【Product Name】

Early pregnancy test paper

【Product Performance】

The early pregnancy detection test paper uses a double antibody sandwich one-step method technology, with colloidal gold as the indicator marker, and detects the hCG concentration in urine using lateral layer chromatography. This product has a minimum detection limit of 25 mIU/ml, and there is no cross-reaction with hTSH, hFSH, and hLH. It can be detected as early as one day after the missed period of menstruation, and the earliest detection can be made 3-4 days before the start of the menstrual period.

【适用范围】

This product is intended for initial diagnosis of early pregnancy patients in various medical institutions and for self-testing by patients at home.

【Operating Instructions】

Specimen collection

Collect fresh urine samples in a single-use sterile container at any time, preferably morning urine. If the urine sample is visible and cloudy, it should be centrifuged, filtered, or wait for it to settle before taking the upper clear liquid for testing. If the urine sample cannot be sent for testing in time, the specimen can be stored at 2℃-8℃ for 48 hours. Long-term storage requires freezing at -20℃, and it is forbidden to freeze and thaw repeatedly.

Steps for Operation

Before performing the test, it is necessary to read the user manual completely, and to restore the reagent and urine specimen to room temperature (18℃-30℃) before use.

1. Remove the test strip from the original packaging and use it within 1 hour.

2. Insert the test strip into the urine specimen following the arrow direction. Note: The liquid level of urine should not exceed the marked line of the test strip.

3. After 3-8 seconds, remove it and place it flat on a clean and flat surface; it can also be left in the urine cup until the result is read.

4. Wait for the appearance of purple-red bands, and the test results should be read at 5 minutes. If no result is obtained after 10 minutes, the test is deemed invalid.

◆Result Determination

Positive (+): Two purple red lines appear. One is in the test area (T), and the other is in the control area (C). This indicates that you are pregnant.

Negative (-): Only the control area (C) shows a purple-red band, and no purple-red band appears in the test area (T). This indicates that you are not pregnant.

Invalid: The control area (C) does not show a purple-red band, indicating an incorrect operation process or that the test strip has become deteriorated or damaged. In this case, one should re-read the instructions carefully and retest with a new test strip. If the problem persists, the use of this lot of product should be immediately discontinued and the local supplier should be contacted.

Note: The color intensity of the control line and the test line on the reagent strip can vary depending on the amount of hCG in the urine, and the results should be judged according to the above standards.

【注意事项】

1. If both the control line and the test line are not visible, it indicates a detection error and should be retried. When the HCG concentration is very high, the test line is very obvious, and the control line may become very weak, which is a normal result.

2. Laboratories with conditions should determine the reference standards simultaneously.

3. If the subject still suspects the possibility of pregnancy and the urine test is negative, they can collect morning urine again after 48 to 72 hours to re-determine;

4. Women with uterine tumors, hydatidiform mole, or menopause, due to higher levels of HCG in their urine, may exhibit a positive result.

【Storage and Stability】

The original packaging should be stored at 4-30°C, in a cool, shaded, and dry place, with a validity period of 24 months.

Avoid freezing storage or use after the expiration date.