Parasitology
Performance of rapid immunochromatographic assay in the diagnosis of Trichomoniasis vaginalis

https://doi.org/10.1016/j.diagmicrobio.2012.05.003Get rights and content

Abstract

Trichomonas vaginalis accounts for nearly half of all curable sexually transmitted diseases worldwide with serious health consequences. Effort to increase the sensitivity of its diagnosis is critical to both control measures and epidemiologic studies. This study was conducted to evaluate the OSOM® Trichomonas Rapid Test (Sekisui Diagnostics, Framingham, MA, USA), a qualitative antigen-detection immunochromatographic (IC) assay in the diagnosis of vaginal trichomoniasis comparable to the conventional methods. The study enrolled 258 females aged 18–50 years classified into symptomatic (185) and asymptomatic (73) groups. Vaginal swab specimens were obtained for wet mount, stained preparation (Giemsa, acridine-orange), culture (InPouch TV™, modified Diamond's), and for rapid OSOM testing. Trichomonas vaginalis was detected in 67, 66, 71, 99, 96, and 97 using wet mount, acridine-orange stain, Giemsa stain, modified Diamond's, InPouch media, and OSOM test, respectively. In comparison to a composite reference standard (CRS) of wet mount microscopy and culture, OSOM test reported 97.98%, 99.37%, 98.98%, 98.75%, and 98.84% for sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy, respectively. The OSOM test proved to be a simple and objective test. This rapid point-of-care-test will contribute significantly in the diagnosis of vaginal trichomoniasis and will increase the understanding of its still vague epidemiology.

Introduction

The protist Trichomonas vaginalis, previously known as a self-clearing minor nuisance (Honigberg, 1987), is now considered of importance concerning public health. According to the World Health Organization (2002), 88 million women were infected in 1999. T. vaginalis infection is associated with diverse reproductive health outcomes including cervical neoplasia (Sayed El-Ahl et al., 2002), cervical carcinoma (Viikki et al., 2000), tubal infertility (Grodstein et al., 1993), post-hysterectomy infection (Soper et al., 1990), pelvic inflammatory disease (Cherpes et al., 2006, Moodley et al., 2002), preterm rupture of membranes (Petrin et al., 1998), preterm birth (Cotch et al., 1997), low birth-weight infants (Land et al., 2004), and neonatal infection (Carter and Whithaus, 2008). Most important is the role played by T. vaginalis as a co-factor in the transmission of human immunodeficiency virus (Guenthner et al., 2005, Miller et al., 2008).

As with other sexually transmitted diseases, symptoms and signs of trichomoniasis are not adequately specific for diagnosis (Aslan et al., 2005). In the light of the increased magnitude of infection and its associated morbidity, the need for a valid, time-saving, cost-effective, quick-to-perform, and easily applicable test for diagnosis becomes imperative (Ojuromi et al., 2007).

Wet mount microscopy, although inexpensive and provides immediate results, is a subjective test requiring experience and access to a microscope (Kingston et al., 2003); even in the hands of trained observers, the wet mount is only 36–75% sensitive compared to culture (Wiese et al., 2000). Staining techniques, which are also a subjective test, are time consuming (Afzan et al., 2010, Stary et al., 2002). Although culture is considered as the “gold standard” (Karaman et al., 2008, Radonjic et al., 2006), there are inherited limitations to its use including the following: long incubation period, during which the patient may be lost to follow-up or continue to transmit infection (Moldwin, 1992); daily examination is required (Swygard et al., 2004); organisms often die in transit (Heine et al., 1997); and some isolates of T. vaginalis grow poorly or do not grow at all on commonly used media (Jeremias et al., 1994). The InPouch TV culture media (BioMed Diagnostics, San Jose, CA, USA) has the following advantages: ease of use as 2 procedures are combined into 1 test; it has a long-shelf life; no expensive equipment is required; and cultures can be obtained even with a very low concentration of trichomonads (Borchardt and Smith, 1991).

The role of this study was to determine the sensitivity and specificity of an immunochromatographic rapid antigen-detection assay (OSOM Trichomonas Rapid Test, Sekisui Diagnostics) in comparison to those of a composite reference standard (CRS) of wet mount microscopy and culture.

Section snippets

Study participants

The study was carried out on 258 females attending the Outpatient Gynecology Clinic and Fertility Care Center at Mansoura University Hospitals, Egypt. Recruited females were between the ages of 18 and 50 years who denied the use of oral or topical metronidazole during the last 4 weeks prior to the specimen collection. Enrollees were classified into the i) symptomatic group, which included 185 females complaining of symptoms consistent with vaginitis; and ii) asymptomatic group, which included

Results

The median age of the 258 enrolled females was 26 years (range, 18 to 57 years). The complaints of the symptomatic group (185, 71.71%) were vaginal discharge (87, 47.04%), vulvar pruritus (39, 21.08%), dyspareunia (24, 12.97%), and pelvic pain (14, 7.56%). A combination of 2 or more symptoms was complained by 21 women (11.35%). Overall, the prevalence of T. vaginalis in this population was 38.37% (99 of 258) by the CRS.

T. vaginalis trophozoite was detected in 67, 66, and 71 using wet mount,

Discussion

The present global toll inflicted by the human immunodeficiency virus with the recognized role of sexually transmitted diseases in its spread (Guenthner et al., 2005, Laga et al., 1993, Miller et al., 2008), the impeachable association of T. vaginalis with a large scale of adverse health complications (Carter and Whithaus, 2008, Cherpes et al., 2006, Petrin et al., 1998, Sayed el-Ahl et al., 2002, Viikki et al., 2000), and, more importantly, the limitations of conventional diagnostic techniques

Acknowledgments

The authors sincerely thank Sekisui Diagnostics (Framingham, MA, USA) for providing the OSOM Trichomonas Rapid Test kits for this study. Also, many thanks to Biomed Diagnostics (San Jose, CA, USA) for kindly supplying the authors with the InPouch TV medium.

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