Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides

References

• Gonçalves BP, Procter SR, Paul P, Chandna J, Lewin A, Seedat F, Koukounari A, Dangor Z, Leahy S, Santhanam S, et al. Group B streptococcus infection during pregnancy and infancy: estimates of regional and global burden. Lancet Glob Health. 2022 Jun;10(6):e807–7. doi:10.1016/S2214-109X(22)00093-6.
   PubMed Web of Science ®Google Scholar
• Absalon J, Simon R, Radley D, Giardina PC, Koury K, Jansen KU, Anderson AS. Advances towards licensure of a maternal vaccine for the prevention of invasive group B streptococcus disease in infants: a discussion of different approaches. Hum Vaccin Immunother. 2022 Dec 31;18(1):2037350. doi:10.1080/21645515.2022.2037350.
   PubMed Web of Science ®Google Scholar
• Siber GR, Chang I, Baker S, Fernsten P, O’Brien KL, Santosham M, Klugman KP, Madhi SA, Paradiso P, Kohberger R, et al. Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies. Vaccine. 2007 May 10;25(19):3816–26. doi:10.1016/j.vaccine.2007.01.119.
   PubMed Web of Science ®Google Scholar
• Kayhty H. Difficulties in establishing a serological correlate of protection after immunization with haemophilus influenzae conjugate vaccines. Biologicals. 1994 Dec;22(4):397–402. doi:10.1006/biol.1994.1062.
   PubMed Web of Science ®Google Scholar
• Parikh SR, Andrews NJ, Beebeejaun K, Campbell H, Ribeiro S, Ward C, White JM, Borrow R, Ramsay ME, Ladhani SN, et al. Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study. Lancet. 2016 Dec 3;388(10061):2775–2782. doi:10.1016/S0140-6736(16)31921-3.
   PubMed Web of Science ®Google Scholar
• Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969 Jun 1;129(6):1307–26. doi:10.1084/jem.129.6.1307.
   PubMed Web of Science ®Google Scholar
• MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M, Martin SW. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rep. 2015 Oct 23;64(41):1171–6. doi:10.15585/mmwr.mm6441a3.
   PubMed Web of Science ®Google Scholar
• Daugla DM, Gami JP, Gamougam K, Naibei N, Mbainadji L, Narbé M, Toralta J, Kodbesse B, Ngadoua C, Coldiron ME, et al. Effect of a serogroup a meningococcal conjugate vaccine (PsA–TT) on serogroup a meningococcal meningitis and carriage in Chad: a community study. Lancet. 2014 Jan 4;383(9911):40–7. doi:10.1016/S0140-6736(13)61612-8.
   PubMed Web of Science ®Google Scholar
• Black SB, Shinefield HR, Ling S, Hansen J, Fireman B, Spring D, Noyes J, Lewis E, Ray P, Lee J, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr Infect Dis J. 2002 Sep;21(9):810–5. doi:10.1097/00006454-200209000-00005.
   PubMed Web of Science ®Google Scholar
• Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, Elvin L, Ensor KM, Hackell J, Siber G, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser permanente vaccine study center group. Pediatr Infect Dis J. 2000 Mar;19(3):187–95. doi:10.1097/00006454-200003000-00003.
   PubMed Web of Science ®Google Scholar
• Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N. A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. N Engl J Med. 2003 Oct 2;349(14):1341–8. doi:10.1056/NEJMoa035060.
   PubMed Web of Science ®Google Scholar
• Wernette CM, Frasch CE, Madore D, Carlone G, Goldblatt D, Plikaytis B, Benjamin W, Quataert SA, Hildreth S, Sikkema DJ, et al. Enzyme-linked immunosorbent assay for quantitation of human antibodies to pneumococcal polysaccharides. Clin Diagn Lab Immunol. 2003 Jul;10(4):514–9. doi:10.1128/CDLI.10.4.514-519.2003.
   PubMedGoogle Scholar
• Baker CJ, Carey VJ, Rench MA, Edwards MS, Hillier SL, Kasper DL, Platt R. Maternal antibody at delivery protects neonates from early onset group B streptococcal disease. J Infect Dis. 2014 Mar 1;209(5):781–8. doi:10.1093/infdis/jit549.
   PubMed Web of Science ®Google Scholar
• Le Doare K, Kampmann B, Vekemans J, Heath PT, Goldblatt D, Nahm MH, Baker C, Edwards MS, Kwatra G, Andrews N, et al. Serocorrelates of protection against infant group B streptococcus disease. Lancet Infect Dis. 2019 May;19(5):e162–e171. doi:10.1016/S1473-3099(18)30659-5.
   PubMed Web of Science ®Google Scholar
• Lin FY, Philips JB 3rd, Azimi PH, Weisman L, Clark P, Rhoads G, Regan J, Concepcion N, Frasch C, Troendle J, et al. Level of maternal antibody required to protect neonates against early-onset disease caused by group B streptococcus type ia: a multicenter, seroepidemiology study. J Infect Dis. 2001 Oct 15;184(8):1022–8. doi:10.1086/323350.
