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INTRODUCTION
One Step LH Ovulation Test is designed to qualitatively determine elevated luteinizing hormone (LH) in urine. The result can be read visually in minutes to indicate a positive or negative result for ovulation.
Test Information: One Step LH Ovulation Test (Midstream)
Cat.#:200-14, For Self-Testing
INSTRUCTIONS
(Please read all the information in this leaflet before performing the test.)
Do not use if pouch is torn or damaged.
Do not use after the expiration date.
Do not reuse.
Store in a dry place at temperatures between 2°C-30°C (Celsius) or 35°F to 86°F (Fahrenheit), but do not freeze.
Ensure the test foil pouch is at room temperature before opening.
Once open, use as soon as possible.
Keep out of the children's reach.
For in vitro diagnostic use. Not to be taken internally.
WHEN TO BEGIN TESTING
First, you must determine the length of your menstrual cycle. This is the number of days from the first day of your menstrual bleeding to the day before your next menstrual bleeding begins. Please refer to the chart to determine when you should start testing. If your cycle is shorter than 21 days or longer than 38 days, consult with your health care provider. If you do not know your cycle length, you may begin the test 11 days after your first period since the average cycle length is 28 days. Perform 1 test each day over a 5-day period, or until the LH surge has been detected.
Your Cycle Length Start To Test On 21 Days Day 6 22 Days Day 6 23 Days Day 7 24 Days Day 7 25 Days Day 8 26 Days Day 9 27 Days Day 10 28 Days Day 11 29 Days Day 12
Your Cycle Length Start To Test On 30 Days Day 13 31 Days Day 14 32 Days Day 15 33 Days Day 16 34 Days Day 17 35 Days Day 18 36 Days Day 19 37 Days Day 20 38 Days Day 21
TEST PROCEDURE
1. Remove the midstream test from the foil pouch and familiarize yourself with the product.
2. Remove the cap. Save cap.
3. Hold the midstream test by the Handle with the exposed Sampling Tip pointing downward directly into your urine stream for at least 10 seconds until it is thoroughly wet. Note: Do not urinate on the Test Window. If you prefer, you can urinate into a clean and dry container, then dip only the Sampling Tip of the midstream test into the urine for at least 10 seconds.
4. After removing the midstream test from your urine, immediately replace the Cap over the Sampling Tip, lay the midstream test on a flat surface with the Test and Control windows facing upwards, and then begin timing.
5. As the test begins to work, you may notice a light red flow moving across the Test Window. Depending on the concentration of LH, positive results may be observed in as little as 40 seconds. However, to confirm negative results, the complete reaction time of 5 minutes is required. Do not read the result after 30 minutes.
INTERPRETATION OF RESULT
LH SURGE: Two color bands are visible and the test (T) band is equal to or darker than the control (C) band. One will probably ovulate in the next 24-48 hours. If one wants to be pregnant, the best time to have intercourse is after 24 but before 48 hours.
NO LH SURGE: Only one color band appears in the control region (C) or the test (T) band is lighter than the control band. There is no LH surge.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor. (Improper storage conditions such as exposure to heat or freezing or expired test device may also contribute to test failure).
Note: The intensity of the red color in the test line region (T) will vary depending on the concentration of LH present in the specimen. However, neither the quantitative value nor the rate of increase in LH can be determined by this qualitative test.
EXPECTED VALUES
The One Step LH Ovulation Test has a sensitivity of 20 mIU/mL. A positive result means your urine contains the level of LH that would indicate you are beginning to ovulate. You can assume that you will ovulate within 24-48 hours. A negative result means that no LH surge has been detected and you should continue daily testing. Not every woman ovulates mid-cycle; therefore you may not see a positive result during the first 5 days of testing. Continue testing with the One Step LH Ovulation Test.
SPECIMEN COLLECTION
Determine the time you will collect your urine. For best results, collect your urine at about the same time each day, for example, between 10:00AM and 8:00PM. Some women have found that their best specimen is after 12 Noon. Do not collect your first morning urine after waking up.
Reduce your liquid intake approximately 2 hours prior to urine collection.
Be sure to write down the cycle day, date and time that you collected your urine.
