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Trichomonas Vaginalis Antigen
Rapid Test Device
|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.
|20 Individually packed test devices||Each device contains a strip with colored conjugates and reactive reagents pre-coated at the corresponding regions.|
|2 Extraction Buffer vial||0.1 M Phosphate buffered saline (PBS) and 0.02% sodium azide.|
1 Positive control swab
(on request only)
|Contain inactived trichomonas and sodium azide. For External control.|
1 Negative control swab
(on request only)
|Not contain trichomonas. For external control.|
|20 Extraction tubes||For specimens preparation use.|
|1 Workstation||Place for holding buffer vials and tubes.|
|1 Package insert||For operation instruction.|
|Timer||For timing use.|
Use only Dacron or Rayon tipped sterile swabs with plastic shafts. It is recommend to use the swab supplied by the kits manufacturer(The swabs are not contained in this kit, for the ordering information, please contact the manufacture or local distributor, the cataloge number is 207000). Swabs from other suppliers have not been validated. Swabs with cotton tips or wooden shafts are not recommended.
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
Ÿ Put the specimen swab into the tube. Vigorously mix the solution by rotating the swab forcefully against the side of the tube for least ten times (while submerged). Best results are obtained when the specimen is vigorously mixed in the solution.
Allow the swab to soak in the Extraction Buffer for one minute prior to the next Step.
Ÿ Squeeze out as much liquid as possible from the swab by pinching the side of the flexible extraction tube as the swab is removed. At least 1/2 of the sample buffer solution must remain in the tube for adequate capillary migration to occur. Put the cap onto the extracted tube.
Discard the swab in a suitable biohazardous waste container.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
Discard used test tubes and Test Cassettes in suitable biohazardous waste container.
|Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).|
|Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).|
|Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.|
|Catalog number||Temperature limitation|
|Consult instructions for use||Batch code|
|In vitro diagnostic medical device||Use by|
|Manufacturer||Contains sufficient for <n> tests|
|Do not reuse||Authorized representative in the European Community|
7. Women with vaginal discharge should be evaluated for risk factors of cervicitis and pelvic inflammatory disease and for other organisms including Neisseria gonorroeae and Chlamydia trachomatis(These can also be diagnosed by our companys’ other three products: 500010 Chlamydia Rapid test; 500020 Gonorrhea Rapid test; 500050 Gonorrhea/Chlamydia combo Rapid Test Device).
8. Samples contaminated with preparations containing iodine or by the immediate prior use of vaginal lubricants are not recommended.
Table: Trichomonas Rapid Test vs. Culture
*95% Confidence Interval
Cross reactivity with other organisms has been studied using suspensions of 107 CFU/ml. The following organisms were not detected using the test:
|Acinetobacter calcoaceticus||Proteus vulgaris|
|Salmonella typhi||Acinetobacter spp.|
|Staphylococcus aureus||Candida albicans|
|Neisseria catarrhalis||Neisseria gonorrhoea|
|Neisseria meningitidis||Neiiseria lactamica|
|Escherichia coli||Gardnerella vaginalis|
|Streptococcus faecalis||Streptococcus faecium|
|Pseudomonas aeruginosa||Chlamydia trachomatis|
|Ureaplasma Urealyticum||Mycoplasma hominis|
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Contact Person: Ms. Anna Lee