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Article: Detection of Anti-Rift Valley Fever Virus Antibodies in Serum Samples of Patients with Suspected Arbovirus Infection.

Lapa, Daniele / Specchiarello, Eliana / Francalancia, Massimo / Girardi, Enrico / Maggi, Fabrizio / Garbuglia, Anna Rosa

Microorganisms

2023 Volume 11, Issue 8

Abstract: The definitive diagnosis of the Rift Valley fever virus (RVFV) requires a form of testing that is available only in reference laboratories. It includes indirect immunofluorescence assay (IFA), the serum neutralization assay (NA), and real-time PCR. ... ...

Abstract	The definitive diagnosis of the Rift Valley fever virus (RVFV) requires a form of testing that is available only in reference laboratories. It includes indirect immunofluorescence assay (IFA), the serum neutralization assay (NA), and real-time PCR. Therefore, often, no attempts are made to detect it, even among travelers from endemic areas. In this study, the presence of anti-RVFV IgG and IgM was retrospectively screened in stored serum samples from people who were admitted with arbovirus symptoms at the National Institute for Infectious Diseases (INMI) L. Spallanzani, Rome, Italy. Overall, 80 residual serum samples were anonymized, and sub-aliquots were prepared and tested for anti-RVFV IgG and IgM. A serum neutralization assay was used as a confirmatory test. There was a positive result in eight out of 80 samples (10%) for anti-RVFV IgG, with titers ranging from 1:40 up to 1:1280. Three of eight (2.6%) samples were confirmed as seropositive through an in-house serum neutralization assay, with antibody titers ranging from 1:10 to 1:160. All samples resulted negative for anti-RVFV IgM and RVFV RNA when tested by IFA and real-time RT-PCR, respectively. Our data highlight that several RVFV infections can possibly escape routine virological diagnosis, which suggests RVFV testing should be set up in order to monitor virus prevalence.
Language	English
Publishing date	2023-08-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms11082081
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Article ; Online: Effect of chemical and physical agents on monkeypox virus infectivity and downstream research applications.

Mariotti, Davide / Bettini, Aurora / Meschi, Silvia / Notari, Stefania / Francalancia, Massimo / Tartaglia, Eleonora / Lapa, Daniele / Specchiarello, Eliana / Girardi, Enrico / Matusali, Giulia / Maggi, Fabrizio

Virology

2024 Volume 592, Page(s) 109993

Abstract: The 2022 global spread of Monkeypox Virus (MPXV) underlined the need to investigate safe-handling procedures of clinical and research samples. Here we evaluated the efficiency in reducing MPXV infectious titer of Triton X-100 (0.1 and 0.2%), UV-C ... ...

Abstract	The 2022 global spread of Monkeypox Virus (MPXV) underlined the need to investigate safe-handling procedures of clinical and research samples. Here we evaluated the efficiency in reducing MPXV infectious titer of Triton X-100 (0.1 and 0.2%), UV-C irradiation (15 or 30 min), and heat (56 °C 30 min or 70 °C 5 min). The treatment of MPXV at 70 °C resulted in the strongest decrease of MPXV infectious titer (5.4 Log TCID50/mL), 56 °C and UV-C had a lighter impact (3.9 and 4.3Log), Triton X-100 was less efficient (1.8-2.5Log). Notably, SARS-CoV-2 was much more susceptible to Triton X-100 (4.0 Log decrease). UV-C had the highest impact on MPXV DNA detection by PCR (2.2-4.3 Ct value increase); protein detection by ELISA was dramatically impaired by heating. Overall, UV-C and heating were more effective in lowering MPXV infectious titer but their impact on nucleic acids or protein detection assays must be considered.
MeSH term(s)	Humans ; Monkeypox virus/genetics ; Mpox (monkeypox) ; Octoxynol ; SARS-CoV-2
Chemical Substances	Octoxynol (9002-93-1)
Language	English
Publishing date	2024-01-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	200425-2
ISSN	1096-0341 ; 0042-6822
ISSN (online)	1096-0341
ISSN	0042-6822
DOI	10.1016/j.virol.2024.109993
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Article: Torquetenovirus Loads in Peripheral Blood Predict Both the Humoral and Cell-Mediated Responses to SARS-CoV-2 Elicited by the mRNA Vaccine in Liver Transplant Recipients.

