The development and evaluation of Sevatest ELISA hCG Micro I. kit as a test for pregnancy

The enzyme-linked immunosorbent assay (ELISA) method of sandwich type for determination of human chorionic gonadotropin (hCG) in serum or urine using horseradish peroxidase as an enzyme label and microtiter ELISA plates (or polystyrene microtubes respectively) as a solid phase support for antibody was developed. Test sensitivity of 200 mIU hCG per milliliter is approximately sixfold greater than the available hemo- or latex agglutination tests; quantitative hCG ELISA method has sensitivity of 6 mIU hCG per milliliter. In order to evaluate the usefulness of the method for early pregnancy detection 5,000 urine samples were prospectively collected and results correlated with outcome of pregnancy. Reliability of the test performed on routine basis at the Institute for the Care of Mother and Child in Prague proved to be 97.2% for intrauterine pregnancy detection, in 2.52% the test result was "+ -", and only in 0.28% the results were erroneous. For samples sent with the diagnosis of suspected extrauterine pregnancy 93.5% of correct results, 4.35% of "+ -" and 2.17% of erroneous results was found.