Introduction:

Ovulation is the release of an egg from the ovary. The egg then passes into the fallopian tube where it is ready to be fertilized.

A baby is conceived when the male sperm successfully fertilizes the female egg. When a woman is about to ovulate, her body releases a large amount of a hormone called L.H. (Luteinising Hormone). L.H. is always present in your urine but the levels increase (surge) in the middle of your cycle, causing you to release an egg from the ovary.

Intended Use:

The One Step Ovulation Test is an immunochromatographic in-vitro assay for the qualitative and semi-quantitative determination of the human luteinizing hormone (LH) in urine to predict the time of ovulation in women. The test detects the sharp increase in LH concentration in urine, the so called “LH surge” which precedes ovulation. Conception is most likely to occur within 36 hours following the LH surge.

Contents:

Each pouch contains one immunochromatographic test. Each test contains a membrane with anti-LH antibodies and conjugates, in a stabilizing matrix containing proteins and sodium azide.

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
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
39 Days Day 22
40 Days Day 23

Storage and Stability:

Store below 30°C; do not freeze.

Limitations

The One Step Ovulation Test is for in vitro diagnostic use only. Elevated concentrations of Human Chorionic Gonadtropin (HCG) interfere with LH testing. Do not test samples from pregnant women and people with pathologic conditions causing higher HCG levels.

The One Step Ovulation Test is not designed to prevent conception. As sperm can survive for 72 hours you might still become pregnant if you had intercourse before you detected your L.H. surge.

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, count the first day of bleeding as day 1. Calculate what the usual length of your menstrual cycle has been over the last few months. Once you have worked out the length of your cycle refer to the chart to determine on which day of your menstrual cycle you should begin testing.

Specimen Collection:

Before you begin:

Test Procedure:

Interpretation of Results:

After each test, you must decide if you are having a L.H. surge.

To determine your result you must compare the colour intensity of the test band to the control band. The control band is used to compare the test band against and also confirms that you have completed the test correctly.

Positive for L.H. surge
If two colour bands are visible and the test band is of equal or greater colour intensity (darker) than the control band, this is a positive result and a good indication that the L.H. surge is occurring. You should ovulate within the next 24-36 hours. Sexual intercourse is advised at anytime after the first positive test.

Negative for L.H. surge
If two bands are visible but the test band is of a less intense colour (paler) than the control band or cannot be seen, this means the L.H. level is at or near its normal level and that the surge is not in progress. You should continue with daily testing.

Invalid result
If no control band appears within 5 minutes, the result is invalid and should be ignored. A visible control line is needed in all cases to confirm a proper test result. Repeat test with a new test kit.

Interpretation of the symbols

20090101 Symbol for “batch code”

Example:

If your cycle is normally 28 days, the cycle chart above indicates you should begin testing on Day 11. The calendar below shows you how to work out when day 11 is.

S M T W T F S
1 3 3
Day 1
4 5 6 7
8 9 10 11 13 13
Day 11
14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30 31        

SAMPLE CALENDAR

3 = The first day of menstrual bleeding (day 1)
13 = The day to begin ovulation testing (day 11)

note:
If your cycle is shorter than 21 days or longer than 40 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 until the LH surge has been detected.