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Clinical Application of High Accuracy hCG Pregnancy Rapid Test Cassette (Urine) in Gynecology

Zhang Lei*, Yang Feng and Zhu Junzhe

Background: Human chorionic gonadotropin (hCG) is a glycoprotein hormone that is essential for the maintenance of pregnancy.Glycosylation of hCG is known to be essential for its biological activity. “Hyperglycosylated” variants secreted during early pregnancy have been proposed to be involved in initial implantation of the embryo and as a potential diagnostic marker for gestational diseases [1]. Therefore, the hCG Pregnancy Rapid Test Cassette (Urine) can detect the gestational diseases during early pregnancy which plays an important role in gynaecology.

Human chorionic gonadotropin (hCG) is an essential pregnancy-associated glycoprotein that is a member of the same family that includes luteinizing hormone, follicle stimulating hormone and thyroid stimulating hormone. Each member is a heterodimer consisting of shared α-subunits in non-covalent association with distinct β-subunits that confer their specific physiological activities. Pregnancy associated hCG is mainly secreted by the syncytiotrophoblast (ST) associated with the embryo and is excreted in urine.

hCG levels in maternal blood increase progressively during early pregnancy, reaching maximal levels between the 8-11th week of gestation. Thereafter, the level of hCG declines until around twenty weeks and then remains comparatively low for the remainder of the pregnancy. The functional roles of hCG throughout pregnancy have been extensively studied and are thought to be necessary for the maintenance of pregnancy by mediating multiple placental, uterine and fetal functions. hCG may play a part in implantation through its receptors on the endometrium and is thought to aid smooth muscle relaxation, maintain quiescence of the myometrium in pregnancy and promote myometrial vasodilatation. hCG induces relaxin secretion by the corpus luteum during the luteal phase and in early pregnancy. Both relaxin and progesterone play an important role in the maintenance of early pregnancy. hCG may also contribute to maternal immune tolerance but as pregnancy progresses into the second and third trimester, the role of this hormone becomes less apparent. hCG is also expressed in several trophoblastic diseases and is often used as a sensitive biomarker for malignancy.This hormone is expressed in both gonadal and non-gonadal tumors.

Objective: The main purpose of this evaluation report was to explore the reliability and performance of the Citest hCG pregnancy Rapid Test Cassette for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.

Method:Run a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine.

Result: The results show that the overall relative sensitivity for the detection of the Citest hCG Pregnancy Rapid Test Cassette (Urine) is >99.9% (98.7%~100%), the relative specificity is >99.9% (99.2%~100%), and the relative accuracy is >99.9% (99.5%~100%).

Conclusion: The Citest hCG Pregnancy Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.

The product is simple to operate, and results can be read within 3 minutes of the sample being tested. A comparison of 608 samples showed an accuracy of 99.9% and an excellent specificity of 99.9%. Women can use this test kit to obtain accurate results and to determine whether they are pregnant or not in an early time.


hCG; Early Pregnancy; Rapid Test

Published Date: 2022-12-28; Received Date: 2022-11-30