HCG One Step Pregnancy Test Device Package Insert

Short Description:


The hCG One Step Pregnancy Combo Test Device (Urine/Serum) is composed of the glass fiber strips of monoclonal antibody against human chorionic gonadotropin (hCG), anti-mouse IgG solid cellulose nitrate membrane and the bonders of absorptive colloidal gold – monoclonal antibody against hCG. It adopts the principles of double antibody sandwich method and immunochromatography to test the hCG in the urine and serum.

  • Cat: FHC-102
  • Specimens: Urine
  • Version: 01
  • Effective Date: 2021-02
  • Product Detail

    Product Tags


    Please read all the information in this package insert before performing the test.
    ★ Do not use after the expiration date printed on the foil pouch.
    ★ Store in a dry place at 2-30°C or 36-86°F. Do not freeze.
    ★ Do not use if pouch is torn or damaged.
    ★ Keep out of the reach of children.
    ★ For in vitro diagnostic use. Not to be taken internally.
    ★ Do not open the test foil pouch until you are ready to start the test.
    ★ The used test should be discarded according to local regulations.

    Kit Components

    Test device Dropper Package insert

    Sample Collection and Preparation

    Urinate into a clean, dry cup or container.


    1.Remove the test device from the foil pouch and familiarize yourself with the product.
    2.Hold the dropper vertically and transfer 3 full drops of samples to the specimen well (S) of the test device, and then begin timing. Avoid trapping air bubbles in the specimen well (S). See illustration below.
    3.As the test begins work, you may notice a light colored flow moving across the test line region (T) and control line region (C) on the test device. Read the result at 5 minutes. If no colored line appears, wait 1 minute longer. Some positive results may be observed in 1 minute or less depending on the concentration of hCG. Do not read the result after 10 minutes.

    Reding the Results


    Two distinct colored lines appear. One line should be in the control line region (C) and another line should be in the test line region (T). One line may be lighter than the other; they do not have to match. This means that you are probably pregnant.
    One colored line appears in the control line region (C). No line appears in the test line region (T). This means that you are probably not pregnant.
    The result is invalid if no colored line appears in the control line region (C), even if a line appears in the test line region (T). You should repeat the test with a new test device.


    1. The hCG One Step Pregnancy Combo Test Device (Urine/Serum) is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in hCG can be determined by this test.
    2. Very low levels of hCG (less than 50 mIU/mL) are present in urine specimens shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons,5 a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.
    3. This test reliably detects intact hCG up to 500,000 mIU/mL. It does not reliably detect hCG degradation products, including free-beta hCG and beta core fragments. Quantitative assays used to detect hCG may detect hCG degradation products and therefore may disagree with the results of this rapid test.
    4. This test may produce false positive results. A number of conditions other than 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 should not be used to diagnose pregnancy unless these conditions have been ruled out.
    5. This test may produce false negative results. False negative results may occur when the levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested. In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.
    6. 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.

    Performance Characteristics

    A multi-center clinical evaluation was conducted comparing the results obtained using the hCG One Step Pregnancy Combo Test Device (Urine/Serum) to another commercially available urine membrane hCG test. The study included 150 urine specimens, and both assays identified 72 negative and 78 positive results. The results demonstrated >99% overall accuracy of the hCG One Step Pregnancy Test Device (Urine) when compared to the other urine membrane hCG test.
    Sensiticity and Specifity
    The hCG One Step Pregnancy Combo Test Device (Urine/Serum) detects hCG at a concentration of 25mIU/mL or greater. The test has been standardized to the W.H.O. International Standard. The addition of LH (500mIU/mL), FSH (1,000mIU/mL), and TSH (1,000µIU/mL) to negative (0mIU/mL hCG) and positive (25mIU/mL hCG) specimens showed no cross-reactivity.
    Interfering Substances
    The following potentially interfering substances were added to hCG negative and positive specimens.

    Acetaminophen 20 mg/dL Caffeine 20 mg/dL
    Acetylsalicylic Acid 20 mg/dL Gentisic Acid 20 mg/dL
    Ascorbic Acid 20 mg/dL Glucose 2 g/dL
    Atropine 20 mg/dL Hemoglobin 1 mg/dL
    Bilirubin 2 mg/dL  

    None of the substances at the concentration tested interfered in the assay.

    Questions and Answers

    1.Q: How does the test work?
    A: The hCG One Step Pregnancy Combo Test Device (Urine/Serum) detects a hormone in your urine that your body produces during pregnancy (hCG-human chorionic gonadotropin). The amount of pregnancy hormone increases as pregnancy progresses.
    2.Q: How soon after I suspect that I am pregnant can I take the test?
    A: You can test your urine as early as the first day you miss your period. You can perform the test anytime of the day; however, if you are pregnant, first morning urine contains the most pregnancy hormone.
    3.Q: Do I have to test with first morning urine?
    A: Although you can test at any time of the day, your first morning urine is usually the most concentrated of the day and would have the most hCG in it.
    4.Q: How do I know that the test was run properly?
    A: The appearance of a colored line in the control region (C) tells you that you followed the test procedure properly and the proper amount of urine was absorbed.
    5.Q: What should I do if the result shows that I am pregnant?
    A: It means that your urine contains hCG and you are probably pregnant. See your doctor to confirm that you are pregnant and to discuss the steps you should take.
    6.Q: What should I do if the result shows that I am not pregnant?
    A: It means that no hCG has been detected in your urine and probably you are not pregnant. If you do not start your period within a week of its due date, repeat the test with a new test device. If you receive the same result after repeating the test and you still do not get your period, you should see your doctor.


    1.Batzer FR. Hormonal evaluation of early pregnancy, Fertil. Steril. 1980; 34(1): 1-13
    2.Catt KJ, ML Dufau, JL Vaitukaitis Appearance of hCG in pregnancy plasma following the initiation of implantation of the blastocyte, J. Clin. Endocrinol. Metab. 1975; 40(3): 537-540
    3.Braunstein GD, J Rasor, H. Danzer, D Adler, ME Wade Serum human chorionic gonadotropin levels throughout normal pregnancy, Am. J. Obstet. Gynecol. 1976; 126(6): 678-681
    4.Lenton EA, LM Neal, R Sulaiman Plasma concentration of human chorionic gonadotropin from the time of implantation until the second week of pregnancy, Fertil. Steril. 1982; 37(6): 773-778
    5.Steier JA, P Bergsjo, OL Myking Human chorionic gonadotropin in maternal plasma after induced abortion, spontaneous abortion and removed ectopic pregnancy, Obstet. Gynecol. 1984; 64(3): 391-394
    6.Dawood MY, BB Saxena, R Landesman Human chorionic gonadotropin and its subunits in hydatidiform mole and choriocarcinoma, Obstet. Gynecol. 1977; 50(2): 172-181
    7.Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross Ectopic production of human chorionic gonadotropin by neoplasms, Ann. Intern Med. 1973; 78(1): 39-45

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