Product Information
| Product Name | One Step TP Rapid Test |
| Model |  |
| Intended Use | This product is an in vitro diagnostic test for the qualitative determination of antibodies of Treponema Pallidum (TP) in whole blood/serum/plasma as an aid in the diagnosis of syphilis infection. |
| Test Method |
? For Model Detecting Serum/Plasma (1) Remove the strip/cassette from the sealed pouch.? (2) For strip, with arrows pointing toward the urine sample, immerse the strip vertically in the sample for at least 10-15 seconds; alternatively, draw sample with dropper and then add 1-2 drops of sample into the sample well of strip. For cassette, place the device on flat surface, draw sample with dropper and then add 2-3 drops of sample into the sample well of cassette.? (3) Start timing and observe the result within 10-20 minutes. ? For Model Detecting Serum/Plasma/Whole Blood (1) Remove the strip/cassette from the sealed pouch.? (2) Put the strip/cassette on a flat surface, draw sample with dropper and then add 1 drop into the sample well of strip/cassette, and then add 1 drop of dilution. ? (3) Start timing and observe the result within 10-20 minutes. |
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Interpretation of Results |
Positive: One red line appears in the test region (T) and another red line appears in the control region (C). ? Negative: A red line appears in the control region (C) but no red line appears in the test region (T).? Invalid：No line in both the test region (T) and control region (C), or a red line appears in the test region (T) but no red line appears in the control region (C). |
