Item Brochure

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the primary anti-Trichomonas antibody conjugated to colored particles (blue). The complex
will then be bound by a second anti-Trichomonas antibody coated on the nitrocellulose
membrane. The appearance of a visible blue test line along with the red control line will
indicate a positive result.
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
1 Patient Sample Collection Instruction Card
Note: Extra components (swabs, tubes) have been provided for your convenience.
Warning: Contains Sodium Azide
MATERIAL REQUIRED BUT NOT PROVIDED
A timer or watch.
OPTIONAL ACCESSORIES
Empty plastic transport tubes, Sekisui Diagnostics Catalog # 7760
WARNING AND PRECAUTIONS
• For in vitro diagnostic use only.
• Follow your clinical and/or laboratory safety guidelines in the collecting, handling, storage,
and disposal of patient specimens, and all items exposed to patient specimens. Swabs,
test tubes, and Test Sticks are for single use only.
• The Sample Buffer contains a saline solution with a preservative (sodium azide) and a
detergent at low concentrations. If solution comes in contact with the skin or eyes, ush
with lots of water.
• Solutions that contain sodium azide may react explosively with lead or copper plumbing.
Use large quantities of water to ush discarded solutions down a sink.
• Do not use or mix components from different lots.
STORAGE CONDITIONS
• Store Test Sticks and reagents tightly capped at room temperature (15°- 30°C).
• Do not freeze.
• Do not use Test Sticks and reagents after expiration date.
• Discard unused Test Sticks that have been removed from the canister after 1 hour.
SPECIMEN COLLECTION AND PREPARATION
• Collect specimens from the vaginal cavity with a sterile rayon swab from the kit.
• Use of the swabs supplied in the kit or the BD BBL™ CultureSwab™ (sterile or with Liquid
Stuarts Media) is recommended. Swabs from other suppliers have not been validated. Swabs
with cotton tips or wooden shafts are not recommended.
• A vaginal swab specimen may be obtained by the patient.
• Patients should be given complete and clear instructions on how to obtain the vaginal swab.
Providing the instruction card as a guide is recommended.
• It is important for patients to understand how to collect a vaginal swab sample, since a negative
result may be obtained if the specimen collection is inadequate.
• If the patient does not understand the instructions we recommend the sample be obtained by
a healthcare professional.
• Process the swab as soon as possible after collecting the specimen. Specimens may be held
at room temperature for no longer than 24 hours. Swabs may also be stored at 4°C or -20°C
for up to 36 hours.
• To transport patient samples place swabs in a clean, dry container such as a plastic or
glass tube. Transport tubes are available from Sekisui Diagnostics, Catalog # 7760.
• The solution remaining in the test tube for the wet mount may also be used as the sample
for the OSOM test. To use this sample type, soak a new kit swab in this solution.
Using this swab, perform the complete test procedure detailed below. There must be
enough solution left after the wet mount to soak the new swab completely. These saline