NADAL hLH ovulation, rapid test for detection of hLH in urine, test cassettes

General information about this test : The NADAL hLH Ovulation Test is a rapid immunoassay for semiquantitative detection of luteinizing hormone in human urine for evaluation of the onset of ovulation. The NADAL hLH Ovulation Test is intended for professional use only. Reagents and material supplied: 30 NADAL hLH Ovulation test cassettes (incl. disposable pipettes) 1 package insert Test time : 5 min Performance characteristics : The analytical detection limit of the NADAL hLH Ovulation Test is 30 mIU/mL. The NADAL hLH Ovulation Test shows no cross-reactivity with the following substances: hCG (200 mIU/ml), hFSH (200 mIU/ml) and hTSH (200 mIU/ml). The sensitivity and specificity of the NADAL hLH Ovulation Test were determined by comparing the results for 200 samples to those of another commercially available assay - Abbott AxSYM. Sensitivity: 98.3% Specificity: 99.3% Overall agreement: 99.0% The following substances do not interfere with the performance of the NADAL hLH Ovulation Test: Acetaminophen (20 mg/dL), Acetylsalicylic acid (20 mg/dL), Ascorbic acid (20 mg/dL), Ethanol (1%), Caffeine (20 mg/dL), Gentisic acid (20 mg/dL), Glucose (2 g/dL), Haemoglobin (1 mg/dL), Albumin (2 g/dL), Ephedrine (20 mg/dL). Test principles : The NADAL hLH Ovulation Test is designed for semiquantitative detection of human luteinizing hormone (hLH) in urine samples. The test utilizes аnti-hLHantibodies immobilized in the test line region of the membrane and anti-mouse antibodies immobilized in the control line region. During testing the hLH, present in the specimen binds to anti-LH antibodies conjugated to colored particles. Further the so formed complex moves along the test membrane and reacts with reagents immobilized to it resulting in colored line in the test line (T) region of the strip. If the test line region is equally or more intensively colored than the control (C) line region, this is an indication of a positive result. If the coloration in the T region is lacking or less intensive than that of the control line, the result is negative. A colored line should always appear in the control line region. It serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. Clinical significance : Even though a woman’s body always produces a small amount of human luteinizing hormone (hLH), there is a sudden increase of this hormone concentration in the middle of the menstrual cycle. This increase of the hLH level, called the hLH surge, promotes the release of a mature ovum from the ovaries (ovulation). For most women, ovulation will occur within 24-36 hours after the peak of the hLH surge. Immediately after ovulation, the ovum is capable of being fertilised for a short time (approx. 12 hours). The fertile days of the menstrual cycle start after the hLH surge.