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Abstract

National surveillance of pneumococcal disease at the serotype level is essential to assess the effectiveness of vaccination programmes. We previously developed a highly sensitive extended-specificity multiplex immunoassay for detection of serotype-specific antigen in urine in the absence of isolates. The assay uses human mAbs that detect the 24 pneumococcal serotype/groups targeted by the pneumococcal conjugate vaccines (PCVs) and pneumococcal polysaccharide vaccine (PPV-23) plus some cross-reactive types and the pneumococcal cell-wall polysaccharide. However, the previous assay had some limitations, namely the reduced specificity of the serotype 7F, 20 and 22F assays, for which non-specific binding in urine samples was observed. Here we report on the further development and re-validation of a new version of the assay (version 2.1), which offers improved sensitivity towards serotypes 7F, 18C and 19F and increased specificity for serotypes 7F, 20 and 22F by replacement of some of the antibody clones with new clones. Using a panel of urine specimens from patients diagnosed with community-acquired pneumonia or pneumococcal disease, the overall clinical sensitivity of this version of the assay based on isolation of from a normally sterile site is 94.3 % and the clinical specificity is 93.6 %, in comparison with clinical sensitivity and specificity values of 96.2 % and 89.9 % in the previous assay.

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2020-01-28
2024-12-07
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References

  1. Skovsted IC. Streptococcus Pneumoniae: Textbook in Serotyping, Virulence Factors and Enzyme-Linked Immunosorbent Assay (Elisa) for Measuring Pneumococcal Antibodies, 2nd ed. Statens Serum Institut; 2015
    [Google Scholar]
  2. Geno KA, Saad JS, Nahm MH. Discovery of novel pneumococcal serotype 35D, a natural WciG-Deficient variant of serotype 35B. J Clin Microbiol 2017; 55:1416–1425 [View Article]
    [Google Scholar]
  3. Kjeldsen C, Slott S, Elverdal PL, Sheppard CL, Kapatai G et al. Discovery and description of a new serogroup 7 Streptococcus pneumoniae serotype, 7D, and structural analysis of 7c and 7D. Carbohydr Res 2018; 463:24–31 [View Article]
    [Google Scholar]
  4. Yu J, Carvalho MdaGS, Beall B, Nahm MH. A rapid pneumococcal serotyping system based on monoclonal antibodies and PCR. J Med Microbiol 2008; 57:171–178 [View Article][PubMed]
    [Google Scholar]
  5. Manna S, Ortika BD, Dunne EM, Holt KE, Kama M et al. A novel genetic variant of Streptococcus pneumoniae serotype 11A discovered in Fiji. Clin Microbiol Infect 2018; 24:428.e1–42428 [View Article]
    [Google Scholar]
  6. van Tonder AJ, Gladstone RA, Lo SW, Nahm MH, du Plessis M et al. Putative novel CPS loci in a large global collection of pneumococci. Microb Genomics 2019; 5: [View Article]
    [Google Scholar]
  7. Butler JC, Breiman RF, Lipman HB, Hofmann J, Facklam RR. Serotype distribution of Streptococcus pneumoniae infections among preschool children in the United States, 1978-1994: implications for development of a conjugate vaccine. J Infect Dis 1995; 171:885–889 [View Article]
    [Google Scholar]
  8. Miller E, Andrews NJ, Waight PA, Slack MPE, George RC. Herd immunity and serotype replacement 4 years after seven-valent pneumococcal conjugate vaccination in England and Wales: an observational cohort study. Lancet Infect Dis 2011; 11:760–768 [View Article]
    [Google Scholar]
  9. Richter SS, Heilmann KP, Dohrn CL, Riahi F, Diekema DJ et al. Pneumococcal serotypes before and after introduction of conjugate vaccines, United States, 1999–20111. Emerg Infect Dis 2013; 19:1074–1083 [View Article]
    [Google Scholar]
  10. Waight PA, Andrews NJ, Ladhani SN, Sheppard CL, Slack MPE et al. Effect of the 13-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in England and Wales 4 years after its introduction: an observational cohort study. Lancet Infect Dis 2015; 15:535–543 [View Article]
    [Google Scholar]
  11. Miyazaki H, Shibuya R, Midorikawa N, Chang B, Ohnishi M et al. Serotype distribution and antimicrobial susceptibility of Streptococcus pneumoniae strains isolated in Japan after introduction of the routine immunization program. J Infect Chemother 2017; 23:234–240 [View Article]
    [Google Scholar]
