Interlaboratory Standardization of the Sandwich Enzyme-Linked Immunosorbent Assay Designed for MATS, a Rapid, Reproducible Method for Estimating the Strain Coverage of Investigational Vaccines
| Autor: | Muhamed-Kheir Taha, Duccio Medini, Brunella Brunelli, Dominique A. Caugant, Jan Oksnes, Elisabeth Fritzsønn, Gowrisankar Rajam, John J. Donnelly, Ulrich Vogel, Brian D. Plikaytis, Rino Rappuoli, Laura Santini, Anne-Marie Klem, George M. Carlone, Mauro Agnusdei, Anna Carannante, Julio A. Vázquez, Stefanie Gilchrist, Eva Hong, Paola Stefanelli, Isabella Simmini, Maria Stella, Marzia Monica Giuliani, Giuseppe Boccadifuoco, Cecilia Fazio, Luca Orlandi, Ray Borrow, Lisa DeTora, Heike Claus, Mariagrazia Pizza, Raquel Abad, Kim Ellie, Jamie Findlow, Morgan Ledroit |
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| Přispěvatelé: | Centers for Disease Control and Prevention [Atlanta] (CDC), Centers for Disease Control and Prevention, Novartis Vaccines and Diagnostics [Siena], Centre National de Référence des Méningocoques et Haemophilus influenzae - National Reference Center Meningococci and Haemophilus influenzae (CNR), Institut Pasteur [Paris] (IP), Institut für Hygiene und Mikrobiologie [Würzburg], Manchester Royal Infirmary, University of Manchester [Manchester], Department of Infectious, Parasitic and Immune-Mediated Diseases [Rome], Istituto Superiore di Sanità (ISS), Norwegian Institute of Public Health [Oslo] (NIPH), Instituto de Salud Carlos III [Madrid] (ISC), Institut Pasteur [Paris], Istituto Superiore di Sanita [Rome] |
| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Microbiology (medical)
MESH: Adhesins Bacterial INVESTIGATIONAL VACCINES Genotype Clinical Biochemistry Immunology Porins Enzyme-Linked Immunosorbent Assay Meningococcal Vaccines Meningococcal vaccine Cross Reactions Meningitis Meningococcal Neisseria meningitidis Biology medicine.disease_cause MESH: Neisseria meningitidis Microbiology MESH: Meningococcal Vaccines MESH: Cross Reactions MESH: Genotype 03 medical and health sciences 0302 clinical medicine Bacterial Proteins Antigen medicine Humans Immunology and Allergy MESH: Protein Binding 030212 general & internal medicine Typing Adhesins Bacterial MESH: Bacterial Proteins 030304 developmental biology Vaccines Antigens Bacterial 0303 health sciences MESH: Porins MESH: Humans Strain (chemistry) MESH: Meningitis Meningococcal MESH: Enzyme-Linked Immunosorbent Assay Virology [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology 3. Good health Bacterial adhesin Protein Binding |
| Zdroj: | Clinical and Vaccine Immunology Clinical and Vaccine Immunology, 2012, 19 (10), pp.1609-1617. ⟨10.1128/CVI.00202-12⟩ Clinical and Vaccine Immunology, American Society for Microbiology, 2012, 19 (10), pp.1609-1617. ⟨10.1128/CVI.00202-12⟩ |
| ISSN: | 1556-6811 |
| DOI: | 10.1128/CVI.00202-12⟩ |
| Popis: | The meningococcal antigen typing system (MATS) sandwich enzyme-linked immunosorbent assay (ELISA) was designed to measure the immunologic cross-reactivity and quantity of antigens in target strains of a pathogen. It was first used to measure the factor H-binding protein (fHbp), neisserial adhesin A (NadA), and neisserial heparin-binding antigen (NHBA) content of serogroup B meningococcal (MenB) isolates relative to a reference strain, or “relative potency” (RP). With the PorA genotype, the RPs were then used to assess strain coverage by 4CMenB, a multicomponent MenB vaccine. In preliminary studies, MATS accurately predicted killing in the serum bactericidal assay using human complement, an accepted correlate of protection for meningococcal vaccines. A study across seven laboratories assessed the reproducibility of RPs for fHbp, NadA, and NHBA and established qualification parameters for new laboratories. RPs were determined in replicate for 17 MenB reference strains at laboratories A to G. The reproducibility of RPs among laboratories and against consensus values across laboratories was evaluated using a mixed-model analysis of variance. Interlaboratory agreement was very good; the Pearson correlation coefficients, coefficients of accuracy, and concordance correlation coefficients exceeded 99%. The summary measures of reproducibility, expressed as between-laboratory coefficients of variation, were 7.85% (fHbp), 16.51% (NadA), and 12.60% (NHBA). The overall within-laboratory measures of variation adjusted for strain and laboratory were 19.8% (fHbp), 28.8% (NHBA), and 38.3% (NadA). The MATS ELISA was successfully transferred to six laboratories, and a further laboratory was successfully qualified. |
| Databáze: | OpenAIRE |
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