hCG Pregnancy, rapid test for detection of hCG in urine or serum, test cassettes

General information about this test : The NADAL hCG Pregnancyis 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 30 NADAL hCG Pregnancy test cassettes (individually packed, incl disposable pipettes) 1 package insert Test time : 5 min Performance characteristics : The analytical detection limit of the NADAL hCG PregnancyTest is 25 mIU/mL. The NADAL hCG PregnancyTest shows no cross-reactivity with the following substances: сhLH (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 419 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 immobilised in the test line region of themembrane and anti-mouse antibodies immobilized in thecontrol 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 thespecimen, 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 propervolume of specimen has been added and membrane wickinghas occurred. Clinical significance : Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization 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.