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Follicle Stimulating Hormone (FSH) Test Kit (Colloidal Gold)

CE Singclean Follicle Stimulating Hormone (FSH) Test Kit

(Colloidal Gold)

For Self-Testing Specimens: Urine


CE 0123

[Product Name]

Follicle Stimulating Hormone (FSH)Test Kit (Colloidal Gold)

[Intended Use]

Please read all the information in this instruction for use before performing the test.

It is intend for qualitative determination of FSH levels in women urine. It provides some useful information for women who will prepare for pregnancy or focus on ovarian health, functions and fertility, also assists the diagnosis and treatment of pituitary and gonadal dysfunction.


Follicle Stimulating Hormone(FSH) Test Kit (Colloidal Gold) is based on the principle of colloidal gold labeling technique and immune chromatography of double-antibody sandwich method. During testing, the FSH in urine specimen migrates via capillary action along the membrane to react with FSH monoclonal antibody conjugated with nanoscale colloidal gold particles forming an antibody-antigen complex.


[Kit Contents]

Strip / Cassette / Midstream, Dropper (for test cassette), Instruction for use, Desiccant.

[Equipment Required But Not Supplied]

Stopwatch, Disposable plastic container.


[Storage and Expiry Date]

·Store the kit at 4~30, keep in a cool and dry place, protected from light. Do not freeze.

·See the package with expiry date.


[Specimen collection]

·Collect urine specimen by a disposable plastic or glass container which is clean, dry and does not contain any preservatives.

·lf there is sediment at the bottom of the container, please use the supernatant.

·lf there is no time to test, urine specimen can be refrigerated at 2~8 for 48 hours.

·Before testing, refrigerated specimen should be reached to room temperature.



· Urinate into a clean, dry container.

· Remove the test kit from the foil pouch and familiarize yourself with the product. The test kit should be used as soon as possible especially at temperature higher than 30 or highly humidity environment.

· Strip: Put the test strip in the urine specimen at the direction of arrow. Do not pass max line. Wait for at least about 5s and then take out to flat on the table.

Cassette: Put the test cassette on the table, add 3 full drops urine vertically into sample well (S) by dropper.

Midstream: Remove the cap of the test midstream, put the tip of test midstream in the urine sample. Wait for at least about 5s and then lay the test kit on a flat surface. If you prefer, tip pointing downward directly into your urine stream.

· Wait for about 5 minutes and then read the result. Don't read the result after 10 minutes.


[Result Interpretation]

POSITIVE: Two red lines are visible. One is located in the test line region (T), the other is in control line region (C).And the line in test line region (T) is the same as or darker than the one in the control line region (C). A positive result indicates ovary tend to menopause.

NEGATIVE: One or two red lines are visible. One is located in the test region (T), the other is in control region (C).And T line is lighter than the C line, or there was no T line. A negative result indicates that no FSH surge has been detected.

INVALID: There is no red line in control region (C). Insufficient specimen volume or incorrect techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. lf the problem persists, stop using the test kit immediately and contact your local distributor.

Drawing of Reading the result as follows:





·The test is only used for qualitative determination of FSH in urine.

·Only use for in vitro diagnostic, and cannot reuse.

·The test kit is a preliminary qualitative detection. Therefore, the quantitative value in FSH cannot be determined by this test.

·In some cases of infertility, gonadotropin therapy, ovarioncus and hypophysoma may cause inaccurate FSH detection.

Hormone medicines which affect the level of FSH, may cause false negative result.

·Please read the result in time, don't read the result after 10 minutes.


[Performance Characteristics]


The Follicle Stimulating Hormone (FSH) Test Kit(Colloidal Gold) detects FSH at a concentration of 25mU/mL or greater.


The results are negative when detect Luteinizing Hormone ovulation (LH,200mIU/mL), thyroid stimulating hormone(TSH,200μ lU/mL) and human chorionic gonadotropin (HCG,1000mlU/mL).

·Interfering Substances

The following potentially interfering substances have been detected. None of the substances at the concentration tested interfered in the assay, and the urine with pH (from 4 to 9) also did not interfere the test result.



Detecting the FSH control materials at the same concentration, the results are consistent, and signal intensity (color) almost be same.



·Do not use if the punch is damaged, and use the product before expiry date printed in foil pouch.

· Please test as soon as possible after unpacking, to avoid the products get damp and influence the test result.

· To avoid the cross contamination of samples, don't touch the nitrocellulose membrane on the product and each test should use new sample container.

·Contaminated urine specimen (e.g. containing bleach or alum) or improper operation cause incorrect result.

·lf you're in pregnancy or already entered menopause, this test can't work properly.

·This test is not used for determine ovulation and pregnancy.

·The positive result means FSH concentration in urine samples no less than 25 mlU/mL(above average), indicate that ovary tend to menopause. When user without menstrual cycle in 12 consecutive months, it can be defined as the menopause.

·When users show some symptoms associated with menopause, but the test results are negative, please see a physician for further diagnosis.

Latest version A3 lssued Date: 2020.11.05

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