CIGA Healthcare Fertility Products FAQ

• Pregnancy
• Ovulation
• Menopause

Pregnancy

Pregnancy Tests

Q: How does the test work?

A: The Early Detection One Step Ultra Pregnancy Test detects a hormone in your urine that your body produces during pregnancy (hCG-human chorionic gonadotropin). The amount of pregnancy hormone increases as pregnancy progresses.

Q: How soon after I suspect that I am pregnant can I take the test?

A: You can test your urine as early as the first day you miss your period. You can perform the test anytime of the day; however, if you are pregnant, first morning urine contains the most pregnancy hormone.

Q: Do I have to test with first morning urine?

A: Although you can test at any time of the day, your first morning urine is usually the most concentrated of the day and would have the most hCG in it.

Q: How accurate is the test?

A: A clinical evaluation was conducted comparing the results obtained using the Early Detection One Step Ultra Pregnancy Test to another commercially available urine membrane hCG test. The consumer clinical trial included 70 urine specimens: both assays identified 27 positive and 43 negative results. The results demonstrated >99.0% overall accuracy of the Early Detection One Step Ultra Pregnancy Test when compared to the other urine membrane hCG test.

Q: How sensitive is the test?

A: The Early Detection One Step Ultra Pregnancy Test detects hCG in urine at a concentration of 10 mIU/mL or greater. The test has been standardized to the W.H.O. Third International Standard. The addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL hCG) and positive (10 mIU/mL hCG) specimens showed no cross-reactivity.

Q: What should I do if the result shows that I am pregnant?

A: It means that your urine contains hCG and you are probably pregnant. See your doctor to confirm that you are pregnant and to discuss the steps you should take.

Q: How do I know that the test was run properly?

A: The appearance of a colored line in the control window (C) tells you that you followed the test procedure properly and the proper amount of urine was absorbed.

Q: What should I do if the result shows that I am not pregnant?

A: It means that no hCG has been detected in your urine and probably you are not pregnant. If you do not start your period within a week of its due date, repeat the test with a new midstream test. If you receive the same result after repeating the test and you still do not get your period, you should see your doctor.

Ovulation

Ovulation Tests

Q: Can I use the Easy Prediction One Step Ovulation Test to avoid pregnancy?

A: No, the test should not be used as a form of birth control.

Q: How accurate is the Easy Prediction One Step Ovulation Test?

A: A clinical evaluation was conducted comparing the results obtained using the Easy Prediction One Step Ovulation Test to another commercially available urine membrane LH test. The in-house clinical trial included 150 urine specimens. The results demonstrated >99.9% specificity and >99.9% sensitivity with an overall accuracy of >99.9%.

Q: How sensitive is the Easy Prediction One Step Ovulation Test?

A: The Easy Prediction One Step Ovulation Test detects luteinizing hormone (LH) in urine at concentrations of 40 mIU/mL or higher. The addition of FSH (1,000 mIU/mL), hCG (10,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL LH) and positive (40 mIU/mL LH) specimens showed no cross-reactivity.

Q: Do alcohol or common medications affect the test?

A: No, but you should consult your physician if you are taking any hormonal medication. Also, recent oral contraceptive use, breastfeeding, or pregnancy could affect the test results.

Q: Why should I not use first morning urine? What time of the day should I perform the test?
A: We do not recommend first morning urine because it is concentrated and may give a false positive result. Any other time of day is suitable. For best results, try to collect your urine at approximately the same time each day.

Q: Will the amount of liquid I drink affect the result?

A: Heavy intake of fluids prior to testing will dilute the hormone in your urine. We suggest that you limit your fluid intake for about two hours before you perform the test.

Q: How long will the lines remain visible?

A: The test should be read at 3 minutes for best results. A positive (Surge) result will never disappear. The colored line(s) may become darker and a tinted background may appear after several hours. Some negative results may later display a faint second color line because of evaporation from the test line. Therefore, you should not read the results after 10 minutes, discard the test once you have read the result.

Q: Once I see a positive result, when is the best time to have intercourse?

A: Ovulation is likely to occur within 24-36 hours. This is your most fertile time. Sexual intercourse within this time frame is advised.

Q: I am now using the basal body temperature method (BBT). Does this test replace BBT?

A: The Easy Prediction One Step Ovulation Test does not replace the BBT method. The shift in basal body temperature primarily indicates that ovulation has already occurred. The Easy Prediction One Step Ovulation Test indicates that ovulation is about to occur.

Q: I received a positive result and had intercourse during these fertile days but I have not become pregnant. What shall I do?

A: There are many factors that can affect your ability to become pregnant. It can take normal, healthy couples many months to achieve a pregnancy and often you may need to use the test kit for 3-4 months before achieving pregnancy. If pregnancy is not achieved after 3-4 months, you and your partner should consult your physician.

Q: I have had a positive result and had intercourse during these fertile days. I think I may be pregnant. How soon can I find out?

A: Our Early Detection One Step Pregnancy Test can provide you with results as early as the first day of your missed period.

Menopause

Menopause Tests

Q: How does the test work?

A: As your body ages and produces less estrogen, FSH levels increase as the hormone tries to stimulate the ovaries to produce a healthy egg. This test measures FSH and can tell you whether your body is producing excess FSH as a result of low estrogen levels, signaling that your body is in the perimenopause stage.

Q: When can I use the test?

A: We recommend performing the test using first morning urine as it contains the most hormone and will give the most accurate result. If you are still menstruating, we recommend testing during the first week of your cycle (see WHEN TO TEST) and then retesting one week later.

Q: How will I know the test worked?

A: The appearance of a colored line in the Control Window (C) tells you that you followed the test procedure properly and the proper amount of urine was absorbed. If you do not see a line in the Control Window (C), you should review the procedure and repeat with a new midstream test. The test is not reusable. If you still experience problems, contact your distributor.

Q: I received a positive result. Can I stop using contraception?

A: No, this test cannot determine fertility. Continue using contraception until your test results have been confirmed by your doctor.

Q: I am not sure that I held the test in my urine stream long enough. Will I still get an accurate result?

A: In order to receive an accurate result, you should hold the Absorbent Tip of the test in your urine stream for at least 10 seconds and wait 3 minutes to read the result. If the line in the Control Window (C) fails to develop, you should repeat with a new midstream test.

Q: How accurate is the test?

A: A clinical evaluation was conducted comparing the results obtained using the Easy Detection One Step Menopause Test to another commercially available urine membrane FSH test. The clinical trial included 200 urine specimens: both assays identified 92 positive and 108 negative results. The results demonstrated >99.0% overall accuracy of the Easy Detection One Step Menopause Test when compared to the other urine membrane FSH test.

Q: How sensitive is the test?

A: The Easy Detection One Step Menopause Test detects follicle-stimulating hormone (FSH) in urine at concentrations of 25 mIU/mL or higher. The addition of LH (1,000 mIU/mL), hCG (100 IU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL FSH) and positive (25 mIU/mL FSH) specimens showed no cross-reactivity.

Q: Do alcohol or common medications affect the test?

A: No, but you should consult your physician if you are taking any hormonal medication. Also, recent oral contraceptive use, breastfeeding, or pregnancy could affect the test results.

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