HCG Pregnancy Test

Principle

The One Step Pregnancy Test is a rapid one-step lateral flow immunoassay in device format for the

qualitative detection of human chorionic gonadotrophin (HCG) in urine to aid in the detection of

pregnancy.

The test utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect

elevated levels of HCG. The assay is conducted by adding urine to the specimen well, and obtaining the

result from the colored lines

Precautions

Contents

*Test device. *Instruction.

*Please read all the information in this package insert before performing the test.

– The product use for diagnosis once only.

– Do not use after expiration date printed on the foil pouch.

– After opening the foil pouch, don’t leave the testing device in the air for a long time, avoid moisture.

– Do not open the test foil pouch until you are ready to start the test, and don’t use if the pouch is torn or

damaged.

– When HCG level is too high, the testing line will be clear, the control line may be weak. This result is

normal.

– If you are under suspicion of pregnancy, but urine testing is negative, you could recollect the morning

urine and rerun the test after 48~72 hours.

– Uterine tumor, vesicular mole, endometrial hyperplasia, choriocarcinoma, gastric cancer or climacteric

age patient’s HCG level higher than normal level, result may positive.

– If patient is under suspicion of Ectopic pregnancy, abnormal pregnancy, it must combine other testing

for clear diagnosis.

– Keep out of the reach of children.

-The used test should be discarded.

– For in vitro diagnostic use. Not to be used internally

Procedure

1. Take out the test midstream, remove the cap.

2. Pour the urine in the absorb stick of test midstream directly for at least 10 seconds.Cover the cap, flat

the test kit onto the table.

3. The result window will turn completely pink to show enough urine has been absorbed. (see the

illustration below).

4. Observe the test results immediately within 5 minutes, the result is invalid over 10 minutes.

Storage

Store in a dry place out of sunlight at room temperature 4-30℃ (39~86F). Do not freeze.

Validity

36 months from the date of manufacture.

Result

Graphic

* Positive (Pregnant):

Two distinct colored lines appear. One line should be in the control line (C) and another line should be

in the test line region (T). One line may be lighter than the other; they don’t have to match.

* Negative (Non-Pregnant):

One colored line appears in the control line region (C) . No line in the test line region(T). This means that

you are probably not pregnant.

* Invalid:

The result is invalid if no colored line appears in the control region (C) within 5 minutes, even if a

lineappears in the test line region (T). You should repeat the test with a new test device.