Product Description
DAVID One Step FSH Urine Test
(Midstream)
(CATALOG:RH-FSH25-B)
Please read instructions carefully before performing the test.
BEFORE YOU BEGIN
1.The unopened test can be stored at room temperature(up to30ºC/ 86ºF) . Do not freeze.
2.Do not open foil pouch until specimen is collected and ready to be tested.
3.Do not use If the foil pouch is torn or not well sealed.
4.Do not use this test past the indicated expiry date on the label.
5.No drinking water within 2 hours before collecting urine specimen to avoid specimen diluted.
CONTENTS OF THE TEST KIT
One pouch containing a test midstream and a desiccant.
Note: The desiccant is for storage purpose only, and is not used in the test procedures.
WHAT ELSE DO YOU NEED
1.Timer(watch or clock).
2.a clean, dry container for a urine sample collection(optional).
SPECIMEN COLLECTION AND PREPARATION
WHEN TO COLLECT URINE FOR THE TEST
1.The test uses women urine as specimen.. (refer to question 2)
2.Specimens collected at any time of day may be used; however, the first morning urine generally contains the highest concentration of FSH.
3.A fresh urine specimen should be used.
HOW TO COLLECT URINE
1.You can collect your urine sample in a clean, dry plastic or glass container.
2.Do not mix urine samples collected at different times.
3.The urine does not require any special pretreatment.
HOW TO DO THE TEST
If the test and urine sample are stored refrigerated, allow to reach room temperature(about 20 minutes).
1.Remove the test midstream from the sealed pouch and take the cap off.
Note: Do not touch the membrane located within the "Show Windows" and "Absorbent Tip".
2.Hold the stick by the thumb grip with the exposed Absorbent Tip pointing downward. Urinate on the Absorbent Tip only until it is thoroughly wet {about 2-3seconds}.
If you prefer, you can urinate into a clean and dry container, then dip only the Absorbent Tip of the test midstream into the urine for at least 10 seconds.
3.After remove the test midstream from your urine, immediately replace with the Cap over the Absorbent Tip, Lay the test midstream down on a flat surface with the "Show Windows"facing upwards.
4.4.Read results between ten (10) to twenty (20) minutes after adding the specimen.. (refer to question 8)
If urine migration is not seen in the result window within one to two minutes, you need to expose the "Absorbent Tip" to additional urine.
HOW TO READ YOUR RESULT
Important:To determine your result you must compare the colour intensity of the test band to the control band.
1.POSITIVE RESULT:Two lines are visible and the Test band(T) is equal to or darker than the Control band (C).. (refer to question 3)
2.NEGATIVE RESULT: Only one color bands appears on the Control(C) region or the Test(T) band is lighter than the Control(C) band.
. (refer to question 4)
3.INVALID RESULT: At 10 minutes, if no bands appear, or a test band appears without a Control band, the result is invalid and the test should be repeated using a new test.
(refer to question 7)
PRECAUTIONS
1.For in vitro diagnostic use (not for internal use).
2.This test is intended for single use only. DO NOT REUSE.
3.Discard with normal household waste.
4.The test should be stored between 2ºC-30ºC/36ºF-86ºF.
5.Keep out of the reach of children.
6.The test is for home use.
LIMITATIONS
1. This test must not be used to determine fertility. Contraception decisions should not be made based on test results.
2.As with all diagnostic tests, a definitive clinical diagnosis should only be made by the physician after all clinical and laboratory findings have been evaluated.
QUESTIONS AND ANSWER
1.How does the DAVID One Step FSH Test work?
This is a home-use test kit to measure Follicle Stimulating Hormone (FSH) in your urine. This may help indicate if you are in menopause or perimenopause.Follicle stimulating hormone (FSH) is a hormone produced by your pituitary gland. FSH levels increase temporarily each month to stimulate your ovaries to produce eggs. When you enter menopause and your ovaries stop working, your FSH levels also increase.
This test may help you be better informed about your current condition when you see your doctor.
2.When can I test with DAVID One Step Ovulation Test?
You should use this test if you want to know if your symptoms, such as irregular periods, hot flashes, vaginal dryness, or sleep problems are part of menopause. While many women may have little or no trouble when going through the stages of menopause, others may have moderate to severe discomfort and may want treatment to alleviate their symptoms. This test may help you be better informed about your current condition when you see your doctor.
3.If the result is positive, what shall I do?
A second test after 5 to 7 days may be performed to confirm the first positive test.If the second result is the same as the first, it is an indication that your normal FSH level has risen to a high level, and consequently, you may have begun the transitional period called perimenopause.
A positive test indicates that you may be in a stage of menopause. If you have a positive test, or if you have any symptoms of menopause, you should see your doctor. Do not stop taking contraceptives based on the results of these tests because they are not foolproof and you could become pregnant.
4.If the result is negative,what should I do?
If you have a negative test result, but you have symptoms of menopause, you may be in perimenopause or menopause. You should not assume that a negative test means you have not reached menopause, there could be other reasons for the negative result. You should always discuss your symptoms and your test results with your doctor. Do not use these tests to determine if you are fertile or can become pregnant. These tests will not give you a reliable answer on your ability to become pregnant.
5.Can any medication or medical conditions affect the result?
The test results should not be affected by pain relievers, antibiotics and other common drugs. After using the pill or patch that contains hCG or LH may affect the test result and should not be taken while using this test kit. In addition, the test will not work properly if you are pregnant or menopausal.
6.Can I determine the concentration of sperm in my semen by providing a single test?
Single measurement of FSH level may give misleading result due to the fluctuating nature of FSH secretion. Samples drawn at different times of the day may vary. Elevated levels of FSH should be confirmed by more than one FSH measurement.
7. How do I know the test was run properly?
The appearance of a coloured line in the control region (C) tells you that you followed the test procedure correctly and the proper amount of urine was absorbed.
8. How long will result last?
The test should be read any time from 10 to 20 minutes. After 30 minutes any change in your result should be disregarded.
9. Do alcohol or common medications affect the test?
No, but you should consult your physician if you are taking any medication. If you do get unexpected results you should discuss them with your doctor.
10.Will the amount of liquid I drink affect the result?
We suggest that you limit your fluid intake for about two hours before you collect your urine. Because heavy intake of fluids prior to testing will dilute the hormone in your urine.
MANUFACTURER
RUNBIO BIOTECH CO., LTD.
Rongsheng Technological Zone, Univ. Rd.
Shantou, Guangdong, P.R.China 515063
EUROPEAN REPRESENTATIVE
MedNet GmbH
Borkstrasse 10, 48163 Münster,Germany
DOCUMENT NUMBER:RH-TD-FSH25-6-B02
VERSION NUMBER: FSH25-B01-1905A
Eff.Date:2019-05-18
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