%0 Journal Article %1 plikaytis_interlaboratory_2012 %A Plikaytis, Brian D %A Stella, Maria %A Boccadifuoco, Giuseppe %A DeTora, Lisa M %A Agnusdei, Mauro %A Santini, Laura %A Brunelli, Brunella %A Orlandi, Luca %A Simmini, Isabella %A Giuliani, Marzia %A Ledroit, Morgan %A Hong, Eva %A Taha, Muhamed-Kheir %A Ellie, Kim %A Rajam, Gowrisankar %A Carlone, George M %A Claus, Heike %A Vogel, Ulrich %A Borrow, Ray %A Findlow, Jamie %A Gilchrist, Stefanie %A Stefanelli, Paola %A Fazio, Cecilia %A Carannante, Anna %A Oksnes, Jan %A Fritzsønn, Elisabeth %A Klem, Anne-Marie %A Caugant, Dominique A %A Abad, Raquel %A Vázquez, Julio A %A Rappuoli, Rino %A Pizza, Mariagrazia %A Donnelly, John J %A Medini, Duccio %D 2012 %J Clinical and vaccine immunology: CVI %K Adhesins Antigens Bacterial Bacterial_Proteins Cross_Reactions Enzyme-Linked_Immunosorbent_Assay Genotype Humans Meningitis Meningococcal Meningococcal_Vaccines Neisseria_meningitidis Porins Protein_Binding molecular_epidemiology %N 10 %P 1609--1617 %R 10.1128/CVI.00202-12 %T Interlaboratory standardization of the sandwich enzyme-linked immunosorbent assay designed for MATS, a rapid, reproducible method for estimating the strain coverage of investigational vaccines %V 19 %X 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.

@article{plikaytis_interlaboratory_2012, abstract = {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.}, added-at = {2013-10-04T09:46:01.000+0200}, author = {Plikaytis, Brian D and Stella, Maria and Boccadifuoco, Giuseppe and {DeTora}, Lisa M and Agnusdei, Mauro and Santini, Laura and Brunelli, Brunella and Orlandi, Luca and Simmini, Isabella and Giuliani, Marzia and Ledroit, Morgan and Hong, Eva and Taha, Muhamed-Kheir and Ellie, Kim and Rajam, Gowrisankar and Carlone, George M and Claus, Heike and Vogel, Ulrich and Borrow, Ray and Findlow, Jamie and Gilchrist, Stefanie and Stefanelli, Paola and Fazio, Cecilia and Carannante, Anna and Oksnes, Jan and Fritzsønn, Elisabeth and Klem, Anne-Marie and Caugant, Dominique A and Abad, Raquel and Vázquez, Julio A and Rappuoli, Rino and Pizza, Mariagrazia and Donnelly, John J and Medini, Duccio}, biburl = {https://www.bibsonomy.org/bibtex/2539032f4da8a7dba7fa8cdc233aadafa/ag_vogel}, doi = {10.1128/CVI.00202-12}, interhash = {f9f3e331f9e0d4bb40bea64b0447a0cd}, intrahash = {539032f4da8a7dba7fa8cdc233aadafa}, issn = {1556-{679X}}, journal = {Clinical and vaccine immunology: {CVI}}, keywords = {Adhesins Antigens Bacterial Bacterial_Proteins Cross_Reactions Enzyme-Linked_Immunosorbent_Assay Genotype Humans Meningitis Meningococcal Meningococcal_Vaccines Neisseria_meningitidis Porins Protein_Binding molecular_epidemiology}, language = {eng}, month = oct, note = {{PMID:} 22875603}, number = 10, pages = {1609--1617}, timestamp = {2013-10-04T09:46:01.000+0200}, title = {Interlaboratory standardization of the sandwich enzyme-linked immunosorbent assay designed for {MATS}, a rapid, reproducible method for estimating the strain coverage of investigational vaccines}, volume = 19, year = 2012 }