Abstract
Methods for detecting microbial antigens in clinical specimens offer an alternative to culture in the diagnosis of some sexually transmitted diseases. Developers of the immunologic methods are faced with a number of problems in evaluating the new tests. Traditionally, these tests are compared to culture as the "gold standard." Unfortunately, culture for Neisseria gonorrhoeae or Chlamydia trachomatis--the two agents most commonly sought--is considerably less sensitive than 100 percent. Immunologic methods may appear to produce false positives when the paired specimens are actually false-negative cultures. Another source of discordant results is sampling variation. These considerations, however, will not account for all false-positive results. Even the best non-culture methods have a low rate of false-positive results. If a new test has a specificity of 97 percent, it, by definition, yields approximately 3 percent false-positive reactions. In low-prevalence settings this false-positive rate will create problems in interpreting the results. For example, in a population with 3 percent prevalence of infection, a positive result in a 97 percent specificity test could only have a predictive value of 50 percent. Most testing for STD agents is performed in low-prevalence settings. None of the currently available immunodiagnostic procedures has a performance profile that suggests it will be satisfactory for diagnostic use in the low-prevalence setting.
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Selected References
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- Adger H., Shafer M. A., Sweet R. L., Schachter J. Screening for Chlamydia trachomatis and Neisseria gonorrhoeae in adolescent males: value of first-catch urine examination. Lancet. 1984 Oct 27;2(8409):944–945. doi: 10.1016/s0140-6736(84)91164-4. [DOI] [PubMed] [Google Scholar]
- Brorson J. E., Holmberg I., Nygren B., Seeberg S. Vancomycin-sensitive strains of Neisseria gonorrhoeae. A problem for the diagnostic laboratory. Br J Vener Dis. 1973 Oct;49(5):452–453. doi: 10.1136/sti.49.5.452. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Chapel T. A., Smeltzer M. Culture of urinary sediment for the diagnosis of gonorrhoea in women. Br J Vener Dis. 1975 Feb;51(1):25–27. doi: 10.1136/sti.51.1.25. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Dans P. E., Rothenberg R., Holmes K. K. Gonococcal serology: how soon, how useful, and how much. J Infect Dis. 1977 Feb;135(2):330–334. doi: 10.1093/infdis/135.2.330. [DOI] [PubMed] [Google Scholar]
- Judson F. N., Werness B. A. Combining cervical and anal-canal specimens for gonorrhea on a single culture plate. J Clin Microbiol. 1980 Aug;12(2):216–219. doi: 10.1128/jcm.12.2.216-219.1980. [DOI] [PMC free article] [PubMed] [Google Scholar]
- McCormack W. M., Reynolds G. H. Effect of menstrual cycle and method of contraception on recovery of Neisseria gonorrhoeae. JAMA. 1982 Mar 5;247(9):1292–1294. [PubMed] [Google Scholar]
- Paavonen J. Chlamydia trachomatis-induced urethritis in female partners of men with nongonococcal urethritis. Sex Transm Dis. 1979 Apr-Jun;6(2):69–71. doi: 10.1097/00007435-197904000-00005. [DOI] [PubMed] [Google Scholar]
- Rudrik J. T., Waller J. M., Britt E. M. Efficacy of an enzyme immunoassay with uncentrifuged first-voided urine for detection of gonorrhea in males. J Clin Microbiol. 1984 Sep;20(3):577–578. doi: 10.1128/jcm.20.3.577-578.1984. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Schachter J., McCormack W. M., Smith R. F., Parks R. M., Bailey R., Ohlin A. C. Enzyme immunoassay for diagnosis of gonorrhea. J Clin Microbiol. 1984 Jan;19(1):57–59. doi: 10.1128/jcm.19.1.57-59.1984. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Schachter J., Stoner E., Moncada J. Screening for chlamydial infections in women attending family planning clinics. West J Med. 1983 Mar;138(3):375–379. [PMC free article] [PubMed] [Google Scholar]
- Schachter J. Urine as a specimen for diagnosis of sexually transmitted diseases. Am J Med. 1983 Jul 28;75(1B):93–97. doi: 10.1016/0002-9343(83)90078-5. [DOI] [PubMed] [Google Scholar]
- Smith T. F., Weed L. A. Comparison of urethral swabs, urine, and urinary sediment for the isolation of Chlamydia. J Clin Microbiol. 1976 Aug;2(2):134–135. [PMC free article] [PubMed] [Google Scholar]
- Stamm W. E., Tam M., Koester M., Cles L. Detection of Chlamydia trachomatis inclusions in Mccoy cell cultures with fluorescein-conjugated monoclonal antibodies. J Clin Microbiol. 1983 Apr;17(4):666–668. doi: 10.1128/jcm.17.4.666-668.1983. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Tam M. R., Stamm W. E., Handsfield H. H., Stephens R., Kuo C. C., Holmes K. K., Ditzenberger K., Krieger M., Nowinski R. C. Culture-independent diagnosis of Chlamydia trachomatis using monoclonal antibodies. N Engl J Med. 1984 May 3;310(18):1146–1150. doi: 10.1056/NEJM198405033101803. [DOI] [PubMed] [Google Scholar]
- Vecchio T. J. Predictive value of a single diagnostic test in unselected populations. N Engl J Med. 1966 May 26;274(21):1171–1173. doi: 10.1056/NEJM196605262742104. [DOI] [PubMed] [Google Scholar]
