[Servatest-ELISA hCG Mirco I. Immunoenzymatic kit for the detection and qualitative determination of human chorionic gonadotropin (hCG). Confirmation of the reliability of the test for the routine determination of pregnancy]

The Central Laboratory at the Prague Institute for Maternal and Child Care uses the Sevatest-ELISA HCG Micro I immunoenzymatic kit for routine diagnosis of pregnancy. This modern pregnancy test is based on the detection and quantitative determination of human chorionic gonadotropin (HCG) in urine using the immunoenzymatic preparation Sevatest. This preparation was developed and is produced in Czechoslovakia. The Laboratory performed 1164 routine urine tests over 5 years which yielded 642 negative 504 positive and 18 of what are referred to as plus-or-minus results. Reliability of the test in routine pregnancy diagnosis was 99.5%. Its sensitivity was 6 times higher than that of commercially available hemo- and latex-agglutination tests. The selectivity of determining HCG by the ELISA method is more than sufficient for routine diagnosis of pregnancy. Research continues at the Prague Institute of Serums and Vaccines aimed at further improvements and modifications of the test. The ongoing research program focuses on the development of high quality immunoenzymatic reagents and monoclonal antibodies.