INTENDED USE
The One Step HCG Pregnancy Test is an immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (HCG) in urine. The test is used to obtain a visual qualitative result for auxiliary diagnosis of pregnancy. The One Step HCG Pregnancy Test is intended to be used at home for self-testing for women.
PRINCIPLE
Human chorionic gonadotropin (HCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone.
When the urine is dropped into the cassette sample well,capillary action carries the specimen to migrate along the membrane. When HCG in the sample reaches the Test area of the membrane, it will form a colored line. Absence of this colored line suggests a negative result.
To serve as a procedure control, a colored line will appear at the control area, if the test has been performed properly.
COMPONENTS
Component of the test strip in the Midstream:
Sample pad: contains buffered salts and detergents.
Label pad: contains gold-labeled HCG antibody.
Nitrocellulose membrane:
Control area: contains Goat anti-mouse IgG and buffer.
Test area: contains mouse anti-HCG antibody and buffer.
Absorbent pad: made of highly absorbent paper.
MATERIALS SUPPLIED
1. One pouch contains a midstream device and a desiccant. The desiccant is for storage purposes only and is not used in the test procedures.
2. Instructions For Use.
MATERIAL REQUIRED BUT NOT PROVIDED
1. Clock or Timer
2. Specimen collection containers.
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