One-Step Urine/Serum Combo Pregnancy Cassette w/ Pipette 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 Cassette 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.
- 50 Cassette & Pipettors per box
- 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
- Equilibrate all materials and reagents to room temperature before testing.
- Remove the "reaction pack" from its foil wrapper by tearing along the "splice".
- Fill the urine dropper with urine and hold the dropper vertically and add four (4) full drops (160 ml), without bubbles, of urine onto the sample (S) well.
- Read results at 5 minutes. Strong positive results may be observed in 2-3 minutes. Do not interpret results after 5 minutes.
INTERPRETATION OF RESULTS
Positive: At 5 minutes, two pink colored bands appear, one in the control region (C) and one in the test region (T), indicate a positive result and that the specimen contains hCG level of 25 mIU/ml or greater.
Negative: At 5 minutes, only one pink colored band appears in the control region (C) indicating a negative result and that the specimen contains hCG level of less than 25 mIU/ml.
Invalid: 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 device.
NOTE: Avoid over flooding the device with sample. This will cause erroneous result. If this occurs, it is strongly recommended that the test be repeated. Also, if the flow of the sample is not observed through the viewing window, this is due to an insufficient amount of urine sample dispensed into the sample well.
-Quantity: 50 Tests
-FDA 510k , CLIA Waived
-CPT Reimbursement Code:
81025QW* ($8.84) - Urine
84703QW ($10.49) - Serum
-This product is for professional use only and it is always healthcare provider responsibility to establish reimbursements.