Quality Control
Internal procedural controls are included throughout the exam. A colored band showing in the delivery space (C) is considered an inner optimistic procedural delivery, confirming a large number of samples and correct procedural technique. Exterior controls will not be equipped with these tools. It is very useful for optimistic and harmful controls to be tested as a good laboratory observation to confirm the testing process and to substantiate the adequate effectiveness of the test.
Principle of the test
Human chorionic gonadotropin (hCG) is a hormone, produced by the increased placenta shortly after conception and secreted in the urine. being pregnant examination incorporates antibodies that react markedly with this hormone. Capillary movement causes the sample to migrate along the membrane. When the hCG in the entire sample reaches the Check Zone gap on the membrane, it will show a colored line. The absence of this colored line suggests a dangerous end result. To take an administration course, a colored line will appear in the space of the administration area, if the exam has been completed accurately.
Expected use
Readability of Being Pregnant One Step Quick Verify (Cassette) is an in vitro diagnostic viewed qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. For expert use and OTC self-test.
Summary And Explanation
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced in pregnancy which is done by the rising embryo after conception and then by the syncytiotrophoblast. In common while pregnant, hCG may also be detected in the urine as early as 1-2 weeks after conception. hCG levels continue to rise over a short time, generally exceeding 100 mIU/mL at the first missed menstrual period, and peaking during the 100,000-200,000 mIU/mL differing around 10-12 weeks of pregnancy. Early pregnancy tests, in general, depending on the detection or measurement of hCG.
The readability of being pregnant One Step Quick Verify uses a combination of monoclonal and polyclonal antibodies to selectively detect elevated hCG levels in urine. Optimistic specimens react with the exact color antibody-hCG conjugate to form a colored line in the scan line space of the membrane. The absence of this colored line suggests a dangerous end result. At the claimed level of sensitivity, pregnancy readability in a rapid verification step shows no cross-reactivity interference from the structurally related glycoprotein hormones FSH, LH, and TSH in extreme physiological ranges.