Intended Use

CHECK-MATE is a one-step immuno chromatographic assay for the determination of HCG in urine.

CHECK-MATE utilises a monoclonal antibody method capable of detecting the intact molecule of HCG in urine. This test is intended for use in the diagnosis of pregnancy and is for professional use only.

Summary and Explanation

Human Chorionic Gonadotropin (HCG) is a glycoprotein normally produced by the placenta. In normal subjects, HCG in urine provides an early indication of pregnancy. However, since elevated HCG levels are also associated with trophoblastic disease and certain non-trophoblastic neoplasms the possibilities of having these diseases must be eliminated before a diagnosis of pregnancy can be made. HCG, like other glycoprotein hormones, lutenizing hormone (LH), follicle stimulating hormone (FSH) and thyroid stimulating hormone (TSH), consists of two subunits - alpha and beta. Alpha subunits of these various glycoprotein hormones are structurally very similar, but beta subunits differ in amino acid sequences. These differences are responsible for their biological and immunological specificity. The development of monoclonal antibodies to HCG provides an unlimited supply of homogenous antibodies with consistent specificity and affinity, consequently, these antibodies are ideally suited for use in immunoassays to detect HCG.

Sensitivity

CHECK-MATE urine dip-strips will detect HCG in urine with concentrations greater than 25 mIU/ml. The test has been standardized to World Health Organisation 1st IRP / 3rd IS 75 / 537.