Usefulness of IVD Kits for the Assessment of SARS-CoV-2 Antibodies to Evaluate the Humoral Response to Vaccination

Background: The introduction of the vaccination against SARS-CoV-2 infection creates the need for precise tools for the quality control of vaccination procedures, detection of poor humoral response, and estimation of the achieved protection against the disease. Thus, the study aimed to compare the results of the anti-SARS-CoV-2 tests to evaluate the application of the WHO standard unitage (the binding antibody units; BAU/mL) for a measurement of response to the vaccination. Methods: Patients undergoing vaccination against SARS-CoV-2 with Pfizer/BioNTech BNT162b2 (BNT162b2) (n = 79), referred for SARS-CoV-2 antibody measurement prior to vaccination and 21 days after dose 1, and 8, 14, and 30 days after dose 2 were included. The sera were tested with three assays: Elecsys SARS-CoV-2 S (Roche), LIAISON® SARS-CoV-2 TrimericS IgG (DiaSorin), and SARS-CoV-2 IgG II Quant (Abbott). Results: The three assays showed varying correlations at different time points in the study. The overall agreement for all samples was moderate to high (ρ = 0.663–0.902). We observed the most uniform agreement for the day of dose 2 (ρ = 0.775–0.825), while it was least consistent for day 8 (ρ = −0.131–0.693) and 14 (ρ = −0.247–0.603) after dose 2. The dynamics of changes of the SARS-CoV-2 antibody levels in patients without history of prior SARS-CoV-2 infection appears homogenous based on the Roche results, more heterogenous when considering the DiaSorin results, and in between for the Abbott results. Conclusions: The results highlight the need for further work on the international standard of measurement of SARS-CoV-2 Ig, especially in the era of vaccination. The serological assays can be useful to detect IgG/IgM antibodies to assess the response to the vaccination. However, they cannot be used interchangeably. In terms of the evaluation of the immune response to the BNT162b2 vaccine, Roche and Abbott kits appear to be more useful.

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Immune-response against Streptococcus pyogenes in the development of abdominal aortic aneurysm – A population-based case-control study

VASA ◽

10.1024/0301-1526.37.2.143 ◽

2008 ◽

Vol 37 (2) ◽

pp. 143-149 ◽

Cited By ~ 3

Author(s):

Wanhainen ◽

Rasmussen ◽

Björck ◽

Björck

Keyword(s):

Immune Response ◽

Abdominal Aortic Aneurysm ◽

Streptococcus Pyogenes ◽

Case Control Study ◽

Population Based ◽

Case Control ◽

Abdominal Aortic ◽

History Of ◽

Antibody Levels ◽

Control Study

Background: In a population-based case-control study the association between antibodies to Streptococcus pyogenes antigens and the development of abdominal aortic aneurysm (AAA) was analysed. Patients and methods: Forty-two patients with screening-detected AAA were compared to 100 age- and sex matched controls with normal aortas. Antibodies against three recently characterized cell wall-attached proteins of S. pyogenes (SclA, SclB and GRAB) were analysed in plasma samples obtained at screening (current), and in samples obtained from a study conducted 12 years previously on the same population (historical). Results: Historical antibody levels against the S. pyogenes antigen GRAB were significantly higher in AAA patients compared with controls (0.25 vs 0.17, p = 0.021). A similar trend was observed in current GRAB antibody levels (0.23 vs 0.17, p = 0.072). GRAB-antibody levels at age 60 years retained the association with AAA in a logistic regression model after adjustment for a history of atherosclerosis (OR 20.2, p = 0.022), current smoking (OR 21.4, p = 0.025) and family history of AAA (OR 12.9, p = 0.053). Current and historical antibody levels against SclA and SclB in AAA patients were similar to those in controls. Conclusions: The results indicate that the immune response against S. pyogenes protein GRAB may be involved in the pathogenesis of AAA.

