Fsh (Follicle Stimulating Hormone) Menopause Test Kit-Pregnancy Assistance/Fertility Test

• Classification: Biological Diagnostics
• Type: Patient Monitor
• Certification: CE, FDA, ISO13485
• Group: Female
• Medical Device Regulatory Type: Type 2
• Transport Package: Cassette, Box, Carton
• Model NO.: FSH-U11/U23/U23H
• Specification: Strip/Cassette
• Trademark: OEM
• Origin: China
• HS Code: 3002190090
• Production Capacity: 5000000000/Month

Product Description

Fsh (Follicle Stimulating Hormone) Menopause Test Kit-Pregnancy Assistance/Fertility Test

Introduction
The Follicle Stimulating Hormone (FSH) Test Kit is a rapid qualitative test for detect FSH in urine. This help to check the function of the pituitary gland and check if hormone levels are normal. The test can be used to see if a women has started the menopause. The test may also be used (along with other tests) for detecting possible causes of both male and female infertility. 
A. Self-detection of ovarian function
B. Prevention of premature ovarian
C. Diagnosis of menopause

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

Storage and Expiry Date
Store the kit at 4~30ºC, keep in a cool and dry place, protected from light. Do not freeze. 
It is valid for 24 months in the storage condition. See the package with expiry date. 

Direction of Use

Allow the test, urine specimen and /or control to reach room temperature(15-30ºC) prior to testin. 

1. Determine the day to begin test. 

2. Bring the pouch or canister to room temperature before opening it. Remove the test Dipstick from the sealed pouch or closed canister and use it as soon as possible. 

3. With arrows pointing toward the urine specimen for at least 15 seconds. Do not pass the maximum line (MAX) on the test Dipstick when immersing the Dipstick. See illustration below. 

4. Place the test Dipstick on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. The result should be read at 3 minutes

INTERPRETATION RESULT (Please refer to the illustration)

Positive: Two lines are visible and the line in 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. Record the results and see the chart below to interpret result. 

Negative: 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 line in the test line region (T). A negative result means that the FSH level is not elevates at this time. Record the results and see the chart below to interpret result. 

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control the failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.  

 

Test Interpretation

Review the result of both tests ( if applicable) and interpret according to the chart below. 

For patients experiencing premenopausal symptoms plus irregular menstrual cycles: 

1^sttest	2^NDtest	Interpretation
Positive	Positive	Most likely in perimenopause. Discuss with patient methods and therapies to promote good health after menopause. Patient should NOT immediately discontinue contraception.
Positive	Negative	May be in early stages of perimenopause. Patient should NOT immediately discontinue contraception.
OR
Negative	Positive
Negative	Negative	Most likely not experiencing perimenopause this cycle. If symptoms persist, repeat patient testing in the following month or review other possible causes for symptoms.

For the patients experiencing menopausal symptoms who have had NO menstrual cycle for the past 12 months: 

1^stTest	Interpretation
Positive	Menopause has most likely occurred. Test may be repeated. Discuss with patient methods and therapies to promote good health after menopause.

Features

1. Rapid Test. Quick result in 1-3 minutes. 
2. 25mIU/mL sensitivity or any customized sensitivity
3. Precise. More than 99% high accuracy
4. Sensitive privacy for Self-test use. 
5. CE Approved & ISO 13485 quality guarantee. 
6. Economical and practical. Wholesale FSH Menopause test price and cheapest disposable FSH menopause test. 

FAQ
Q1: What's the method u use to do the test?
A: Colloidal Gold Method.


Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.


Q3: What's ur packing of the tests?
A: If u choose the low cost, we will suggest you the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.


Q4: What's the main differences when comparing products from different suppliers?
A: U can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.
 
Q5: Some tests can be tested with serum/plasma or with whole blood, so what's the difference?
A: Well, if the specimen is whole blood, people will need buffer, lancet and alcohol swab to help the test. If they buy all the accessories, they can test very easily at home. But if the specimen is serum/plasma, it will need centrifuge to separate serum from whole blood first. This way, it's better to use at lab or hospital. And in some words, serum/plasma test will always give a more accurate results.


Q6: How can i distinguish a good test kit?
A: U can judge from the 4facts:Technical data: Such as the accuracy, specificity and sensitivity.
Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.

Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. You can refer to the instruction for more accurate time.

Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice