Annals of Emergency Medicine
Volume 37, Issue 4 , Pages 377-381 , April 2001

Critical evaluation of a CLIA-waived streptococcal antigen detection test in the emergency department

Presented at the Ambulatory Pediatric Association annual meeting, Section on Emergency Medicine, San Francisco, CA, May 1999.

Received 23 June 2000 ,Revised 22 November 2000 ,Accepted 15 December 2000.

References 

  1. Tanz RR, Shulman ST. Diagnosis and treatment of group A streptococcal pharyngitis. Semin Pediatr Infect Dis. 1995;6:69–78
  2. Wegner DL, Witte DL, Schrantz RD. Insensitivity of rapid antigen detection methods and single blood agar culture for diagnosis streptococcal pharyngitis. JAMA. 1992;267:695–697
  3. Facklam RR. Specificity study of kits for detection of group A streptococci directly from throat swabs. J Clin Microbiol. 1987;25:504–508
  4. Gerber MA, Tanz RR, Kabat W, et al.  Optical immunoassay test for group A β-hemolytic streptococcal pharyngitis. JAMA. 1997;277:899–903
  5. Lieu TA, Fleisher GR, Schwartz JS. Cost-effectiveness of rapid latex agglutination testing and throat culture for streptococcal pharyngitis. Pediatrics. 1990;85:246–256
  6. Centers for Disease Control and Prevention . Regulations for implementing the Clinical Laboratory Improvement Amendments of 1988: a summary. MMWR Morb Mortal Wkly Rep. 1992;41(RR-2):1–17
  7. Harbeck RJ, Teaige K, Crossen GR, et al.  Novel, rapid optical immunoassay technique for detection of group A streptococcal from pharyngeal specimens: comparison with standard culture methods. J Clin Microbiol. 1993;31:839–844
  8. Della-Latta P, Whittier S, Hosmer M, et al.  Rapid detection of group A streptococcal pharyngitis in a pediatric population with optical immunoassay. Pediatr Infect Dis J. 1994;13:742–743
  9. Webb KH. Does culture confirmation of high-sensitivity rapid streptococcal tests make sense? A medical decision analysis. Pediatrics. 1998;101:e2
  10. Roe M, Kishiyama C, Davidson K, et al.  Comparison of BioStar Strep A OIA optical immune assay, Abbott TestPack Plus Strep A, and culture with selective media for diagnosis of group A streptococcal pharyngitis. J Clin Microbiol. 1995;33:1551–1553
  11. Schlager TA, Hayden GA, Woods WA, et al.  Optical immunoassay for rapid detection of group A β-hemolytic streptococci. Arch Pediatr Adolesc Med. 1996;150:245–248
  12. Daly JA, Korgenski EK, Munson AC, et al.  Optical immunoassay for streptococcal pharyngitis: evaluation of accuracy with routine and mucoid strains associated with acute rheumatic fever outbreak in the intermoutain area of the U.S. J Clin Microbiol. 1994;32:531–532
  13. Pitetti RD, Drenning SD, Wald ER. Evaluation of a new rapid antigen detection kit for group A beta-hemolytic streptococci. Pediatr Emerg Care. 1998;14:396–398
  14. Heiter BJ, Bourbeau PP. Comparison of two rapid streptococcal antigen detection assays with culture for diagnosis of streptococcal pharyngitis. J Clin Microbiol. 1995;33:1408–1410
  15. Pillai S, Dennis L, Schwartz B, et al.  How accurate are pediatrician office laboratories in identification of group A beta streptococci from throat swabs?. Clin Infect Dis. 1998;27:1058
  16. Brown K, Sheehan E, Sawyer M, et al.  Parent satisfaction with services in an emergency department located at paediatric teaching hospital. J Paediatr Child Health. 1995;31:435–439
  17. Thompson DA, Yarnold PR, Williams DR, et al.  Effects of actual waiting time, perceived waiting time, information delivery, and expressive quality on patient satisfaction in the emergency department. Ann Emerg Med. 1996;28:657–665
  18. Emergency Physician Associates . A secret risk management weapon: customer service in the emergency department. Emergency Physician Legal Bulletin. 1993;3:1–8
  19. Rosenzweig S. Emergency rapport. J Emerg Med. 1993;11:775–778
  20. Hickson GB, Clayton EW, Entman SS, et al.  Obstetricians’ prior malpractice experience and patients’ satisfaction with care. JAMA. 1994;272:1583–1587
  21. Entman SS, Glass CA, Hickson GB, et al.  The relationship between malpractice claims and subsequent obstetric care. JAMA. 1994;272:1588–1591
  22. Rousel PL. Impact of CLIA on physician office laboratories in rural Washington state. J Fam Pract. 1996;43:249–254
  23. Born PH, Thran SL. The influence of CLIA ‘88 on physician office laboratories. J Fam Pract. 1998;46:319–327
  24. Binns HJ, LeBaily S, Gardner G. The physicians’ office laboratory: 1988 and 1996 survey of Illinois pediatricians. Arch Pediatr Adolesc Med. 1998;152:585–592
  25. Centers for Disease Control and Prevention . CLIA waived test list. Available at www.phppo.cdc.gov/dls/clia/waived.aspNovember 20, 2000; Accessed
  26. Binns HJ, LeBaily S, Gardner G. The physicians’ office laboratory: 1988 and 1996 survey of Illinois pediatricians. Arch Pediatr Adolesc Med. 1998;152:585–592
  27. Fries SM. Diagnosis of group A streptococcal pharyngitis in a private clinic: comparative evaluation of an optical immunoassay method and culture. J Pediatr. 1995;126:933–936
  28. Roddey OF, Clegg HW, Clardy LT, et al.  Comparison of an optical immunoassay technique with two culture methods for the detection of group A streptococci in a pediatric office. J Pediatr. 1995;126:933–936

 Address for reprints: Genie E. Roosevelt, MD, MPH, Division of Pediatric Emergency Medicine, Box #62, The Children’s Memorial Hospital, 2300 Children’s Plaza, Chicago, IL 60614; 773-880-3935, fax 773-880-8267; E-mail geroos@nwu.edu.

PII: S0196-0644(01)59446-9

doi: 10.1067/mem.2001.114090

Annals of Emergency Medicine
Volume 37, Issue 4 , Pages 377-381 , April 2001