General information about this test:
The NADAL® FSH Menopause Test is a rapid immunoassay for qualitative detection of follicle-stimulationg hormone (FSH) in urine for evaluation of the onset of menopause. The NADAL® FSH Menopause Test is intended for professional use only.
Reagents and material supplied:
- 10 test cassettes, incl. disposable pipettes
- 1 package insert
Test time: 5 min
Performance characteristics:
The analytical detection limit of the NADAL® FSH Menopause Test is 25 mLU/ml.
The NADAL® FSH Menopause Test shows no cross-reactivity with the following substances: LH (1.000 mIU/ml), hCG (100 mLU/ml) and TSH (1.000 IU/ml).
The sensitivity and specificity of the NADAL® FSH Menopause Test were determined by comparing the results for 220 samples to those of another commercially available assay.
Sensitivity: 100%
Specificity: 98.4%
Overall agreement: 99.0%
The following substances do not interfere with the performance of the NADAL® FSH Menopause Test: 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), Acetoacetic acid (2 g/dl), Hemoglobin (500 mg/dl), Bilirubin (100 mg/dl).
Test principles:
The NADAL® FSH Menopause Test is designed for qualitative detection of follicle-stimulating hormone (FSH) in urine samples. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH. After addition of specimen to the sample well, the FSH, present in it binds to anti-FSH antibodies conjugated to colored particles. Further the so formed complex moves along the test membrane and reacts with reagents immobilized to it. If detectable quantity of FSH is present in the sample, a colored line appears at the test line (T) region of the test, indicating positive result.
A colored line should always appear in the control line region. It serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Clinical significance:
The menopause is a permanent cease of menstruation. It is usually diagnosed only after a continuous lack of menstruation for 12 months. The term perimenopause designates the period leading up to menopause and 12 months which follow it. During this time, many women experience such symptoms as hot flushes, irregular menstrual cycles, sleep disorders, vaginal dryness, hair loss, anxiety and mood swings, short-term memory deterioration and fatigue. The onset of menopause is a result of a change in the levels of hormones in the female body that regulate the menstrual cycle. During that period the body produces reduced levels of estrogen and increases the production of follicle-stimulating hormone. Therefore by following the level of FSH it can be determined when menopause is beginning. Early detection of the onset of the perimenopause allows women to keep her body healthy and avoid the health risks associated with menopause, which include osteoporosis, increased blood pressure and cholesterol, as well as increased risk of heart disease.