Storage and Expiry
Store in a dry environment at 4-30°C, avoid hot and sunshine, valid for 36 months.
DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.
Sample Requirement
1. The reagent can be used for the serum, plasma and whole blood samples.
2. Serum, plasma and whole blood samples must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as the anticoagulants. Recommend to detect immediately after collecting blood. If blood coagulation occurs, serum sample are suggested to use.
3. Serum and plasma samples may be stored at 2-8°C for 1 week prior to assay, and at -20°C for 2 years. Frozen and refrigerated samples should be equilibrated to room temperature before detection and thoroughly mixed. Repeat freeze and thaw for no more than 3 times. Samples that exhibiting visible precipitates, stink or muddy should not be used.
4. Whole blood sample with anticoagulants may be stored at 2-8°C for 24 hours, It should be used immediately without anticoagulants.
DO NOT FREEZE. Mix the sample well by gentle inversion of the tube immediately before testing.
Test Procedure
Instruction for use must be read entirely before taking the test. Allow the reagent to equilibrate to room temperature for 30 minutes (10-30°C) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 10-30°C). Please use immediately when the humidity exceed to 60%. 1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.
2. Add 2 drops (50µL) of serum, plasma or whole blood vertically into the sample well.
3. Add 1 drop (40-50µL) of sample diluent into the sample well.
4. Observe the test result immediately within 15-20 minutes, the result is invalid over 20 minutes.
Note: The diagram is for reference only. See the real object for details.The appearance and color of reagent components may be different from the actual product, which has no effect on normal use.
Result Explanation
Positive: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the T1 test region (T1), indicating the IgG positive. Positive: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the T2 test region (T2), indicating the IgM positive. Positive: Three distinct colored lines appear. One line should be in all the control region (C), the T1 test region (T1) and the T2 test region (T2), indicating the IgG and IgM positive.
Negative: One colored line appears in the control region(C). No line appears in the test region (T).
Invalid: No colored lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.