Minosse, Claudia / Matusali, Giulia / Meschi, Silvia / Grassi, Germana / Francalancia, Massimo / D'Offizi, Gianpiero / Spezia, Pietro Giorgio / Garbuglia, Anna Rosa / Montalbano, Marzia / Focosi, Daniele / Girardi, Enrico / Vaia, Francesco / Ettorre, Giuseppe Maria / Maggi, Fabrizio

Vaccines

2023 Volume 11, Issue 11

Abstract: Three years into the COVID-19 pandemic, mass vaccination campaigns have largely controlled the disease burden but have not prevented virus circulation. Unfortunately, many immunocompromised patients have failed to mount protective immune responses after ... ...

Abstract	Three years into the COVID-19 pandemic, mass vaccination campaigns have largely controlled the disease burden but have not prevented virus circulation. Unfortunately, many immunocompromised patients have failed to mount protective immune responses after repeated vaccinations, and liver transplant recipients are no exception. Across different solid organ transplant populations, the plasma levels of Torquetenovirus (TTV), an orphan and ubiquitous human virus under control of the immune system, have been shown to predict the antibody response after COVID-19 vaccinations. We show here a single-institution experience with TTV viremia in 134 liver transplant recipients at their first or third dose. We found that TTV viremia before the first and third vaccine doses predicts serum anti-SARS-CoV-2 Spike receptor-binding domain (RBD) IgG levels measured 2-4 weeks after the second or third dose. Pre-vaccine TTV loads were also associated with peripheral blood anti-SARS-CoV-2 cell-mediated immunity but not with serum SARS-CoV-2 neutralizing antibody titers.
Language	English
Publishing date	2023-10-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines11111656
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Article ; Online: Profiling the acute phase antibody response against mpox virus in patients infected during the 2022 outbreak.

Colavita, Francesca / Matusali, Giulia / Mazzotta, Valentina / Bettini, Aurora / Lapa, Daniele / Meschi, Silvia / Francalancia, Massimo / Pinnetti, Carmela / Bordi, Licia / Mizzoni, Klizia / Coen, Sabrina / Girardi, Enrico / Vaia, Francesco / Nicastri, Emanuele / Antinori, Andrea / Maggi, Fabrizio

Journal of medical virology

2023 Volume 95, Issue 6, Page(s) e28851

Abstract: Information on the immune response during the mpox virus (MPXV) infection is still scarce or limited to past studies when cross-reactive immunity from smallpox vaccination was predominant. Here, we describe the short-term kinetics of the antibody ... ...

Abstract	Information on the immune response during the mpox virus (MPXV) infection is still scarce or limited to past studies when cross-reactive immunity from smallpox vaccination was predominant. Here, we describe the short-term kinetics of the antibody response in patients with acute MPXV infection during the 2022 multicountry outbreak. A total of 64 samples from 18 MPXV-positive patients were longitudinally collected from the day of symptom onset (DSO) up to 20 days after and tested for anti-MPXV immunoglobulin G (IgG), IgM, IgA, and neutralizing antibodies (nAb) using the whole-live virus isolated in May 2022. IgG, IgM, and IgA were detected as early as 4 DSO (median time of seroconversion 7.5 DSO for IgG, 8 DSO for IgM and IgA). Anti-MPXV nAb were detectable in samples collected as early as 1 week after symptoms, with stable levels up to 20 DSO. After 2 weeks, IgG and nAb reached high titers. No significant differences were observed regardless of status of smallpox vaccination, human immunodeficiency virus positivity, or disease severity. Significant lower levels of IgM and IgG were observed in the patients treated with antivirals. These results contribute to extending the knowledge of the MPXV infection and the antibody response in a population with no historic smallpox vaccination.
MeSH term(s)	Humans ; Monkeypox virus ; Immunoglobulin G ; Immunoglobulin M ; Smallpox ; Antibody Formation ; Antibodies, Viral ; Antibodies, Neutralizing ; Immunoglobulin A ; Disease Outbreaks
Chemical Substances	Immunoglobulin G ; Immunoglobulin M ; Antibodies, Viral ; Antibodies, Neutralizing ; Immunoglobulin A
Language	English
Publishing date	2023-06-08
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	752392-0
ISSN	1096-9071 ; 0146-6615
ISSN (online)	1096-9071
ISSN	0146-6615
DOI	10.1002/jmv.28851
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Article ; Online: Third dose of SARS-CoV2 mRNA vaccination produces robust persistent cellular and humoral immune responses in liver transplant recipients.

