The FSH Test Cassette (Whole Blood/Serum/Plasma) is intended for in vitro quantitative
determination of follicle stimulating hormone (FSH) in human whole blood, serum or
plasma as an aid in the diagnosis of menopause.
【SUMMARY】
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 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 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 1 mIU/mL.
【PRINCIPLE】
The FSH Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence
Immunoassay for the detection of FSH in human whole blood/serum/plasma to evaluate
the onset of menopause in women. The specimen moves through the strip from specimen
pad to absorbent pad. If the specimen contains FSH, it attaches to the fluorescent
microspheres-conjugated anti-FSH antibodies. Then the complex will be captured by the
capture antibodies coated on the nitrocellulose membrane (Test line). The concentration
of FSH in the specimen correlates linearly with the fluorescence signal intensity captured
on the T line. According to the fluorescence intensity of the test and standard curve, the
concentration of FSH in the specimen can be calculated by
Analyzer to
show FSH concentration in specimen.
【REAGENTS】
The test contains anti-FSH antibody conjugated fluorophores and capture reagents
coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the
foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection container
for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled.
5. Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye
protection when specimens are assayed.
7. Do not interchange or mix reagents from different lots.
8. Humidity and temperature can adversely affect results.
9. Used testing materials should be discarded in accordance with local regulations.
10. Read the entire procedure carefully prior to any testing.
11. The FIATEST GO FSH Test Cassette should only be used with the
Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do not
use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
Preparation
1. Before performing the test, please make sure that all components are brought to room
temperature (15-30 °C). Cold buffer solution or moisture condensation on the membrane
can lead to invalid test results.
2. Take a tube with buffer solution out of the kit. Document patients name or ID on it.
Specimen Handling
1. Collect the specimen according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Serum and plasma
specimens may be stored at 2-8 °C for up to 1 day, for long term storage, specimens
should be kept below -20 °C. Whole blood collected by venipuncture should be stored at
2-8 °C if the test is to be used within 1 day of collection. Do not freeze whole blood
specimens. Whole blood collected by finger stick should be tested immediately.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing
of specimens.
4. EDTA K2, Heparin sodium, Citrate sodium and Oxalate potassium can be used as the
coagulant tube for collecting the blood specimen.
Specimen Dilution
1. The specimen (75 μL of whole blood/serum/plasma) can be added directly with the
micro pipette into the buffer.
2. Close the tube and shake the specimen by hand for approximately 10 seconds so
specimen and dilution buffer mix well.
3. Let the diluted specimen homogenize for approximately 1 minute.
4. It is best to place the diluted specimen on an ice pack and leave the specimen at room
temperature for no more than 8 hours.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with Extraction Buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge
• Pipette • Fluorescence Immunoassay Analyzer
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions for 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 requirement, select “Standard Test”
or “Quick Test” mode.
2. Take out the ID Card and insert it into the Analyzer ID Card Slot.
3. Transfer 75 μL of whole blood/serum/plasma into the buffer tube by pipette; mix the
specimen and the buffer well.
4. Add diluted specimen with a Pipette: transfer 75 μL of diluted specimen into the
specimen well of the test cassette. Start the timer at the same time.
5. There are two test modes for Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of Fluorescence Immunoassay Analyzer for details.
“Quick Test” mode: After 15 minutes of adding specimen, 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.
