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The UniMark® Home Pregnancy Test Device is intended for the qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy. UniMark® Home Pregnancy Test Device (provided as a test strip contained within a plastic test strip holding cassette) is for the rapid and qualitative determination of humane Chorionic Gonadotropin (hCG) in urine. It is intended for consumer use at home. It is indicated for use in the early detection of pregnancy.

The UniMark® Home Pregnancy Test Device is a colored solid-phase Chromatographic Immunoassay (CIA) for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is a home use, rapid, visual, one step pregnancy screening test. Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone synthesized by the placenta and released in blood and urine soon after the implantation of a fertilized ovum in the chorionic tissue. HCG is the principal signal and specific marker of the pregnancy. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies conjugated to colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat anti-hCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates the presence of an hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.

UniMark® hCG Combo Pregnancy Test (provided either as an individual test strip or as a test strip contained within a plastic test strip holding device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only. It is indicated for use in the early detection of pregnancy.

UniMark® hCG Combo Pregnancy Test is a chromatographic immunoassay (CIA) for qualitative detection of elevated levels of hCG in serum and urine specimens for the early pregnancy diagnosis. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies coated on colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat antihCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negtive result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.

The UniMark™ Midstream Pregnancy Test Stick is intended for the qualitative measurement of human chorionic gonadotropin (hCG) in urine as a home use screening test for pregnancy.

The UniMark™ Midstream Pregnancy Test Stick is a home use, rapid, visual, one step screening test for pregnancy. UniMark™ is a colored solid-phase immunoassay for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is based on a two-site sandwich immunometric assay which utilizes a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG with a high degree of sensitivity. UniMark™ contains a strip with a sample pad and a membrane area. The former contains mouse anti-hCG monoclonal antibody conjugated with colloid gold. The latter is coated with goat anti-mouse IgG at the control zone and goat anti-hCG antibody at the test zone. During the test, the urine is sucked up through sample pad by capillary action, and hCG in the urine sample binds to the gold conjugate, moving chromatographically toward the membrane. The immobilized goat anti-hCG antibody at the test zone catches the resulting complexes, forming an antibody-hCG-gold conjugate complex. The appearance of a purple band in the test window resulted from the complex shows a positive result, which indicates presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the urine sample. The appearing of a purple band in the control window demonstrates proper performance and validity of the reactive reagent.