Montalbano, Marzia / Piccolo, Paola / Lionetti, Raffaella / Visco-Comandini, Ubaldo / Agrati, Chiara / Grassi, Germana / Meschi, Silvia / Matusali, Giulia / Conte, Federica / Angelone, Federica / Ettorre, Giuseppe Maria / Guglielmo, Nicola / Maggi, Fabrizio / Francalancia, Massimo / Mereu, Tiziana / Puro, Vincenzo / Girardi, Enrico / D'Offizi, Gianpiero

Liver international : official journal of the International Association for the Study of the Liver

2023 Volume 43, Issue 5, Page(s) 1120–1125

Abstract: Weaker responses have been described after two doses of anti-SARS-CoV2 vaccination in liver transplant recipients (LTRs). At the Italian National Institute for Infectious Diseases, 122 LTRs (84% males, median age 64 years) were tested for humoral and ... ...

Abstract	Weaker responses have been described after two doses of anti-SARS-CoV2 vaccination in liver transplant recipients (LTRs). At the Italian National Institute for Infectious Diseases, 122 LTRs (84% males, median age 64 years) were tested for humoral and cell-mediated immune response after a third doses of anti-SARS-CoV2 mRNA vaccines. Humoral response was measured by quantifying anti-receptor binding domain and neutralizing antibodies; cell-mediated response was measured by quantifying IFN-γ after stimulation of T cells with SARS-CoV-2-specific peptides. Humoral and cellular responses improved significantly compared to the second vaccine dose; 86.4% of previous non-responders to the first 2 vaccine doses (N = 22) became responders. Mycophenolate mofetil-containing regimens were not associated with lower response rates to a third vaccine; shorter time since transplantation (<6 years) was associated with lower humoral and cellular responses to third vaccine. Protective antibodies against Omicron variant were detected in 60% of patients 12 weeks after third vaccine dose.
MeSH term(s)	Male ; Humans ; Middle Aged ; Female ; Immunity, Humoral ; Liver Transplantation ; COVID-19/prevention & control ; SARS-CoV-2 ; Vaccination ; RNA, Messenger ; Antibodies, Viral ; Transplant Recipients
Chemical Substances	RNA, Messenger ; Antibodies, Viral
Language	English
Publishing date	2023-04-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2102783-3
ISSN	1478-3231 ; 1478-3223
ISSN (online)	1478-3231
ISSN	1478-3223
DOI	10.1111/liv.15557
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Zs.A 1632: Show issues

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Article ; Online: Comparative analysis of the neutralizing activity against SARS-CoV-2 Wuhan-Hu-1 strain and variants of concern: Performance evaluation of a pseudovirus-based neutralization assay.

D'Apice, Luciana / Trovato, Maria / Gramigna, Giulia / Colavita, Francesca / Francalancia, Massimo / Matusali, Giulia / Meschi, Silvia / Lapa, Daniele / Bettini, Aurora / Mizzoni, Klizia / Aurisicchio, Luigi / Di Caro, Antonino / Castilletti, Concetta / De Berardinis, Piergiuseppe

Frontiers in immunology

2022 Volume 13, Page(s) 981693

Abstract: Objectives: Emergence of new variants of SARS-CoV-2 might affect vaccine efficacy. Therefore, assessing the capacity of sera to neutralize variants of concern (VOCs) in BSL-2 conditions will help evaluating the immune status of population following ... ...

