9 SCREEN MOTHERS TEST PREGNANCY TEST ultra-sensitive Description The hCG Rapid Pregnancy Test is a rapid, lateral flow, mid-flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the diagnosis of pregnancy. The test uses a combination of antibodies, including monoclonal hCG, to selectively detect high levels of hCG. The test is performed by pouring urine onto the hydrophilic stick and obtaining the result based on the colored lines. Precautions Please read all information before taking the test. 1. Do not use after the expiration date printed on the sealed package. 2. Store in a dry place between 2 and 30°C or 35.6 and 86°F. Do not freeze. 3. Do not use if the packaging is open or damaged. 4. Keep out of reach of children. 5. For in vitro diagnostic use only. Not intended for internal use. 6. Do not open the sealed test package until you are ready to perform the test. 7. The used test should be disposed of in accordance with local regulations. How to use 1. Remove the test from the sealed pouch and perform the test immediately within one hour. 2. Remove the test cap, then urinate directly on it or insert it into a urine sample collected in a clean container for at least 15 seconds. 3. Replace the lid on the test, then place everything on a clean, flat surface and immediately start the timer. 4. Wait 3 minutes to read the result; do not wait longer than 10 minutes. Reading the results POSITIVE: Two distinct colored lines appear. One should be in the control region (C) and the other in the test region (T). One line may be fainter than the other; the two lines should not match. This means you are probably pregnant. NEGATIVE: One line appears in the control region (C). No line appears in the test region (T). This means you are probably not pregnant. NULL: The result is invalid if no line appears in the control region (C), even if a faint line appears in the test region (T). The test should be repeated with a new device. limitation There is a possibility that this intermediate test may produce false results. Please consult your doctor before making any medical decisions. 1. Medications containing hCG (such as Pregnyl, Profasi, Pergonal, APL) may produce a false positive result. Alcohol, oral contraceptives, painkillers, antibiotics or hormone therapies that do not contain hCG should not affect the test. 2. Highly diluted urine samples, indicated by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a new early morning urine sample should be collected after 48 hours and tested. 3. Very low levels of hCG (less than 50 mlU/ml) are present in urine samples collected immediately after fertilization. However, because a large number of pregnancies end in the first trimester due to natural causes, a weak positive test result should be reconfirmed by testing a new urine sample collected early in the morning, 48 hours later. 4. This test may produce false positive results. A number of conditions other than pregnancy, including gestational trophoblastic disease and some non-trophoblastic neoplasms, including testicular, prostate, breast, and lung cancers, cause elevated hCG levels. 2,3 Therefore, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions have been ruled out. 5. This test may produce false negative results. False negative results may occur when hCG levels are below the sensitivity of the test. If pregnancy is still suspected, a new urine sample should be collected early in the morning after 48 hours for testing. If pregnancy is suspected but the test continues to produce negative results, consult a doctor for further diagnosis. 6. This test provides a presumptive diagnosis of pregnancy. A confirmatory diagnosis should only be made by a physician, after evaluating all clinical and laboratory tests. Format Box containing 2 pieces. BIBLIOGRAPHY 1. Steier JA, Bergsjo P, Myking OL Human chorionic gonadotropin in maternal plasma after induced abortion, spontaneous abortion and distant ectopic pregnancy, Obstet. Gynecol.1984; 64(3): 391-394 2. Dawood MY, Saxena BB, Landesman R Human chorionic gonadotropin and its subunits in hydatidiform mole and choriocarcinoma, Obstet. Gynecol. 1977; 50(2): 172-181 3. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross Ectopic production of human chorionic gonadotropin by neoplasms, Ann. Intern Med. 1973; 78(1): 39-45