NADAL hCG Pregnancy

General information about this test: The NADAL hCG Pregnancy is a rapid immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum for early detection of pregnancy. The NADAL hCG Pregnancy Test is intended for professional use only. Reagents and material supplied: 50 NADAL hCG Pregnancy test strips (individually packed) 1 package insert Test time : 5 min Performance characteristics : The analytical detection limit of the NADAL hCG Pregnancy Test is 25 mIU/mL. The NADAL hCG PregnancyTest shows no cross-reactivity with the following substances: hLH (300 mLU/ml), hFSH (1000 mLU/ml) and hTSH (1 mLU/ml). The sensitivity and specificity of the NADAL hCG PregnancyTest were determined by comparing the results for 308 samples to those of another commercially available assay. Sensitivity: 99.9% Specificity: 99.9% Overall agreement: 99.9% The following substances do not interfere with the performance of the NADAL hCG PregnancyTest: Acetaminophen (0.2 mg/ml), Acetylsalicylic acid (0.2 mg/ml), Ascorbic acid (0.2 mg/ml), Atropine (0.2 mg/ml), Bilirubin (0.2 mg/ml), EDTA (0.2 mg/ml), Ethanol (1.0%), Caffeine (0.2 mg/ml), Gentisic acid (0.2 mg/ml), Glucose (20 mg/ml), Haemoglobin (10 μg/ml), Urea (20 mg/ml), Uric acid (0.2 mg/ml), Creatinine( 0.2 mg/ml), Oxalic acid (0.4 mg/ml), THC (0.1 mg/ml). Test principles : The NADAL hCG Pregnancy Test is designed for qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum samples. The test utilizes аnti-hCGantibodies immobilized in the test line region of the membrane and anti-mouse antibodies immobilized in the control line region. During testing the hCG, present in the specimen binds to anti-hCG antibodies conjugated to colored particles. Further the so formed complex moves along the test membrane and reacts with reagents immobilized to it. If there is sufficient hCG in the specimen, a colored line will appear in the test line (T) region of the strip, indicating positive result 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 : Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilisation and can already be detected in the early stage of pregnancy (In normal pregnancies, hCG can be detected in both serum and urine as early as 7 days after conception) in urine and serum. The hCG level continues to rise very rapidly, frequently exceeding 50 mIU/ml by the first missed menstrual period, and culminates in the 10th-12th weeks of pregnancy in the range of 30,000- 290,000 mIU/ml. The early appearance of hCG in urine and blood soon after conception and its subsequent rapid rise in concentration makes it an ideal marker for the early detection of pregnancy. Elevated hCG levels, comparable to the early stages of pregnancy may be associated with a hydatidiform mole or choriocarcinoma. For this reason, these possibilities should be ruled out before a pregnancy is diagnosed.