Abstract	Objectives: Emergence of new variants of SARS-CoV-2 might affect vaccine efficacy. Therefore, assessing the capacity of sera to neutralize variants of concern (VOCs) in BSL-2 conditions will help evaluating the immune status of population following vaccination or infection. Methods: Pseudotyped viruses bearing SARS-CoV-2 spike protein from Wuhan-Hu-1/D614G strains (wild type, WT), B.1.617.2 (Delta), or B.1.1.529 (Omicron) VOCs were generated to assess the neutralizing antibodies (nAbs) activity by a pseudovirus-based neutralization assay (PVNA). PVNA performance was assessed in comparison to the micro-neutralization test (MNT) based on live viruses. Sera collected from COVID-19 convalescents and vaccinees receiving mRNA (BNT16b2 or mRNA-1273) or viral vector (AZD1222 or Ad26.COV2.S) vaccines were used to measure nAbs elicited by two-dose BNT16b2, mRNA-1273, AZD1222 or one-dose Ad26.CO2.S, at different times from completed vaccination, ~ 1.5 month and ~ 4-6 months. Sera from pre-pandemic and unvaccinated individuals were analyzed as controls. Neutralizing activity following booster vaccinations against VOCs was also determined. Results: PVNA titers correlated with the gold standard MNT assay, validating the reliability of PVNA. Sera analyzed late from the second dose showed a reduced neutralization activity compared to sera collected earlier. Ad26.CO2.S vaccination led to very low or absent nAbs. Neutralization of Delta and Omicron BA.1 VOCs showed significant reduction of nAbs respect to WT strain. Importantly, booster doses enhanced Omicron BA.1 nAbs, with persistent levels at 3 months from boosting. Conclusions: PVNA is a reliable tool for assessing anti-SARS-CoV-2 nAbs helping the establishment of a correlate of protection and the management of vaccination strategies.
MeSH term(s)	Ad26COVS1 ; Antibodies, Neutralizing ; COVID-19/prevention & control ; Carbon Dioxide ; ChAdOx1 nCoV-19 ; Humans ; Membrane Glycoproteins/metabolism ; RNA Viruses ; RNA, Messenger ; Reproducibility of Results ; SARS-CoV-2/genetics ; Spike Glycoprotein, Coronavirus ; Viral Envelope Proteins
Chemical Substances	Ad26COVS1 ; Antibodies, Neutralizing ; Membrane Glycoproteins ; RNA, Messenger ; Spike Glycoprotein, Coronavirus ; Viral Envelope Proteins ; spike protein, SARS-CoV-2 ; Carbon Dioxide (142M471B3J) ; ChAdOx1 nCoV-19 (B5S3K2V0G8)
Language	English
Publishing date	2022-09-26
Publishing country	Switzerland
Document type	Comparative Study ; Journal Article
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.981693
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Article: Cysteamine exerts in vitro antiviral activity against the SARS-CoV-2 Delta and Omicron variants.

Alonzi, Tonino / Aiello, Alessandra / Repele, Federica / Falasca, Laura / Francalancia, Massimo / Garbuglia, Anna Rosa / Delogu, Giovanni / Nicastri, Emanuele / Piacentini, Mauro / Goletti, Delia

Cell death discovery

2022 Volume 8, Issue 1, Page(s) 288

Abstract: The novel SARS-CoV-2 variants of concern (VOC) represent a considerable global alarm because their mutations are known to affect transmissibility and cause immune escape. While preventing severe disease and deaths, the available vaccines do not avoid ... ...

Abstract	The novel SARS-CoV-2 variants of concern (VOC) represent a considerable global alarm because their mutations are known to affect transmissibility and cause immune escape. While preventing severe disease and deaths, the available vaccines do not avoid infection; therefore, COVID-19 disease management still requires effective therapies. We have recently reported that the aminothiol cysteamine, a drug already applied to humans, exerts direct antiviral activity against SARS-CoV-2 and has in vitro immunomodulatory effect. To evaluate whether this compound exerts antiviral effects also against SARS-CoV-2 variants, we performed different infected cell-based assays using Wild type, Delta, or Omicron VOC. We found that cysteamine significantly reduces the cytopathic effect induced by SARS-CoV-2 Wild type strain and Delta variant in Vero E6 cells. On the other hand, cysteamine had no effects on the survival of cells infected with the Omicron variant, due to the lack of cytotoxicity on Vero E6 cells, at least when infected at MOI = 0.001 for 72 h. Moreover, cysteamine significantly reduced the production of Wild type, Delta, and Omicron variants as measured by the virus released in the culture media (Vero E6 and Calu-3 cells) and by transmission electron microscopy analysis (Vero E6 cells). Notably, cysteamine is more effective in inhibiting the Omicron rather than Delta or Wild type viruses, with an 80% inhibition of Omicron production compared to 40% of Wild type and Delta variant. Overall, our findings demonstrate that cysteamine exerts direct antiviral actions against SARS-CoV-2 Delta and Omicron variants, in addition to the Wild type virus. Our data further demonstrate that cysteamine is a good candidate as repurposing drug for the treatment of SARS-CoV-2 infection for the present and, likely, the future VOC and, therefore, it would be important to investigate its clinical relevance in randomized clinical trials.
Language	English
Publishing date	2022-06-15
Publishing country	United States
Document type	Journal Article
ISSN	2058-7716
ISSN	2058-7716
DOI	10.1038/s41420-022-01080-8
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Article ; Online: Differential Dynamics of SARS-CoV-2 Binding and Functional Antibodies upon BNT162b2 Vaccine: A 6-Month Follow-Up.

