- Assay Procedure
1. Allow the test, specimen diluent and/or controls to reach room temperature 10â~30â (50â~86â) prior to testing.Â
2. Remove the test device from the sealed pouch and use it as soon as possible.Â
3. Place the test device on a clean and level surface.Â
4. FROM THE TOP OF THE SPECIMEN WELL:Add 20µL venous whole blood or 10µL serum/plasma specimen into each specimen well.Â
5. FROM THE BOTTOM OF THE SPECIMEN WELL:Add 80µL or 2 drops of specimen diluent into each specimen well.Â
6. Wait for the colored o appear. Read results within 15 minutes. Do not read the result after 15 minutes.
- Interpretation of Results
1. IgM Positive: The presence of two purple bands (T and C) within the IgM result window indicates positive for 2019-nCoV IgM antibody.Â
2. IgG Positive: The presence of two purple bands (T and C) within the IgG result window indicates positive for 2019-nCoV IgG antibody.Â
3. Negative: Only one purple band appearing at the control indicates negative result.Â
4. Invalid: If control fails to appear, no matter whether the T isible or not, the test is invalid. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control ure. Review the procedure and repeat the test with a new test device. If the problem persists, you should immediately stop using the kit with the same LOT No. and your local distributor.
- Product Properties