scholarly journals A Trans-Governmental Collaboration to Independently Evaluate SARS-CoV-2 Serology Assays

2022 ◽  
Author(s):  
Ligia A. Pinto ◽  
Ribhi M. Shawar ◽  
Brendan O’Leary ◽  
Troy J. Kemp ◽  
James Cherry ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Immune Responses ◽  
Contact Tracing ◽  
Independent Evaluation ◽  
Antibody Assays

The SARS-CoV-2 pandemic created a crucial need for accurate serology assays to evaluate seroprevalence, contact tracing, and antiviral immune responses. The initial flood of serology assays entering the market with inadequate performance emphasized the need for independent evaluation of commercial SARS-CoV-2 antibody assays using performance evaluation panels to determine suitability for use under emergency use authorization (EUA).

Antibody assays suitable for assessing immune responses to live varicella vaccine

Vaccine ◽  
1991 ◽  
Vol 9 (2) ◽  
pp. 111-116 ◽  
Author(s):  
P PROVOST ◽  
D KRAH ◽  
B KUTER ◽  
D MORTON ◽  
T SCHOFIELD ◽  
...  
Keyword(s):  
Immune Responses ◽  
Varicella Vaccine ◽  
Antibody Assays

Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products

Bioanalysis ◽  
2019 ◽  
Vol 11 (24) ◽  
pp. 2283-2296 ◽  
Author(s):  
Nazneen Bano ◽  
Troy McKelvey ◽  
Nathan Spear ◽  
Tong-Yuan Yang ◽  
Gopi Shankar ◽  
...  
Keyword(s):  
Immune Responses ◽  
Antibody Testing ◽  
Regulatory Guidance ◽  
Antidrug Antibody ◽  
Antibody Assays ◽  
Guidance Documents ◽  
Potential Impact ◽  
Us Fda ◽  
Key Aspects ◽  
Development And Validation

Therapeutic proteins have the potential to induce unwanted immune responses. The potential impact of immunogenicity on pharmacokinetics, pharmacodynamics, safety and efficacy are well established. Here, we analyze key aspects of current US FDA and EMA guidelines on the development and validation of antidrug antibody assays. Although FDA and EMA guidance documents are in harmony on most points, EMA allows greater leeway for scientific judgement, while FDA recommends specific approaches that may not be appropriate in some situations. Many white papers suggest approaches different from the guidance documents, however, these can conflict with each other and are themselves only scientifically valid in certain situations. Here, we indicate when alternatives to guidance may be needed and what those approaches might be.

scholarly journals Performance evaluation of antibody-based point-of-care devices intended for the identification of immune responses to SARS-CoV-2

2021 ◽  
Vol 99 (4) ◽  
pp. 115298
Author(s):  
Andrea K.M. Furuya ◽  
Christine Wagner ◽  
Julia Connors ◽  
Janine Bodnar ◽  
Thomas Miller ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Immune Responses ◽  
Point Of Care

scholarly journals Nasal and Salivary Mucosal Humoral Immune Response Elicited by mRNA BNT162b2 COVID-19 Vaccine Compared to SARS-CoV-2 Natural Infection

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1499
Author(s):  
Mariapia Guerrieri ◽  
Beatrice Francavilla ◽  
Denise Fiorelli ◽  
Marzia Nuccetelli ◽  
Francesco Maria Passali ◽  
...  
Keyword(s):  
New York ◽  
Immune Response ◽  
Immune Responses ◽  
Humoral Immune Response ◽  
Natural Infection ◽  
Serum Antibody ◽  
Vaccine Dose ◽  
Humoral Immune ◽  
Antibody Assays ◽  
Nasal Secretions

SARS-CoV-2 antibody assays are crucial in managing the COVID-19 pandemic. Approved mRNA COVID-19 vaccines are well known to induce a serum antibody responses against the spike protein and its RBD. Mucosal immunity plays a major role in the fight against COVID-19 directly at the site of virus entry; however, vaccine abilities to elicit mucosal immune responses have not been reported. We detected anti-SARS-CoV-2 IgA-S1 and IgG-RBD in three study populations (healthy controls, vaccinated subjects, and subjects recovered from COVID-19 infection) on serum, saliva, and nasal secretions using two commercial immunoassays (ELISA for IgA-S1 and chemiluminescent assay for IgG-RBD). Our results show that the mRNA BNT162b2 vaccine Comirnaty (Pfizer/BioNTech, New York, NY, USA) determines the production of nasal and salivary IgA-S1 and IgG-RBD against SARS-CoV-2. This mucosal humoral immune response is stronger after the injection of the second vaccine dose compared to subjects recovered from COVID-19. Since there is a lack of validated assays on saliva and nasal secretions, this study shows that our pre-analytical and analytical procedures are consistent with the data. Our findings indicate that the mRNA COVID-19 vaccine elicits antigen-specific nasal and salivary immune responses, and that mucosal antibody assays could be used as candidates for non-invasive monitoring of vaccine-induced protection against viral infection.

scholarly journals Comprehensive staff evaluation

2019 ◽  
Vol 67 ◽  
pp. 06002
Author(s):  
Khalida Ahaverdiieva
Keyword(s):  
Performance Evaluation ◽  
Management System ◽  
Evaluation System ◽  
Professional Experience ◽  
Staff Management ◽  
Evaluation Data ◽  
Managerial Decisions ◽  
Personnel Assessment ◽  
Independent Evaluation ◽  
Made In

Evaluation is indispensable for the staff management system of any company, as according to evaluation data any reasonable managerial decisions can be made in the field of staff rotation, training, establishment of salary amount, etc. The evaluation results constitute an important factor of performance motivation and positive change in approaches towards professional experience. Due to staff evaluation the efficient company can be established that ensures better conditions for development and growth of the employees. Performance evaluation of various officials varies depending on tasks, importance, values, difficulty of scoring. Thus, staff evaluation may be considered as a part of the staff management system and independent evaluation system to be applied within any company in a particular form. The article proposes a method of personnel assessment using a comprehensive assessment. It proposes the scale of evaluation, which is used to implement actions for measuring of the bonuses and personnel developing of the enterprise. A number of criteria for evaluating staff have been set. It distributes the share of each criterion in total amount, certain levels and their scores are also determined.

Specific humoral immune responses in 12 cases of food sensitization to sesame seed

1997 ◽  
Vol 27 (11) ◽  
pp. 1285-1291 ◽  
Author(s):  
M. N. KOLOPP-SARDA ◽  
D. A. MONERET-VAUTRIN ◽  
B. GOBERT ◽  
G. KANNY ◽  
M. BRODSCHII ◽  
...  
Keyword(s):  
Immune Responses ◽  
Sesame Seed ◽  
Humoral Immune ◽  
Humoral Immune Responses ◽  
Food Sensitization
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