One-Step H. pylori Ab Rapid Test is a rapid, one-step, visual test for the for the qualitative detection of antibodies (IgG, IgM, and IgA) anti- Helicobacter pylori (H. pylori) in human serum, plasma, whole blood. The test is to be used as an aid in the diagnosis of infection due to H. pylori, formely known as Campylobacter pylori, in patients with gastrointestinal symptoms
SPECIMEN COLLECTION AND PREPARATION Whole blood Collection using a lancet:Finger prick whole blood sample could be collected by first using an alcohol swabto clean the finger of the person being tested, then puncturing the center of the finger pad skin with a disposable sterile blood lancet, holding the finger downward, dripping the blood into the test cassette's sample well, or collect blood from the puncture site with a disposable plastic dropperand dispense one full drops (about 25µl) of fresh blood into the sample well Collection by venipuncture: Collect whole blood in a collection tube (containing anticoagulants such as heparin, EDTA and sodium citrate) by venipuncture. -If blood specimens are not immediately tested, they should be stored refrigerated at 2-8°C. When stored at 2-8°C, the blood specimens must be used within 3 days. Whole Blood can not be frozen. Plasma or Serum 1.Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzedsamples can be used. Avoid grossly lipemic or turbid samples.Whole Blood can not be frozen. 2.If serum or plasma samples are not tested immediately, they should be refrigerated at 2‐8ºC. For storage period longer than 7 days, freezing is recommended. Avoid frequent (more than 3 times) thaw-and-freeze of specimens. Prior to testing, bring frozen specimens and refrigerated specimens to room temperature slowly and mix gently. 6.Do not use heat-inactivated samples.
TEST PROCEDURE If stored refrigerated, ensure that the pouched device ,Sample diluents and specimen is brought to room temperature(about 20 minutes) before use. 1.Remove the Test Device from the sealed pouch . Use it as soon as possible within 1 hour after removal from pouch. 2.Place the test device on a clean, flat surface. 3.Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense One drop(about 25μL) of specimen into the sample well. 4.Then holding the bottle in a vertical position,add One drop (about 50μL) of the Sample Diluent from the dropper bottle to the sample well.Set up timer. 5.Read the test results within 10-20 minutes. Do not read the results after 20 minutes. To avoid confusion, discard the test device after interpreting the result.
For the interpretation of the test result the line(s) that has(ve) appeared in the test result window are visually interpreted. 1. Positive Result: If both C and T bands are developed, the test indicates for the presence of antibodies to H. Pylori in the specimen. The result is positive. 2. Negative Result: If only the C band is developed, the test indicates that no detectable antibodies to H. Pylori are present in the specimen. The result is negative. 3. Invalid Result: No visible band at all or no colored band appears on the control (C) region. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributors.
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