Follicle­Stimulating Hormone (FSH) Test

Fertility TestsTesting Kits

Follicle­Stimulating Hormone Test is a rapid chromatographic immunoassay for the qualitative detection of Follicle Stimulating Hormone (FSH) in urine to aid in the detection of menopause.

Description

Intended Use

Follicle­Stimulating Hormone Test is a rapid chromatographic immunoassay for the qualitative detection of Follicle Stimulating Hormone (FSH) in urine to aid in the detection of menopause.

 

Introduction

Follicle­Stimulating Hormone Test is a qualitative, lateral flow immunoassay for the qualitative detection of human Follicle Stimulating Hormone in urine to evaluate the onset of menopause in women. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-FSH colored conjugate to form a colored line at the Test Line Region of the membrane which is darker than or the same shade as the line in the Control Line Region. To serve as a procedural control, a colored line will always appear in the Control Line Region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

When to test?

● If the subject is still having monthly periods, then the first test should be taken during the first week of her menstrual cycle (Days 2-7, with Day 1 being the first day of menstruation). Repeat with the second test 1 week later.

● If the subject is no longer having regular periods, the first test should be taken at any time during the month and the second test should be taken 1 week later.

P

POSITIVE RESULT:

1

Two lines are visible and the color intensity of the line in the 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.
NEGATIVE RESULT:

2

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 visible line in the Test Line Region (T). A negative result means that the FSH level is not elevated at this time.
INVALID RESULT:

3

If there is no line in the Control Line Region (C) after 3-4 minutes, the result is invalid. The test should be repeated. The test is not reusable. The most likely reasons for an invalid result are that not enough urine specimen was used, or the test was performed the wrong way. Review the Directions for Use and repeat with a new test. If the problem persists, discontinue using the test kit and contact your distributor.

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How to Use