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The duration and specificity of the humoral immune response to SARS-CoV-2

Likarska sprava ◽

10.31640/jvd.3-4.2021(2) ◽

2021 ◽

pp. 7-12

Author(s):

E. I. Dubrovskyi ◽

B. V. Dons’koi

Keyword(s):

Immune Response ◽

Quality Control ◽

Humoral Response ◽

Threshold Value ◽

Spike Protein ◽

Obstetrics And Gynecology ◽

Study Group ◽

Specific Antibodies ◽

Humoral Immune ◽

Pcr Test

Background. Our assumption that immunity after COVID-19 will persist has been fully confirmed in the researches already conducted. Our work is a continuation of research that demonstrates the results obtained 12 months of determining the humoral response in patients after COVID-19. Materials and methods. The research involved 42 individuals. All subjects had a positive PCR test for COVID-19. At certain intervals, from 40 to 240 days, individuals in the group were tested for IgG SARS-CoV-2. The last step was to check the level of IgG to the COVID-19 nucleocapsid and spike protein in the research group for 360 days from the onset of the disease. A private certified laboratory in Kyiv, the “DNA Laboratory”, was involved. Patients were tested for antibodies to COVID-19 by ELISA using serology COVID-19 test systems VitroTest (Ukraine). The immunological laboratory of the Institute of Pediatrics, Obstetrics and Gynecology was used in parallel for interlaboratory quality control. The results of the research coincided. Results. The level of class G immunoglobulins to nucleocapsid in the subjects has gradually decreased over 8 months. It is noteworthy that in the period from 40 to 150 days in all 42 patients (100 %) antibodies did not disappear. Decreasing of antibodies occurred between 150 and 240 days. However, the data obtained for 360 days significantly changed the picture. In a certain part of the subjects, who had low or even negative levels of antibodies for 8 months, as of 12 months, the level of immunoglobulin (Ig) class G again rose above the threshold value. Thus, we see that from the group of 42 people 92.8 % have positive antibodies to the nucleocapsid, and 7.2 %. Conclusions. The data obtained illustrate that in the study group within 12 months after SARS-CoV-2, the vast majority of individuals remain with specific antibodies to the nucleocapsid and spike-protein.

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Evaluation of complements serum level (C3 and C4) in pregnant women with history of toxoplasmosis

Journal of Biotechnology Research Center ◽

10.24126/jobrc.2011.5.2.154 ◽

2011 ◽

Vol 5 (2) ◽

pp. 12-16

Author(s):

Dunya F. Salloom ◽

Harith S. AL-Warid ◽

Ali H. Abbas

Keyword(s):

Immune Response ◽

Serum Level ◽

Pregnant Women ◽

Normal Pregnancy ◽

Igm Antibodies ◽

History Of ◽

Group A ◽

Group B ◽

Group D

C3 and C4 serum level were evaluated in 30 pregnant women which divided into groups: Group A16 (53.3%) (Pregnant women with history of abortion and positive anti toxoplasma IgM antibodies), Group B10 (33%) (Normal pregnancy women with no history of abortion or Toxoplasmosis.), Group C6 (20%) (Pregnant women with history of two abortion and positive anti toxoplasma IgM), group D 10 (33.3%) (Pregnant women with history of only one abortion and positive anti- toxoplasma IgM), group E 4 (13.3%) (Pregnant women with history of only one abortion and negative anti-toxoplasma IgM). The results showed that highest level of both C3 and C4 in women with positive anti toxplasma IgM and history of one or two abortion/abortions while the lowest level of these two complements were in women with negative anti toxplasma IgM even they had one abortion or no abortion. There is significant differences in concentration of C3 ( 189.7 ± 20.3 mg/dl ) and C4 ( 59.3 ± 7.5 mg/dl ) in group A and C3 ( 189.6 ± 17.7 mg/dl ) and C4 ( 63.08 ± 4.7 mg/dl) when compared with group B and E, and the result showed statistical differences in C4 concentration between group C and D at P< 0.05. We conclude that complement was play role in immune response of pregnant women especially against toxoplasmosis that cause abortion to these women.

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Antibody responses to BNT162b2 mRNA vaccine: infection-naive individuals with abdominal obesity warrant attention

10.1101/2021.09.10.21262710 ◽

2021 ◽

Author(s):

ALEXIS ELIAS MALAVAZOS ◽

Sara Basilico ◽

Gianluca Iacobellis ◽

Valentina Milani ◽

Rosanna Cardani ◽

...

