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icon Technician Test PREGNANCY TEST Description The Midstream HCG Rapid Pregnancy Test (Urine) is a rapid, lateral flow, one-step, midstream format immunochromatographic assay for the qualitative determination of human chorionic gonadotropin (hCG) to selectively detect elevated levels of hCG. The test utilizes a combination of antibodies, including a monoclonal hCG antibody, to selectively detect elevated levels of hCG. The test is performed by applying urine to the test strip and checking the result based on the colored lines. The test contains anti-hCG and anti-hCG particles deposited on the membrane. How to use The urine sample should be collected in a clean, dry container. A first-morning urine sample is preferred as this generally contains the highest concentration of hCG; however, urine samples collected at any time of day may be used. Urine samples with visible particles should be centrifuged, filtered, or allowed to settle to obtain a clear sample for analysis. If the urine specimen cannot be collected immediately, it should be stored at 2-8°C for up to 48 hours prior to testing. For extended storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed prior to testing. 1. Remove the test from the pouch and perform the test within one hour. 2. Remove the cap from the stick; hold and position the stick so that the absorbent tip is wet with the urine stream or urinate into a clean container and insert the absorbent tip (= 2/3) into the collected urine for at least 15 seconds. 3. Reattach the cap to the test; place the test flat on a clean, stable surface and immediately start the timer. 4. Read the first result at 3 minutes; but do not interpret results after 10 minutes have passed. POSITIVE: Two distinct lines appear. One line in the test control window (C) and another in the test window (T). One line may be lighter than the other; they dont necessarily have to be the same. This indicates that you are most likely pregnant. NEGATIVE: A colored line appears in the control window (C). No line appears in the test window (T). This indicates that you are most likely not pregnant. INVALID: The result is considered invalid if no line appears in the control window (C), even if a line appears in the test window (T). The test must be repeated with another test during the process. warnings Please read the information in this guide carefully before performing the test. - Do not use after the expiry date stated on the sachet. - Do not freeze. - Do not use if the pouch is open or damaged. - Keep out of reach of children. - For in vitro diagnostic use only. Not intended for internal use. - Do not open the foil pouch until you are ready to perform the test. - The used mid-course test must be disposed of according to local regulations. The test may produce unreliable results. Consult a doctor before making any health-related decisions. 1. Medications containing hCG (such as Pregnyl, Profasi, Pergonal, APL) may produce false positive results. Alcohol, oral contraceptives, painkillers, antibiotics, or non-hCG hormone therapies are not expected to affect the test result. 2. Highly diluted urine samples (indicated by low specific gravity) may not contain sufficient levels of hCG. If pregnancy is still suspected, a first morning urine sample is collected after 48 hours and the test is performed. 3. Very low levels of hCG (less than 50 mIU/ml) are present in urine samples immediately after implantation. However, given the high number of pregnancies that end naturally in the first trimester, weak positive results should be confirmed by repeating the test after 48 hours, using a first morning urine sample. 4. The test may produce false positive results. Several conditions other than pregnancy can cause elevated hCG levels (including trophoblastic disease and some non-trophoblastic malignancies such as breast cancer and lung cancer).2,3 Therefore, the presence of hCG in urine should not be considered useful in diagnosing pregnancy unless these conditions have been ruled out. 5. The test may produce false negative results. False negative results may occur if hCG levels are below the sensitivity threshold of the test. If you still suspect pregnancy, you will need to collect a urine sample in the morning after 48 hours and perform the test. If you suspect pregnancy but the test continues to produce negative results, please consult a doctor to confirm the diagnosis. 6. The test only provides a presumptive diagnosis of pregnancy. The actual diagnosis of pregnancy must be made by a doctor after evaluating all clinical and laboratory test results. Conservation Store in a dry place, at a temperature between 2-30°C. Shelf life in intact packaging: 36 months. Format Package containing: - Mid-process testing; - methodical. Code 7541151
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