Intended Use:
This test device is used for in vitro qualitative detection of
Human Chorionic Gonadotropin (HCG) in human urine.
1. This product is only for HCG test in human urine sample.
2. Unfresh or unclean test sample, or test sample with impurities,
will produce
incorrect results. Unclean urine collection containers, or improper
operation
will also produce incorrect results.
3. This test is used for qualitative detection in the early stage
of pregnancy.
The quantitive result should be further confirmed by other methods.
4. In some cases, the test results will be affected. For example:
Injection or
taking of hormone or steroid medications, those with history of
previous
injection of HCG, germ cell tumor of ovary (GCTO) and others. It is
suggested
to repeat the test or further confirm from the specialized
laboratory and make
a comprehensive judgement in combination with clinical symptoms and
signs,
provided that the test results are suspected.
5. Test results of this product will not be affected by
hematuresis, bilirubin and
turbid urine. Higher chyle level may affect the test result.
6. This product will produce a hook effect on the sample with HCG
level above
50,000 mIU/ml due to the limitation of the methodology. The test
result may be
negative.
The test should be performed at room temperature.
1. When you are ready for a test, take out the test midstream from
the foil. The
test should be used as soon as possible within 1 hour.
2. Remove the cap of test midstream.
If Test in Urine Stream: put just the absorbent tip pointing
downwards into
your urine stream (Fig.2). Take care not to splash the urine on
other parts of
the test midstream.
If Test in a Container: after you collect the urine, dip more than
half of the
absorbent tip to the urine (Fig.3). Do not get other parts of the
test wet except
the absorbent tip.
3. When adding sample, the display screen will light up and the
Hourglass
symbol" " will flash (Fig.4).
4. When sample adding is completed, the test midstream will beep.
Then
remove the test midstream. Replace the cap and lay it flat.
5. The result will be displayed on the display screen within 5
minutes after
adding sample.
Specification
| Product name | Digital Pregnancy Rapid Test |
| Method | Immunochromatography |
| Specimen | Urine |
| Accuracy | over 99% |
| Sensitivity | 25mIU/ml |
| Certificate | CE |
| Shelf life | 30months |
| package | 1test/box,2test/box |
1.Store in dry places at 2℃—30℃,do not freeze.
2.The self life is 30 months.Please use the test midstream within 1
hour after opening the foil pouch.
3.See the product package for manufacture date and expiration date.
1. This product is only for in vitro testing of human urine.
2. This product is for single-use . Please use within the validity
period. Reuse
is not allowed.
3. The test should be use indoor.
4. Please read the instruction for use carefully before use and
operate strictly,
otherwise the test results will be affected.
5. The desiccant in the foil pouch is for storage purposes only. Do
not swallow.
6. Do not use the test if the pouch is punctured or not well
sealed.
