Skip to main content
NCBI home page
Journal of Clinical Microbiology logoLink to Journal of Clinical Microbiology
. 1995 Jan;33(1):193–198. doi: 10.1128/jcm.33.1.193-198.1995

Sensitivity and specificity of rapid diagnostic tests for detection of group B streptococcal antigen in bacteremic neonates.

D N Greenberg 1, D P Ascher 1, B A Yoder 1, D M Hensley 1, H S Heiman 1, J F Keith 3rd 1
PMCID: PMC227906  PMID: 7699040

Abstract

Latex particle agglutination (LPA) testing for antigen to group B streptococcus (GBS) has been useful in the diagnosis of GBS sepsis in newborns. However, recent reports have demonstrated that the sensitivity of LPA assays may be as low as 27 to 54%. The purposes of the present study were to directly compare the abilities of four urine antigen assays to detect GBS antigen with clinical urine samples from neonates with GBS bacteremia and to evaluate the effect of the urine concentration on the sensitivities and specificities of these assays. Urine samples were collected serially from neonates with blood cultures positive for GBS or on admission from healthy full-term infants. One milliliter of urine was removed, and the remainder was concentrated to a volume of 1 ml. Unconcentrated samples were serially diluted with normal saline and were assayed to determine the highest dilution which would produce a positive test result. The Wellcogen, Bactigen, and Directigen LPA tests and ICON immunoassay were directly compared by using concentrated and unconcentrated urine specimens and urine specimens with known titers. A total of 94 urine specimens, including 61 concentrated and 75 unconcentrated specimens, from bacteremic infants were available for sensitivity testing, and 220 urine specimens from uninfected infants were available for specificity testing. There were significant differences in sensitivity among the four assays when they were performed on concentrated urine specimens, as follows: Directigen, 98%; Bactigen, 92%; ICON, 89%; Wellcogen, 68%. When the assays were performed on unconcentrated urine specimens, the Directigen (84%) and Bactigen (76%) assays were each significantly more sensitive than the ICON (59%) or Wellcogen (43%) assay.(ABSTRACT TRUNCATED AT 250 WORDS)

