Introduction：One Step Strip Style ANTI-HP Rapid Screen Test is a lateral flow, immunochromatographic screening test.Purified recombinant antigens of HP are precoated onto membrane as a capture reagent on the test band region. If the antibody of HP is present in the sample in concentration above the labeled anti-human IgG-dye complex will be formed.This complex is the captured by antigens immonilized in the Test Zone of the membrane.The color intensity will depend on the concentration of the anti-HP present in the sample.This one step test is very sensitive and only takes about 15-20 minutes.Test results are read visually without any instrument.
Specimen collection:For serum, collect blood into a container without anticoagulant.If the specimen cannot be tested on the day of collection,store the serum specimen in a refrigerator or freezer.Bring the specimens to room temperature before testing.
- To begin testing,open the sealed pouch by tearing along the notch. remove the . test from the pouth.
- Immerse the strip into the sample with the arrow end pointing towards the sample.Do not immerse past the MAX(maximum)line. Take the strip out after 8-10 seconds and Lay the strip flat on a clean,dry,nonabsorben surface.
- Wait for colored bands to appear.Read results within 10-15 minutes.Do not read results after 20minutes.
Interpretation of results:
Negative: Only one color band appears on test region of the strip.. This indicates that there is no detectable anti-HP in the whole blood.
Positive: Two pink bands appear on test region of the strip.This indicate that the specimen contains detectable amount of anti-HP.
Invalid: If without colored band appears on test region,this is an indication of a possible error in performing the test. The test should be repeated using a new device.
- Must use fresh specimen and avoid repetitive freezing,the result will be invalid.
- Use it before expiry date.
- The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
- Old whole blood can not be used. If the whole blood is thick, it can be used only after being separated.
- The test is for in-vitro diagnostic use only.
- The test is qualitative filter detection, it can not be used as the final test for blood donor.
Storage and stability
The test kit can be stored at room temperature(2-30℃) in the sealed pouch the date of expiration. The test kit should be kept away from direct sunlight,moisture and heat.