A rapid test for measuring Menopause in whole blood /serum /plasma with the use of NovatrendTM fluorescence Immunoassay Analyzer. For professional in vitro diagnostic use only.
Application And 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 , it increases its production of FSH, which normally regulates the development of a female’s eggs.1-3. 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.4,5
The FSH Test cassette is a rapid test that quantitatively detects the FSH level in Whole Blood /Serum/Plasma specimen. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH. The minimum detection level is 10mIU/mL.
How to use?
Refer to NovatrendTM Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the Test. The test should be conducted in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “Standard Test” or“Quick Test” mode.
2. Take out the ID card and insert it into the Analyzer ID Card Slot.
3. Squeeze 75μL Whole Blood /Serum/Plasma into the buffer tube by pipette; mix the specimen and the buffer well.
4. Add diluted specimen with a Pipette: Pipette 75μL diluted specimen into the sample well of the test cassette. Start the timer at the same time.
5. There are two test modes for NovatrendTM Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of NovatrendTMFluorescence Immunoassay Analyzer for details.
“Quick Test” mode: After 15 minutes of adding sample, Insert the test cassette into the Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST" immediately.
The Analyzer will automatically give the test result after a few seconds.
“Standard Test” mode: Insert the test cassette into the Analyzer immediately after adding specimen, click “STANDARD TEST”, fill the test information and click "NEW TEST" at the same time, The Analyzer will automatically countdown 15 minutes. After the countdown, the Analyzer will give the result at once.