   PubMed Web of Science ®Google Scholar
• Lin FY, Weisman LE, Azimi PH, Philips III J, Clark P, Regan J, Rhoads G, Frasch C, Gray B, Troendle J, et al. Level of maternal IgG anti–group B streptococcus type III antibody correlated with protection of neonates against early-onset disease caused by this pathogen. J Infect Dis. 2004 Sep 1;190(5):928–34. doi:10.1086/422756.
   PubMed Web of Science ®Google Scholar
• Fabbrini M, Rigat F, Rinaudo CD, Passalaqua I, Khacheh S, Creti R, Baldassarri L, Carboni F, Anderloni G, Rosini R. et al. The protective value of maternal group B streptococcus antibodies: quantitative and functional analysis of naturally acquired responses to capsular polysaccharides and pilus proteins in European maternal sera. Clin Infect Dis. 2016 Sep 15;63(6):746–753. doi:10.1093/cid/ciw377.
   PubMed Web of Science ®Google Scholar
• Dangor Z, Kwatra G, Izu A, Adrian P, Cutland CL, Velaphi S, Ballot D, Reubenson G, Zell ER, Lala SG, et al. Correlates of protection of serotype-specific capsular antibody and invasive group B Streptococcus disease in South African infants. Vaccine. 2015 Nov 27;33(48):6793–9. doi:10.1016/j.vaccine.2015.10.019.
   PubMed Web of Science ®Google Scholar
• Madhi SA, Anderson AS, Absalon J, Radley D, Simon R, Jongihlati B, Strehlau R, van Niekerk AM, Izu A, Naidoo N, et al. Potential for maternally administered vaccine for infant group B streptococcus. N Engl J Med. 2023 Jul 20;389(3):215–227. doi:10.1056/NEJMoa2116045.
   PubMed Web of Science ®Google Scholar
• Gaylord MA, Larrier M, Giordano-Schmidt D, Grube CD, Singh S, Nguyen HH, McKeen A, Tan C, Anderson AS, Kalina WV, et al. Development and validation of a 6-plex luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides. Human Vaccines & Immunotherapeutics; 2023. accepted
   Google Scholar
• Madrid L, Seale AC, Kohli-Lynch M, Edmond KM, Lawn JE, Heath PT, Madhi SA, Baker CJ, Bartlett L, Cutland C, et al. Infant group B streptococcal disease incidence and serotypes worldwide: systematic review and meta-analyses. Clin Infect Dis. 2017 Nov 6;65(suppl_2):S160–S172. doi:10.1093/cid/cix656.
   PubMedGoogle Scholar
• GASTON. Group B streptococcus: standardization of laboratory assays London, United Kingdom: St George’s, University of London; 2019 [accessed 2021 Mar 17]. https://www.gbsatstgeorges.co.uk/_files/ugd/cb083f_54c3427d57094e4082e79a7e27b9ec91.pdf.
   Google Scholar
• Esadze A, Grube CD, Wellnitz S, Singh S, Nguyen HH, Gaylord MA, Zhu A, Gribenko A, Tan CY, Anderson AS, et al. Calibration of a serum reference standard for Group B streptococcal polysaccharide conjugate vaccine development using surface plasmon resonance. NPJ Vaccines. 2023 May 19;8(1):71. doi:10.1038/s41541-023-00667-1.
   PubMed Web of Science ®Google Scholar
• Tan C. RSD and other variability measures of the lognormal distribution. Pharmacopeial Forum. 2005; 31(2):653–655.
   Google Scholar
• Pavliakova D, Giardina PC, Moghazeh S, Sebastian S, Koster M, Pavliak V, McKeen A, French R, Jansen KU, Pride M, et al. Development and validation of 13-plex luminex-based assay for measuring human serum antibodies to streptococcus pneumoniae capsular polysaccharides. mSphere. 2018 Aug 8;3(4). doi:10.1128/mSphere.00128-18.
   Web of Science ®Google Scholar
• Linnet K. Evaluation of regression procedures for methods comparison studies. Clin Chem. 1993 Mar;39(3):424–32. doi:10.1093/clinchem/39.3.424.
   PubMed Web of Science ®Google Scholar
• Buurman ET, Timofeyeva Y, Gu J, Kim J-H, Kodali S, Liu Y, Mininni T, Moghazeh S, Pavliakova D, Singer C, et al. A novel hexavalent capsular polysaccharide conjugate vaccine (GBS6) for the prevention of neonatal group B streptococcal infections by maternal immunization. J Infect Dis. 2019 Jun 5;220(1):105–115. doi:10.1093/infdis/jiz062.
   PubMed Web of Science ®Google Scholar