- Product Name
PSA Test Cassette
- Storage and Stability
1. Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
- Test Procedure
Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen well(S) of the test device, then start the timer. See illustration below.
4. For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood(approximately 35μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer. See illustration below.
5. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
- Product Properties
Product Format: Cassette
Products name: PSA Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, SGS
- Product Name
FOB Feces Test Cassette
- Storage and Stability
1. Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
- Test Procedure
Allow the test, specimen and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Holding the sample collection tube upright, carefully take off the tip of collection tube, then break off the tip of collection tube, transfer 3 drops (approximately 100μl) to the specimen well(S) of the test device, then start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.
- Notes
Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of specimen to the specimen well.
- Product Properties
Product Format: Cassette
Products name: FOB Feces Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Feces
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, SGS
- Product Name
CEA Serum/Plasma Test Cassette
- Storage and Stability
1. Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
- Test Procedure
Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen well(S) of the test device, then start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes
- Notes
Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of specimen (serum or plasma) to the specimen well.
- Product Properties
Product Format: Cassette
Products name: CEA Serum/Plasma Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, SGS
- Product Name
AFP Serum/Plasma Test Cassette
- Storage and Stability
1. Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
- Test Procedure
Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen well(S) of the test device, then start the timer. See illustration below
4. For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood(approximately 35μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer. See illustration below.
5.5. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
- Note
Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of buffer (for whole blood) or specimen (for serum or plasma) to the specimen well.
- Interpretation of Results
Positive: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region.
Negative: One colored line appears in the control region(C).No apparent colored line appear in the test line region.
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 device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
- Product Properties
Product Format: Cassette
Products name: PSA Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, SGS