Evaluation of fluorescein-conjugated monoclonal antibody test to detect Chlamydia trachomatis endocervical infections in adolescent girls

Shafer, Mary–Ann; Vaughan, Elaine; Lipkin, Ellen S.; Moscicki, Barbara; Schachter, Julius

doi:10.1016/s0022-3476(86)81068-x

Cited by 31 publications

(6 citation statements)

References 10 publications

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“…This may have affected the sensitivity of the cell culture technique. This technique was chosen in this study to minimize the number of swabbings and thereby prevent depletion of chlamydial material in the asymptomatic women studied where lower levels of organisms could be expected (8,25,29).…”

Section: Discussionmentioning

confidence: 99%

Comparison of three techniques for detection of Chlamydia trachomatis in endocervical specimens from asymptomatic women

et al. 1988

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Culture in DEAE-dextran-treated HeLa 229 cells, a solid-phase enzyme immunoassay (EIA) (Chlamydiazyme; Abbott Laboratories, North Chicago, 111.), and a direct immunofluorescence test (DFA) (MicroTrak; Syva Co., Palo Alto, Calif.) were compared for the detection of Chlamydia trachomatis in endocervical specimens from 715 asymptomatic women. Response to antibiotic therapy was also monitored at least 4 weeks after completion of therapy. An additional sample was collected at a control visit, and a second culture was performed if discrepancies were observed between the three tests. A total of 48 infections were diagnosed, for a prevalence of 6.7%. At the first visit, 37 specimens were positive by culture. The respective sensitivities of EIA and DFA were 78.4 and 81.1% and the respective specificities were 96.8 and 97.9% when compared with the cell culture technique. The positive predictive values were 56.9 and 68.2%, respectively. When the additional 11 infections detected by the second culture were included to establish a new standard of positivity, the sensitivity of the first culture was estimated at 77.1%. The positive predictive values of EIA and DFA increased to 77.6 and 83.7%, respectively. EIA and DFA performed as well as culture for control of therapy; a 100% agreement among the three techniques was observed.

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Section: Discussionmentioning

confidence: 99%

Comparison of three techniques for detection of Chlamydia trachomatis in endocervical specimens from asymptomatic women

et al. 1988

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“…10,11 These serovars are poor antigens, so serodiagnosis has not been helpful. Identification of the organism by more affordable tests such as enzyme immunoassay, 12 direct fluorescent antibody staining, 13 Pap test, 14 and DNA probes 15 is relatively insensitive. Culture of the organism is slow, labor intensive, and expensive but has traditionally been taken as the gold standard for laboratory diagnosis of genital chlamydial infection.…”

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confidence: 99%

Performance of a commercial polymerase chain reaction test for endocervical Chlamydia trachomatis infection in a university hospital population

Livengood

Boggess

Wrenn

et al. 1998

Infect. Dis. Obstet. Gynecol.

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Objectives: To examine the accuracy of a commercial polymerase chain reaction (PCR) test (Amplicor CT R , Roche Diagnostic Systems, Branchburg NJ) for identification of endocervical chlamydial infections through both laboratory evaluation and among a diverse teaching hospital patient population.Methods: Testing of reliable threshold inocula and reproducibility were carried out using laboratory stock organisms. Paired endocervical samples from patients with a wide range of indications were tested by PCR and an established culture procedure, and discrepant pairs were further analyzed to determine true results.Results: Laboratory evaluation suggested that one copy of target DNA from a viable organism consistently yielded a positive result, and test reproducibility was very good, with an overall coefficient of variation of 15%. Compared to true results in 1,588 paired clinical samples from 1,489 women with a 10% prevalence of infection, the PCR test and culture yielded respective sensitivities of 87.4% and 78.0%, and negative predictive values of 98.6% and 97.6%. Specificity and positive predictive value for both tests were 100%. Cost per specimen was nearly identical at $18.84 and $18.88 respectively. Polymerase inhibitors and organisms lacking target DNA were not found in false-negative PCR samples.Conclusion: This commercial PCR test is accurate, cost-competitive, and much faster than culture for diagnosis of endocervical chlamydia infections in our population of intermediate prevalence of chlamydial infection. Infect. Dis. Obstet. Gynecol. 6:224-229, 1998.

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“…Differences in the reported performance of EIAs can be attributed to differences in chlamydial culture systems or to clinical and statistical sampling variabilities. However, another possible source of variation might be the characteristics of the patients being tested (2,24,26). The performance of ETAs has been shown to be related to the number of inclusions found in positive cultures (1,25); and the number of inclusions found in positive cultures was found to be significantly associated with age, birth control method, and other patient characteristics in several studies (2,10).…”

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Effect of patient characteristics on performance of an enzyme immunoassay for detecting cervical Chlamydia trachomatis infection

et al. 1990

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We compared the performance of a commercial enzyme immunoassay (EIA) (Chlamydiazyme; Abbott Diagnostics, North Chicago, Ill.) with that of cell culture for the detection of Chlamydia trachomatis cervical infection in 1,417 women attending public health clinics. Confirmatory chlamydial testing by a direct fluorescent-antibody test (MicroTrak; Syva Co., Palo Alto, Calif.) was performed on specimens from women who had positive EIAs. Overall, only 57% of women who had a positive chlamydial test by cell culture were also positive by EIA. We noted a strong association between the number of chlamydial inclusions in cell culture and a positive EIA outcome. The proportion of culture-positive women who also had a positive EIA declined with age and a history of previous sexually transmitted disease and increased among oral contraceptive users. The results of direct fluorescent-antibody confirmatory testing suggested that cell culture was also insensitive for the detection of C. trachomatis infection. Our observations demonstrate that the performance of the chlamydia EIA may vary greatly with individual patient characteristics and that the utility of EIA as a screening test may be limited, especially in older women.

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Evaluation of fluorescein-conjugated monoclonal antibody test to detect Chlamydia trachomatis endocervical infections in adolescent girls

Cited by 31 publications

References 10 publications

Comparison of three techniques for detection of Chlamydia trachomatis in endocervical specimens from asymptomatic women

Comparison of three techniques for detection of Chlamydia trachomatis in endocervical specimens from asymptomatic women

Performance of a commercial polymerase chain reaction test for endocervical Chlamydia trachomatis infection in a university hospital population

Effect of patient characteristics on performance of an enzyme immunoassay for detecting cervical Chlamydia trachomatis infection

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