INTENDED USE

Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis (“Trichomonas”) antigens from vaginal swabs or from the saline solution prepared when making wet mounts from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen.

SUMMARY

Trichomonas infection is responsible for the most common, non-viral sexually transmited disease (vaginitis or trichomoniasis) worldwide. Trichomoniasis is a significant cause of morbidity among all infected patients.1,2 Effective diagnosis and treatment of Trichomonas infections have been shown to eliminate symptoms.2 Conventional identification procedures for Trichomonas from vaginal swabs or vaginal washes involve the isolation and subsequent identification of viable pathogens by wet mount microscopy or by culture,3 a process that can take 24 – 120 hours. Wet mount microscopy has a reported sensitivity of 58% versus culture.4 The OSOM Trichomonas Rapid Test is an immunochromatographic assay that detects pathogen antigens directly from vaginal swabs. Results are rapid, occurring within approximately 10 minutes.

PRINCIPLE

Trichomonas Rapid Test uses color immunochromatographic capillary flow “dipstick” technology. The test procedure requires the solubilization of Trichomonas proteins from a vaginal swab by mixing the swab in Sample Buffer. The OSOM Trichomonas Rapid Test Stick is then placed in the sample mixture and the mixture migrates along the membrane surface. If Trichomonas is present in the sample, it will form a complex with the primary anti-Trichomonas antibody conjugated to colored particles (blue). The complex will then be bound by a second anti-Trichomonas antibody coated on the nitrocellulose membrane. The appearance of a visible blue test line along with the red control line will indicate a positive result.