Ovulation Test Instructions

IMPORTANT

Our online ovulation test instructions provide all the information that is needed to use our tests.
If used incorrectly, the tests will not be accurate, so please read the entire set of instructions
before beginning to test. If you have any questions, please don't hesitate to contact us.

INTENDED USE

The ovulation tests are used to obtain quick visual, semi-quantitative results for early detection of
Luteinizing Hormone (LH) in urine samples. The LH surge is used to predict a release of mature ovum
within 24-48 hours, at which the patient is most likely to become pregnant.

INTRODUCTION

Luteinizing Hormone (LH) plays important roles in the regulating the ovulation and ovarian functions
during the menstrual cycle. Normally present in very small concentration in urine, LH rapidly increases
in the mid cycle (commonly referred to as "ovulation surge"), usually 1 to 2 days prior to release of
the mature ovum (ovulation). By monitoring the surge of LH in urine it is possible to determine the
optimal chance for egg fertilization and planned pregnancy.

"WHEN" TO TEST...

Please note that using the ovulation test strips is only OPTIONAL and will NOT make a difference
between succeeding or not with our Baby Gender Selection Program. However, the suggested use
is to determine if you are fertile (ovulating) or not during our Program's "Crucial Dates" to conceive
the desired gender.

Suggested use:
To determine if you are ovulating on the monthly "Crucial Dates" to conceive the desired gender,
simply test for five (5) consecutive days starting one (1) day BEFORE the 1st monthly crucial date.

General (traditional) use:
Prior to administering an ovulation test in general (NOT gender selection related), it is necessary
to determine the length of your menstrual cycle. This is the number of days from the first day of
menstrual bleeding to the day before the next bleeding starts again. Refer to the following chart
to determine when you should start testing. The first day of bleeding is day 1.  Perform testing
five (5) days in a row or until the LH surge (darkest test line) has been detected.

My cycle is:            Start testing on:

21 days                Day 5
22 days                Day 6
23 days                Day 7
24 days                Day 8
25 days                Day 9
26 days                Day 10
27 days                Day 11
28 days                Day 12
29 days                Day 13
30 days                Day 14
31 days                Day 15
32 days                Day 16
33 days                Day 17
34 days                Day 18
35 days                Day 19
36 days                Day 20
37 days                Day 21
38 days                Day 22
39 days                Day 23
40 days                Day 24

SPECIMEN COLLECTION (DO NOT USE FIRST MORNING URINE)

1. Obtain a clean plastic or glass container to collect a urine sample.
2. Collect urine once per day. LH is synthesized during the day so best time to test is 10am to 8pm.
3. Make sure to test daily at approximately the same time.
4. Specimen should be allowed to settle for 5 minutes and reach room temperature before testing.

TEST PROCEDURE

1. Make sure the urine sample and unopened ovulation test are at room temperature prior to administering the test.
2. Remove the test device from its protective pouch by tearing along a side notch.

APPLICATION

Hold the green plastic handle and immerse the test strip into the urine with the white absorbent
arrow end pointing towards the sample. Make sure not to immerse past the maximum line marker.
Take the strip out after 3 seconds and place it horizontally on a clean, dry, surface.

>>> Do NOT immerse for longer than 5 seconds.

>>> Allow 5 minutes to complete the test reaction.

RESULT INTERPRETATION

Make sure to read test results at 5-minute mark. Reading too early or too late may yield incorrect
interpretation of the results and may vary according to users experience.

NEGATIVE Result: No Ovulation Surge

• Only one color band appears on the top Control (C) region.



• There should be no apparent band on the Test (T) region.



• The control line is designed to validate the test and should be
  crisp and clear in intensity with white membrane background.

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POSITIVE Result: Possible Ovulation

• Distinct and consistent color bands appear on the Control (C) and Test (T) regions.



• Color intensity of the bands is directly proportional the concentration of LH hormone in urine.



• The test line during LH surge is usually equal to or darker than the intensity of the control line.



• The test line prior to and after the LH surge is usually weaker than the intensity of the control line.

Therefore the pattern of darkening of the color of the test line up to the maximum intensity
(usually 1-3 days) is a best predictor of ovulation surge, which in turn signifies the release
of the egg (within 24-48 hours).

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INVALID RESULTS

Uncertain test results should be discarded in case there is no visible control line.
Repeat test with a new test device.

NOTE: Listed below are some of the reasons why a surge may not be detected.

1. Urine is collected at the wrong time of day, such as first morning urine, which should not be used.



2. The concentration of LH is too low to accurately detect. If you are consistently experiencing this
   problem please contact your fertility specialist.



3. Testing is performed too early or too late in the menstrual cycle. Refer to table in the "WHEN to test"
   section of the instructions to determine when to start testing.



4. Testing is stopped before the surge occurs, and should have been continued for a few more days.



5. A LH surge did not occur during this menstrual cycle, or was missed when testing.

PERFORMANCE CHARACTERISTICS

Sensitivity: 25 mIU/mL LH detection limit

Specificity: > 98% correlation was determined from cross reaction studies with known amounts of human
Chrionic Gonadotropin Hormone (200 mIU hCG/mL ), Follicle Stimulating Hormone (200 mIU hFSH/mL), and
Thyroid Stimulating Hormone (200 µIU hTSH/mL). All tests yielded color much less intensive than that of
20 mlU/ml hLH Reference.

Standardization:
The ovulation test has been standardized to World Health Organization Second International Standard (IS 80/552).

Reagents:
Containing membrane coated with goat anti-LH colored colloidal gold - monoclonal mouse anti-LH conjugated
predried in pad.

Interference Testing:
The following substances were added in hLH free and hLH spiked urine samples. None of the substances at
concentration tested interfered in the assay:

~ Acetaminophen 20 mg/dl
~ Acetylsaticylic Acid 20 mg/dl
~ Ascorbic Acid 20 mg/dl
~ Atropin 20 mg/dl
~ Caffeine 20 mg/dl
~ Gentesic Acid 20 mg/dl
~ Glucose 2 g/dl
~ Hemoglobin 1 mg/dl

Built in Quality Control:
The procedural control is built in to the test. A color band appearing on the control region of the strip
indicates proper test performance.

TEST LIMITATIONS

1. The urine ovulation test is designed for in vitro diagnostic use only.



2. Do not use the results of this test as an aid for contraception.



3. A test device can only be used once. Discard the test after use.



4. Always compare the color of the test band to that of the control band of the same device
   on the day the test is performed. Do not compare bands from different devices.



5. Urine from pregnant women, women in menopause, or after receiving a hCG shot (injection)
   should not be used with this test, and will cause inaccurate results.



6. If you are taking hormonal medications please consult with your fertility specialist.



7. If irregular or unusually long cycles are experienced, or if you are experiencing consistent
   problems in detecting ovulation surge please contact your physician or fertility specialist.

STORAGE AND STABILITY

The test devices should be kept from prolonged exposure to direct sunlight, moisture, heat, and
other related conditions.

The test kit can be stored at normal room temperature (2°C to 30°C) in the sealed pouch up to
the expiration date of 2 years, which is indicated on the package.

DISPOSAL

Urine samples and used test devices are potentially infectious so please keep them away from direct
contact with objects. Proper handling, hands washing, and immediate disposal is recommended.

WARNING AND PRECAUTION

1. Keep away from children and prolonged exposure to extreme storage conditions.



2. This test is designed for single in vitro diagnostic use only.



3. Do not use test kit beyond expiry date printed on package.



4. Tests results may vary for different individuals.