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Product Information
| Product Name | One Step Pregnancy Test (Colloidal Gold) |
| Model |  |
| Intended Use | This product is a device for rapid, visual, qualitative determination of human chorionic gonadotropin (HCG) in urine or serum to aid in early detection of pregnancy. |
| Test Method |
? Strip (1) Remove the device from the sealed pouch.? (2) With arrows pointing toward the urine sample, immerse the device vertically in the urine sample for at least 10 seconds.? (3) Start timing and observe the result within 5-10 minutes.? ? Cassette? (1) Remove the device from the sealed pouch and lay it on a flat surface.? (2) Take out the dropper provided with the device, draw urine and then continuously add 2-3 drops into the sample well.? (3) Start timing and observe the result within 5-10 minutes.? ? Midstream? (1) Remove the device from the sealed pouch.? (2) Hold the handle of the device, take off the cap (if any), then directly urinate towards the absorbent tip for 2-3s. After that put on the cap (if any) and lay the device on a flat surface or keep holding it flat. The alternative method is that hold the handle of the device, take off the cap (if any), immerse the device vertically in the urine sample for at least 10 seconds. Remove the device from urine sample and lay it on a flat surface or keep holding it.? (3) Start timing and observe the result within 5-10 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). |