You can store your urine for testing later in the day. Your urine can be stored at room temperature for up to 8 hours or in the refrigerator for up to 24 hours. Do not freeze it. For best results, test your urine on the same day that it is collected. If you refrigerate your urine, let it reach room temperature before testing (about 30 minutes). Do not shake the container, allow the sediment to settle. Use only urine from the top of the container.
LIMITATIONS
The test works only when the test procedures are precisely followed.
Do not reuse the test device.
This test is not to be used as a form of birth control.
The test results should not be affected by pain relievers, antibiotics and other common drugs. Medication containing hCG or LH may affect the test and should not be taken while using the One Step LH Ovulation Test. In addition, the test will not work properly if you are pregnant, menopausal, or taking birth control pills.
Keep out of the reach of children.
QUESTIONS & ANSWERS
1. Q: How accurate is the One Step LH Ovulation Test?
A: The One Step LH Ovulation Test has been shown to be 99% accurate in laboratory testing and 96% accurate in consumer testing.
2. Q: When can I do the test?
A: After you determine the best day to start testing based on your monthly cycle, you can do the test any time on that day. Testing with first morning urine is not recommended. Testing between 10am and 8pm is a good time frame, with many REs suggesting testing at 10 am. Test at about the same time each day. Reduce your liquid intake for 2 hours before testing..
3. Q: What if no band appears in the Control Window?
A: If no band appears in the Control Window after 5 minutes, the result is invalid and you should repeat the test with the One Step LH Ovulation Test Stick.
4. Q: I have tested for 5 days and I did not see a surge. What do I do?
A: Since every woman does not always ovulate at mid-cycle, you may not detect the LH surge in the first 5 days of testing. This could mean you have not ovulated yet and you should continue testing with an additional One Step LH Ovulation Tests.
5. Q: I have tested for 8 days or more and I still did not see my LH surge, what is wrong?
A: About 90% of ovulating women with regular cycles will see their surge during 8-10 days of testing. If you do not, it could mean that you have not ovulated this month. If you are having a short cycle this month, it is possible that you have ovulated before you started testing. If you are having a long cycle this month, you may not have ovulated yet. You may continue testing or test again next month. Don't worry; it is normal to have an occasional short or long cycle, or to have a cycle without ovulating.
6. Q: I have used the ovulation test for three months, and each month I have seen a surge and have had intercourse that day or night. I have not become pregnant yet. What is wrong?
A: First, it is important to remember that it can take normal, healthy couples many months to become pregnant. There are many factors that can affect your ability to become pregnant even if you have been able to have intercourse during your most fertile days. If after several months you have no success, consult with your health care provider.
7. Q: What could interfere with my test result?
A: If you are already pregnant, have recently been pregnant, or have reached menopause you may get a misleading result. Some prescription drugs, such as menotropins for injection and danazol may affect the results you see. Please consult your health care provider if you have questions about prescription drug interactions.
8. Q: Will oral contraceptives affect the result?
A: After using the pill, your cycle may be irregular and may take some time to stabilize again. You may wish to wait until you have had two regular periods before starting to use the One Step LH Ovulation Test.
9. Q: If the One Step LH Ovulation Test can determine my most fertile time, why can't I use it for contraception?
A: Sperm can survive up to 72 hours, and this test predicts your LH surge only up to 24 to 36 hours in advance. Therefore, if you have intercourse before you discover your surge, the egg can still be fertilized.
REFERENCES
1. Batzer FR. Fertility & Sterility, Vol 34, 1, 1980
2. Catt KJ, ML Dufau, & JL Vaitukaitis, Journal of Clinical Endocrinol. Metlab. 1975; Vol 40, 537
3. Braunstein GD, J Rasor, H. Danzer, D Adler, ME Wade, Am. J. Obstet. Gynecol. Vol 126, 677, 1976
4. Lenton EA, LM Neal, R Sulaiman, Fertility & Sterility, Vol 37, 773, 1982
5. Dawood MY, B Saeba & R Landesman, Ob. Gyn., Vol 126, 678, 1976
6. Braunstein GD, et al, Ann. Inter. Med. Vol 78, pp39-45
7. Engvall E, Methods in Enzymology, Vol 70, pp 419-439, 1980
8. Uotila M, Ruoslahti E, Engvall E, J. Immun. Meth. Vol 42, 11, 1981
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