Research
Basic science: Gynecology
Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women

Preliminary findings from a subset of participants were presented at the 22nd International Union Against Sexually Transmitted Infections Europe Conference on Sexually Transmitted Infections, Versailles, France, Oct. 19-21, 2006.
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Objective

We evaluated the performance characteristics of APTIMA Trichomonas vaginalis (ATV) transcription-mediated amplification (TMA) for diagnosis of T vaginalis (TV) infection from female vaginal swab, endocervical swab, and urine specimens and from male urethral swab and urine specimens. Performance of ATV TMA was compared with wet mount microscopy, culture, and polymerase chain reaction (PCR).

Study Design

In all, 296 female and 298 male subjects who attended the Jefferson County Health Department sexually transmitted diseases clinic were enrolled in the study and provided specimens for each test. Results were analyzed using 3 interpretative algorithms.

Results

For women, vaginal swab ATV TMA was significantly more sensitive than wet mount or culture. In male subjects, urethral swab ATV TMA was significantly more sensitive than culture or PCR.

Conclusion

ATV TMA provides a sensitive, commercially available nucleic acid amplification test for improved diagnosis of TV in male and female patients.

Section snippets

Study population

All adult women and men aged 18 years or older who attended the Jefferson County Health Department sexually transmitted diseases (STD) clinic (Birmingham, AL) were invited to participate in this prospective study. Subjects were excluded from the study if they had taken an antibiotic within the last 14 days, had urinated within 1 hour prior to the collection of the urine specimen, or could not provide all required specimens. The study protocol was approved by the University of Alabama,

Results

Specimens were collected from 296 women and 298 men. The TV prevalence in women ranged from 16.2% by wet mount to 28.7% by vaginal swab ATV TMA. The TV prevalence in men ranged from 4.0% by culture to 13.4% by urethral swab ATV TMA.

Table 3 shows the performance characteristics of wet mount, culture, PCR, and ATV TMA in women. The infected patient status algorithm identified 69 infected women. One subject was positive only by wet mount; the other 47 of 48 (97.9%) subjects with positive wet mount

Comment

Nucleic acid amplification methods have changed the laboratory diagnosis of STIs; NAAT is now the standard of care for Chlamydia and gonorrhea detection. This study demonstrates the improved diagnostic accuracy of ATV TMA NAAT for TV in men and women compared with traditional methods. In the current study, vaginal swab ATV TMA was found to be more sensitive than wet mount, culture, endocervical swab PCR, and urine PCR for the diagnosis of TV in women using the molecular-resolved algorithm.

Acknowledgments

We thank Moira Venglarik, CRNP, for recruiting and examining patients. We thank Phyllis Davis, Erin Christensen, and Rebecca Amos for their assistance with testing specimens and data management.

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    Cite this article as: Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol 2009;200:188.e1-188.e7.

    This study is supported by Gen-Probe Incorporated.

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