INTENDED USE One-Step anti-TP Rapid Test is a rapid, one-step, visual test for the qualitative detection of antibodies to Treponema pallidum (TP) in whole blood, serum and plasma samples. It is intended to be used as an aid for the diagnosis of clinical conditions related to infection with T. pallidum (also known as syphilis).
TEST PROCEDURE If stored refrigerated, ensure that the pouched device ,Sample diluent buffer 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 30μL) of specimen into the sample well. 4.Then holding the bottle in a vertical position,add One drop (about 50μL) of the Sample Dilution buffer from the dropper bottle to the sample well.Set up timer. 5.Wait for the red line(s) to appear. Results can be read in 10-20 minutes. Don't read result after 30 minutes. Note: Applying sufficient amount of samples diluents is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after 2-3 minutes, add one more drop of diluents to sample well.
INTERPRETATION OF RESULTS 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: Two pink / purple colored bands appear. One line should be in the control region (C) and another line should be in the test region (T). This indicates that the specimen contains detectable amount of TP antibody. 2. Negative Result: Only one pink / purple colored band appears in the Control Region (C). No apparent red or pink line appears in the test regions (T). The test indicates that no detectable antibodies to TP antibody are present in the specimen. 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.
Complaint
