Item Brochure

1
EN
OSOM
®
Trichomonas Rapid Test
Catalog number 181E
CLIA Complexity: Waived
FOR EXPORT USE ONLY. NOT FOR SALE IN THE U.S.
FOR LABORATORY AND PROFESSIONAL USE ONLY.
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.
Patient-collected vaginal swab specimens are an option for screening women when a pelvic
exam is not otherwise indicated. The vaginal swab specimen collection is not for home use.
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SUMMARY AND EXPLANATION OF TEST
Trichomonas infection is responsible for the most common, non-viral sexually transmitted
disease (vaginitis or trichomoniasis) worldwide. Trichomoniasis is a signicant cause of
morbidity among all infected patients
1,2
. Effective diagnosis and treatment of Trichomonas
infections have been shown to eliminate symptoms
2
. Conventional identication procedures
for Trichomonas from vaginal swabs or vaginal washes involve the isolation and subsequent
identication 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 OF TEST
The OSOM Trichomonas Rapid Test uses color immunochromatographic, capillary ow,
“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
EN......................................................................................................................1
DK .....................................................................................................................8
FR ....................................................................................................................15
DE....................................................................................................................23
IT .....................................................................................................................31
NO ...................................................................................................................38
ES ....................................................................................................................45
SV ....................................................................................................................53
FI .....................................................................................................................60
ET ....................................................................................................................67
Trichomonas Rapid Test