IFU.LH

Note: Results after 10 minutes may not be accurate. INTERPRETATION OF RESULTS

LH TEST CARD For the Semi-Quantitative Detection of Luteinizing Hormone (LH) in Urine Specimens Catalog Number: 73004 For In Vitro Diagnostic Use Only

INTENDED USE The QuickProfile TM LH Test Card 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 Test Card 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 Test Card 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. WHEN TO START TESTING Determine the Length of Your Menstrual Cycle. 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. Circle your usual cycle length on the WHEN TO START CHART below. Select the number directly underneath. 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 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. PRINCIPLE The QuickProfile TM LH Test Card 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 QuickProfile TM 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 stonger 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, and will be stable in the sealed pouch for the duration of the shelf life. PRECAUTION 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

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. LIMITATION 1. LH is normally detected at low levels in urine or serum of healthy men (2-15mIU/ml), or premenopausal women not during the LH serge. Prior to the test, the following charts should be referred: LH level (mIU/ml) Postmenopausal Women 10-200 premenopausal Women Basal level 5-20 Surge level 40-100 Men 2-15 2. Women suffering from polycystic ovary syndrome may have elevated LH concentration. 3. As with all other diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test. The ultimate decision should be made by the physician following evaluations of all clinical and laboratory findings.. 4. The test results should not be affected by pain relievers, antibiotics and other common drugs. Medication containing hCG or LH may affect the test and should not be taken while using the QuickProfile TM LH Test Card. In addition, the test will not work properly if you are pregnant, menopausal, or taking birth control pills. PERFORMANCE CHARACTERISTICS 1. Sensitivity and Specificity: The QuickProfile TM LH Test Card 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 human luteinizing hormone) at room temperature. During the evaluation of this test kit, the samples was test 75 times, and definitive color bands at the test region were detected and more intense than that of the reference band 100% of times. The specificity of the QuickProfile TM LH Test Card was determined through the cross reaction studies with the known amounts of hFSH, hTSH, and hCG. Samples containing 500mIU/ml hFSH or 500µIU/ml hTSH yielded color of intensity less than that of the 25mIU/ml hLH reference. 2. Accuracy: Correlation with a qualitative visual test: 70 urine specimens from 11 menstrual cycles were analyzed by QuickProfile TM LH Test Card procedure in parallel with a commercially available visual test kit. The data of LH surge of all of these cycles determined by both kits were consistent. 3. Interference Testing: The following substances were added in LH "free" (<10mIU/ml LH) and 25mIU/ml LH spiked urine. None of the substances at the concentration tested interfered with the assay. Acetamidophen 20 mg/dl Acetylsalicylic Acid 20 mg/dl Ascorbic Acid 20 mg/dl Atropine 20 mg/dl Caffeine 20 mg/dl Glucose 2 g/dl Hemoglobin 1 mg/dl REFERENCE 1. Speroff,L. et al, Clinical Gynecolooogic Endocrinology and Infertility, 3rd ed., Williams and Wilkins, Baltimore, MD, 1983. 2. France, J.T. Recent Advances in Obstetrics and Gynecology No.14, J. Bonnor, ed., Churchill Livingstone, New York, NY, 1982, pp 215-239. 3. Batzer, F. R.: Fertility & Sterility, 1980, 34:1. 4. Engvall, E.: Method in Enzymology, 1980, 70:419. 5. Winter G, Griffiths AD, Hawkins RE, et al. Making antibodies by phage display technology. Annu Rev Immunol, 1994, 12:433-455.

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 Test Card. 2. Instructions for use MATERIAL REQUIRED BUT NOT PROVIDED 1. Urine collection container. 2. Timer or clock. SPECIMENS COLLECTION 1.

Determine the time you will collect your urine. For best results, collect your urine at about the same time each day, for example, between 10:00AM and 8:00PM. Some women have found that their best specimen is after 12 noon. Do not collect your first urine after waking up. 2. Reduce your liquid intake approximately 2 hours prior to urine collection. 3. The urine can be stored at room temperature for up to 8 hours or in the refrigerator for up to 24 hours. Do not freeze. If specimen was refrigerated, it must be equilibrated to room temperature before testing. ASSAY PROCEDURE 1. Bring all materials and specimens to room temperature. 2. Remove the test card from the sealed foil pouch. 3. Label the test card with specimen identity on the “ID ____ “ area of the cassette. 4. Place the test card on a flat horizontal surface. 5. Using the transfer pipet to draw up the sample. 6. Hold the transfer pipet in a vertical position over the sample well and dispense 3 drops of urine to the sample well. 7. Read the result between 3 and 10 minutes after adding the sample.

Emergo Europe Prinsessegracht 20 2514 AP The Hague, The Netherlands

LumiQuick Diagnostics, Inc. 2946 Scott Blvd. Santa Clara, CA 95054 USA Tel : (408) 855.0061 Fax: (408) 855.0063 Email: info@lumiquick.com www.lumiquick.com

DCR 17-028 5050-TC E3R1

73004

4-28-2017

Page 1 of 1

08707 / 180727

Made with FlippingBook flipbook maker