- Product Name
Malaria Pf/Pv Antigen Whole Blood Test Cassette (Colloidal Gold)
- Storage and Stability
Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
- Assay Procedure
1. Allow all test components and specimen to come to room temperature prior to testing .
2. Remove the test device from the foil pouch, and place it on a flat, dry surface
3. With a micropipette or a disposable dropper, add about 5 -10 μL whole blood specimen into the sample well.
4. Add two drops (80 μL) of assay buffer into developer well
5. As the test begins to work, you will see red color move across the result window in the center of the test cassette.
6. Interpret test results at 15-20 minutes. Caution: Do not read test results after 20 minutes. Reading too late can give false results.
- Interpretation of Results
1. Negative: The control line is the only visible line on the test cassette. No Pf or Pv antigens were detected. Retest in 3-5 days if Malaria infection is suspected.
2. Pv Positive: The control line (C) and the Pv line (Pv or T1) are visible on the test cassette. This is positive for Pv antigen to Malaria virus.
3. Pf Positive: The control line (C) and Pf line (Pf or T2) are visible on the test cassette. This is positive for Pf antigen to Malaria virus.
4. Pf and Pv Positive: The control line (C), Pf line (Pf or T2) and Pv line (Pv or T1) lines are all visible on the test cassette. This is positive for both Pf and Pv antigens.
5. Invalid: The control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the likeliest reasons for control line failure. Repeat the test using a new test cassette.
- Product Properties
Product Format: Cassette
Products name: Malaria Pf/Pv Antigen Whole Blood Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Whole Blood
Reading Time: with 15-20 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, SGS
- 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. Place the test device on a clean and level surface.
2. For IgG/IgM Test :Hold the dropper vertically and transfer 1 drop of specimen (approximately 10μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer. See illustration below.
3. For NS1 Test: Hold the dropper vertically and transfer 8~10 drops of specimen (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.
- Interpretation of Results
Positive: - For IgG/IgM Test: Control line and at least one test line appear on the membrane. The appearance of T2 test line indicates the presence of dengue specific IgG antibodies. The appearance of T1 test line indicates the presence of dengue specific IgM antibodies. And if both T1 and T2 line appear, it indicates that the presence of both dengue specific IgG and IgM antibodies. The lower the antibody concentration is, the weaker the result line is.
- For NS1 Test: 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.
