| EVANCARE HAV Hepatitis A Virus IgG/IgM Rapid Test Specification |
| Catalog No. | EC-HAV1002 | Format | Strip/Cassette |
| Specimen | Whole blood/Serum/Plasma | Test/Box | 50T/25T
|
| Reading Time | 10-15 minutes | Shelf Life | 3 Years |
| Storage Temperature | 4-30°C | Specificity | >99.9% |
| Sensitivity | ＞99.9% | Composition | Individually packed test device, Package insert,Dropper,Buffer |
| Accuracy | ＞99.9% | Feature 1 | High Accuracy |
| Feature 2 | High Sensitivity | Feature 3 | Clear Results |
| Feature 4 | Easy To Read | Feature 5 | Easy To Use |
| Feature 6 | OEM/ODM Available | Feature 7 | Quality Guarantee |
EVANCARE HAV Hepatitis A Virus IgG/IgM Rapid Test Test Procedure
EVANCARE HAV Hepatitis A Virus IgG/IgM Rapid Test
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 is 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 samples with anticoagulation may be stored at 2-8°C for 24 hours, and should be used immediately without anticoagulation. 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%.
Strip:
1. Remove the test strip from the sealed pouch, and place it on a clean and flat surface.
2. Add 1.5μL serum, plasma or 2μL whole blood vertically onto the nitrocellulose membrane. The pipette tip of micro pipette is required to touch the membrane gently for an accurate operation when the sample is added. If a disposable plastic sample ring is used, the ring body should be completely immersed in the sample, and then the ring body vertical touch the membrane surface of reagent. Samples should be sucked onto the membrane, and the membrane surface of the sample adding area should have wetting marks.
3. Add 2 drops (80μL-100μL) of sample diluent into the sample pad of the strip. Observe the test result immediately within 15-20 minutes, the result is invalid over 20 minutes.
Cassette:
1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.
2. Add 1.5μL serum, plasma or 2μL whole blood vertically onto the nitrocellulose membrane. The pipette tip of micro pipette is required to touch the membrane gently for an accurate operation when the sample is added. If a disposable plastic sample ring is used, the ring body should be completely immersed in the sample, and then the ring body vertical touch the membrane surface of reagent. Samples should be sucked onto the membrane, and the membrane surface of the sample adding region should have wetting marks.
3. Add 2 drops of (80-100μL) sample diluent into the diluent well of the cassette. Observe the test results immediately within 15-20 minutes, the results 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: Three distinct colored lines appear. One line should be in the control line region (C) and other two lines should be in the test line region (T1 and T2), indicating the IgG and IgM positive.
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. Negative: One colored line appears in the control region(C). No colored line appears in the test region (T1 and T2).
Invalid: No colored lines appear or control line fails to appear, indicating that the operator error or reagent failure.
