INTENDED USE
The OSOM® 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.
Easy-to-Run: Dipstick simple, one reagent
Accurate: 95% agreement against Composite Reference Standard (culture and wet mount). Unaffected by other common infections
Fast: Results in approximately10 minutes
Flexible: Requires minimal training and lab personnel
Objective: Provides easy-to-read two color results
Room Temperature Storage: 16 month shelf life
ABOUT
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. Effective diagnosis and treatment of Trichomonas infections have been shown
to eliminate symptoms. 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, a process that can take 24120 hours. Wet mount microscopy
has a reported sensitivity of 58% versus culture. 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.
REAGENTS AND MATERIALS PROVIDED
25 Test Sticks
25 Sterile Swabs
25 Test Tubes
1 Sample Buffer vial, 25 ml (saline buffer with 0.01% sodium azide)
1 Sample Buffer dropper top
1 Positive control swab (contains sodium azide and a desiccant tablet)
1 Workstation
1 Directional Insert
Note: Extra components (swabs, tubes) have been provided for your convenience
Warning: Contains Sodium Azide
-FDA 510k , CLIA Waived
-Remibursement Code: 87808-QW
-Amount: $17.52 (National Limit)
-Part#- 181
-It is always the responsibility of the medical professional to establish the reimbursement codes