Female Fertility Midstream/Menopause Test Kits Fsh Test Strip One Step Hormonal Disorders Analysis

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Product Description

Basic Information
Reading Time: 3~5 Min
Accuracy: Over 99%
Storage Temp: 2-30℃
Shelf Life: 24 Months
Certification: CE
OEM: Acceptable
Capacity: 1M pcs/Month
Origin: China
FSH Test Strip

Female Fertility Midstream/Menopause Test Kits

FSH Test Strip One Step Hormonal Disorders Analysis

Product Introduction
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 estrogen, it increases its production of FSH, which normally regulates the development of a female's eggs. Testing for FSH can help determine whether a woman is in the perimenopause stage.
Key Features
  • Easy to Use
  • Fast Result within 3-5 minutes
  • High Accuracy (Over 99%)
  • Professional Grade Quality
Testing Principle
The FSH One Step Menopause Test Device (Urine) is a qualitative, lateral flow immunoassay for the qualitative detection of human Follicle-Stimulating Hormone in urine. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH. Positive specimens react with the specific antibody-FSH-colored conjugate to form a colored line at the test line region (T) of the membrane.
Operating Procedure
Important: Allow the test and urine specimen to reach room temperature (15-30°C) before starting.
  1. Remove the test device from the sealed pouch and use it as soon as possible.
  2. Place the test device on a level surface. Transfer 3 full drops of urine (approx. 100μL) to the specimen well (S).
  3. Read results at 3 minutes. Do not interpret the result after 10 minutes.
Testing Method Illustration
Result Interpretation

POSITIVE: Two lines are visible, and the test line (T) is the same as or darker than the control line (C).

NEGATIVE: Two lines are visible, but the test line (T) is lighter than the control line (C), or no line appears in the test region (T).

INVALID: Control line (C) fails to appear. Review the procedure and repeat with a new test.

Clinical Accuracy
Method Other FSH Rapid Test Total Results
FSH One Step Device Positive 78 80
Negative 120 120
Total Results 78 / 122 200
Relative Sensitivity: 99.9% | Relative Specificity: 98.4% | Relative Accuracy: 99.0%
Frequently Asked Questions
? When is the best time to collect urine for the test?
A first morning urine specimen is preferred as it generally contains the highest concentration of FSH. However, specimens collected at any time of day can be used.
? When should I start testing if I still have periods?
The first test should be taken during the first week of your menstrual cycle (Days 2-7). Repeat with a second test one week later.
? What if I no longer have regular periods?
You can take the first test at any time during the month. The second test should be taken exactly one week after the first one.
? Does a positive result mean I am definitely in menopause?
A positive result indicates elevated FSH levels, which is a common sign of perimenopause or menopause. It should be discussed with a healthcare professional for a complete clinical diagnosis.
? How accurate is this FSH test?
In multi-center clinical evaluations, this test demonstrated a 99.0% accuracy rate compared to other professional laboratory membrane FSH tests.
? Can air bubbles in the specimen well affect the result?
Yes, you should avoid trapping air bubbles in the specimen well (S) to ensure the proper volume of urine is absorbed by the test strip.

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