 patients were hospitalized in San Giovanni di Dio Hospital (Florence, Italy) and had a positive oro/nasopharyngeal swab reverse-transcription polymerase chain reaction result. The highest sensitivity with a very good specificity performance was reached at a cutoff value of 10.0 AU/mL for IgM and of 7.1 for IgG antibodies, hence near to the manufacturer's cutoff values of 10 AU/mL for both isotypes. The receiver operating characteristic curves showed area under the curve values of 0.918 and 0.980 for anti-SARS CoV-2 antibodies IgM and IgG, respectively. iFlash1800 CLIA analyzer has shown highly accurate results for the anti-SARS-CoV-2 antibodies profile and can be considered an excellent tool for COVID-19 diagnostics.


Subject(s)
Antibodies, Viral/immunology , COVID-19/diagnosis , COVID-19/immunology , Immunoassay , Immunoglobulin G/immunology , Immunoglobulin M/immunology , Luminescent Measurements , SARS-CoV-2/immunology , Aged , Aged, 80 and over , Antibodies, Viral/blood , Automation, Laboratory , COVID-19/virology , Female , Humans , Immunoassay/methods , Immunoassay/standards , Immunoglobulin G/blood , Immunoglobulin M/blood , Luminescent Measurements/methods , Luminescent Measurements/standards , Male , Middle Aged , ROC Curve , Reproducibility of Results , Sensitivity and Specificity
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