Complaint
| Product Name | One Step Gonorrhea Rapid Test |
| Intended Use | This product is a rapid test for the visual detection of Gonorrhea antigen in the secretory specimen from urogenital system, as an aid in the diagnosis of Gonorrhea infection. |
| Test Method | Strip (1) Pre-treat the specimen. (2) Remove the device from the sealed pouch. (3) With arrows pointing toward the sample, immerse the device vertically in the sample for at least 10 seconds. (4) Start timing and observe the result within 10-20 minutes. Cassette (1) Pre-treat the specimen. (2) Remove the device from the sealed pouch. (3) Take out the dropper provided with the device, draw sample and then continuously add 2 drops into the sample well. (4) Start timing and observe the result within 10-20 minutes. |
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). |
