Descrizione Clinica
Diagnostics - diagnostics Screen test menopause/fsh 2pz
SCREEN
CHECK TEST
MenopauseDescription
Quick swivel test for qualitative detection of Follicle-Stimulating Hormone (FSH) on urine samples.
Only for self-diagnostic use in vitro.
Precautions
- Do not use beyond the printed expiration date on the sealed package.
- The test must remain in the sealed package until the time of use.
- Store in a dry place at 2-30°C or 36-86°F. Don't freeze.
- Do not use if the package is torn or damaged.
- Just for in vitro diagnostics.
- Keep away from the children's reach.
- Don't open the test box until you're ready to start the test.
- Use only once.
- The test used must be disposed of according to local regulations.
When performing the test
If you still have menstruation every month, do the first test during the first week of the cycle (days 2-7, considering day 1 the first of the menstruation). If the result is negative but the symptoms persist, repeat the test a week later.
If you no longer have regular menstruation, run the test at any time of the month and repeat it 1 week later.
Mode of use
Bring the test, urine sample and/or ambient temperature controls (15-30°C) before testing.
1. Determine the day you test.
2. Bring the packaging to room temperature before opening it. Extract the test device from the sealed package and use it immediately within an hour.
3. Remove the cap from the device and hold the test so as to place the absorbent tip in the urine flow or place the absorbent tip (=2/3) in the urine sample in a clean container for at least 10-15 seconds.
4. Put the cap on the test, then place it on a clean and stable surface with the test windows and control upwards, then start the timer immediately.
5. When the test begins to work, you might notice a slight color that flows through the results window.
Read results after 3 minutes. If there is no result, wait a minute. Do not read the results after 10 minutes.
Reading results
POSITIVO: two visible lines appear and that in the test zone (T) is equal to or greater than that in the control zone (C). A positive result indicates that the FSH level is higher than normal. Record the results and compare them with the table to interpret the results.
NEGATIVE: Two lines are visible, but the one in the test zone (T) is lighter than in the control zone (C) or there is no line in the test zone (T). A negative result indicates that the FSH level is not high. Record the results and compare them with the table to interpret the results.
NULLO: no control line appears. The most likely causes of the failure of the control line are insufficient volume or incorrect procedural techniques. Review the procedure and repeat the test with a new device. If the problem persists, stop using the kit immediately and contact the local distributor.
Test interpretation
For women experiencing pre-menopausal symptoms combined with irregular menstrual cycles:
For women experiencing pre-menopausal symptoms WITHOUT menstrual cycle in the previous 12 months:
Limits
There is a possibility that this test produces false positive or false negative results. Consult your physician before making any medical decision. No results can be caused by not following the instructions carefully. Review the instructions and or repeat the test with a new device. If the problem persists, stop using the kit immediately and contact your local distributor.
Format
Box containing 2 pieces.
BIBLIOGRAPHY:
1. Turkington CA. The Perimenopause Sourcebook. Contemporary Books, New York, NY 1998.
2. Perry S, O’Hanlan K. Natural Menopause: The Complete Guide. Reading, MA, Addison-Wesley, 1997.
3. Stanford, JL, Weiss NS, et al. Combined Estrogen and Progestin Hormone Replacement Therapy in Relation to Risk of Breast Cancer, J. Am. Med. Assoc. 1995; 274(2): 137-142.
4. Speroff L, Glass RH, Kase NG, Clinical Gynecologic Endocrinology and Infertility 5th Ed, Williams and Wilkins, Baltimore, MD. 1994; 588.
5. Jacobs DS, Demott DR, Grady HJ, Horvat RT, Huestis DW, Kasten BL, Laboratory Test Handbook 4th Ed, Lippincott Williams and Wilkins, Baltimore, MD 1996
Quick swivel test for qualitative detection of Follicle-Stimulating Hormone (FSH) on urine samples.
Only for self-diagnostic use in vitro.
Precautions
- Do not use beyond the printed expiration date on the sealed package.
