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                                           CLEAR-MARKâ One Step

                                                     Ovulation Strip Predictor

 

Before you begin

¨      Read all the information before testing.

¨      Do no use the test after the expiration date printed on the pouch.

¨      Keep out of reach of children

¨      For in-vitro diagnostic use only.

 

 

How the predictor works

Luteinizing Hormone (LH) plays a important role in regulation the ovulation. It is present in your urine and its level increases sharply just before ovulation. This LH surge triggers ovulation, which is the release of an egg from your ovary.

 

The ClearMark Ovulation Strip Predictor is a one step assay system for detecting the surge of LH in urine to help you predict the time of ovulation. The ovulation is likely to occur in the next 24-48 hours after the surge. The conception is most likely to occur during this period.

 

Material Supplied

The ClearMark  Ovulation Strip Predictor contains minimum 7 test strips enough to detect your most fertile days during one menstrual cycle. You will perform one test per day starting from a specific day that can be calculated as in “When to begin testing”

 

Storage

Store in a dry place below 86°F (30°C) and away from direct sunlight.

 

When to begin testing

1.        Determine the length of your normal cycle. The length of your cycle is from and including the first day of your period (menstrual bleeding) through the day before your next period starts.

2.        Decide the average length of your cycles over the last few months. Use the Table “When to Begin Chart” below to decide when to start testing.

3.        Locate your cycle length number from the left column of When to Start Chart. On the same row of the right column, you will find the number of days you should count forward from the first day of your period.

4.        Mark day one of your period on your calendar. Remember: Day One is the first day of bleeding.

5.      Counting Day One as one, count forward the number of days you have found in step 3. When finished counting, mark that day on your calendar. This is the day you should start testing.

 

Text Box: Sample Pad

 

Notes: If your cycle length is irregular or your are unsure about your cycle length, you may want to use your shortest cycle length when reading the chart. If you do this, you may need to test for more than 5 days.

 

When to Begin Chart

Cycle Length

Begin testing this many days from when your period begins

21

5

22

5

23

6

24

7

25

8

26

9

27

10

28

11

29

12

30

13

31

14

32

15

33

16

34

17

35

18

36

19

37

20

38

21

39

22

40

23

 

Sample Calendar

S

M

T

W

T

F

S

 

1

2

3

4

5

6

(7)

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

 

 

 

 

 

 

 

Example:  My usual cycle length is 27 days. My last period started on the 7th. From “when to Begin Chart”, I will count 10 days forward beginning with the 7th.  When I count 10 days forward on the calendar, I find that I will start my testing on the 16th (see sample calendar).

 

Performing the Test

For best results, perform the test at about the same time each day, between 10:00 AM and 8:00 PM.

Reduce your liquid intake for 2 hours before collecting urine. Be sure to write

Down the date, cycle day and time that you collect your urine in Test Results Chart at the end of this pamphlet.

 

Caution

¨        Be sure to follow each step carefully.

¨        Have a watch or timer available.

¨        Do not touch the test window.

 

Procedure

1.   This test stick should be brought to room temperature prior to assay if it was stored at refrigerated condition.

Open the foil pouch by tearing along the split. Remove the test stick from the pouch. Take either Method 1 or Method 2 to process the test.

3.        Method 1

a.        Dip the strip in the urine specimen. Make sure that the urine level is below the line pointed by “MAX”.

      Place the strip on a clean level surface as soon as the solvent front reaches the membrane area.

c.        Wait for 3 to 10 minutes to observe the result.

 

4.        Method 2

a.        Place the strip on a clean level surface and let the arrow sign pointed to the operator.

b.        Add 2-3 drops of urine onto the exposed portion of the sample pad below the “MAX” line.

a.        Wait for 3 to 10 minutes to observe the result.

 

4.   The result could be read between 3 -10 minutes after adding the urine samples. To verify a negative result, wait the full 10 minutes before reading.

 

Reading Result

Wait at least 4 minutes after placing the stick on desktop. This is a color comparison assay. You should compare the color, not the thickness, of the test band to the control band to determine if you have a positive or negative result.

1.        Positive Result: If the test band is the same color as, or darker than the control band, you will probably ovulate within next 24-48 hours. This time period is the best time for conception.

2.        Negative Result: If the test band is lighter than the control band, or if there is no test band in the window, no LH surge has been detected. You would better to continue your daily testing.

3.   

     Invalid Result: If there is no control band, the test should avoid and a new test should be performed.

 

Explanation and Suggestion

1.   A positive result indicates a surge of LH level in your urine. Most likely, you will ovulate within next 24-48 hours. Please plan accordingly. The unused sticks may be saved for your next cycle if you are not yet pregnant.

 

2.   A negative result indicates no LH surge has been detected. You should continue your daily testing. Do not disappointed or surprised about a negative result during the first few days you perform the test. Not every woman ovulates mid-cycle. So, you may not see a positive result during the first 5 days of testing.

3.    An invalid result is created mostly by improper test procedure or by use of expired stick. The control band is served as an internal control telling you that the test is performed and worked properly. The band is also serves as a level control for the LH surge.

 

Limitation of the Test

1.        The test works only when the instructions are followed properly.

2.        The test may not be used as a form of birth control.

3.        Medication containing hCG or LH may affect the test and should not be taken while using this test. In addition, the test will not work properly if you are pregnant, menopausal, taking birth control pills, or breast-feeding.

4.        If your urine contains excessive amounts of bacteria, the results may not be stable.

 

Please Review Questions and Answers section for the Ovulation Test