Keyword(s):

Immune Response ◽

Abdominal Obesity ◽

Neutralizing Antibodies ◽

Vaccine Dose ◽

Antibody Responses ◽

Time Points ◽

Trimeric Complex ◽

Antibody Levels ◽

Visceral Adipose ◽

Prior Infection

Objective. The excess of visceral adipose tissue might hinder and delay the immune response. How people with abdominal obesity will respond to mRNA vaccines against SARS-CoV-2 is yet to be established. We evaluated SARS-CoV-2-specific antibody responses after the first and second dose of the BNT162b2 mRNA vaccine comparing the response of individuals affected by abdominal obesity (AO) to those without, discerning between individuals with or without prior infection. Methods. IgG neutralizing antibodies against the Trimeric complex (IgG-TrimericS) were measured at four time points: at baseline, at day 21 after vaccine dose-1, at one month and three months after dose-2. Nucleocapsid antibodies were assessed to detect prior SARS-CoV-2 infection. Waist circumference was measured to determine abdominal obesity. Results. Between the first and third month after vaccine dose-2, the drop in IgG-TrimericS levels was more remarkable in individuals with AO compared to those without AO (2.44 fold [95%CI: 2.22-2.63] vs 1.82 fold [95%CI: 1.69-1.92], respectively, p<0.001). Multiple linear regression confirmed this result even when adjusting for possible confounders (p<0.001). Conclusions. Our findings highlight the need to extend the duration of serological monitoring of antibody levels in infection-naive individuals with abdominal obesity, a higher-risk population category in terms of possible weaker antibody response.

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Sensitivity of SARS-CoV-2 antibody tests with late convalescent sera

10.1101/2021.07.07.21259772 ◽

2021 ◽

Author(s):

Judith Kannenberg ◽

Carolin Schnurra ◽

Nina Reiners ◽

Reinhard Henschler ◽

Raymund Buhmann ◽

...

Keyword(s):

Confidence Interval ◽

Antibody Test ◽

Igg Antibody ◽

Time Points ◽

Igm Antibodies ◽

Antibody Assays ◽

Previous Infection ◽

Antibody Levels ◽

Antibody Tests ◽

Over Time

SARS-CoV-2-specific IgM antibodies wane during the first three months after infection and IgG antibody levels decline. This may limit the ability of antibody tests to identify previous SARS CoV-2 infection at later time points. To examine if the sensitivity of antibody tests falls off, we compared the sensitivity of two nucleoprotein-based antibody tests, the Roche Elecsis II Anti-SARS-CoV-2 and the Abbott SARS-CoV-2 IgG assay and three glycoprotein-based tests, the Abbott SARS-CoV-2 IgG II Quant, Siemens Atellica IM COV2T and Euroimmun SARS-CoV-2 assay with 56 sera obtained 6-8 months after SARS-CoV-2 infection. The sensitivity of the Roche, Abbott SARS-CoV-2 IgG II Quant and Siemens antibody assays was 94.6 % (95% confidence interval (CI) 85.1-98.9 %), 98.2 % (95% CI: 90.4-99.9 %) and 100 % (95% CI: 93.6-100 %). The sensitivity of the N-based Abbott SARS-CoV-2 IgG and the glycoprotein-based Euroimmun ELISA was 48.2 % (95% CI: 34.7-62.0 %) and 83.9 % (95% CI: 71.7-92.4 %). The nucleoprotein-based Roche and the glycoprotein-based Abbott RBD and Siemens tests were more sensitive than the N-based Abbott and the Euroimmun antibody tests (p=0.0001 to p=0.039). The N-based Abbott antibody test was less sensitive 6-8 months than 4-10 weeks after SARS-CoV-2 infection (p = 0.0002). The findings show that most SARS CoV-2 antibody assays correctly identified previous infection 6-8 months after infection. The sensitivity of pan-Ig antibody tests was not reduced at 6-8 months when IgM antibodies have usually disappeared. However, one of the nucleoprotein-based antibody tests significantly lost sensitivity over time.

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Effects of Age, Sex, Serostatus and Underlying Comorbidities on Humoral Response Post-SARS-CoV-2 Pfizer-BioNTech Vaccination: A Systematic Review

10.1101/2021.10.10.21264825 ◽

2021 ◽

Author(s):

Kin Israel Notarte ◽

Abbygail Therese Ver ◽

Jacqueline Veronica Velasco ◽

Adriel Pastrana ◽

Jesus Alfonso Catahay ◽

...