- The test must remain in the sealed package until the time of use.
- Store in a dry place at 2-30°C or 36-86°F. Don't freeze.
- Do not use if the package is torn or damaged.
- Just for in vitro diagnostics.
- Keep away from the children's reach.
- Don't open the test box until you're ready to start the test.
- Use only once.
- The test used must be disposed of according to local regulations.
When performing the test
If you still have menstruation every month, do the first test during the first week of the cycle (days 2-7, considering day 1 the first of the menstruation). If the result is negative but the symptoms persist, repeat the test a week later.
If you no longer have regular menstruation, run the test at any time of the month and repeat it 1 week later.
Mode of use
Bring the test, urine sample and/or ambient temperature controls (15-30°C) before testing.
1. Determine the day you test.
2. Bring the packaging to room temperature before opening it. Extract the test device from the sealed package and use it immediately within an hour.
3. Remove the cap from the device and hold the test so as to place the absorbent tip in the urine flow or place the absorbent tip (=2/3) in the urine sample in a clean container for at least 10-15 seconds.
4. Put the cap on the test, then place it on a clean and stable surface with the test windows and control upwards, then start the timer immediately.
5. When the test begins to work, you might notice a slight color that flows through the results window.
Read results after 3 minutes. If there is no result, wait a minute. Do not read the results after 10 minutes.
Reading results
POSITIVO: two visible lines appear and that in the test zone (T) is equal to or greater than that in the control zone (C). A positive result indicates that the FSH level is higher than normal. Record the results and compare them with the table to interpret the results.
NEGATIVE: Two lines are visible, but the one in the test zone (T) is lighter than in the control zone (C) or there is no line in the test zone (T). A negative result indicates that the FSH level is not high. Record the results and compare them with the table to interpret the results.
NULLO: no control line appears. The most likely causes of the failure of the control line are insufficient volume or incorrect procedural techniques. Review the procedure and repeat the test with a new device. If the problem persists, stop using the kit immediately and contact the local distributor.
Test interpretation
For women experiencing pre-menopausal symptoms combined with irregular menstrual cycles:
| 1st Test | 2nd Test | Interpretation |
| Positive | Positive | Probable perimenopause. Discuss methods and therapies to promote health after menopause with your doctor. Don't stop contraception right away. |
| Positive or negative | Negative or positive | Probable first stage of perimenopause. Don't stop contraception right away. |
| Negative | Negative | Probably not yet in perimenopause. If symptoms persist, repeat the test the following month or investigate other possible causes for symptoms. |
For women experiencing pre-menopausal symptoms WITHOUT menstrual cycle in the previous 12 months:
| 1st Test | Interpretation |
| Positive | Menopause almost certainly in place. You can repeat the test. Discuss methods and therapies to promote health after menopause with your doctor. |
Limits
There is a possibility that this test produces false positive or false negative results. Consult your physician before making any medical decision. No results can be caused by not following the instructions carefully. Review the instructions and or repeat the test with a new device. If the problem persists, stop using the kit immediately and contact your local distributor.
Format
Box containing 2 pieces.
BIBLIOGRAPHY:
1. Turkington CA. The Perimenopause Sourcebook. Contemporary Books, New York, NY 1998.
2. Perry S, O’Hanlan K. Natural Menopause: The Complete Guide. Reading, MA, Addison-Wesley, 1997.
3. Stanford, JL, Weiss NS, et al. Combined Estrogen and Progestin Hormone Replacement Therapy in Relation to Risk of Breast Cancer, J. Am. Med. Assoc. 1995; 274(2): 137-142.
4. Speroff L, Glass RH, Kase NG, Clinical Gynecologic Endocrinology and Infertility 5th Ed, Williams and Wilkins, Baltimore, MD. 1994; 588.
5. Jacobs DS, Demott DR, Grady HJ, Horvat RT, Huestis DW, Kasten BL, Laboratory Test Handbook 4th Ed, Lippincott Williams and Wilkins, Baltimore, MD 1996
