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HEALTH-CHEM DIAGNOSTICS LLC
3341 S.W 15th ST. POMPANO BEACH, FL 33069 – USA – T: (954) 979-3845 F: (954) 979-7997 – WWW.HEALTHCHEMDIAGNOSTICS.COM
Ovulation Detection Test
Midstream Wand
IMPORTANT: When dipping the test wand into your urine to perform the HealthChem Ovulation Detection Test offers:
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test, be sure to hold the wand so that the urine level does not exceed the Easy Use: Just dip the Test Wand into urine or hold in urine stream for at wick (the area that was covered by the cap on the Test Fast Readable Results in as little as 3-10 minutes. Wand). The test will not work properly if urine level exceeds wick area. Sensitive test results detecting concentrations of LH at 25 mIU/ml or It is better to use a smaller volume of urine than a larger volume of urine. Precise and accurate laboratory test findings with an accuracy of > 96%. Instructions for Testing
Technical Assistance: You can call our toll-free number and talk to a Determine the average length of your menstrual cycle over the past few months. Technical Professional for information about your test or result by calling the HealthChem Toll Free Help Line at 1- 800-482-2907, Monday- Friday. To calculate the length of your menstrual cycle, start from the 1st day of bleeding for one cycle, to day before bleeding starts your next cycle. Once you For in-vitro diagnostic use only. have defined the length of your cycle, See Figure 1 to determine when to begin Do not take any part of this kit internally. Please read all instructions before performing the test * Example (from chart) to determine when to start testing: A 27 Day Menstrual Cycle would = 10 Days from the start of your HealthChem Ovulation Detection Test
This kit contains enough supplies to determine your LH surge over a period of five days. During each day 1 Test Wand will be used to measure LH. Simply Then the 10th day after beginning your current menstrual cycle dip the Test Wand into your urine stream or a small container of urine. The result in the form of 2 magenta (reddish) bands should appear in the Result Window within 3-10 minutes. But before you begin, familiarize yourself with the test components shown below. Important: Do not open the foil packet until Menstrual Cycle Chart
you are ready to perform the test. The HealthChem Ovulation Detection
Test is not reusable.
HealthChem Ovulation Detection Test Contents
This wand contains one reaction strip, which in turn contains a polyclonal antibody coated membrane and a pad containing mouse monoclonal lgG (antibody) dye conjugate in a protein matrix. How does the HealthChem Ovulation Detection Test Work?
The test will help you to identify the time that you are the most likely to ovulate. The test measures Luteinizing Hormone (LH). The female body makes LH, which causes ovulation to take place. During a woman’s menstrual cycle the NOTE: If your cycle is less than 21 or greater than 40 days, call your physician LH is low, but during the middle part of the cycle, the amount of LH suddenly increases for a brief period. This rapid increase or “surge” in LH triggers the ovary to release an egg. This process is called ovulation. Remove the HealthChem Ovulation Detection Test from the foil
NOTE: Ovulation usually takes place within 20-44 hours after the detection of Pull off the protective cap from the Test Wand, but do not discard it. your LH surge.
Urine Collection
Try to perform the test at about the same time each day. Do not collect your
first morning urine.
Before You Begin
1.
Read this entire pamphlet carefully. Do not open the foil packet until you Please note the two different sides of the wand. This device is intended for self testing.
Select a well-lighted room with a clean, flat surface for performing the test. Make sure you have a timer or clock within view. Hold the wick in your urine stream or place in collection container so that Hold the test wand in your urine stream for at least 6 seconds or collect it remains upright. The Test Wand should remain in urine for a period of your urine in a clean glass container. Then dip the test wand into the at least 6 seconds. Note: No urine should come in contact with the Result Do not use the test wand beyond the expiration date printed on the package or on the foil packet. Replace the protective cap and place the Test Wand on a flat surface with the Result Windows facing up. Results will appear in as little as 3 minutes. Best results are observed after 5 minutes. DO NOT READ RESULT AFTER 10 MINUTES. As the test begins to work, you will see the formation of a magenta (reddish) Question and Answer Section
line in the Control Window (the round window) indicating the test is working Q. Can I use the Ovulation Detection Test for contraception?
A. No. The use of the test will not prevent pregnancy.
Reading Your Results
Q. Why can’t I use the first morning urine sample?
A. If you use the first morning sample, you may miss the real first day of your
Two magenta (reddish) bands should appear in the Result Windows. The line in LH surge because your urine is concentrated during sleep and the concentrated the round window is the Control Line. The line in the triangular window is the urine may give a false positive result. The best time to perform the test is Test Line. If the color intensity of the Test line is less than that of the Control between 10 a.m. and 8 p.m. Be sure to collect your urine about the same time line, or if there is no line in the Test Window, the result is negative. The test did not detect an LH surge and you should continue testing the following day. Q. I noticed that today’s CONTROL LINE was a different shade of
magenta (reddish) than yesterday’s Control Line. Should I be concerned?
