1) Remove the outer packaging and place the test cassette on a flat surface with the sample wells facing upwards.
2) Using the pipette held vertically, add 3 full drops of blood into the sample wells (IgM & IgG) on the cassette. Add 1 drop of buffer solution (light blue vial) into the same sample wells (IgM & IgG) where the blood was applied. Avoid air bubbles in the pipette, as bubbles may prevent complete sample transfer and invalidate the test. Use a new pipette for each test performed, even when using the same sample.
3) Read the test results within 15–30 minutes. Results are invalid after 35 minutes.
POSITIVE:
Two distinct colored lines appear. One line should appear in the control region (C) and the other line should appear in the test region (T).
NEGATIVE:
One colored line appears in the control region (C). No visible colored line appears in the test region (T). A negative result does not indicate the complete absence of analytes in the sample; it only indicates that the level of analytes tested is below the detection threshold.
INVALID:
No colored lines appear, or the control line does not appear. This indicates an operator error or reagent failure. Review the procedure and repeat the test using a new test device.
Notes:
1. Any shade of color in the test region should be considered positive. Please note that this is a qualitative test and cannot determine the concentration of analytes in the sample.
2. Insufficient sample volume, incorrect operating procedure, or expired tests are the most common causes of control line failure.
3. The color intensity of the control line may vary between different test areas on the same cassette. This is normal. The strength of the quality control line does not indicate any issue with the reagent. A clearly visible test result indicates that the reagent is functioning correctly.
