Trichomonas Vaginalis Antigen Rapid Test Device
	500040	Specimen: Swab
Language: English		Version: 02
Effective Date: 2017-07

For professional in vitro diagnostic use only.

The Trichomonas Vaginalis Antigen 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 mount from vaginal swabs. This kit is intended to be used as an aid in the diagnosis of Trichomonas infection.

Trichomonas infection is responsible for the most common, non-viral sexually transmitted 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 will cost 24 -120 hours. Wet mount microscopy has a reported sensitivity of 58% versus culture.(4) The Trichomonas Rapid Test is an immunochromatographic assay that detects pathogen antigens directly from vaginal swabs. Results are rapid, occurring within approximately 10 minutes.

The Trichomonas Vaginalis Antigen Rapid Test uses color immunochromatographic, capillary flow technology. The test procedure requires the solubilization of Trichomonas proteins from a vaginal swab by mixing the swab in Sample Buffer. Then the mixed sample buffer is added to the test cassette sample well 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 (red). The complex will then be bound by a second anti-Trichomonas antibody coated on the nitrocellulose membrane. The appearance of a visible test line along with the control line will indicate a positive result.