Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
CATALOG
CATALOG
Catalog No. Product Name Note
ABT-FT-A3 LH Urine Strip CE0197
ABT-FT-B3 LH Urine Cassette CE0197
ABT-FT-C3 LH Urine Midstream CE0197
Accu-Tell ® Rapid LH Ovulation Test is a fast and easy-to-use Rapid chromatographic immunoassay for the qualitative determination of LH in urine.
Human luteinizing hormone (hLH) is a glycoprotein hormone secreted by the anterior pituitary. HLH, hFSH together with other steroid hormones are known to play important roles in regulating ovulation and other ovarian functions during the menstrual cycle. Maturation of an ovarian follicle and its oocyte begins during the end of the preceding menstrual cycle. In response to hFSH released by the pituitary, the follicle undergoes rapid growth. As follicles develop, estradiol secretion begins to rise slowly and is followed by a rapid increase. This increase of estradiol level is generally believed as the trigger for the rapid rise and peaking of hLH activity at the mid-cycle (hLH surge). Approximately 12-24 hours after the hLH surge, the wall of the enlarged follicle ruptures at ovulation and the mature ovum is extruded. After ovulation, hLH returns to its base line level within two days with the concomitant increase of progesterone level to initiate luteal phase. The luteal phase lasts predictably about 14 days. Unless pregnancy occurs, a new follicle begins the selection procedure for maturation in the next menstrual cycle.
In view of the characteristic variation of hLH during the menstrual cycle, rapid and sensitive measurement of hLH is an important tool in the diagnosis and management of infertility in females. Detection of the hLH surge can aid in predicting the time of ovulation. The onset of the hLH surge proceeds ovulation by approx. 30 hours. The analysis of hLH has been used successfully to time oocyte retrieval for in vitro fertilization and would similarly assist timing of artificial insemination.
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 bleeding begins again. 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 your doctor. 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 one test each day over a 5 days period or until the LH surge has been detected.
1.Do not use first morning urine samples as LH is synthesized in your body early in the morning. It will not show up in your urine until later in the day.
2.The best time to collect your urine is between 10 am to 8 pm.
3.Collect urine at about the same time each day.
4.Reduce liquid intake about 2 hours before collecting your urine as a diluted urine sample can prevent the test from detecting LH serge.
PREPARATION
1.Bring the test components and patient samples to room temperature (18 ~ 30℃) before testing.
2.Do not break the seal of the foil pouch until ready to perform the test.
TESTING
1.Open the foil pouch and remove the test strip.
2.Dip the test strip with arrow downside into the urine for about 5 minutes and lay the strip flat on a clean, dry, non-absorbent surface. Do not exceed the marker line.
3.Wait for colored bands to appear. Depending on the concentration of LH in the test specimen, positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (10 minutes) is required. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS
No LH Surge: If there is only one colored band appears on the control region (C), or the test band is lighter than the control band, there is no LH surge.
LH Surge: If two color bands are visible and the test band is equal to or darker than the control 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.
INVALID:No visible band at all. Repeat test with a new test kit.
TESTING
1.Open the foil pouch and remove the test cassette.
2.Draw 0.2ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.
3.Wait 5 minutes and read results. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS
No LH Surge: If there is only one colored band appears on the control region (C), or the test band is lighter than the control band, there is no LH surge.
LH Surge: If two color bands are visible and the test band is equal to or darker than the control 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.
INVALID: No visible band at all. Repeat test with a new test kit.
MIDSTREAM
TESTING
Allow the test kit, urine specimen and/or controls to equilibrate to room temperature (15-30℃) prior to testing
1.Bring the pouch to room temperature before opening it. Remove the test device form the sealed pouch and use it as soon as possible. Remove the cap to expose the sample absorbent.
2.Hold the handle with the exposed sample absorbent pointing downward. Urinate on the sample absorbent.
3.Lay the test midstream down on flat surface with the windows on top and wait for the red line(s) to appear. Read result within 10 minutes but no longer than 15 minutes.
INTERPRETATION OF RESULTS
POSITIVE: Two lines are visible and the test line (T) is the same as or darker than the Control line (C). This indicates that the specimen is likely at or around the surge level within 24-36 hours.
NEGATIVE: There is no test line (T) or two lines are visible, but the test line (T) is lighter than the Control line (C). This indicates that no LH surge has been detected and you should continue daily testing,
INVALID: Control line fails to appear
Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for an invalid result. Review the procedure and repeat the test with a new test kit. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
The test kit can be stored at room temperature (2 to 30℃) in the sealed pouch for duration of shelf life. The test kit should be kept away from direct sunlight, moisture and heat.
1.Do not use kit beyond the expiration date.
2.Samples may be infectious; properly handle and dispose of all used reaction devices in the biohazard container.
3.For in vitro diagnostic use only.
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 Accu-Tell ® Rapid LH Ovulation Test Cassette. In addition, the test will not work properly if you are pregnant, in menopause, or are taking birth control pills.
1. Can I use Rapid LH Ovulation Test Cassette to avoid pregnancy?
No, the test shouldn’t be used as a form of birth control.
2. Do alcohol or common medications affect the test?
No, but you should consult your physician if you are taking any medication.
3. How long will the line remain visible?
The test should be read at 5 minutes for best results. A positive (Surge) result will never disappear. The color line may become darker and a tinted background may appear after several hours. Some negative results may later display a faint second color line because of evaporation from the test region, which prevents complete migration of the test chemicals. Therefore, you should discard the test cassette once you have read the test.
4. Once I see a positive result, when is the best time to have intercourse?
Ovulation is likely to occur within 24-48 hours. This is your most fertile time. Sexual intercourse within this time frame is advised.
5. I am now using the basal body temperature method (BBT). Does this test replace BBT?
The shift in basal body temperature primarily indicates that ovulation has already occurred. Rapid LH Ovulation Test Cassette indicates that ovulation is about to occur.
6. I have received a positive result and had intercourse during these fertile days. I have not become pregnant. What shall I do?
There are many factors that can affect your ability to become pregnant. Often you may need to use the test kit for 3-4 monthsbefore achieving pregnancy. You and your partner should consult your physician if pregnancy is not achieved after 3-4 months.
7. What time of the day should I perform the test? Do I need to use first morning urine?
We do not recommend first morning urine. For best results, try to collect your urine at approximately the same time each day.
8. Will the amount of liquid I drink affect the result?
Heavy intake of fluids prior to testing will dilute the hormone in your urine. We suggest that you limit your fluid intake for about two hours before you collect your urine.
PERFORMANCE CHARACTERISTICS
Accuracy: In laboratory studies, Accu-Tell ® Rapid LH Ovulation Test Cassette has been proven to be 98.7 accurate.
Specificity: Accu-Tell ® Rapid LH Ovulation Test Cassette has been tested with commonly known drugs and hormones including FSH (700 mIU/mL), TSH (500 IU/mL), and hCG (1000 mIU/mL). At the levels tested, none of these substances interfered with the expected test results.
TEST RESULTS CHART
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
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