Matusali, Giulia / Sberna, Giuseppe / Meschi, Silvia / Gramigna, Giulia / Colavita, Francesca / Lapa, Daniele / Francalancia, Massimo / Bettini, Aurora / Capobianchi, Maria R / Puro, Vincenzo / Castilletti, Concetta / Vaia, Francesco / Bordi, Licia

Viruses

2022 Volume 14, Issue 2

Abstract: To investigate the dynamic association among binding and functional antibodies in health-care-workers receiving two doses of BNT162b2 mRNA COVID-19-vaccine, SARS-CoV-2 anti-RBD IgG, anti-Trimeric-S IgG, and neutralizing antibodies (Nabs) were measured in ...

Abstract	To investigate the dynamic association among binding and functional antibodies in health-care-workers receiving two doses of BNT162b2 mRNA COVID-19-vaccine, SARS-CoV-2 anti-RBD IgG, anti-Trimeric-S IgG, and neutralizing antibodies (Nabs) were measured in serum samples collected at 2 weeks, 3 months, and 6 months from full vaccination. Despite the high correlation, results for anti-RBD and anti-Trimeric S IgG were numerically different even after recalculation to BAU/mL following WHO standards indications. Moreover, after a peak response at 2 weeks, anti-RBD IgG levels showed a 4.5 and 13 fold decrease at 3 and 6 months, respectively, while the anti-Trimeric S IgG presented a less pronounced decay of 2.8 and 4.7 fold. Further different dynamics were observed for Nabs titers, resulting comparable at 3 and 6 months from vaccination. We also demonstrated that at NAbs titers ≥40, the area under the receiver operating characteristic curve and the optimal cutoff point decreased with time from vaccination for both anti-RBD and anti-Trimeric S IgG. The mutating relation among the anti-RBD IgG, anti-Trimeric S IgG, and neutralizing antibodies are indicative of antibody maturation upon vaccination. The lack of standardized laboratory procedures is one factor interfering with the definition of a correlate of protection from COVID-19.
MeSH term(s)	Adult ; Antibodies, Neutralizing/blood ; Antibodies, Neutralizing/immunology ; Antibodies, Neutralizing/metabolism ; Antibodies, Viral/blood ; Antibodies, Viral/immunology ; Antibodies, Viral/metabolism ; BNT162 Vaccine/administration & dosage ; BNT162 Vaccine/immunology ; Binding Sites, Antibody ; COVID-19/immunology ; COVID-19/prevention & control ; Cohort Studies ; Female ; Follow-Up Studies ; Health Personnel/statistics & numerical data ; Humans ; Immunity, Humoral ; Immunoglobulin G/blood ; Immunoglobulin G/immunology ; Immunoglobulin G/metabolism ; Kinetics ; Longitudinal Studies ; Male ; Middle Aged ; SARS-CoV-2/immunology ; SARS-CoV-2/metabolism ; Vaccination
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Immunoglobulin G ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2022-02-02
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v14020312
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Article: Differential Dynamics of SARS-CoV-2 Binding and Functional Antibodies upon BNT162b2 Vaccine: A 6-Month Follow-Up

Matusali, Giulia / Sberna, Giuseppe / Meschi, Silvia / Gramigna, Giulia / Colavita, Francesca / Lapa, Daniele / Francalancia, Massimo / Bettini, Aurora / Capobianchi, Maria R. / Puro, Vincenzo / Castilletti, Concetta / Vaia, Francesco / Bordi, Licia

