One step digital urine hcg pregnancy test strip

10-25 mIU/mL

strip:2.5, 3.0, 3.5, 4.0

cassette:3.0,4.0

midstream:4.5,5.5,6.0

One Step HCG Urine Pregnancy Test is a test kit for the determination of hCG (Human Chorionic Gonadotropin) in urine specimens. This test kit is used to obtain a visual qualitative result for early detection of pregnancy. The test sensitivity is 10-25 mIU/mL.

Precaution

1.  For in vitro diagnostic use only.

2.  Do not use test kit beyond expiry date.

3.  The test device should not be reused.

4.  All test devices and specimens must be at room temperature (2-30°C) before running the assay.

Specimen Collection and Preparation

 A urine specimen must be collected in a clean and dry container. A first morning urine specimen is preferred since it generally contains the highest concentration of hCG; however, urine specimens collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.

Test procedure

1. To begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.                                   

2. Draw 0.15ml (about 3 drops) sample into the pipette, and dispense it into the sample well on the cassette.

3. Wait for the colored bands to appear. Depending on the concentration of HCG in the test specimen, positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (5 minutes) is required.

Do not read results after 10 minutes.

Interpretation of Results

1.Negative: Only one color band appears on the control region . No apparent band on the test region. There is no pregnancy.

2.Positive: Distinct color bands appears on the control and test regions. Beth test line and control line indicate that you are pregnant. Color intensity of the test bands may vary. Different stages of pregnancy have different concentrations of HCG hormone.

3.Invalid: No visible bang at all. Repeat test with a new test kit.

Limitations

1. Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hCG.

2. False negative results may occur when the levels of hCG are below the sensitivity level of the test.

3. Very low levels of hCG (less than 50 mIU/mL) are present in urine specimen shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.

4.Other conditions except pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hCG (6-7). Therefore, the presence of hCG in urine or serum specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.

5. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.