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SoFarma PREGNANCY TEST Description Rapid immunochromatographic test for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for early detection of pregnancy. The test uses a combination of antibodies, including the hCG monoclonal antibody, to selectively detect high levels of hCG. The test is performed by pouring urine onto the hydrophilic stick and interpreting the result based on the colored lines that appear. How to use Sample collection and preparation The urine sample should be collected in a clean, dry container. A first-morning urine sample is preferable as it generally contains the highest concentration of hCG. However, urine samples collected at any time of day can be used. Urine samples containing visible particles should be centrifuged, filtered, or allowed to settle to obtain a clear sample for analysis. If testing is not possible immediately, urine specimens may be stored at 2-8°C for up to 48 hours prior to analysis. For extended storage, specimens may be frozen and stored below -20°C. Frozen specimens must be thawed and mixed prior to analysis. Testing procedure Before proceeding with the analysis, allow the test and sample to reach room temperature (15-30°C). Remove the test from the foil pouch and use within one hour. Remove the cap from the test. Hold the swab by the handle, placing the absorbent end under the urine stream or immersing it (≥2/3) in urine collected in a clean container for at least 15 seconds. Do not urinate into the result window. Cover the stick with the lid, then leave it on a flat, clean surface. Start the timer immediately. Read the result after 3 minutes; do not interpret after 10 minutes. Interpretation of results POSITIVE: Two colored lines appear, the control line (C) and the test line (T). One line may be lighter in color than the other; they do not necessarily have to be the same. This indicates that you are probably pregnant. NEGATIVE: Control line (C) appears. Test line (T) does not appear. This indicates that you are probably not pregnant. INVALID: The control line does not appear, therefore the result should be considered invalid even if the test line (T) appears. Repeat the test with a new test stick. warnings For in vitro diagnostic use. For external use only. Before performing the test, read all the information in the package insert. Keep out of reach of children. Do not use if the pouch is torn or damaged. Do not open the stick until you are ready to start testing. The used swab should be disposed of in accordance with local regulations. Do not use after the expiration date printed on the foil pouch. The test may produce incorrect results. Consult your doctor before making any medical decisions. Medications containing hCG (such as Pregnyl, Profasi, Pergonal, APL) may produce false positive results. Alcohol, oral contraceptives, painkillers, or hormone therapies that do not contain hCG should not interfere with the results. Highly diluted urine samples, characterized by low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a new morning urine sample should be collected and tested 48 hours later. Immediately after fertilization, hCG levels in urine samples are very low (less than 50 mIU/ml). However, because a significant number of first-trimester pregnancies end naturally, a weak positive result should be confirmed with a second test performed on a first-morning urine sample collected 48 hours later. This test may produce false positive results. A number of conditions other than pregnancy, including trophoblastic disease and some non-trophoblastic malignancies, including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated hCG levels. Therefore, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions have been ruled out. The 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 morning urine sample should be collected and tested 48 hours later. If pregnancy is suspected but the test continues to produce negative results, consult a doctor for further diagnosis. The test provides a presumptive diagnosis of pregnancy. A confirmatory diagnosis should only be made by a doctor after evaluating all clinical laboratory tests. Conservation Store in the original packaging at room temperature or in a refrigerator (2-30°C). Do not freeze. Shelf life in intact packaging: 24 months. Format The kit contains: - stick test; - the prospectus. Code SF003
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