Full Text

The Full Text of this article is available as a PDF (181.6 KB).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Ascher D. P., Wilson S., Fischer G. W. Comparison of commercially available group B streptococcal latex agglutination assays. J Clin Microbiol. 1991 Dec;29(12):2895–2896. doi: 10.1128/jcm.29.12.2895-2896.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Ascher D. P., Wilson S., Mendiola J., Fischer G. W. Group B streptococcal latex agglutination testing in neonates. J Pediatr. 1991 Sep;119(3):458–461. doi: 10.1016/s0022-3476(05)82063-3. [DOI] [PubMed] [Google Scholar]
  3. Baker C. J., Rench M. A. Commercial latex agglutination for detection of group B streptococcal antigen in body fluids. J Pediatr. 1983 Mar;102(3):393–395. doi: 10.1016/s0022-3476(83)80657-x. [DOI] [PubMed] [Google Scholar]
  4. Baker C. J., Webb B. J., Jackson C. V., Edwards M. S. Countercurrent immunoelectrophoresis in the evaluation of infants with group B streptococcal disease. Pediatrics. 1980 Jun;65(6):1110–1114. [PubMed] [Google Scholar]
  5. Becker J. A., Ascher D. P., Mendiola J., Yoder B., Weisse M., Waecker N., Heroman W. M., Davis C., Fajardo J. E., Fischer G. W. False-negative urine latex particle agglutination testing in neonates with group B streptococcal bacteremia. A function of improper test implementation? Clin Pediatr (Phila) 1993 Aug;32(8):467–471. doi: 10.1177/000992289303200805. [DOI] [PubMed] [Google Scholar]
  6. Blecker D. L., Zimbro M. J., Erbe M. B., Mortensen J. E., Dickinson B. Polyclonal anti-group B Streptococcus latex antigen detection test. Pediatr Infect Dis J. 1989 Apr;8(4):251–252. [PubMed] [Google Scholar]
  7. Bradley J. S. Management of neonates with suspected sepsis. Pediatr Infect Dis J. 1991 Apr;10(4):343–345. doi: 10.1097/00006454-199104000-00022. [DOI] [PubMed] [Google Scholar]
  8. Bromberger P. I., Chandler B., Gezon H., Haddow J. E. Rapid detection of neonatal group B streptococcal infections by latex agglutination. J Pediatr. 1980 Jan;96(1):104–106. doi: 10.1016/s0022-3476(80)80340-4. [DOI] [PubMed] [Google Scholar]
  9. Edwards M. S., Kasper D. L., Baker C. J. Rapid diagnosis of type III group B streptococcal meningitis by latex particle agglutination. J Pediatr. 1979 Aug;95(2):202–205. doi: 10.1016/s0022-3476(79)80651-4. [DOI] [PubMed] [Google Scholar]
  10. Friedman C. A., Wender D. F., Rawson J. E. Rapid diagnosis of group B streptococcal infection utilizing a commercially available latex agglutination assay. Pediatrics. 1984 Jan;73(1):27–30. [PubMed] [Google Scholar]
  11. Greenberg D. N., Ascher D. P., Yoder B. A., Heiman H. S., Keith J. F., 3rd Group B streptococcus serotype V. J Pediatr. 1993 Sep;123(3):494–495. doi: 10.1016/s0022-3476(05)81778-0. [DOI] [PubMed] [Google Scholar]
  12. Greenberg D. N., Yoder B. A. Changes in the differential white blood cell count in screening for group B streptococcal sepsis. Pediatr Infect Dis J. 1990 Dec;9(12):886–889. doi: 10.1097/00006454-199012000-00006. [DOI] [PubMed] [Google Scholar]
  13. Hachey W. E., Wiswell T. E. Limitations in the usefulness of urine latex particle agglutination tests and hematologic measurements in diagnosing neonatal sepsis during the first week of life. J Perinatol. 1992 Sep;12(3):240–245. [PubMed] [Google Scholar]
  14. Hamoudi A. C., Marcon M. J., Cannon H. J., McClead R. E. Comparison of three major antigen detection methods for the diagnosis of Group B streptococcal sepsis in neonates. Pediatr Infect Dis. 1983 Nov-Dec;2(6):432–435. doi: 10.1097/00006454-198311000-00004. [DOI] [PubMed] [Google Scholar]
  15. Harris M. C., Deuber C., Polin R. A., Nachamkin I. Investigation of apparent false-positive urine latex particle agglutination tests for the detection of group B streptococcus antigen. J Clin Microbiol. 1989 Oct;27(10):2214–2217. doi: 10.1128/jcm.27.10.2214-2217.1989. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Ingram D. L., Suggs D. M., Pearson A. W. Detection of group B streptococcal antigen in early-onset and late-onset group B streptococcal disease with the Wellcogen Strep B latex agglutination test. J Clin Microbiol. 1982 Oct;16(4):656–658. doi: 10.1128/jcm.16.4.656-658.1982. [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Kaldor J., Asznowicz R., Buist D. G. Latex agglutination in diagnosis of bacterial infections, with special reference to patients with meningitis and septicemia. Am J Clin Pathol. 1977 Aug;68(2):284–289. doi: 10.1093/ajcp/68.2.284. [DOI] [PubMed] [Google Scholar]
  18. Manroe B. L., Rosenfeld C. R., Weinberg A. G., Browne R. The differential leukocyte count in the assessment and outcome of early-onset neonatal group B streptococcal disease. J Pediatr. 1977 Oct;91(4):632–637. doi: 10.1016/s0022-3476(77)80522-2. [DOI] [PubMed] [Google Scholar]
  19. Rabalais G. P., Bronfin D. R., Daum R. S. Evaluation of a commercially available latex agglutination test for rapid diagnosis of group B streptococcal infection. Pediatr Infect Dis J. 1987 Feb;6(2):177–181. doi: 10.1097/00006454-198702000-00007. [DOI] [PubMed] [Google Scholar]
  20. Rench M. A., Baker C. J. Neonatal sepsis caused by a new group B streptococcal serotype. J Pediatr. 1993 Apr;122(4):638–640. doi: 10.1016/s0022-3476(05)83554-1. [DOI] [PubMed] [Google Scholar]
  21. Rench M. A., Metzger T. G., Baker C. J. Detection of group B streptococcal antigen in body fluids by a latex-coupled monoclonal antibody assay. J Clin Microbiol. 1984 Nov;20(5):852–854. doi: 10.1128/jcm.20.5.852-854.1984. [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Sánchez P. J., Siegel J. D., Cushion N. B., Threlkeld N. Significance of a positive urine group B streptococcal latex agglutination test in neonates. J Pediatr. 1990 Apr;116(4):601–606. doi: 10.1016/s0022-3476(05)81613-0. [DOI] [PubMed] [Google Scholar]
  23. Thore M., Faxelius G., Hedin G., Johnsson H., Ringertz S., Schröder S., Schwan A., Thid S., Ohrner Y. The role of a commercial latex agglutination test in the diagnosis of group B streptococcal infection in neonates. Acta Paediatr Scand. 1991 Feb;80(2):167–172. doi: 10.1111/j.1651-2227.1991.tb11829.x. [DOI] [PubMed] [Google Scholar]
  24. Webb B. J., Baker C. J. Commercial latex agglutination test for rapid diagnosis of group B streptococcal infection in infants. J Clin Microbiol. 1980 Sep;12(3):442–444. doi: 10.1128/jcm.12.3.442-444.1980. [DOI] [PMC free article] [PubMed] [Google Scholar]
  25. Weisman L. E., Stoll B. J., Cruess D. F., Hall R. T., Merenstein G. B., Hemming V. G., Fischer G. W. Early-onset group B streptococcal sepsis: a current assessment. J Pediatr. 1992 Sep;121(3):428–433. doi: 10.1016/s0022-3476(05)81801-3. [DOI] [PubMed] [Google Scholar]

Articles from Journal of Clinical Microbiology are provided here courtesy of American Society for Microbiology (ASM)

RESOURCES