FSH Menopause Test

Intended Use

Rapid FSH Urine Dipstick Test is a colloidal gold/antibody complex based immunoassay designed for the qualitative determiation of follicle stimulating hormone (FSH) in human urine. It is intended for laboratory use only.

Summary and Explanation

FSH is a glycoprotein hormone weighing approximately 30,000 Da. It is composed of two polypeptide chains: the alpha and beta subunits. In response to Gonadotropinreleasing hormone (GnRH) produced by the hypothalamus, the basophilic cells of the anterior pituitary secrete FSH and Luteinizing Hormone (LH). Both these hormones control gonadal development and maintenance. FSH controls the development of the ovarian follicles in females. FSH controls spermatogenesis in males. Both LH and FSH act in a negative feedback effect on the hypothalamus, thus regulating the circulatory levels of both hormone. The FSH Urine dipstick test is helpful in identifying hypothalamic, pituitary or gonadal dysfunction.

Test Principle

The FSH Urine dipstick Test consists of a chromatographic absorbent device and an unique combination of monoclonal antibodies that selectively detect FSH in test samples with a high degree of sensitivity. In ten minutes, levels of FSH as low as 25 mIU/ml are detected. An anti-FSH antibody is immobilized in a test zone (T) of a nitrocellulose membrane located in the middle section of the the test strip. Another FSH antibody labeled with colloidal gold is supported in a different section of the test strip. When the sample addition zone the arrow pointed end is in contact with urine, the urine sample migrates through the abosorbent area before it flows to the test membrane. FSH present in the specimen is bound by antibody-gold conjugate forming a labeled antibody-antigen complex. The complex is captured by anti-FSH antibody immobilized in the T zone of the membrane forming a red line. The intensity of the test line is proportional to the concentration of FSH in the urine sample. Another gold conjugate is captured by the antibody immobilized in the control zone (C) of the membrane producing another red color line, regardless of the presence or absence of FSH in the sample. The color intensity of the C line represents the T line intensity of a 25mIU/ml sample test. The level of FSH in the urnie sample above or below 25mIU/ml cutoff is determined by comparing the color intensity of the T line and the C line. If the T line is absent or less intense than the C line, the test result is negative, which means, the FSH level of the urine sample is below the 25mIU/ml cutoff. If the T line is more intense than the C line, the test result is positive, i.e., the FSH level of the urine sample is above 25mIU/ml.

Storage and Stability

Store the test device at 2 – 28 ℃. Prior to use bring test device and components to room temperature.

Assay Procedure

1. Bring test components including urine to room temperature.
2. Remove test strip from the pouch.
3. Dip the arrow pointed end of test strip into a container of the urine sample, ensuring that the level of the urine sample does not surpass the edge of the arrow tape. Keep contact between the test strip and the urine specimen for 10 seconds or longer. 4. Read results at 10 minutes; do not interpret results after 10 minutes.

Interpretation of Results

1. NEGATIVE: A negative result is observed when there is no T line (a) or the T line is less intense (b) than the C line. A negative result indicates the FSH level of the urine sample is below the 25mIU/ml cutoff.
2. POSITIVE: If FSH concentration in the urine sample is equal to or above 25mIU/ml, the intensity of the T line will be equal to (c) or higher (d) than that of the C line. A second test after 5 to 7 days may be performed to confirm the first positive test.
3. INVALID: If there is no rose-color line visible in the control window, then the test result is invalid. It is recommended that the urine be re-tested.