IFU.LH

PERFORMANCE CHARACTERISTIC Sensitivity and Specificity:

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 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 Midstream Test was determined through the cross reaction studies with the known amounts of hFSH, hTSH, and hCG. Samples containing 500mIU/ml hFSH or 500┬ÁIU/ml hTSH yielded color of intensity less than that of the 25mIU/ml hLH reference. Accuracy: Correlation with a qualitative visual test: 70 urine specimens from 11 menstrual cycles were analyzed by QuickProfile TM LH Midstream Test 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. 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 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 Midstream Test. In addition, the test will not work properly if you are pregnant, menopausal, or taking birth control pills. Glucose 2 g/dl Hemoglobin 1 mg/dl LIMITATION

Emergo Europe Molenstraat 152513 BH 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

REFERENCE 1. Cart, K. J.: J. Clin. Endocrinol.Metab., 1975, 40:537 2. Brauntein, G. D.: Am. J. Obstet. Gynecol., 1976, 126:678 3. Batzer, F. R.: Fertility & Sterility, 1980, 34:1

4. Engvall, E.: Method in Enzymology, 1980, 70:419 5. Wilcox, A. J.: N.England J. Med., 1988, 319:189 6. Dawood, M. Y.: Ob. Gyn., 1990, 126:678 7. Winter G, Griffiths AD, Hawkins RE, et al. Making antibodies by phage display technology. Annu Rev Immunol, 1994, 12:433-455.

DCR 13-050

73003

5050-MidS-T E3R0

10-07-2013

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