INTENDED USE
One-Step Urine Pregnancy Midstream Test is a colloidal gold antibody complex based immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy.
One-Step Urine Pregnancy Midstream Test is a qualitative, sandwich dye conjugate immunoassay for the determination of human hCG in urine. 4.5 The method employs a combination of monoclonal and polyclonal antibodies to selectively identify hCG in test samples with a high degree of sensitivity. In less than 5 minutes, elevated levels of hCG equal to or greater than 25 mIU/mL can be detected.
FEATURES
- In less than 5 minutes, elevated levels of hCG equal to or greater than 25 mIU/mL can be detected.
- Tests Urine
- FDA 510k & CLIA WAIVED
- Built-in control system
- Shelf-life up to 18-24 months
TEST PROCEDURE
- To begin testing, open the sealed pouch by tearing along the notch. Remove test kit from the pouch.
- Hold the round end of cover with one hand. Use the other hand to pull out the test device and expose the absorbent.
- Point the absorbent tip downward; place the absorbent tip in urine stream for at least 10 seconds to be thoroughly wet. Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 10 seconds.
- Re-cap the device and wait for colored bands to appear.
Do not stream past the arrow end
INTERPRETATION OF RESULTS
- Negative: Only one color band appears on the control region. No apparent band on the test region. There is no pregnancy.
- Positive: Distinct color bands appear on the control and test regions. Both test line and control line indicates that you are pregnant. Color intensity of the test bands may vary. Different stages of pregnancy have different concentrations of hCG hormone.
- Invalid: No visible band at all. Repeat test with a new test kit.
STORAGE AND STABILITY
The test kit can be stored at temperatures between 2 to 30°C in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.
PRECAUTION
- For in vitro diagnostic use only.
- Do not use test kit beyond expiry date.
- The test device should not be reused.