OSOM Trichomonas Test Instruction Manual

1. บทนำ

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

2. วัตถุประสงค์การใช้งาน

This device is for professional and laboratory use only. It is a CLIA-waived rapid test for the qualitative detection of ทริโคโมนาส วาจินาลิส แอนติเจน

3. ชุดส่วนประกอบ

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 sampการประมวลผลไฟล์
• 1 วินาทีample Buffer Vial: Reagent for sampการเจือจาง
• 1 วินาทีample 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: คู่มือนี้.

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

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

4. คำเตือนและข้อควรระวัง

• สำหรับ ในหลอดทดลอง ใช้เพื่อการวินิจฉัยเท่านั้น
• 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. การจัดเก็บและความเสถียร

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 sampเลอ คอลเลกชั่น
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. ขั้นตอนการทดสอบ

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

1. เตรียมเอสample 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. ฟักไข่: Allow the test to develop for 10 minutes. Do not read results after 15 minutes.

8. การตีความผลลัพธ์

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 ทริโคโมนาส วาจินาลิส แอนติเจน

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 ทริโคโมนาส วาจินาลิส 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. การควบคุมคุณภาพ

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. ข้อจำกัด

• The OSOM Trichomonas Test is a qualitative test and does not indicate the quantity of ทริโคโมนาส วาจินาลิส antigen present.
• A negative result does not rule out the possibility of ทริโคโมนาส วาจินาลิส 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 การแก้ไขปัญหา

12. ข้อมูลจำเพาะ

• ชื่อสินค้า : OSOM Trichomonas Test
• หมายเลขรุ่น: 181
• ประเภทการทดสอบ: Rapid Immunoassay
• Sampประเภทไฟล์: Vaginal Swab
• Results Time: 10 นาทีหรือน้อยกว่า
• ความไว: 83% (vaginal swab)
• ความจำเพาะ: 99% (vaginal swab)
• CLIA Status: Waived
• CPT Code: 87808 คิวดับเบิลยู
• ขนาดแพ็คเกจ: 8.39 x 4.84 x 3.78 นิ้ว
• น้ำหนักสินค้า: 7.04 ออนซ์

13. Manufacturer and Support Information

ผู้ผลิต: Sekisui Diagnostics

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

โทรศัพท์: 1-800-332-1042

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