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HCG One Step Pregnancy Test
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SUMMARY

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum or plasma as early as 7 to 10 days after conception. hCG levels continue to rise very rapidly, frequently exceeding 100mIU/ml by the first missed menstrual period , and peaking in the 100,000-200,000mIU/ml range about 10-12 weeks into pregnancy. The appearance of hCG in both the urine and serum or plasma soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. hCG Pregnancy Rapid Test Strip is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25mIU/ml. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, hCG Pregnancy Rapid Test Strip shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.

DIRECTIONS FOR USE

1. Bring the pouch or canister to room temperature before opening it. Remove the test Strip from the sealed pouch or closed canister and use it within one hour.

NOTE: For canister packaging, immediately close the canister tightly after removing the required number of the test Strip(s). Record the initial opening date on the canister. Once the canister has been opened, the remaining test Strip(s) are stable for 90 days only.

2. With arrows pointing toward the urine specimen, immerse the test Strip vertically in the urine specimen for at least 10 seconds. Do not pass the maximum line (MAX) on the test  Strip when immersing the Strip. See illustration below.

3. Place the test Strip on a non-absorbent flat surface, start the timer and wait for the  colored line(s) to appear. The result should be read at 3 minutes.

NOTE: A low hCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time. Do not interpret the result after 10 minutes.

DIRECTIONS FOR USE


1. Bring the pouch to room temperature (15-30℃) before opening it. Remove the cassette from the sealed pouch and use it as soon as possible.

2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approximately 75ul) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.

3. Wait for the colored line(s) to appear. The result should be read at 3 minutes.

NOTE: A low hCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time; therefore, do not interpret the result after 10 minutes.



INSTRUCTIONS
1. Remove the midstream from the foil pouch and test them immediately in one hour.
2. Take down the cap of the midstream, hold the midstream so as to place the absorbent tip in the urine stream or place the absorbent tip (≥2/3) in urine in a clean cup for at least 15 seconds.
3. Cover the cap on the testing midstream, then lay down the product on a clean and stable desk, start the timer immediately.
4. Read the result at 3 minutes; don’t interpret the result after 10 minutes.