Follicle Stimulating Hormone FSH Rapid Test Semiquantitative Detection

A rapid test for the qualitative detection of follicle stimulating hormone (FSH) in urine CE certified

Applications:

The FSH Rapid Test Midstream (Urine) is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of menopause.

Description:

Menopause is the permanent cessation of menstruation but is usually not scientifically diagnosed until one full year after a woman’s menstrual periods have stopped. The period leading up to menopause, and the 12 months following, is known as perimenopause..

Many women experience symptoms during this time including hot flashes, irregular menstrual cycles, sleep disorders, vaginal dryness, hair loss, anxiety and mood swings, short-term memory loss and fatigue. The onset of perimenopause is caused by changes in the levels of hormones in the female body that regulate the menstrual cycle.

As the body produces less and less estro/gen, it increases its production of Follicle-Stimulating Hormone (FSH), which normally regulates the development of a female’s eggs. Therefore, testing for FSH can help determine whether a woman is in the perimenopause stage. If a woman knows she is perimenopausal, she can take the appropriate steps to keep her body healthy and avoid the health risks associated with menopause, which include osteoporosis, increased blood pressure and cholesterol, and increased risk of heart disease.

FSH Rapid Test Midstream is a rapid, one-step lateral flow immunoassay for the qualitative detection of FSH in urine to aid in the detection of menopause. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibodies to selectively detect elevated levels of FSH. The assay is conducted by urinating on the Absorbent Tip or immersing the Absorbent Tip in urine, and obtaining the result from the colored lines.

How to use?

Allow the test, urine specimen and/or controls to reach room temperature (15-30°C) prior to testing.

1. Determine the day to begin testing. (See the above section: “WHEN TO START TESTING”).
2. Bring the pouch to room temperature before opening it. Remove the test midstream from the sealed pouch and use it as soon as possible.
3. Take down the cap of the midstream, then urinate on it or place the head of sponge(≥2/3) into urine sample in a clean cup at least 15 seconds(see illustration below).
4. Cover the cap on the testing midstream, then lay down the products on a clean and stable desk with the test and control window face upwards, and then start the timer immediately.
5. As the test begins to work, you may notice a light colored flow moving across the test and control window. Read the result at 3 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration)

POSITIVE:

Two lines are visible and the line in test line region (T) is the same as or darker than the line in the control line region (C). A positive result means that the FSH level is higher than normal. Record the results and see the chart below to interpret results.

NEGATIVE:

Two lines are visible, but the line in the test line region (T) is lighter than the line in the control line region (C), or there is no line in the test line region (T). A negative result means that the FSH level is not elevated at this time. Record the results and see the chart below to interpret results.

INVALID:

Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the Reference Line region (C) is an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

It is recommended that external positive and negative controls be tested with each new kit, lot or shipment of product, with each change in operator within the test kit, weekly as a check on continued storage conditions, and as otherwise required by your laboratory's internal quality system procedures.

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