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MEDICAL ASSISTANCE PREGNANCY TEST Description Rapid immunochromatographic test for the qualitative detection of human chorionic gonadotropin in urine, to facilitate early diagnosis of pregnancy. It is a rapid, one-step, mid-course lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to facilitate early pregnancy detection. The test uses a combination of antibodies, including a monoclonal hCG antibody, to selectively detect high levels of hCG. The test is performed by adding urine to the hydrophilic dipstick and obtaining the result in the form of colored lines. How to use Sample collection and preparation 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 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 samples can be stored at 2-8°C for up to 48 hours prior to testing. For extended storage, samples can be frozen and stored at temperatures below -20°C. Frozen samples should be thawed and mixed before analysis. Running the test Before proceeding with the analysis, allow the test and sample to reach room temperature (15-30°C). Remove the urine stream from the foil pouch and test immediately or within one hour. Remove the urine stream cap, insert the absorbent tip into the urine stream or immerse the absorbent tip (≥2/3) in urine in a clean container for at least 15 seconds. Do not urinate into the result display window. Replace the cap on the middle of the test jet, then place the middle jet on a clean, stable desk and immediately start the timer. Read the result after 3 minutes; do not interpret the result after 10 minutes. Reading the results POSITIVE: Two colored lines appear. One line should be in the control line region (C) and the other in the test line region (T). One line may be lighter in color than the other; it does not have to be the same intensity. This result indicates the likelihood of pregnancy. NEGATIVE: A colored line appears in the control region (C). No line appears in the test line region (T). This result indicates the likelihood of not being pregnant. INVALID: The result is invalid if no colored line appears in the control line region (C), even if a line appears in the test line region (T). You must repeat the test with a new test strip. warnings Please read all the information in this leaflet before performing the test. For in vitro diagnostic use only. Do not administer internally. Do not use after the expiration date printed on the foil pouch. Do not use if the casing is broken or damaged. Keep out of reach of children. Do not open the foil pouch for the test until you are ready to begin testing. The used test should be disposed of according to local regulations. There is a possibility that this intermediate test may produce false results. Please consult your doctor before making any medical decisions. Medications containing hCG (such as Pregnyl, Profasi, Pergonal, APL) may cause a false positive result. Alcohol, oral contraceptives, painkillers, antibiotics, or hormone therapies that do not contain hCG do not affect the test result. Highly diluted urine samples, indicated by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a morning urine sample is collected after 48 hours and sent for testing. Very low levels of hCG (less than 50 mIU/ml) are present in urine samples shortly after implantation. However, because a significant number of pregnancies end naturally in the first trimester, a weak positive test result should be confirmed by retesting with a 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. This test may produce false negative results. False negative results may occur when hCG levels are below the sensitivity of the test. If you still suspect pregnancy, collect a first-day urine sample after 48 hours and send it for testing. If you suspect pregnancy and the test continues to produce negative results, consult a doctor for further diagnosis. This test provides a presumptive diagnosis of pregnancy. A confirmed diagnosis of pregnancy should only be made by a physician after evaluating all clinical and laboratory results. Conservation Store in the original packaging at room temperature or in a refrigerator (2-30°C). Do not freeze. The test is stable until the expiration date printed on the sealed pouch. The test should remain in the sealed pouch until use. Do not use after the expiration date. Shelf life with intact packaging: 36 months. Format The kit contains: - mid-process testing; - the prospectus. Bibliography 1. Steier JA, Bergsjo P, Myking OL Human chorionic gonadotropin in maternal plasma after induced abortion, spontaneous abortion and removal of ectopic pregnancy, Obstet. Gynecol.1984; 64(3): 391-394 2. Dawood MY, Saxena BB, Landesman R Human chorionic gonadotropin and its subunits, indatiform moles and choriocarcinoma, Obstet. Gynecol.1977;50(2):172-181 3. Braunstein GD, JL Vaitukaitis, PP Carbon, GT Ross Ectopic production of human chorionic gonadotropin by neoplasms, Ann.Intern Med.1973; 78(1): 39-45 Code MM-FHC-U103H
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