A. No. Variations in the Control Line will not affect the Test Result. You
should always compare your Test Line to the Control Line only on the day you
Control Window (round)
Test Window (four sided)
Q. Do I need to use all 5 tests?
A. No, you can stop testing when you detect your LH surge and save the
remaining tests to use, if needed, next month. If the color of the Test line is darker or equal to that of the Control line, then the test result is a positive indication of an LH surge. Q. What could interfere with my Test Results?
A. If you are pregnant, have recently been pregnant or have reached menopause, If both a Test Line and a Control Line do not appear in the you may get a misleading result. This may also be true if you are taking drugs, Result Windows of the test wand, the test is invalid. This is such as Danocrine, or injections containing hCG (e.g. A.P.L. or Profasi) or LH probably due to either improper testing procedure or the test (e.g. Pergonal), all of which affect the outcome of this test, so check with your wand may have deteriorated. Please call our HealthChem Help doctor before testing. Alcohol, aspirin, Clomid (Clomiphene Citrate) and any Line 8:00 a.m. to 8:00 p.m. Monday-Friday Eastern Time at Q. Will oral contraceptives affect the results?
A. After using the Pill, your cycle can be irregular. You may need to use more than one test kit each cycle or you may want to wait until you have had 2 If You Have A Question
normal menstrual cycles before starting to use the test. However, you should If you have a question about the instructions or your test results, please call the follow your doctor’s advice as to when you should try to conceive. HealthChem Help Line for assistance at 1-800-482-2907 between 8:00 a.m. to Q. Can I be sure of getting pregnant by using the Ovulation Detection Test?
8:00 p.m. Monday-Friday Eastern Time. Please have the Product Lot Number A. No. Since so many other factors can influence conception, knowing when which appears on the package available when you call the toll-free number. Our you are fertile may not be enough. It is important to know that the LH surge technical staff will gladly answer your questions. and ovulation may not occur each month. Menstrual bleeding is not always a Storage & Disposal
Q. I’ve used all 5 tests as instructed, but have not yet detected my LH
The contents of the test kit should be stored at room temperature (68-85°F). surge. Why not?
The test kit and its contents should be kept out of the reach of children. Used A. The 5 tests contained in the kit are sufficient for many women with regular cycles. However, if your cycle is irregular, you may need to use additional kits to predict the time of peak fertility. Ten days of testing will detect an LH surge What the Results Mean
in about 90% of women. You should be aware that it can normally take couples After each test, you must decide if you are having an LH surge. many months to conceive. If after several months you have had no success, If your Test Result is positive, your level of LH has increased. You are likely to ovulate sometime in the next 20-44 hours. This is when you Q. How do I know that the test has worked correctly?
A. You should see 2 magenta (reddish) bands in the result area. The first line is If your Test Result is negative, you probably are not having an LH surge. the Test Band, which measure your LH, and the 2nd line is the Control Band that tells you the test is working properly. NOTE: You may not see a Test Band if your LH level is too low. If you do not see a control Band please call Reasons Why You May Not Detect an LH Surge:
HealthChem Help Line for assistance at 1-800-482-2907 between 8:00 a.m. to Urine may have been collected at the wrong time of day. First morning urine should not be used when testing for LH. Q. How soon can I find out if I’m pregnant?
The amount of LH in your urine may be too low. A. You can find out as early as the first day of your missed period with the You may have tested too early or too late in your cycle. HealthChemOne-Step One Minute Pregnancy Test. The test is a unique
home pregnancy test in that it requires only one simple step that can give you an When to Stop Testing
accurate result in just 1 minute. You should contact your physician if the result Unless otherwise specified by your physician, you can stop testing once you have detected your LH surge. The remaining tests may be used, if needed, for Accuracy
Precise and accurate laboratory test findings with an accuracy of > 96%. Limits of the Test
You must follow the directions carefully to get accurate results. Do not open a foil pouch until you are ready to perform each test. The results of the test cannot be used as an aid to contraception. Consult your physician if you have irregular or unusually long cycles. You should not use this test if you are pregnant, menopausal, or after hCG HEALTH-CHEM DIAGNOSTICS LLC,
POMPANO BEACH, FLORIDA
Do not use this kit after the expiration date listed on the package. Website: www.healthchemdiagnostics.com

Source: http://dev.healthchemdiagnostics.com/wp-content/uploads/2011/12/45-001-B-OVULATION-TEST-WAND-revB-on-7-20-2011-US.pdf