Keyword(s):

Immune Response ◽

Humoral Response ◽

Older Individuals ◽

Response Mechanism ◽

Humoral Immune ◽

Different Populations ◽

Male Sex ◽

Mrna Technology ◽

Antibody Levels ◽

Response Post

With the advent of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic, several vaccines have been developed to mitigate its spread and prevent adverse consequences of the Coronavirus Disease 2019 (COVID-19). The mRNA technology is an unprecedented vaccine, usually given in two doses to prevent SARS-CoV-2 infections. Despite effectiveness and safety, inter-individual immune response heterogeneity has been observed in recipients of mRNA-based vaccines. As a novel disease, the specific immune response mechanism responsible for warding off COVID-19 remains unclear at this point. However, significant evidence suggests that humoral response plays a crucial role in affording immunoprotection and preventing debilitating sequelae from COVID-19. As such this paper focused on the possible effects of age, sex, serostatus, and comorbidities on humoral response (i.e., total antibodies, IgG and/or IgA) of different populations post-mRNA-based Pfizer-BioNTech vaccination. A systematic search of literature was performed through PubMed, Cochrane CENTRAL, and Google Scholar. Studies were included if they reported humoral response to COVID-19 mRNA vaccines. A total of 32 studies was identified and reviewed, and the percent difference of means of reported antibody levels were calculated for comparison. Findings revealed that older individuals, the male sex, seronegativity, and those with more comorbidities mounted less humoral immune response. Given these findings, several recommendations were proposed regarding the current vaccination practices. These include giving additional doses of vaccination for immunocompromised and elderly populations. Another recommendation is conducting clinical trials in giving a combined scheme of mRNA vaccines, protein vaccines, and vector-based vaccines.

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Sex differences in the decline of neutralizing antibodies to SARS-CoV-2

10.1101/2020.11.12.20230466 ◽

2020 ◽

Cited By ~ 1

Author(s):

Ludivine Grzelak ◽

Aurélie Velay ◽

Yoann Madec ◽

Floriane Gallais ◽

Isabelle Staropoli ◽

...

Keyword(s):

Body Mass Index ◽

Sex Differences ◽

Neutralizing Antibodies ◽

Humoral Response ◽

Time Points ◽

Mild Disease ◽

Duration Of Protection ◽

Antibody Levels ◽

Post Onset ◽

Over Time

The evolution of SARS-CoV-2 humoral response in infected individuals remains poorly characterized. Here, we performed a longitudinal study of sera from 308 RT-qPCR+ individuals with mild disease, collected at two time-points, up to 6 months post-onset of symptoms (POS). We performed two anti-S and one anti-N serology assays and quantified neutralizing antibodies (NAbs). At month 1 (M1), males, individuals > 50 years of age or with a body mass index (BMI) > 25 exhibited higher levels of antibodies. Antibody levels decreased over time. At M3-6, anti-S antibodies persisted in 99% of individuals while anti-N IgG were measurable in only 59% of individuals. The decline in anti-S and NAbs was faster in males than in females, independently of age and BMI. Our results show that some serology tests are less reliable overtime and suggest that the duration of protection after SARS-CoV-2 infection or vaccination will be different in women and men.

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Convalescent plasma treatment for SARS-CoV-2 infection: analysis of the first 436 donors in England, 22 April to 12 May 2020

Eurosurveillance ◽

10.2807/1560-7917.es.2020.25.28.2001260 ◽

2020 ◽

Vol 25 (28) ◽

Cited By ~ 14

Author(s):

Heli Harvala ◽

Jennifer Mehew ◽

Matthew L Robb ◽

Samreen Ijaz ◽

Steven Dicks ◽

...

Keyword(s):

Antibody Response ◽

Plasma Treatment ◽

Neutralising Antibodies ◽

History Of Disease ◽

Serological Reactivity ◽

History Of ◽

Binding Antibody ◽

Antibody Levels ◽

Selection Of

Serological reactivity was analysed in plasma from 436 individuals with a history of disease compatible with COVID-19, including 256 who had been laboratory-confirmed with SARS-CoV-2 infection. Over 99% of laboratory-confirmed cases developed a measurable antibody response (254/256) and 88% harboured neutralising antibodies (226/256). Antibody levels declined over 3 months following diagnosis, emphasising the importance of the timing of convalescent plasma collections. Binding antibody measurements can inform selection of convalescent plasma donors with high neutralising antibody levels.

