TEST DESCRIPTION

One Step LH Urine Ovulation Test is fast and easy-to-use. It is a qualitative test that predicts LH (Luteinizing Hormone) surge, and in turn, when you are likely to ovulate and conceive. Females who are trying to become pregnant may use this information to improve their chances of conception. Luteinizing Hormone is a hormone released by the pituitary gland, a small gland at the base of the brain. The hormone stimulates the ovaries to produce and release eggs each month during the menstrual cycle. The level of LH in the blood and urine is highest before ovulation. This increase in hormone level is sometimes called a "surge". If fertility drugs are given to stimulate ovulation, an LH test can help determine the best time for sexual intercourse. The LH test may also be used to determine when eggs are mature enough to be surgically removed from the ovary as part of the in vitro fertilization process. LH tests may also aid in the diagnoses of polycystic ovary disease, premature ovarian failure, and menopause.

The tests detect LH in urine in a qualitative format with sensitivity of 25mIU/mL (International Standard Value) and specificity is 99.8%. Tests have an expiry date of 2 years and can be stored in a dry environment ranging from 2 to 30 degrees Celsius. Results are available in just minutes.

FORMATS

The tests are available in 3 different formats:

1. STRIP

2. CASSETTE

3. MIDSTREAM

The format applications range from professional to domestic usage.

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 bleeding begins again. Please refer to the chart below 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 1 test each day over a 5 day period or until the LH surge has been detected.

URINE COLLECTION

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 10am - 8pm.

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 surge.

Please refer to the list below for information on when to start using ovulation tests:

If you cycle length is 21 days Test on Day 6
If you cycle length is 22 days Test on Day 6
If you cycle length is 23 days Test on Day 7
If you cycle length is 24 days Test on Day 7
If you cycle length is 25 days Test on Day 8
If you cycle length is 26 days Test on Day 9
If you cycle length is 27 days Test on Day 10
If you cycle length is 28 days Test on Day 11
If you cycle length is 29 days Test on Day 12
If you cycle length is 30 days Test on Day 13
If you cycle length is 31 days Test on Day 14
If you cycle length is 32 days Test on Day 15
If you cycle length is 33 days Test on Day 16
If you cycle length is 34 days Test on Day 17
If you cycle length is 35 days Test on Day 18
If you cycle length is 36 days Test on Day 19
If you cycle length is 37 days Test on Day 20
If you cycle length is 38 days Test on Day 21



TEST PROCEDURE

STEP 1

Bring the test pouch to room temperature (18-30°C). Collect urine into a clean container (such as plastic cup). The best way to collect sample is by placing a cup in the middle of urination process. To begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch when you are ready to use it.

STEP 2 (TEST FORMATS)

STRIP TEST

Immerse the strip into the urine with the arrow end pointing towards the urine. Do not immerse past the MAX (maximum) line. Take the strip out after 5 seconds and lay the strip flat on a clean, dry, non-absorbent surface (e.g., mouth of the urine container). Do not immerse for longer than 7 seconds.

CASSETTE TEST

Draw the sample into the provided pipette, and dispense 0.2ml (about 4 drops) into the round dropping well of the cassette.

MIDSTREAM TEST

Hold the round end of cover with one hand. Use the other hand to pull out the test device and expose the absorbent window. Point the absorbent tip downward; place the absorbent tip in urine stream for at least 10 seconds to be thoroughly wet. Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 10 seconds. Re-cap the device and place it on the clean, flat surface.

STEP 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 the results after 30 minutes as this type of test is designed for rapid determination only.

INTERPRETATION OF RESULTS

No LH Surge:
Only one color band appears on the control region or the test band is present but lighter in color intensity than the control band. There is no LH surge even if two lines present - as long as test line is fainter than the control line the result is negative.



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 hours but before 48 hours.



Invalid - Uncertain Results: No visible bands in the control and test regions. Make sure to follow the above specified instructions for optimum results.

Test results may vary for different individuals depending on the concentration of LH your body produces, as well as monitoring frequency, and testing technique. The best method is to test once a day, preferably later in the afternoon or early evening.

PRECAUTIONS

1. For single in vitro diagnostic use only - use test only once for urine screening.

2. Do not use test kit beyond expiry date.

3. Keep away from moisture, direct sunlight, and children.

Note: If you suspect that you have ovulation problems, or problems with detecting LH surge, please see your physician. There are numerous stimulatory procedures that can induce the ovulation surge.