IFU.LH

directly underneath. 4. Starting the first day of your last period, count ahead the selected number of days on your calendar. This is the day you should begin testing. Circle Your Usual Cycle Length 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 4 5 6 7 8 9 9 9 9 10 10 10 12 13 14 15 16 17 18 19 Count ahead this many days STARTING WITH THE FIRST DAY of your LAST period. Note: If you 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. ASSAY PROCEDURE 1. Remove the test stick from its foil pouch by tearing at the notch and take the cap off the test stick. 2. To perform the test, turn the test stick so the absorbent tip is pointing in a downward direction and hold the test stick in your stream of urine so the urine makes contact with the absorbent area. Hold it for at least ten seconds so that adequate urine goes into the absorbent part of the tip. Do not allow urine to splash into the result window. 3. Re-cap the pregnancy test stick and lay the test stick flat on a horizontal surface with the result window facing upwards. 4. Wait for red lines to appear. The test should be read in approximately 3-10 minutes. Note: Results after 10 minutes may not be accurate.

LH Midstream Test FOR THE QUALITATIVE DETECTION OF HUMAN LUTEINIZING HORMONE (LH)

IN URINE SPECIMENS Catalog Number: 73003 For In Vitro Diagnostic Use Only

INTENDED USE The QuickProfile TM LH Midstream Test is a rapid chromatographic immunoassay for the semi-quantitative detection of human luteinizing hormone (LH) in women’s urine to predict the time of ovulation. The test is intended for healthcare professional and home use. INTRODUCTION Ovulation is the release of an egg from the ovary. The egg passes into the fallopian tube where it is ready to be fertilized. In order for pregnancy to occur, the egg must be fertilized by sperm within 24 hours after its release. Immediately prior to ovulation, the body produces a large amount of luteinizing hormone (LH). This is known as the “LH surge” and usually takes place in the middle of the menstrual cycle. LH triggers the release of an egg from the ovary. The QuickProfile TM LH Midstream Test is a complete system to help you predict the time of ovulation and peak fertility. It is during this fertile time that pregnancy is most likely to occur. The QuickProfile TM LH Midstream Test detects the LH surge in urine, signaling that ovulation is likely to occur in the next 24-36 hours. Important: The LH surge and ovulation may not occur in all cycles. PRINCIPLE The QuickProfile TM LH Midstream Test is a qualitative or semi-quantitative, two site sandwich immunoassay for the determination of human luteinizing hormone (LH) in urine specimens. The membrane was precoated with sheep anti-hLH on the test region. During the test, the specimen is allowed to react with the mouse anti-hLH monoclonal antibody-colloidal conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by the capillary action. For a positive specimen, the conjugate binds to the LH forming an antibody-antigen complex. This complex binds to the LH antibody as a capture regent on the test region and produces a colored band when LH concentration is equal to or greater than 25mIU/ml. The Rapid LH Test Card also provides a built-in process control. A colored band should always appear in the Control Region, regardless of the presence of any urinary LH. This control band serves as a reference of the color intensity of about 25mIU/ml hLH. When the intensity of the test band is equal to or stronger than that of the control/reference band, the test result is positive, indicating that the LH surge is likely in progress. STORAGE The kits should be stored at temperature 4-30°C in the sealed pouch for the duration of the shelf life. PRECAUTION

Result window

Absorbent tip

INTERPRETATION OF RESULTS

Positive: Two colored bands appear, and the color of the test band is equal to or more intense than that of the control/reference band. This result indicates and LH surge level of the tested specimen. Negative: One colored band appear in the control region, no band found in the test region, or the color of the test band is less intense than that of the control /reference band. The result indicates basal LH level of the tested specimen. Invalid: If no colored bands appear in the control region, the test result is invalid. Retest the specimen using a new test device.

1. For in vitro diagnostic use only. 2. Do not use after expiration date.

3. Test device should remain sealed until use. 4. Handle all specimens as potentially infectious. REAGENTS AND MATERIALS PROVIDED 1. QuickProfile TM LH Midstream Test 2. Instructions for use WHEN TO START TESTING 1. Determine the Length of Your Menstrual Cycle.

PERFORMANCE CHARACTERISTIC Sensitivity and Specificity:

2. Your Menstrual Cycle Length is the number of days from the first day of your period (menstrual bleeding) to the last day before your next period starts. Think back over the last few months to decide what your usual cycle length has been. 3. Circle your usual cycle length on the WHEN TO START CHART below. Select the number

The QuickProfile TM LH Midstream Test has been designed to produce a definitive color band at the test region when tested with 25 mIU/ml or higher hLH (WHO 1 st International Reference Standard for

DCR 17-028

73003

5050-MidS-T E3R1

4-28-2017

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