Trichomonas Vaginalis Rapid Test Cassette with Vaginal Swab and CE
Certificate
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | Vaginal Swab |
| Certificate | CE |
| Reading Time | 15 minutes |
| Pack | 10 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 90.00% |
| Specificity | 96.30% |
| Accuracy | 95.00% |
Application:
The Trichomonas Vaginalis Rapid Test Cassette (Vaginal Swab) is a rapid chromatographic
immunoassay for the qualitative detection of Trichomonas Vaginalis antigen from vaginal swabs. This test is intended to be used as an
aid in the diagnosis of Trichomonas infection.
Description:
Trichomonas Vaginalis is an anaerobic, flagellated protozoan parasite and the causative
agent of trichomoniasis. It is the most common pathogenic protozoan
infection of humans in industrialized countries.Infection rates between men and women are similar with women being
symptomatic, while infections in men are usually asymptomatic.
Transmission usually occurs via direct, skin-to-skin contact with
an infected individual, most often through vaginal intercourse. The
WHO has estimated that 160 million cases of infection are acquired
annually worldwide. The estimates for North America alone are between 5 and 8 million
new infections each year, with an estimated rate of asymptomatic
cases as high as 50%. Usually treatment consists of metronidazole and tinidazole.
How to use?
Allow the test, specimen swab, buffer and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Place a clean extraction tube in the designated area of the
workstation. Add 10 drops of extraction buffer (approx. 560μl) into the extraction tube.
2. Put the specimen swab into the extraction tube, vigorously mix
the solution by rotating the swab forcefully against the side of
the tube for least 10 times (while submerged). Best results are
obtained when the specimen is vigorously mixed in the solution.
3. Allow the swab to soak in the reaction buffer for 1 minute prior
to the next step. Squeeze out as much liquid as possible from the
swab by pinching the slide of the flexible extraction tube as the
swab is removed. At least 1/2 of the reaction buffer solution must
remain in the tube for adequate capillary migration to occur.
4. Discard the swab in a suitable bio-hazardous waste container,
then fit on the extraction tube tip onto the extraction tube.
5. Remove the test cassette from its sealed pouch, and place it on
a clean and level surface. To obtain a best result, the assay
should be performed within one hour.
6. Add 3 drops of extracted sample (approx. 100μl) from the extraction tube to the specimen well(S) on
the test cassette. Please note avoid trapping air bubbles in the
specimen well(S) and do not drop any solution in observation
window.
7. Wait for the colored line(s) to appear. The result should be
read at 15 minutes, do not interpret the results after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE: * Two colored lines appear. One colored line should be in the control line region (C) and
another colored line should be in the test line region (T). A
positive result indicates that Trichomonas Vaginalis antigen was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary
depending on the concentration of Trichomonas Vaginalis antigen present in the specimen. Therefore, any shade of color in
the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result
indicates that Trichomonas Vaginalis antigen is not present in the specimen, or is present below the
detectable level the test.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are
the most likely reasons for control line failure. Review the
procedure and repeat the test with a new test. If the problem
persists, discontinue using the test kit immediately and contact
your local distributor.
Order Information
| Cat. No. | Product Description | Specimen | Format | Kit Size | Cut-Off | Status |
| ITV-502 | Trichomonas Vaginalis Rapid Test Cassette | Vaginal Swab | Cassette | 10 T | See Insert | CE |
SUMMARY
Trichomonas Vaginalis is an anaerobic, flagellated protozoan
parasite and the causative agent of trichomoniasis. It is the most
common pathogenic protozoan infection of humans in industrialized
countries.1Infection rates between men and women are similar with
women being symptomatic, while infections in men are usually
asymptomatic.
Transmission usually occurs via direct, skin-to-skin contact with
an infected individual, most often through vaginal intercourse. The
WHO has estimated that 160 million cases of infection are acquired
annually worldwide.2 The estimates for North America alone are
between 5 and 8 million new infections each year, with an estimated rate of asymptomatic cases as high
as 50%.3 Usually treatment consists of metronidazole and tinidazole