  12. Richter L, Schmid D, Kanitz EE, Zwazl I, Pöllabauer E et al. Invasive pneumococcal diseases in children and adults before and after introduction of the 10-valent pneumococcal conjugate vaccine into the Austrian national immunization program. PLoS One 2019; 14:e0210081 [View Article]
    [Google Scholar]
  13. Hammitt LL, Akech DO, Morpeth SC, Karani A, Kihuha N et al. Population effect of 10-valent pneumococcal conjugate vaccine on nasopharyngeal carriage of Streptococcus pneumoniae and non-typeable Haemophilus influenzae in Kilifi, Kenya: findings from cross-sectional carriage studies. The Lancet Global Health 2014; 2:e397–e405 [View Article]
    [Google Scholar]
  14. Cilloniz C, Martin-Loeches I, Garcia-Vidal C, San Jose A, Torres A. Microbial etiology of pneumonia: epidemiology, diagnosis and resistance patterns. Int J Mol Sci 2016; 17:2120 [View Article]
    [Google Scholar]
  15. Said MA, Johnson HL, Nonyane BAS, Deloria-Knoll M, O′Brien KL et al. Estimating the burden of pneumococcal pneumonia among adults: a systematic review and meta-analysis of diagnostic techniques. PLoS One 2013; 8:e60273 [View Article]
    [Google Scholar]
  16. Lim WS et al. Study of community acquired pneumonia aetiology (SCAPA) in adults admitted to hospital: implications for management guidelines. Thorax 2001; 56:296–301 [View Article]
    [Google Scholar]
  17. Eletu SD, Sheppard CL, Thomas E, Smith K, Daniel P et al. Development of an extended specificity multiplex immunoassay for detection of Streptococcus pneumoniae serotype-specific antigen in urine by use of human monoclonal antibodies. Clin Vaccine Immunol 2017; 24:e00262–17 [View Article]
    [Google Scholar]
  18. Smith K, Muther JJ, Duke AL, McKee E, Zheng N-Y et al. Fully human monoclonal antibodies from antibody secreting cells after vaccination with Pneumovax 23 are serotype specific and facilitate opsonophagocytosis. Immunobiology 2013; 218:745–754 [View Article]
    [Google Scholar]
  19. Sheppard CL, Harrison TG, Smith MD, George RC. Development of a sensitive, multiplexed immunoassay using xMAP beads for detection of serotype-specific Streptococcus pneumoniae antigen in urine samples. J Med Microbiol 2011; 60:49–55 [View Article]
    [Google Scholar]
  20. Binax A. NOW S.pneumoniae product insert. Alere 20171–12
    [Google Scholar]
  21. Sinclair A, Xie X, Teltscher M, Dendukuri N. Systematic review and meta-analysis of a urine-based pneumococcal antigen test for diagnosis of community-acquired pneumonia caused by Streptococcus pneumoniae . J Clin Microbiol 2013; 51:2303–2310 [View Article]
    [Google Scholar]
  22. Boulware DR, Daley CL, Merrifield C, Hopewell PC, Janoff EN. Rapid diagnosis of pneumococcal pneumonia among HIV-infected adults with urine antigen detection. J Infect 2007; 55:300–309 [View Article]
    [Google Scholar]
  23. Shoji H, Domenech A, Simonetti AF, González A, García-Somoza D et al. The Alere BinaxNOW pneumococcal urinary antigen test: diagnostic sensitivity for adult pneumococcal pneumonia and relationship to specific serotypes. J Clin Microbiol 2018; 56:
    [Google Scholar]
  24. Huijts SM, Pride MW, Vos JMI, Jansen KU, Webber C et al. Diagnostic accuracy of a serotype-specific antigen test in community-acquired pneumonia. Eur Respir J 2013; 42:1283–1290 [View Article]
    [Google Scholar]
  25. Kamerling P J. Pneumococcal polysaccharides: a chemical view. Streptococcus Pneumoniae 200081–114
    [Google Scholar]
  26. Gillespie SH, McWhinney PH, Patel S, Raynes JG, McAdam KP et al. Species of alpha-hemolytic streptococci possessing a C-polysaccharide phosphorylcholine-containing antigen. Infect Immun 1993; 61:3076–3077 [View Article]
    [Google Scholar]
  27. Sjögren AM, Holmberg H, Krook A. Etiologic diagnosis of pneumonia by antigen detection: Crossreactions between pneumococcal C-polysaccharide and oral microorganisms. Diagn Microbiol Infect Dis 1987; 6:239–248 [View Article]
    [Google Scholar]
  28. Sørensen UB, Henrichsen J. Cross-Reactions between pneumococci and other streptococci due to C polysaccharide and F antigen. J Clin Microbiol 1987; 25:1854–1859 [View Article]
    [Google Scholar]
  29. Pimenta F, Gertz RE, Park SH, Kim E, Moura I et al. Streptococcus infantis, Streptococcus mitis, and Streptococcus oralis strains with highly similar cps5 loci and antigenic relatedness to serotype 5 pneumococci. Front Microbiol 2019; 9:3199 [View Article]
