OSOM Trichomonas Test Instruction Manual

1. හැඳින්වීම

The OSOM Trichomonas Test is a rapid, qualitative immunoassay designed for the detection of ට්රයිකොමොනාස් සයාේනිය antigen from vaginal swab specimens. This test is intended for in vitro diagnostic use and provides results in 10 minutes or less, aiding in the timely diagnosis of trichomoniasis.

2 අපේක්ෂිත භාවිතය

This device is for professional and laboratory use only. It is a CLIA-waived rapid test for the qualitative detection of ට්රයිකොමොනාස් සයාේනිය ප්රතිදේහජනක.

3 කට්ටල සංරචක

Each OSOM Trichomonas Test kit contains the following components, sufficient for 25 tests:

• 25 Test Sticks: Individually pouched test devices.
• 25 Sterile Swabs: For specimen collection.
• 25 Test Tubes: Reaction tubes for sample සැකසුම්.
• 1 එස්ample Buffer Vial: Reagent for sample තනුක කිරීම.
• 1 එස්ample Buffer Dropper Top: For dispensing buffer.
• 1 Positive Control Swab: For quality control purposes.
• 1 Workstation: To organize tubes during testing.
• 1 Instructions for Use: මෙම අත්පොත.

Note: Extra components (swabs, tubes) are provided for convenience.

රූපය 3.1: ඉවරයිview of the OSOM Trichomonas Test kit contents, including the test box, test sticks, sterile swabs, test tubes, and buffer vial.

4. අනතුරු ඇඟවීම් සහ පූර්වාරක්ෂාවන්

• සඳහා in vitro රෝග විනිශ්චය භාවිතය සඳහා පමණි.
• Do not use components beyond the expiration date printed on the label.
• Handle all specimens and reagents as if capable of transmitting infectious agents.
• Wear appropriate personal protective equipment (PPE), such as gloves and lab coats, when handling specimens.
• Dispose of all used materials in accordance with local, state, and federal regulations for biohazardous waste.
• Do not interchange components from different kit lots.

5. ගබඩා කිරීම සහ ස්ථාවරත්වය

Store the OSOM Trichomonas Test kit at room temperature (15-30°C or 59-86°F). Do not freeze. The kit components are stable until the expiration date printed on the outer box when stored properly.

6. Specimen Collection and Handling

Proper specimen collection is crucial for accurate results.

6.1 Vaginal Swab Specimen

1. Collect the vaginal swab specimen using the sterile swab provided in the kit.
2. Insert the swab into the posterior fornix of the vagina and rotate it firmly against the vaginal wall for 10-15 seconds to ensure adequate sampලේ එකතුව.
3. Immediately place the swab into a clean, dry test tube.
4. Specimens should be tested as soon as possible after collection. If immediate testing is not possible, specimens may be stored at 2-8°C for up to 24 hours.

7. පරීක්ෂණ පටිපාටිය

Allow all kit components and specimens to reach room temperature (15-30°C) prior to testing.

1. එස් සූදානම් කරන්නample Tube: Place one clean test tube into the workstation. Add 0.5 mL (approximately 10 drops) of Sample Buffer to the test tube using the dropper top provided.
2. Add Specimen: Insert the patient swab into the test tube containing the Sample Buffer. Rotate the swab vigorously against the side of the tube for 10 seconds. Squeeze the sides of the tube as the swab is removed to express as much liquid as possible from the swab. Discard the swab.
3. Add Test Stick: Remove one test stick from its foil pouch. Immediately place the test stick into the test tube with the arrows pointing down into the liquid.
4. ඉන්කියුබේට්: Allow the test to develop for 10 minutes. Do not read results after 15 minutes.

8. ප්රතිඵල අර්ථ නිරූපණය

Results are easy-to-read, two-color results.

8.1 Positive Result

Two distinct colored lines appear: one in the Control (C) region and one in the Test (T) region. The presence of a line in the Test region, regardless of its intensity, indicates a positive result for ට්රයිකොමොනාස් සයාේනිය ප්රතිදේහජනක.

8.2 Negative Result

Only one colored line appears in the Control (C) region. No line appears in the Test (T) region. This indicates that ට්රයිකොමොනාස් සයාේනිය antigen was not detected.

8.3 Invalid Result

No colored line appears in the Control (C) region, or only a line appears in the Test (T) region. An invalid result indicates that the test procedure was not performed correctly or the test device has deteriorated. Repeat the test with a new test stick and a new specimen if possible. If the problem persists, contact Sekisui Diagnostics Technical Support.

9. තත්ත්ව පාලනය

Internal procedural controls are included in the test. A colored line appearing in the Control (C) region indicates that sufficient sample volume was added and membrane wicking occurred correctly.

A Positive Control Swab is provided with the kit. It is recommended that a positive control be run with each new lot of kits or as required by local regulations and laboratory accreditation requirements.

10. සීමාවන්

• The OSOM Trichomonas Test is a qualitative test and does not indicate the quantity of ට්රයිකොමොනාස් සයාේනිය antigen present.
• A negative result does not rule out the possibility of ට්රයිකොමොනාස් සයාේනිය infection, as the antigen concentration may be below the detection limit of the test.
• Test results should be interpreted in conjunction with other clinical and laboratory findings.
• The test has a sensitivity of 83% and a specificity of 99% for vaginal swab specimens.

11. දෝශ නිරාකරණය

12. පිරිවිතර

• නිෂ්පාදන නම: OSOM Trichomonas Test
• ආදර්ශ අංකය: 181
• පරීක්ෂණ වර්ගය: Rapid Immunoassay
• Sample වර්ගය: Vaginal Swab
• Results Time: විනාඩි 10ක් හෝ ඊට අඩුවෙන්
• සංවේදීතාව: 83% (vaginal swab)
• විශේෂත්වය: 99% (vaginal swab)
• CLIA Status: අත්හැර දමන ලදී
• CPT Code: 87808QW ට
• පැකේජ මානයන්: අඟල් 8.39 x 4.84 x 3.78
• අයිතමයේ බර: අවුන්ස 7.04 කි

13. නිෂ්පාදකයා සහ සහාය තොරතුරු

නිෂ්පාදකයා: Sekisui Diagnostics

For technical support or inquiries, please contact Sekisui Diagnostics at:

දුරකථනය: 1-800-332-1042

Please have the lot number of your kit available when contacting support.