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Association between Toxoplasma gondii infection and history of blood transfusion: a case-control seroprevalence study

Journal of International Medical Research ◽

10.1177/0300060518757928 ◽

2018 ◽

Vol 46 (4) ◽

pp. 1626-1633 ◽

Cited By ~ 10

Author(s):

Cosme Alvarado-Esquivel ◽

Luis Francisco Sánchez-Anguiano ◽

Jesús Hernández-Tinoco ◽

Agar Ramos-Nevarez ◽

Sergio Estrada-Martínez ◽

...

Keyword(s):

Toxoplasma Gondii ◽

Blood Transfusion ◽

Igg Antibody ◽

Igm Antibodies ◽

Significant Difference ◽

History Of ◽

The Difference ◽

Toxoplasma Gondii Infection ◽

Antibody Levels ◽

Positive Controls

Objectives This study was performed to determine the association between seropositivity to Toxoplasma gondii and a history of blood transfusion. Methods Patients who had undergone blood transfusion (n = 410) and age- and sex-matched controls who had not undergone blood transfusion (n = 1230) were examined for anti- T. gondii IgG and IgM antibodies using enzyme-linked immunoassays. Results Anti- T. gondii IgG antibodies were detected in 57 (13.9%) patients and in 129 (10.5%) controls with a borderline difference [odds ratio (OR) = 1.37, 95% confidence interval (CI) = 0.98–1.92]. High anti- T. gondii IgG antibody levels (>150 IU/mL) were found in 27 (47.4%) of the 57 anti- T. gondii IgG-positive patients and in 37 (28.7%) of the 129 anti- T. gondii IgG positive controls with a significant difference (OR = 2.23, 95% CI = 1.17–4.26). Anti- T. gondii IgM antibodies were found in 13 (22.8%) of the 57 seropositive patients and in 37 (28.7%) of the 129 seropositive controls, but the difference was not significant (OR = 0.73, 95% CI = 0.35–1.52). Seroprevalence was significantly higher in patients aged >50 years than in controls of the same age and in female patients than in female controls. Conclusions These findings indicate that a history of blood transfusion is a risk factor for T. gondii infection.

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Addressing anti-syncytin antibody levels, and fertility and breastfeeding concerns, following BNT162B2 COVID-19 mRNA vaccination

10.1101/2021.05.23.21257686 ◽

2021 ◽

Author(s):

Citra Nurfarah Mattar ◽

Winston Koh ◽

Yiqi Seow ◽

Shawn Hoon ◽

Aparna VENKATESH ◽

...

Keyword(s):

Breast Milk ◽

Humoral Response ◽

Cross Reactivity ◽

Neutralising Antibodies ◽

Post Vaccination ◽

History Of ◽

Observational Cohort ◽

Front Line Workers ◽

Antibody Levels ◽

Breast Fed

Objective: To determine whether antibodies against the SARS-CoV-2 spike protein following BNT162B2 (Pfizer-BioNTech) COVID-19 mRNA vaccination cross-react with human syncytin-1 protein, and if BNT162B2 mRNA enters breast milk. Methods: In this observational cohort study of female front-line workers with no history of COVID-19 infection, we amplified BNT162B2 mRNA in plasma and breast milk and assayed anti-SARS-CoV-2 neutralising antibodies and anti-human syncytin-1 binding antibodies in plasma, at early (1-4 days) and late (4-7 weeks) time points following first-dose vaccination. Results: Fifteen consented participants (mean age 40.4 years, various ethnicities) who received at least one dose of BNT162B2, including five breast-feeding women and two women who were inadvertently vaccinated in early pregnancy, were recruited. BNT162B2 mRNA, detected by amplifying part of the spike-encoding region, was detected in plasma 1-4 days following the first dose (n=13), but not 4-5 weeks later (n=2), nor was the mRNA isolated from aqueous or lipid breast milk fractions collected 0-7 days post-vaccination (n=5). Vaccine recipients demonstrated strong SARS-CoV-2 neutralising activity by at least four weeks after the first dose (n=15), including the two pregnant women. None had placental anti-syncytin-1 binding antibodies at either time-point following vaccination. Conclusions: BNT162B2-vaccinated women did not transmit vaccine mRNA to breast milk, and did not produce a concurrent humoral response to syncytin-1, suggesting that cross-reactivity to syncytin-1 on the developing trophoblast, or other adverse effects in the breast-fed infant from vaccine mRNA ingestion, are unlikely.

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