One-Step Urine/Serum Combo Pregnancy DipStick 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/Serum Combo Pregnancy DipStick 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.
- In less than 5 minutes, elevated levels of hCG equal to or greater than 25 mIU/mL can be detected.
- Tests Urine or Serum
- FDA 510k & CLIA WAIVED
- Built-in control system
- Shelf-life up to 18-24 months
- Bring device and sample to room temperature (18-30°C).
- Remove the "test strip" from its foil wrapper by tearing along the "splice".
- Fill a test tube or a sample collection container with urine or serum sample and hold the strip in a vertical position.
- Place the test strip into the tube or container containing the sample.
- The specimen level should not be lower than 150 ml or higher than the "small arrows pointing down" level indicated on the strip.
- The strip must be placed in the tube or container so that the words "dip" and "read" are in an upright position.
- Read results at 5 minutes.
- Do not interpret results after 5 minutes.
||At 5 minutes, two pink colored bands appear, one in the control (C) region and one in the test (T) region, indicates a positive result and that the specimen contains hCG level of 25 mIU/ml or greater.
||At 5 minutes, only one pink colored band appears in the control region (C), the result is negative and that the specimen contains hCG level of less than 25mIU/mL.
||At 5 minutes, if no bands appear, or a test band appears without a control band, the result is invalid and the test should be repeated using a new test strip.
Pregnancy Urine/Serum Dipstick (Single)