Transactions of the annual meeting of the american gynecological and obstetrical society
Predictive value of the clinical diagnosis of lower genital tract infection in women

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Abstract

Objective

We hypothesized that diagnostic approaches to lower genital tract infections are inaccurate and proposed this study to evaluate typical approaches.

Study design

Clinical diagnoses were made with symptoms, direct observation, wet mount, vaginal pH, and amines in 598 women with genital complaints. Laboratory testing for N gonorrhoeae, yeast, T vaginalis, C trachomatis, and bacterial vaginosis by Gram stain.

Results

The most frequent symptoms were vaginal discharge (64%), change in discharge (53%), malodor (48%), and pruritis (32%). The infection rates were 46% bacterial vaginosis, 29% yeast, 12% trichomoniasis, 11% chlamydia or gonorrhea; 21% of the patients had no infection. The symptoms did not predict laboratory diagnosis. Clinical signs and symptoms with office-based tests and microscopy improved the accuracy of diagnoses. Amsel's clinical diagnosis of bacterial vaginosis was the most sensitive at 92%. The sensitivity of wet mount diagnosis of trichomoniasis was 62%, of yeast by microscopy was 22%, and of mucopus for the prediction of gonorrhea and/or chlamydia was 30%.

Conclusion

Symptoms alone should not be used to direct treatment in instances in which resources permit more complete evaluation with office-based testing that includes microscopy. Treatment failures or diagnostic uncertainty should prompt specific laboratory testing.

Section snippets

Methods

Nonpregnant women between the ages of 18 and 45 years who have ≥1 untreated genital complaints were enrolled under a research protocol that was approved by the institutional review board at Magee-Womens Hospital, Pittsburgh, Pa, and the United States Department of Defense. After written and verbal informed consent was obtained, women were enrolled prospectively in a study that was aimed at developing improved diagnostic testing for lower genital tract infections in women. Women were enrolled at

Results

Among the 598 women who were enrolled, 60% were black, 32% were white, 0.6% were Asian, 0.5% were Hispanic, 5% were of another ethnicity, and 1% were multiethnic or biracial. Most of the enrolled patients were unmarried and employed and had a history of ≥1 previous genital tract infections. More complete demographics are shown in Table I.

The overall infection rates by laboratory diagnosis (the gold standard) among the 598 women with lower genital complaints were bacterial vaginosis in 276 women

Comment

The data support the hypothesis that the presumptive diagnosis of lower genital tract infections in women with genital tract complaints invariably leads to significant numbers of women being misdiagnosed or under diagnosed. This diagnostic inaccuracy is also accompanied by a significant number of women who are treated and labeled with presumed infection who, in fact, are not infected with the suspected pathogens. In this study, the sensitivity data indicate that only 30% of women with Neisseria

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Supported by a Department of Defense grant no. DAMD17-96-1-6298.

Presented at the Twenty-Second Annual Meeting of the American Gynecological and Obstetrical Society, Napa, California, September 18-20, 2003.

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