    [Google Scholar]
  30. Sheppard CL, Kapatai G, Broughton K, Schaefer U, Hannah M et al. Clinical streptococcal isolates, distinct from Streptococcus pneumoniae, but containing the β-glucosyltransferase tts gene and expressing serotype 37 capsular polysaccharide. PeerJ 2017; 5:e3571 [View Article]
    [Google Scholar]
  31. Lessa FC, Milucky J, Rouphael NG, Bennett NM, Talbot HK et al. Streptococcus mitis expressing pneumococcal serotype 1 capsule. Sci Rep 2018; 8:17959 [View Article]
    [Google Scholar]
  32. Laurens C, Michon A-L, Marchandin H, Bayette J, Didelot M-N et al. Clinical and antimicrobial susceptibility data of 140 Streptococcus pseudopneumoniae isolates in France. Antimicrob Agents Chemother 2012; 56:4504–4507 [View Article]
    [Google Scholar]
  33. van Gageldonk-Lafeber AB, Wever PC, van der Lubben IM, de Jager CPC, Meijer A et al. The aetiology of community-acquired pneumonia and implications for patient management. Neth J Med 2013; 71:418–425
    [Google Scholar]
  34. Cillóniz C, Ewig S, Polverino E, Marcos MA, Esquinas C et al. Microbial aetiology of community-acquired pneumonia and its relation to severity. Thorax 2011; 66:340–346 [View Article]
    [Google Scholar]
  35. Dowell SF, Garman RL, Liu G, Levine OS, Yang Y-H. Evaluation of Binax now, an assay for the detection of pneumococcal antigen in urine samples, performed among pediatric patients. Clin Infect Dis 2001; 32:824–825 [View Article]
    [Google Scholar]
  36. Hamer DH, Egas J, Estrella B, MacLeod WB, Griffiths JK et al. Assessment of the Binax NOW Streptococcus pneumoniae urinary antigen test in children with nasopharyngeal Pneumococcal carriage . Clin Infect Dis 2002; 34:1025–1028 [View Article]
    [Google Scholar]
  37. Domínguez J, Blanco S, Rodrigo C, Azuara M, Galí N et al. Usefulness of urinary antigen detection by an immunochromatographic test for diagnosis of pneumococcal pneumonia in children. J Clin Microbiol 2003; 41:2161–2163 [View Article]
    [Google Scholar]
  38. Navarro D, García-Maset L, Gimeno C, Escribano A, García-de-Lomas J et al. Performance of the Binax now Streptococcus pneumoniae urinary antigen assay for diagnosis of pneumonia in children with underlying pulmonary diseases in the absence of acute pneumococcal infection. J Clin Microbiol 2004; 42:4853–4855 [View Article]
    [Google Scholar]
  39. Devine VT, Cleary DW, Jefferies JMC, Anderson R, Morris DE et al. The rise and fall of pneumococcal serotypes carried in the PCV era. Vaccine 2017; 35:1293–1298 [View Article]
    [Google Scholar]
  40. Lindstrand A, Galanis I, Darenberg J, Morfeldt E, Naucler P et al. Unaltered pneumococcal carriage prevalence due to expansion of non-vaccine types of low invasive potential 8 years after vaccine introduction in Stockholm, Sweden. Vaccine 2016; 34:4565–4571 [View Article]
    [Google Scholar]
  41. Desai AP, Sharma D, Crispell EK, Baughman W, Thomas S et al. Decline in pneumococcal nasopharyngeal carriage of vaccine serotypes after the introduction of the 13-Valent pneumococcal conjugate vaccine in children in Atlanta, Georgia. Pediatr Infect Dis J 2015; 34:1168–1174 [View Article]
    [Google Scholar]
  42. Grant LR, Hammitt LL, O’Brien SE, Jacobs MR, Donaldson C et al. Impact of the 13-Valent pneumococcal conjugate vaccine on pneumococcal carriage among American Indians. Pediatr Infect Dis J 2016; 35:907–914 [View Article]
    [Google Scholar]
  43. Roca A, Bojang A, Bottomley C, Gladstone RA, Adetifa JU et al. Effect on nasopharyngeal pneumococcal carriage of replacing PCV7 with PCV13 in the expanded programme of immunization in the Gambia. Vaccine 2015; 33:7144–7151 [View Article]
    [Google Scholar]
  44. Adegbola RA, DeAntonio R, Hill PC, Roca A, Usuf E et al. Carriage of Streptococcus pneumoniae and other respiratory bacterial pathogens in low and Lower-Middle income countries: a systematic review and meta-analysis. PLoS One 2014; 9:e103293 [View Article]
    [Google Scholar]
  45. Southern J, Andrews N, Sandu P, Sheppard CL, Waight PA et al. Pneumococcal carriage in children and their household contacts six years after introduction of the 13-valent pneumococcal conjugate vaccine in England. PLoS One 2018; 13:e0195799 [View Article]
    [Google Scholar]
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