Viruses. 2022 Feb. 02, v. 14, no. 2

2022

Abstract	To investigate the dynamic association among binding and functional antibodies in health-care-workers receiving two doses of BNT162b2 mRNA COVID-19-vaccine, SARS-CoV-2 anti-RBD IgG, anti-Trimeric-S IgG, and neutralizing antibodies (Nabs) were measured in serum samples collected at 2 weeks, 3 months, and 6 months from full vaccination. Despite the high correlation, results for anti-RBD and anti-Trimeric S IgG were numerically different even after recalculation to BAU/mL following WHO standards indications. Moreover, after a peak response at 2 weeks, anti-RBD IgG levels showed a 4.5 and 13 fold decrease at 3 and 6 months, respectively, while the anti-Trimeric S IgG presented a less pronounced decay of 2.8 and 4.7 fold. Further different dynamics were observed for Nabs titers, resulting comparable at 3 and 6 months from vaccination. We also demonstrated that at NAbs titers ≥40, the area under the receiver operating characteristic curve and the optimal cutoff point decreased with time from vaccination for both anti-RBD and anti-Trimeric S IgG. The mutating relation among the anti-RBD IgG, anti-Trimeric S IgG, and neutralizing antibodies are indicative of antibody maturation upon vaccination. The lack of standardized laboratory procedures is one factor interfering with the definition of a correlate of protection from COVID-19.
Keywords	COVID-19 infection ; Severe acute respiratory syndrome coronavirus 2 ; blood serum ; vaccination ; vaccines
Language	English
Dates of publication	2022-0202
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2516098-9
ISSN	1999-4915
ISSN	1999-4915
DOI	10.3390/v14020312
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Article ; Online: External quality assessment of SARS-CoV-2 serology in European expert laboratories, April 2021.

Mögling, Ramona / Colavita, Francesca / Reimerink, Johan / Melidou, Angeliki / Leitmeyer, Katrin / Keramarou, Maria / Lapa, Daniele / Francalancia, Massimo / Murk, Jean-Luc / Vossen, Ann / Carletti, Fabrizio / Hogema, Boris / Meijer, Adam / Deprez, Liesbet / di Caro, Antonino / Castilletti, Concetta / Reusken, Chantal Bem

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin

2022 Volume 27, Issue 42

Abstract: BackgroundCountries worldwide are focusing to mitigate the ongoing SARS-CoV-2 pandemic by employing public health measures. Laboratories have a key role in the control of SARS-CoV-2 transmission. Serology for SARS-CoV-2 is of critical importance to ... ...

Abstract	BackgroundCountries worldwide are focusing to mitigate the ongoing SARS-CoV-2 pandemic by employing public health measures. Laboratories have a key role in the control of SARS-CoV-2 transmission. Serology for SARS-CoV-2 is of critical importance to support diagnosis, define the epidemiological framework and evaluate immune responses to natural infection and vaccine administration.AimThe aim of this study was the assessment of the actual capability among laboratories involved in sero-epidemiological studies on COVID-19 in EU/EEA and EU enlargement countries to detect SARS-CoV-2 antibodies through an external quality assessment (EQA) based on proficiency testing.MethodsThe EQA panels were composed of eight different, pooled human serum samples (all collected in 2020 before the vaccine roll-out), addressing sensitivity and specificity of detection. The panels and two EU human SARS-CoV-2 serological standards were sent to 56 laboratories in 30 countries.ResultsThe overall performance of laboratories within this EQA indicated a robust ability to establish past SARS-CoV-2 infections via detection of anti-SARS-CoV-2 antibodies, with 53 of 55 laboratories using at least one test that characterised all EQA samples correctly. IgM-specific test methods provided most incorrect sample characterisations (24/208), while test methods detecting total immunoglobulin (0/119) and neutralising antibodies (2/230) performed the best. The semiquantitative assays used by the EQA participants also showed a robust performance in relation to the standards.ConclusionOur EQA showed a high capability across European reference laboratories for reliable diagnostics for SARS-CoV-2 antibody responses. Serological tests that provide robust and reliable detection of anti-SARS-CoV-2 antibodies are available.
MeSH term(s)	Humans ; SARS-CoV-2 ; Laboratories ; COVID-19 ; Antibodies, Viral ; Sensitivity and Specificity ; Immunoglobulin M ; Antibodies, Neutralizing
Chemical Substances	Antibodies, Viral ; Immunoglobulin M ; Antibodies, Neutralizing
Language	English
Publishing date	2022-10-21
Publishing country	Sweden
Document type	Journal Article
ZDB-ID	1338803-4
ISSN	1560-7917 ; 1025-496X
ISSN (online)	1560-7917
ISSN	1025-496X
DOI	10.2807/1560-7917.ES.2022.27.42.2101057
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