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The Plasmatec Direct Monoclonal Latex
Pregnancy Test Kit is designed for the qualitative detection of
human chorionic gonadotrophin in urine. Human chorionic
gonadotrophin (HCG) is a glycoprotein hormone secreted by the
developing placenta beginning shortly after fertilisation. At the
time of the first missed menstrual period, HCG concentrations in
serum and urine are about 100mlU/ml and double in concentration
every 1.2 to 2 days. Peak levels of over 100,000 mlU/ml HCG are seen
late in the first trimester of pregnancy (1-4). The early appearance
of HCG in urine following conception have been made in the marker of
choice in the early detection of pregnancy.
The Plasmatec Direct Pregnancy assay is
based upon the latex agglutination reaction between latex particles
coated with anti-HCG antibodies and HCG present in the test
specimen. The presence of HCG in the urine specimen results in the
formation of an agglutination matrix which is visually
differentiated from the non-agglutinating negative control.
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